THE SUPREME COURT OF APPEAL OF SOUTH AFRICA
JUDGMENT
Reportable
Case no: 294/2025
In the matter between:
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA FIRST APPELLANT
ASTELLAS PHARMA EUROPE LTD SECOND APPELLANT
ASTELLAS PHARMA INC THIRD APPELLANT
ASTELLAS PHARMA (PTY) LTD FOURTH APPELLANT
and
EUROLAB (PTY) LTD FIRST RESPONDENT
DIS-CHEM ONCOLOGY (PTY) LTD SECOND RESPONDENT
DIS-CHEM ONCOLOGY DISTRIBUTION (PTY) LTD THIRD RESPONDENT
DIS-CHEM PHARMACIES (PTY) LTD FOURTH RESPONDENT
Neutral citation: The Regents of the University of California & Others v Eurolab (Pty)
Ltd & Others (294/2025) [2026] ZASCA 30 (17 March 2026)
Coram: MOLEMELA P, SMITH and BAARTMAN JJA
Judgments: Smith JA: [majority] [1] to [124]
Molemela P: [concurrence] [125] to [145]
Baartman JA: [minority] [146] to [179]
Heard: 8 September 2025
Delivered: 17 March 2026
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Summary: Patent Law – application for revocation in terms of s 61 of the Patents Act
57 of 1978 (the Act) – whether entitlement to apply for a patent must exist at time of filing
a patent application or when revocation application is brought – application under s 70 of
the Act for interdict to prevent groundless threats of patent infringement litigation –
whether the invention is obvious – interim interdict prohibiting infringement of the patent
– relevance of public interest considerations.
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ORDER
On appeal from: Court of the Commissioner of Patents, Pretoria (Le Grange AJ sitting
as the Commissioner of Patents):
1 The appeal is upheld with costs, including the costs occasioned by the employment of
two counsel.
2 The order of the Court of the Commissioner of Patents is set aside and replaced with
the following:
‘(a) The application by the first respondent, Eurolab (Pty) Ltd, brought under the
provisions of s 70 of the Patents Act 57 of 1978, is dismissed with costs on Scale
C, including the costs occasioned by the employment of two counsel where so
employed, and the qualifying fees for the expert witnesses representing the
applicants (the Regents of the University of California; Astellas Pharma Europe
Ltd; Astellas Pharma Inc and Astellas Pharma (Pty) Ltd, respectively).
(b) The counter-application for revocation of patent no 2007/10870 instituted by the
second to fourth respondents (Dis-Chem Oncology (Pty) Ltd; Dis-Chem Oncology
Distribution (Pty) Ltd; and Dis -Chem Pharmacies (Pty) Ltd, respectively) is
dismissed with costs on Scale C, including the costs of two counsel where so
employed, and the qualifying fees of the applicants’ expert witnesses.
(c) The application for interim relief instituted by the applicants is dismissed. Each
party shall pay its own costs.’
JUDGMENT
Smith JA (Molemela P concurring)
Introduction
[1] This is an appeal against the decision of the Court of the Commissioner of Patents
(the Commissioner) revoking patent 2007/10870 (the patent) on the ground that the first
appellant, the Regents of the University of California (UC) , was not a person entitled to
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apply for the patent in terms of s 61(1) (a),1 read with s 27 (1)2 of the Patents Act 57 of
1978 (the Act). The patent claims a novel hormone treatment therapy, Xtandi, used for
treating prostate cancer. The appeal is with the leave of the Commissioner.
[2] UC is the registered owner of the patent , and the second to fourth appellants,
Astellas Pharma Europe Ltd, Astellas Pharma Inc., and Astellas Pharma (Pty) Ltd
(Astellas), are licensees. For convenience and where the context so requires, I also refer
to the appellants collectively as UC.
[3] The first respondent, Eurolab (Pty) Ltd (Eurolab), is a generic oncology company
and holds a generic registration with the South African Health Products Regulatory
Authority for a product named Enzutrix. This product was introduced in South Africa and
is distributed by the second, third, and fourth respondents: Dis-Chem Oncology (Pty) Ltd,
Dis-Chem Oncology Distribution (Pty) Ltd, and Dis -Chem Pharmacies (Pty) Ltd,
respectively. Where appropriate, these parties are referre d to collectively as ‘the
respondents’, and the Dis-Chem companies as ‘Dis-Chem’.
[4] The following three related applications served before the Commissioner:
(a) Eurolab’s application for an interdict to prevent UC from making groundless threats
of patent infringement litigation;
(b) UC’s application for an interim order to prohibit Eurolab and Dis -Chem from
making, importing, or selling Enzutrix, a generic of Xtandi; and
(c) A counterapplication filed by Dis-Chem to revoke the patent under s 61 of the Act.
[5] The Commissioner determined that, under s 27(1) of the Act, an applicant for a
patent must acquire rights to the invention from the inventor before submitting the
1 Section 61(1)(a) reads as follows:
‘Grounds for application for revocation of patent
(1) Any person may at any time apply in the prescribed manner for the revocation of a patent on any of the
following grounds only, namely-
following grounds only, namely-
(a) that the patentee is not a person entitled under section 27 to apply for the patent .’
2 Section 27(1) reads as follows:
‘Who may apply for a patent
(1) An application for a patent in respect of an invention may be made by the inventor or by any other
person acquiring from him the right to apply or by both such inventor and such other person. ’
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application. Crucially, in accordance with that finding, the relevant time for assessing
whether an applicant is entitled to apply for a patent is the date on which the patent
application is filed, not the date of any later revocation proceedings. The Commissioner
found that UC had not secured assignments from all inventors prior to the filing of the
patent application. Consequently, UC was deemed not to have met the entitlement
requirement at the critical time. Therefore, the Commissioner dismissed UC’s request for
interim relief and granted the applications brought by Eurolab and Dis-Chem.
[6] The Commissioner’s decision was limited to the interpretation of s 61(1)(a) of the
Act, without consideration of other matters raised during the proceedings. Before this
Court, Eurolab submitted that th e Court should confine its adjudication to issues
previously determined by the Commissioner, leaving all other questions for future
consideration. Conversely, UC proposed that all outstanding issues be resolved in the
present hearing, emphasi sing the importance of avoiding extended litigation and
unnecessary delays. Given the imminent expiration of the patent, this Court determined
that a comprehensive and timely resolution of all issues was required in the interests of
justice.
The facts
[7] The material facts can be briefly summarised as follows. Xtandi, the
pharmaceutical compound central to the patent, utilises enzalutamide as its active
pharmaceutical ingredient (API). The invention resulted from a collaboration between UC
and the Howard Hughes Medical Institute (HHMI). Of the eight inventors, five were
employed by UC (the UC inventors) and three by HHMI (the HHMI inventors). The patent
application was filed on 29 March 2006 and will expire on 29 March 2026.
[8] Upon commencing employment with UC, each of the five inventors employed by it
executed patent acknowledgments. Through these acknowledgments, the inventors
executed patent acknowledgments. Through these acknowledgments, the inventors
agreed to assign to UC all rights in any inventions they created during their employment.
UC subsequently secured formal assignments from these inventors at two key intervals.
First, in July and August 2005, the inventors assigned their rights pertaining to the USA
priority patent application to UC . Second, in May and June 2006, assignments were
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obtained in respect of priority applications P2 and P3, as well as the Patent Cooperation
Treaty (PCT) application corresponding to the patent.3
[9] HHMI and UC concluded a Collaboration Agreement in 1 986 (the 1986
Collaboration Agreement) in terms whereof HHMI, inter alia, granted UC the right to take
assignment of any inventions made by its employees pursuant to a program of research
funded wholly or partially by UC. It is common cause that the patent was such an
invention. The three remaining inventors, namely Mr Charles Sawyers (Mr Sawyers), Mr
Chris Tran (Mr Tran), and Mr John Wongvipat (Mr Wongvipat), were employed by HHMI
at the time of the invention. In 2003, they assigned all their rights in inventions created
during their employment with HHMI to the latter under Intellectual Property Statements of
Agreement.
[10] HHMI purportedly assigned its rights in accordance with the 1986 Collaboration
Agreement to UC in 2009 (2009 assignment). In that transaction, HHMI was represented
by Mr Sawyers, who ostensibly acted as its agent. The respondents assert that UC failed
to establish Mr Sawyers’s authority.
[11] The respondents concede that Enzutrix constitutes an infringement of the patent;
however, they oppose UC's application for an interim interdict on the following grounds:
(a) Eurolab argues that the patent is invalid under s 61(1)(a) and (g) of the Act due to
UC's alleged lack of entitlement and material misrepresentations in the application (P3),
also citing an 'obviousness' challenge in terms of ss 61(1)(c) and 25.
(b) The Dis-chem respondents withdrew their s 61(1)(c) and (g) revocation arguments
but maintained opposition against the interdict, asserting invalidity for lack of
inventiveness in terms of s 61(1)(g).
[12] The following issues must consequently be addressed:
3 The Patent Cooperation Treaty is an international agreement that allows inventors and companies to seek
patent protection for their inventions in multiple countries simultaneously by filing a single application.
Instead of submitting separate applications to each country, applicants file one PCT application, which is
then processed and examined centrally. After this initial phase, the applicant can pursue national patent
protection in participating countries. The treaty is administered by the World Intellectual Property
Organisation.
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(a) Was UC entitled to apply for the patent under s 27 of the Act, and should this
entitlement exist at the initial filing or at the time of the revocation application? A negative
answer resolves all three applications; if positive, the following questions are relevant:
(b) Did UC make material misrepresentations in the Form 3 declaration?
(c) Was the invention unpatentable due to lack of an inventive step, i.e., was it obvious
to a skilled person?
(d) Has UC met all the requirements for interim relief?
Is UC a person entitled to apply for the patent in terms of s 27 of the Act?
The respondents’ submissions
[13] The respondents assert that the phrase ‘entitled to apply’ in s 61(1) (a) of the Act
pertains to the point in time when the patent application is submitted, rather than any
subsequent period. They emphasise that this section addresses the process of applying
for patents and determines eligibility. According to the respondents , UC’s entitlement to
apply for the patent must be assessed with specific reference to the date on which the
application was filed.
[14] The respondents further argue that s 27 of the Act does not provide that simply
having the right to an assignment is sufficient to establish entitlement to apply for a patent.
In their submission, a proper interpretation of the section confirms that only the actual
owner of the right may submit a patent application. This means that a person seeking to
apply as a secondary applicant must first acquire the right to apply from the true owner
before applying. Furthermore, the respondents maintain that the language in s 27 –
specifically the phrase “any other person acquiring from him the right to apply” – implies
that there must have been an actual transfer of the right to apply for the patent.
Accordingly, they contend that a mere expectation of assignment or a contractual right to
receive an assignment does not meet the requirement; actual transfer is nec essary for
entitlement.
entitlement.
[15] According to the respondents, t he 2009 a ssignment cannot assist UC since it
seeks ex post facto to validate UC’s entitlement to apply for the patent. That right should
have existed at the time of the patent application. Also, Mr Sawyers did not have the
authority to assign anything other than the invention (RD162) to UC because he only had
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the authority to assign the first priority application (P1), which did not include the claimed
invention (RD162’). I explain the chemical properties of these compounds below.
[16] The respondents further assert that UC's argument – that it is eligible to apply in
terms of the 1986 Collaboration Agreement in conjunction with the Intellectual Statements
of Agreement – is untenable. The latter agreement did not confer any rights upon UC, and
the 2009 assignment could not validate UC’s rights, as it was not in existence at the time
of the patent application. The 1986 Collaboration Agreement stipulates, among other
provisions, that HHMI will assign all rights in HHMI inventions to UC. Con sequently, the
respondents contend, this agreement merely establishes a general framework for
collaboration and includes an undertaking by HHMI to assign inventions to UC in the
future; it does not transfer ownership of the patent to UC.
[17] Furthermore, they submit, s 73(3 ) of the Act is fatal to UC’s reliance on the
Collaboration Agreement. That section provides:
‘Except for the purposes of section 52, a document or instrument in respect of which no entry has
been made in the register in terms of section 10, shall not be admitted in evidence in any
proceedings in proof of the title to a patent or application for a patent or to any interest therein
unless the commissioner or a court, on good cause shown, otherwise directs.’
[18] The respondents further submit that the 1986 Collaboration Agreement was not
filed or recorded in the patents register and is consequently not admissible to prove UC’s
title. UC did not show good cause for its failure to file the 1986 Collaboration Agreement,
and it is consequently not entitled to rely on that document.
[19] Moreover, they argue, s 60(1) provides that an applicant for a patent or a patentee
may assign his or her rights in an application or patent to any other person. Unless the
may assign his or her rights in an application or patent to any other person. Unless the
assignment is duly recorded in terms of that section, ‘it shall not be valid, except as
between the parties thereto’.
[20] The respondents consequently submit that as of 29 March 2006, UC had not
obtained rights from the HHMI inventors for the following reasons: (a) the inventors
assigned their rights to HHMI in 2003 . HHMI assigned those rights to UC in 2009 , after
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the PCT application; ( b) the 2009 assignment was ineffective because Mr Sawyers’ s
authority pertained only to P1, which did not encompass the invention RD162’; and ( c)
UC is not able to rely on the 1986 Collaboration Agreement for the reasons previously
outlined.
UC and Astellas’ submissions
[21] UC criticises the Commissioner for having ignored the plain language of s 61(1)(a),
in particular, the phrase ‘the patentee is not a person entitled under s 27 to apply for the
patent’. The term ‘patentee’ is defined in the Act as the person whose name is for the time
being entered into the record as the grantee or proprietor of the patent. The Act further
distinguishes between a ‘patentee’ as the proprietor and ‘patentee’ being the person who
applies or is applying for the patent.
[22] UC argues that since this section is drafted in the present tense , s 61(1)(a) does
not require an investigation into the patentee's right to apply at the time of the application
but instead focuses on whether, at the time of revocation proceedings, the patentee would
have been entitled to apply at the time of the application.
[23] They argue that the cross-reference in s 61(1) (a) to s 27 serves to identify what
rights the patentee must possess at the time of the revocation application to avoid
revocation. The operative words being, ‘the patentee is…’. Section 27 makes it clear that
the patentee must have acquired the right to apply for the patent from the inventor. The
right to apply vests in the owner or the person who has a claim or contractual rights to
compel the inventor to assign or transfer righ ts to the invention. According to UC, t his
interpretation gives effect to the purpose of s 27 because otherwise a firm that owns the
rights in an invention may be precluded from applying because it was unable to secure
the assignment timeously.
[24] UC maintains that, as of the date of the revocation application, it had fulfilled the
[24] UC maintains that, as of the date of the revocation application, it had fulfilled the
requirements to be regarded as a person entitled to apply for the patent under s 27. UC
asserts its entitlement based on a series of assignments that collectively establish its right
to apply. As stated, UC initially secured assignments directly from its own inventors in
2005 and again in 2006. Beyond these internal assignments, UC also acquired rights
10
from the HHMI inventors, which occurred through a succession of agreements. This
included the Intellectual Property Statements of Agreement as well as a subsequent
assignment executed in 2009. The 2009 assignment was significant as it implemented
the terms of the longstanding 1986 Collaboration Agreement between UC and HHMI,
thereby confirming the transfer and formalisation of the relevant patent rights to UC.
[25] Furthermore, UC maintains that even if s 61(1) (a) were interpreted in the manner
contended by the respondents – meaning it would consequently be precluded from relying
on the 2009 assignment – UC would still meet the eligibility criteria to apply for the patent.
This is so because at the time of filing the patent application, UC had secured all requisite
assignments and authorisations from both UC and HHMI inventors. In sum, UC contends
that its entitlement is firmly grounded in the assignments and authority originating from
both groups of inventors and formalised through the relevant collaborative and intellectual
property agreements.
[26] With respect to the question of Mr Sawyers’s authority, UC contends that Dis-Chem
has not established a prima facie case demonstrating that Mr Sawyers lacked the
requisite authority to assign HHMI’s rights. Dis-chem instead relied solely on its attorney’s
interpretation of the 2009 assignment. Even if this interpretation is accepted, Dis -Chem
has not provided evidence indicating that Mr Sawyers was not authorised to assign rights
in all patentable inventions. In his affidavit, Mr Sawyers expressly affirms that he was
empowered to assign the PCT patent application to HHMI, and any assertion to the
contrary is purely speculative. The 2009 assignment explicitly indicates that Mr Sawyers
acted as a representative of HHMI. Consequently, Dis -Chem, as a non-party to the
agreement, is precluded from challenging its validity where the parties themselves are in
agreement regarding its enforceability.
agreement regarding its enforceability.
[27] UC also relies on the abstract theory of ownership. It asserts that even though
there may have been shortcoming s in the underlying assignment agreements, once the
right had been transferred, ownership vested in it.
Analysis and discussion
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[28] The foundational legal principles governing the interpretation of statutory
provisions and contrac ts are firmly established. According to these principles, statutory
language and contractual terms must be given practical meaning and effect by
considering the language employed in light of standard rules of grammar and syntax. The
starting point is the language of the provision it self, which must be read in its proper
context and with regard to the purpose behind the provision, as well as the background
circumstances surrounding the creation and drafting of the document.4
[29] In Capitec Bank Holdings Limited and Another v Coral Lagoon Investments 194
(Pty) Ltd and Others ,5 this Court cautioned that ‘the triad of text, context and purpose
should not be used in a mechanical fashion. It is the relationship between the words used,
the concepts expressed by those words and the place of the contested provision within
the scheme of the agreement (or instrument) as a whole that constitutes the enterprise
by recourse to which a coherent and salient interpretation is determined’ . The
interpretation of s 61(1)(a), must align with these legal principles.
[30] The first question that must be addressed in the light of the abovementioned legal
principles is whether the entitlement to apply in terms of s 27 is assessed at the time of
the filing of the application or when the revocation application is filed. The answer to this
question determines whether UC can rely on the 2009 assignment.
[31] The Commissioner interpreted ‘any other person acquiring from him [the inventor]
the right to apply’ in s 27 of the Act as requiring a non-inventor to have obtained this right
– by assignment, agreement, or other legal means – before filing for a patent. I agree with
this interpretation for the reasons outlined below.
[32] In my view, revocation proceedings pursuant to s 61(1) (a) involve a retrospective
[32] In my view, revocation proceedings pursuant to s 61(1) (a) involve a retrospective
assessment of whether the patentee, as defined by statute, was eligible to apply for the
4 Natal Joint Municipal Pension Fund v Endumeni Municipality [2012] ZASCA 13; [2012] 2 All SA 262 (SCA);
2012 (4) SA 593 (SCA) para 18; Airports Company South Africa v Big Five Duty Free (Pty) Ltd and Others
[2018] ZACC 33; 2019 (2) BCLR 165 (CC); 2019 (5) SA 1 (CC) para 29.
5 Capitec Bank Holdings Ltd and Another v Coral Lagoon Investments 194 (Pty) Ltd and Others [2021]
ZASCA 99; [2021] 3 All SA 647 (SCA); 2022 (1) SA 100 (SCA) para 25 ; University of Johannesburg v
Auckland Park Theological Seminary and Another [2021] ZACC 13; 2021 (6) SA 1 para 65.
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patent at that point in time. Any alternative interpretation would compromise the legislative
purpose of the section.
[33] In proceedings under s 61(1)(a), the applicant must prove that the patentee is not
a person entitled to apply under s 27 – either because they were not the inventor or did
not validly acquire the right to apply from the inventor. UC argued that the use of the
present tense in the section compels the inference that the patentee’s entitlement to apply
must be assessed at the time of the revocation application. I do not agree with that
argument. The purpose of s 27 is to delineate the criteria applicants must satisfy when
applying for a patent. The section therefore applies at the time when the patent application
is filed , thus making the assessment contingent upon the patentee’s rights as of the
application date.
[34] UC further argued that the respondents' interpretation would lead to absurd results,
citing a scenario in which a patentee assigns their patent years after its registration. UC
claimed this would shift focus to whether the assignee – and not the original patentee –
could apply for the patent under s 27 of the Act at the time of revocation. However, this
example instead supports the opposite view , namely that the key issue is whether the
assignment is valid and whether the original patentee had the right to file the initial
application.
[35] Section 61(1)(a) thus establishes a clear requirement that the right to apply for a
patent under s 27 must exist at the time the application is submitted. This means that the
applicant must either be the inventor themselves or must have lawfully acquired the right
to apply for the patent before filing the application. If this criterion is not satisfied, any
patent issued as a result is invalid. The process of revocation treats such a patent as if it
was never granted, effectively nullifying its legal standing. Importantly, transferring rights
was never granted, effectively nullifying its legal standing. Importantly, transferring rights
after the application has been filed does not remedy the original deficiency. If the applicant
lacked entitlement at the time of filing, the patent cannot be retrospectively validated, and
its revocation confirms its invalidity from the outset.
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[36] This interpretation finds support in the legal systems of other international
jurisdictions. The United Kingdom Patents Act 1977, in s 7(2),6 outlines the basis on which
applications can be made in that country. In Thaler v Comptroller,7 which concerned an
Artificial Intelligence generated invention, the UK Supreme Court confirmed that the
applicant’s entitlement is assessed at the time of filing. That court affirmed that the
applicant must identify a human inventor from whom the right to the patent was derived.
It held that the applicant’s failure to do so at the time of the application led to the
application being deemed withdrawn.
[37] Similarly, in Edwards Lifesciences v Cook Biotech Inc,8 the English Patents Court
emphasised that an assignment of rights must have been legally executed before the
filing date of the application to be valid for priority claims. In that case, the plaintiff sought
revocation of the defendant’s patent, inter alia, on the ground that priority was improperly
granted to a US provisional application. The defendant only acquired assignment of two
of the inventors’ rights after the patent application was filed. The plaintiff argued that
because the patent was not entitled to an earlier priority date, relevant prior art would
have become available which had the potential to validate the claims. Citing, inter alia,
ss 59 and 7 of the UK Patents Act 1977, the Court states at para 95 of the judgment:
‘…A person who files a patent application for an invention is afforded the privilege of claiming
priority to himself only if he himself filed the earlier application from which priority is claimed or if
he is the successor in title to the person who filed that earlier application. If he is neither the person
who filed the earlier application nor his successor in title then he is denied the privilege. Moreover,
his position is not improved if he subsequently acquires title to the invention. It remains the case
6 That section reads as follows: ‘A patent for an invention may be granted –
(a) primarily to the inventor or joint inventors;
(b) in preference to the foregoing, to any person or persons who, by virtue of any enactment or rule of law,
or any foreign law or treaty or international convention, or by virtue of an enforceable term of any agreement
entered into with the inventor before t he making of the invention, was or were at the time of the making of
the invention entitled to the whole of the property in (other than equitable interests) in the United Kingdom;
(c) in any event, to the successor or successors in title of any person or persons mentioned in paragraph
(a) or paragraph (b) above or any person so mentioned and the successor or successors in title of another
person so mentioned; and to no other person.’
7 Thaler v Comptroller [2023] UKSC 49, on appeal from: [2021] EWCA Civ 1374.
8 Edwards Lifesciences v Cook Biotech Inc. [2009] EWHC 1304 (Pat).
9 Section 5(1) of the UK Patents Act 1977 reads as follows: ‘For the purposes of this Act the priority date of
an invention to which an application for a patent relates and also of any matter (whether or not the same
as the invention) contained in any such application is except, as provided by the following provisions of the
Act, the date of the filing of the application.’
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that he was not entitled to the privilege when he filed the later application and made his claim.
Any other interpretation would introduce uncertainty and the risk of unfairness to third parties.’
[38] The European Patent Office, which governs patents for most of Europe, also
requires the entitlement to be established at the time of filing. Article 61 of the European
Patent Convention provides that where an application has been filed by a person who
was not properly entitled to do so, the true inventor is allowed to take over the application
or to file a new one. The inventor may also request that the patent application should be
refused. However, the assessment of entitlement is based on the original application date.
[39] These authorities reinforce the core idea that entitlement to apply for a patent is a
foundational requirement assessed at the very beginning of the patent process. Any
subsequent actions, such as a later assignment cannot retroactively cure a defect that
existed at the time of filing.
UC’s entitlement to apply for the patent
[40] The question then arises as to whether UC is a person entitled to apply for the
patent in terms of s 27. As mentioned, that question must be answered having regard to
the rights UC had at the time of the original filing of the application.
[41] It is common cause that UC sought to rely on the following grounds to establish its
entitlement to apply for the patent. First, the five UC inventors all signed patent
acknowledgments, agreeing to assign their rights in any inventions made while in the
employ of UC. They had in fact subsequently formally assigned those rights to UC in P1
and the priority applications P2 and P3 in 2005 and 2006, respectively. The remaining
three inventors (which included Mr Sawyers) assigned their rights to HHMI in 2003 by
virtue of the ‘Intellectual Property Statements of Agreement’. This is common ground.
[42] Second, the assignments in terms of the Intellectual Property Statements of
[42] Second, the assignments in terms of the Intellectual Property Statements of
Agreement w ere made pursuant to the 1986 Collaboration Agreement , concluded
between UC and HHMI. In terms of that agreement HHMI granted UC the right to take
assignment of any patentable inventions made by its employees pursuant to research
15
financed wholly or partly by UC. The patent was such an invention. Exhibit H of that
agreement (The Patent Agreement) provides in paragraph B:
‘Except as provided for in paragraph F of this Article II, HHMI shall assign to the University all of
its rights, title and interest in HHMI Patent Inventions, and HHMI further agrees that the
University’s policies and procedure, including the execution of the Patent Agreement pursuant to
the University’s Patent Policy, pertaining to the management and disposition of such Patentable
Inventions shall apply thereto subject to the following conditions…’10
[43] Third, HHMI formally assigned its rights in the invention to UC in 2009. However,
for the reasons stated above, UC is precluded from relying on the 2009 assignment to
resist an attack on the validity of the patent based on s 61(1)(a) because the assignment
did not exist at the time of the patent application. In light of this finding, it is not necessary
to determine the question of Mr Sawyers’s authority. However, of significance is that the
employment of the three inventors with HHMI on the terms asserted by UC is confirmed
in Sawyers’s affidavit and stands undisputed. Furthermore, on 31 August 2005, under a
document titled ‘Appointment of Investigator as Agent’ HHMI confirmed Mr Sawyers’
appointment as its agent for the purpose of assigning certain rights in respect of the patent
entitled ‘Novel Androgen Receptor Inhibitors with Minimal Agonistic Activities’ to UC.
[44] UC argues that even if the 2009 assignment is ignored, it was nevertheless a
person entitled under s 27 to apply for the patent by virtue of the assignments by the UC
inventors of their rights and the provisions of the 1986 Collaboration Agreement, read
with the Intellectual Property Statements of Agreement concluded between the HHMI
inventors and the HHMI. I agree.
[45] The respondents’ reliance on ss 30(4); 59; and 60(1)(a) and regulations 22 and 58
[45] The respondents’ reliance on ss 30(4); 59; and 60(1)(a) and regulations 22 and 58
for the submission that UC is not entitled to rely on the 1986 Collaboration Agreement
because it has not been recorded in the Patents Register, is misplaced. This is so
because: (a) s 30(4)11 pertains to the submission of evidence demons trating title or
10 Paragraph F is not applicable because it refers to inventions involving third parties and the conditions
pertain to the patents being made available to the public on a non-discrimination basis, HHMI has the right
to non-exclusive license.
11 Section 30(4) reads as follows:
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authority to apply for a patent. The critical enquiry under s 61(1) (a) is whether the
applicant held the necessary authority at the time of the application; the subsequent filing
of supporting documents is not relevant for that determination; (b) ss 59 and 60 prescribe
formalities for the assignment of patents or patent applications that have already been
filed and therefore find no application under s 27 of the Act; (c) regulation 22 requires an
applicant who has acquired a right to apply from the inventor, to file together with the
patent application form, an assignment or other proof, to the satisfaction of the registrar,
of the right apply. This requirement is, however, also not relevant to the enquiry whether
UC had right to apply for the patent at the time of filing; and (d) regulation 58 provides for
the recording of assignments of title to and interest in inventions, patent applications and
patents. It requires the filing of proof of such assignments. These provisions are therefore
irrelevant for the enquiry under s 61(1)(a), read with s 27 of the Act.
[46] The respondents’ contention that the provisions of s 72(3)12 of the Act preclude UC
from relying on the 1986 Collaboration Agreement because it was not filed or recorded in
the patents register as required in terms of the regulations is similarly untenable. That
section provides that a document which has not been so entered shall not be admitted in
evidence in any proceedings in proof of (a) the title to a patent ; (b) an application for a
patent; or (c) of any interest in the patent. UC does not rely on the 1986 Collaboration
Agreement either to prove title to the patent or to prove a patent application. It relies on
that agreement to establish that it had acquired the right to apply for the patent from HHMI
before the filing of the application.
[47] The respondents further contend that the 1986 Collaboration Agreement did not
vest any rights in the UC but was at best a general framework for cooperation.
vest any rights in the UC but was at best a general framework for cooperation.
Accordingly, i t did no more than record an inter partes obligation to execute future
‘Any person other than the inventor making or joining in an application for a patent shall in the prescribed
manner shall furnish such proof of his title or authority to apply for a patent as may be prescribed.’
12 That section provides:
‘72. Register to be evidence
(3) Except for the purposes of section 52, a document or instrument in respect of which no entry has been
made in the register in terms of section 10, shall not be admitted in evidence in any proceedings in proof of
the title to a patent or application for a patent or to any interest therein unless the commissioner or a court,
on good cause shown, otherwise directs.’
17
assignments. Exhibit H does not contemplate direct assignments and immediate vesting
of the rights to the patent . This was what UC purported to correct by filing the 2009
assignment. But that assignment , they argue, is inconsequential for a revocation
application since it did not exist at the time of the initial filing of the application.
[48] Relying on E I Du Pont de Nemours and Company v SA Nylon Spinners
(Proprietary) Limited, (Du Pont)13 UC argued that properly interpreted, the Collaboration
Agreement vests in it the rights to all patentable inventions made by the HHMI inventors.
UC, however, did not contend that the 1986 Collaboration Agreement constituted an
immediate assignment of ownership – neither could it because that agreement clearly
contemplated assignment at some time in the future.
[49] In my view, the facts in Du Pont are clearly distinguishable. The relevant clause of
the employment agreement in that case provided as follows:
‘Any and all improvements and inventions conceived or made by the employee during the period
of his said employment, relating in any way to the activities or business of the employer, shall be
disclosed promptly to the employer and shall be the sole and exclusive property of the employer
or it nominee; and whenever requested so to do by the employer, the employee shall execute any
and all applications, assignments and other documents which the employer shall deem necessary
to apply for and obtain Letters of Patent…’
[50] In Du Pont, the agreement unequivocally and automatically vested ownership of
any patentable invention in the employer. The 1986 Collaboration Agreement in this
matter does not affect such automatic vesting of ownership in UC but rather envisages
future action in terms of which ‘HHMI shall assign to the University all of its rights, title
and interest in HHMI Patent Inventions’.
[51] The conclusion in the preceding paragraph does not in any manner impact UC’s
[51] The conclusion in the preceding paragraph does not in any manner impact UC’s
right to apply for the patent because it was not constrained to prove ownership by way of
assignment to establish entitlement to do so . Section 27 of the Act also permits an
individual who has lawfully acquired the right to apply from the inventor – whether by
13 E I Du Pont de Nemours and Company v SA Nylon Spinners (Proprietary) Limited 1987 BP 287 (CP) at
287F-G.
18
contract or other legal mechanisms – to submit a patent application. Notably, unlike its
predecessor, s 8 of the repealed Patents Act 37 of 1952, s 27 of the current Act omits any
reference to an ‘assignment agreement’ or ‘assignee’.
[52] It was therefore sufficient for UC to show that it had authority to apply for the patent
by virtue of a contractual provision. In this regard it relied on the 1986 Collaboration
Agreement. The question then arises whether that agreement authorises UC to apply for
patents in respect of all patentable inventions made by the HHMI inventors . In my view,
and for the reasons explained below, it clearly does.
[53] As stated earlier, the 1986 Collaboration Agreement expressly obligates HHMI to
assign to UC all of its rights, title, and interest in HHMI Patent Inventions.' HHMI agreed
to do so in return for a multimillion -dollar investment by UC . And contrary to Eurolab’s
contentions, that obligation is unconditional. The clauses on which Eurolab relies for its
assertion that the obligation is conditional are terms that relate to UC’s contractual
obligations following the grant of a patent. They do, therefore, not constitute conditions
precedent.
[54] Apart from HHMI’s irrevocable contractual obligation to assign to UC all its rights,
title, and interest in ‘HHMI Patentable Inventions’ , in terms of the 1986 Collaboration
Agreement, UC assumed the obligation ‘to file for patent protection and prosecute
diligently such application with respect to any such HHMI patentable Invention for which
patent protection can be obtained… .’ I t is only in the event of UC declining or failing to
do so ‘after reasonable request and notice by HHMI’, that it must ‘assign back’ to HHMI
all right, title, and interest in such patentable inventions. In effect , therefore, the parties
agreed that UC bore the primary obligation to apply for patents in respect of all ‘HHMI
Patentable Inventions’ for the duration of the 1986 Collaboration Agreement. The parties’
Patentable Inventions’ for the duration of the 1986 Collaboration Agreement. The parties’
subsequent conduct supported this interpretation of the agreement. The evidence
indicates that they shared a mutual understanding concerning UC’s authority to apply for
the patent . They have been performing the ir respective obligations in terms of that
agreement for almost 20 years , including sharing the royalties derived from the
commercial exploitation of the patent.
19
[55] I therefore find that UC properly obtained the right from HHMI to apply for the
patent under the terms of the 1986 Collaboration Agreement and was therefore ‘a person
who is entitled to apply for the patent’ as contemplated by s 27 of the Act.
Did UC make any material misrepresentations?
[56] Section 61(1)(g) of the Act provides that any person may apply for the revocation
of a patent on the ground that ‘the prescribed declaration lodged in respect of the
application for the patent contains a false statement or representation which is material
and which the patentee knew or ought reasonably to have known to be false at the time
when the statement or representation was made’. Eurolab submitted that the declaration
contained two material misrepresentations.
[57] The first argument was that UC's declaration, stating it had acquired ‘the right to
apply by virtue of an assignment from the inventors, ’ was false. The respondents
contended that this statement materially misrepresented the timing of UC's acquisition of
rights, implying that UC had already obtained such rights prior to the patent application
being filed. It was undisputed that UC had not secured HHMI's patent rights in the form
of an assignment of the type executed in 2009 before submitting the application. They
argued that UC must have been aware of the absence of such rights at the relevant time,
given that the assignment from HHMI was only filed in 2009. I find no merit in this
argument.
[58] When the statement in P3 was made, HHMI had already received assignment
through the 2003 agreement and was contractually required to assign invention rights to
UC. There was no dispute that UC had obtained assignment form the UC inventors by
the filing date. In addition, it was contractually entitled to the invention rights of the HHMI
inventors by virtue of the 1986 Collaboration Agreement . Given the various legal
instruments granting these rights to UC, it would be unreasonable to assert that UC’s
instruments granting these rights to UC, it would be unreasonable to assert that UC’s
agent should have known that there was a possib ility that the statement could be
incorrect, let alone false.
[59] Second, Eurolab posited that the prescribed declaration falsely claimed priority
from the US patent application (P1) whereas the claims in the application filed, the PCT
20
application, were not fairly based on the priority document. In my view, there is also no
merit in this contention.
[60] The global patent system allows a patentee to secure a priority date by filing a
provisional or priority patent application in any country that is a party to the Paris
Convention, provided that a complete application is filed within 12 months. When the
application is filed , the patentee may claim priority in terms of s 31 of the Act for those
aspects of the invention which are fairly based on the disclosure in the priority application.
That section provides:
‘An application accompanied by a complete specification may claim priority from–
(a) the date of the lodging of a prior application relating to the same subject-matter, accompanied
by a provisional specification;
(b) the date of the lodging of a prior application relating to the same subject-matter, accompanied
by a complete specification and claiming no priority; or
(c) the date of an application in a convention country relating to the same subject-matter.’
[61] In respect of any matter not sufficiently disclosed in the first priority application, the
patentee may claim priority either from any later priority application filed in respect of that
matter or, in the absence of any priority application, the filing date of the complete patent
application. A patentee can therefore claim priority from more than one earlier priority.
[62] Where the patentee claims priority from more than one priority application or adds
new matter not disclosed in any priority application, the priority date of the complete
application shall be the earliest priority date claimed in an application in terms of s 33 of
the Act. The onus is on the applicant for revocation to show that the patentee is not
entitled to that priority date.
[63] Form P3 requires an applicant to identify the earliest priority claimed. The form
states that ‘the earliest application from which priority is claimed as set out above is the
states that ‘the earliest application from which priority is claimed as set out above is the
first application in a convention country in respect of the invention claimed in any of the
claims.’ The form does not state that the complete application is fairly based on the
21
earliest patent application as s 33 of the Act14 allows for various aspects of the invention
to be based on different priorities.
[64] The first priority application was P1, which was followed by priority applications P2
and P3. The identification of P1 as the earliest prior ity application was therefore correct
and did not amount to a material ly false statement or representation . The respondents
consequently failed to establish any basis for the revocation of the patent under s 61(1)(g)
of the Act.
Was the invention patentable under s 25 of the Act?
[65] Section 25 of the Act provides that a patent ‘may be granted for any new invention
which involves an inventive step, and which is capable of being used or applied in trade
or industry or agriculture’ . Notably, s 61(1)(c) provides a patent may be revoked on the
ground that the invention is not patentable under s 25 of the Act.
[66] In terms of s 25(10), an invention ‘shall be deemed to involve an inventive step if
it is not obvious to a person skilled in the art, having regard to any matter which,
immediately before the priority date of the invention, forms part of the state of the art by
virtue only of subsection (6) (and disregarding subsections (7) and (8))’. Subsection 25(6)
provides that the state of the art shall comprise ‘all matter (whether a product, a process,
14 Section 33 provides: ‘Priority dates
(1) For the purposes of this Act, the priority date of an invention to which an application for a patent relates,
and also that of any matter contained in any such application, whether or not such matter is the same as
the invention, shall, except as otherwise provided in this Act, be the date of the lodging of the application.
(2) Where priority is claimed in an application in terms of section 31(1) from one or more prior applications,
or one or more prior applications in a convention country or countries, or both, and the invention claimed in
the application is fairly based on matter disclosed in one or more of any such prior applications, the priority
date of the invention shall be the date of lodging of the earliest of such prior applications in which that matter
was disclosed in so far as it is fairly based on such earliest application.
(3) Any invention claimed in an application may have one or more priority dates.
(4) Until the contrary is proved, the priority date of an invention shall be the earliest priority date claimed in
an application.
(5) In determining whether an invention claimed in an application is fairly based on the matter disclosed in
a prior application or a prior application in a convention country, regard shall be had to the disclosures
contained in all documents lodged at the sam e time as and in support of that prior application or prior
application in a convention country.
(6) The priority date of new matter introduced by way of a supplementary disclosure in terms of section
51(8) shall be the date of lodging of the supplementary disclosure.’
22
information about either, or anything else) which has been made available to the public
(whether in the Republic or elsewhere) by written or oral description, by use or in any
other way’.
[67] This Court in Ausplow (Pty) Ltd v Northpark Trading 3 (Pty) Ltd and Others 15
(Ausplow), set out the issues to be determined a s part of the obviousness enquiry as
follows: (a) who is the notional person skilled in the art? (b) what is the relevant common
knowledge that person has of the state of the art? (c) what is the inventive concept of the
claim? (d) the difference between the state of the art and the inventive concept; and (e)
viewed without knowledge of the alleged invention, do the differences constitute s teps
that would have been obvious to the person skilled in the state of the art? While the
ultimate question of the validity of a patent is a question of law, the preceding enquiries
are factual in nature and must thus be considered on a case-by-case basis – drawing on
the evidence adduced in each specific matter.
[68] The United States Supreme Court in Graham v John Deere Co.,16 stated that, as
part of the factual enquiry into obviousness, ‘secondary considerations’ such as, amongst
others, commercial success, long felt but unresolved needs, and failure of others ‘might
be utilised to give light to the circumstances surrounding the origin of the subject matter
sought to be patented’. In my view, and depending on the specific circumstances of the
case, the abovementioned factual enquiries can encompass such secondary
considerations.
[69] Eurolab advanced its obviousness attack based on the evidence of Prof Veale
supplemented by the evidence of Prof Greeff , as a defence in the interim interdict. Dis -
Chem’s attack on inventive step was initially advanced as a ground in the revocation
application. However, it has abandoned that stance and now also advances that point as
a defence in the interim interdict proceedings.
a defence in the interim interdict proceedings.
15 Ausplow (Pty) Ltd v Northpark Trading 3 (Pty) Ltd 2011 BIP 12 (SCA); [2011] ZASCA 123; [2011] 4 All SA
221 (SCA); 2011 JDR 1058 (SCA) (Ausplow) paras 34 and 35.
16 Graham v John Deere Co., 383 U.S. 1 (1966) at 383.
23
[70] To address whether the patent in this matter involves an inventive step, it is
important to outline the established causes of prostate cancer and the history of its
treatment. The key facts are common cause.
[71] Androgens, such as testosterone and its metabolite 5a-dihydrotestosterone (DHT),
are steroid hormones essential for prostate development and function. Testosterone is
mainly produced in the testicular stroma. Both testosterone and DHT bind to the androgen
receptor (AR), activating it. Upon activation, AR changes shape, forms a dimer (a
molecule made of two similar subunits and joined by a chemical bond) , moves to the
nucleus, and triggers pathways that regulate cell growth and survival in normal and
cancerous cells.
[72] When androgen receptors are activated, they affect certain genes, especially the
gene responsible for producing prostate-specific antigen (PSA). Because people suffering
from prostate cancer often have higher PSA levels, PSA is commonly used by doctors to
determine how the disease is progressing. When PSA levels go down, it typically means
that the activity of androgen receptors in the tissue has decreased.
[73] Treating advanced prostate cancer at first involved lowering male hormones, either
by surgery to remove the testicles or by using estrogen therapy. However, estrogen
therapy caused many side effects, so it was not used widely. These methods mainly
helped ease symptoms but did not cure the disease. More definitive treatments included
surgically removing the prostate, using external radiation, or placing radiation directly into
the prostate.
[74] LHRH, a drug developed in the 1990s, helped to reduce circulating androgens to
castrate levels after an initial stimulus. Androgen deprivation resulted in a reduction of the
rate at which the cancer cells proliferated. More drugs were developed in the 1960’s and
1980s.
[75] Prior to the development of the patent , metastatic or recurrent cancer was
1980s.
[75] Prior to the development of the patent , metastatic or recurrent cancer was
commonly managed by reducing androgen or testosterone levels in patients. Alternative
treatments included the administration of anti -androgens instead of castration therapy.
24
Hormonal therapies aimed at decreasing activity at the androgen receptor are collectively
referred to as Androgen Deprivation Therapy (ADT).
[76] The invention described in the patent addresses a significant challenge in the
treatment of prostate cancer, specifically the transition from Hormone Sensitive Prostate
Cancer (HSPC) to Hormone Resistant Prostate Cancer (HRPC) following the application
of ADT. Historically, available therapies failed to provide effective solutions once prostate
cancer progressed to a hormone -resistant state. The inventive step, as claimed by UC,
lies in the development of enzulatamide as a treatment for prostate cancer, with particular
focus on its efficacy against HRPC. This advancement represents a critical improvement
in therapeutic approaches, targeting the problem of resistance that undermined previous
treatments.
The person or team skilled in the art
[77] UC argues that a team skilled in the art would be a biologist specializing in prostate
cancer treatment and an advanced synthetic or medicinal chemist. It relies on the
evidence of two experts: (a) Prof Neal, a renowned urological surgeon and prostate
cancer researcher with several peer -reviewed publications; and (b) Prof Carreira, a
chemistry professor at the Eidgenossische Technische Hochschule, Zurich, for 26 years,
experienced in API design, drug development, and patent inventorship.
[78] Eurolab asserts that a team skilled in the art would include a medicinal chemist,
biologist, pharmacologist, therapeutic specialist, and pharmaceutic chemist. Their experts
are: (a) Prof Greeff, an experienced pharmacologist in drug development, including
oncology drugs like nilutamide; (b) Prof Horak, a biochemist; (c) Dr Lourens, a urologist
since 2017; and (e) Prof Veale, a medicinal chemist.
[79] UC contends that Eurolab’s experts do not possess the requisite expertise. It
maintains that, as a pharmacologist, Prof Greeff does not engage in the design or
maintains that, as a pharmacologist, Prof Greeff does not engage in the design or
synthesis of new APIs for biological diseases, which they assert is the domain of
medicinal chemists.
25
[80] The respondents stated that the difference between RD162 and RD162’ primarily
concerns the evaluation of the safety and efficacy of the compound following a change to
a less expensive substituent at C5 of the middle ring. This decision typically falls under
the responsibility of a pharmacologist. Accordingly, even if Prof Greeff does not have the
qualifications to provide an opinion on earlier stages of API development, the final phase
of lead optimization – specifically the transition from RD162 to RD162’ – is within the
scope of pharmaceutical expertise.
[81] I find it unnecessary to decide if the respondents’ experts are a skilled team for the
obviousness enquiry. Instead, I shall instead evaluate all expert evidence according to
the following dictum from this Court in Schlumberger Logelco Inc v Coflexip SA:17
‘It is the technical evidence by expert witnesses in respect of the nature of the step claimed to
have been inventive, the state of the art as at the priority date relevant to that step and the respect
or respects in which the step goes beyond or differs f rom that state of the art, which constitutes
the primary evidence.’:
This Court further stated that expert evidence should be evaluated without considering
experts’ opinions on obviousness. While experts may express views regarding this issue,
their conclusions about obviousness are not relevant.
The state of the art
[82] It is not disputed that the prior art is represented by slides prepared by one of the
HHMI inventors (the slides), and a poster (the poster) used in a presentation at a
conference in Scottsdale, Arizona, from 29 September to 1 October 2005. The slides
describe a process to develop a drug that has stronger antagonism than classic agonists18
and was not an agonist in the presence of high levels of AR, ie, in HRPC.
[83] The slides further describe the development of a component called RD162 from
RU59063. The latter component had agonist properties in HRPC conditions. It is the only
RU59063. The latter component had agonist properties in HRPC conditions. It is the only
component whose structure is depicted with a substituted dimethyl in the middle
thiohydantoin ring (the C5 position). Starting from RU59063, the slides depict RD37,
which differs structurally from RU59063 in that (a) RD37 includes a phenyl group on the
17 Schlumberger Logelco Inc v Coflexip SA 2002 BIP 35 (SCA); 2003(1) SA 16 (SCA) para 34.
18 An agonist is a substance that initiates a physiological response when combined with a receptor. An
antagonist is a substance that interferes with or inhibits the physiological action of another.
26
right-hand side of the structure, to which a methyl group is attached; and (b) the dimethyl
at position C5 has been replaced with a cyclobutyl.
[84] The introduction of two specific structural modifications resulted in a marked
enhancement of the molecule's biological activity. In particular, RD37 was demonstrated
to function as a highly potent antagonist in in vitro studies – those performed outside a
living organism – across HSPC and HRPC models. This advancement effectively
addressed the previously observed issue wherein antagonists would convert into agonists
under HRPC conditions, thereby losing their therapeutic effectiveness. Nevertheless, the
efficacy of RD37 was found to be sustained only for a brief period, necessitating very
frequent dosing to maintain therapeutic levels. Alternatively, the compound required
formulation as a slow-release preparation to extend its duration of efficacy.
[85] The authors therefore developed further compounds to try and solve the problem.
This resulted in the development of RD162. Improved properties were achieved by
changing substituents on the phenyl group on the right-hand side. RD162 retained the
activity achieved with RD37.
[86] The poster, which is reproduced below, shows that the authors tested dimethyl
(RD2, 6 and 7), cyclobutyl (RD37) , and cyclopentyl (RD54) substituents at C5, then
positively selected the cyclobutyl to take forward in the later RD compounds, namely
RD131, 161, and finally 162. The poster includes a graph on the right -hand side
comparing RD7 (dimethyl) and RD37 (cyclobuthyl), respectiv ely at C5 in an in vivo
experiment, and shows that RD37 performed better than RD7. It also includes a
histogram which shows that when tested at the highest concentration, RD37 was more
potent than RD7.
[87] The poster indicates that modifying the substituent at C5 influences activity .
Compounds with dimethyl and cyclobutyl groups at C5 show different levels of activity
Compounds with dimethyl and cyclobutyl groups at C5 show different levels of activity
compared to those with only a cyclobutyl group. The inventors compared these variations
and selected cyclobutyl due to its observed performance.
27
Difference between the state of the art and the inventive concept
[88] It is common cause that the difference between the prior art, namely RD162 and
enzalutamide (RD162’), is the creation of a substituent through the substitution at position
C5 of the thiohydantoin (central) ring of the compound, namely dimethyl in RD162’ and
cyclobutyl in RD162. The following diagrams better illustrate this.
28
Was the inventive step obvious to a person skilled in the art?
[89] Eurolab contends that RD162 and RD162’ are, in terms of efficacy, equivalent, ie,
they do exactly the same thing. There is nothing in the specifications to suggest that one
of the two analogues is better than the other. Thus, Eurolab submits, simply choosing one
above the other cannot involve an inventive step and would be obvious to a person skilled
in the art.
[90] Eurolab’s experts explained the process involved in subjecting a lead compound
to modifications, considering chemical stability, costs, clinical efficacy and the ability to
formulate satisfactorily for administration with the objective to generate structural
analogues of lead compounds. According to them, o nce the lead compound, namely
RD162, is identified, it becomes a matter of routine experimentation to ascertain whether
substitutions would produce a superior result. The skilled team would have been
influenced by the dimethyl on RU59063. Having used that structure as the initial starting
29
point, the skilled team would have been led to test for activity by replacing cyclobuyl with
dimethyl. The skilled team would then have been motivated to experiment with dimethyl
as the substituent because of the substantial cost savings, the former being at least 1000
percent cheaper. Prof Greeff submitted that it was therefore obvious to try a dimethyl at
position C5 instead of cyclobutyl because it would lower the cost of manufacturing and
both RU59063 and nilutamide – which is also nonsteroidal antiandr ogen – included a
dimethyl at position C5.
[91] UC, on the other hand, argued that it would not have been obvious in 2006 to the
skilled person that one could change the substituent at C5 of RD162 from a cyclobutyl to
a dimethyl and have any confidence that it would be effective in the treatment of HRPC.
This is so because, in taking that step, the skilled team would have to ignore the fact that
the slides and poster show that the authors proposed to take RD162 into in vivo trials, ie,
medical experiments involving living organisms, which is the next stage of the
pharmaceutical development process. The slides did not suggest to the skilled team that
any structural changes needed to be made to RD162. It is only with hindsight that one will
focus on C5 and consider only dimethyl as a potential substituent in that position.
[92] Furthermore, even accepting that the skilled team would have focussed on C5, the
step taken would have required them to reverse the developmental steps already taken
in developing RD162 from RU59063. Such a step would have risked the biological
potency achieved with RD37 and RD162. The developmental step from RD162 to RD
162’, UC submits, would therefore not have been obvious to the skilled team.
[93] In my view, a person skilled in the art and having regard to the slides would have
noticed that: (a) the cyclobutyl at position C5 was introduced for the first time on RD37;
noticed that: (a) the cyclobutyl at position C5 was introduced for the first time on RD37;
(b) RD37 was the first compound that exhibited the desired activity; (c) the authors did
not thereafter change the cyclobutyl and appeared to have settled on it. The skilled person
would, therefore, having read the slides, clearly be concerned that changing back to a
dimethyl at C5 would reverse the progress achieved with the devel opment of RD37 and
RD162.
30
[94] Counsel for UC correctly argued that if one were to make structural changes to the
compound, then there are many other possible changes on other parts of the molecule ,
other than C5 , that one would consider. There would have been no reason to make
changes to C5 only. Even if there were such an improbable focus on C5, there are literally
thousands of other chemical substituents that could have been considered, and the slides
and poster show that there were good reasons to choose cyclobutyl over dimethyl in that
position.
[95] Furthermore, such a step would have been counterintuitive to the skilled person,
dimethyl having been previously discarded in favour of cyclobutyl. Dimethyl had been
used in less effective compounds, and the preference for cyclobutyl indicates that it was
considered optimal for the desired activity. There would therefore have been no
motivation for the skilled team to make any changes to RD162. It is only with hindsight
that there would be a focus on C5 and a preference for dimethyl over cyclobutyl.
Additionally, there would have been no motivation for the skilled team to use a substituent
from RU59063 and nilutamide, a compound which was not effective in HRPC conditions.
[96] Prof Greeff’s claim that cost savings motivated further development of RD162 is
undermined by hindsight, as he had read a post -priority article by inventor , Mr Michael
Jung, discussing manufacturing cost benefits. Similarly, Prof Veale and Dr Horak’s
evidence was also influenced, since they had seen Prof Greeff’s affidavit and would have
known about the Jung article.
[97] Curiously, both Prof Greeff and Dr Horak disavowed any knowledge of the Jung
article in their replying affidavits. They did so to explain that their testimonies were based
on their knowledge and experience of how the skilled team would have gone about
developing an identified lead compound by March 2006. It appears that they both
developing an identified lead compound by March 2006. It appears that they both
overlooked the fact that Prof Greeff had referred to the article in his initial affidavit. While
I am satisfied that they did not intend to mislead the Commissioner, the inference is
ineluctable that their evidence was fundamentally tainted by hindsight.
[98] There is therefore very little, if any, cogent evidence to challenge Prof Carreira’s
compelling testimony. He explained that the costs of manufacturing a drug are a small
31
fraction of the costs of developing a new drug and would therefore not have been a
relevant or primary consideration for the skilled team at that stage of the invention.
[99] These findings are consistent with the approach adopted by the English, Dutch ,
and German courts, where the validity of the patent was challenged on the same grounds.
In those cases , the courts were also called upon to determine whether enzalutamide,
claimed in the European Patent, was invalid as obvious in light of prior art, namely the
posters and slides.
[100] In Accord Healthcare Ltd and Others v Regents of the University of California and
Another,19 the claimants also argued that the poster and slides disclose that RD126 is
structurally close to enzalutamide and that substituting the cyclobut yl with dimeth yl at
position X (C5) was a routine and obvious modification. They further argued that the
skilled medicinal chemist would have been motivated to explore such substitutions as part
of structure-activity relationship studies. The skilled team, they submitted, would therefore
have experimented with substituents and inevitably arrived at enzalutamide.
[101] UC argued that the modification was not routine and that small changes in
substituents could yield unpredictable and sometimes adverse pharmacological results.
Furthermore, the poster and slides taught away from enzalutamide by highlighting
cyclobutyl or cyclopentyl rather than dimethyl.
[102] On appeal, the court upheld the trial judge’s finding that the intense focus by the
experts on the change from cyclobutyl to dimethyl was tainted by hindsight, namely the
knowledge that RD162’ was the target. It held that obviousness must be assessed on a
case-by-case basis. Just because institutions embark on research does not present a
point against obviousness.
[103] The court emphasised that it is not necessary to establish a specific motivation to
determine whether a claimed invention is obvious. While the presence of strong
determine whether a claimed invention is obvious. While the presence of strong
motivation can make it easier to prove obviousness, the absence of motivation does not
19 Accord Healthcare Ltd and Others v Regents of the University of California and Another [2025] EWHC
Civ 936.
32
preclude a finding of obviousness, particularly if the inventive step in question is not a
trivial one. However, the court noted that lack of motivation may be a relevant
consideration, especially in cases where the modification is not straightforward or routine.
Ultimately, motivation is not a decisive factor, but rather one aspect among many to be
weighed in the overall assessment. On this basis, the court dismissed the obviousness
challenge. This approach was consistent with the conclusions reached in si milar
proceedings before the Dutch20 and German21 courts, where the validity of the patent was
also upheld because obviousness had not been established.
[104] Finally, there is no merit in the argument that the invention of RD162’ should be
considered obvious merely because enzalutamide is allegedly functionally equivalent to
RD162. This Court, in Ausplow, clarified the misconception that an inventive step
necessarily requires an invention to be ‘a step forward’ in the sense of being superior to
prior products. The Court explained that such a view is misleading and does not
accurately reflect the requireme nts for inventiveness. The Court further illustrated this
point by noting that a new analgesic does not need to surpass the efficacy of Aspirin, a
century-old remedy, to qualify as inventive. Similarly, the seeding apparatus at issue in
Ausplow might perform the same general function as existing seeding machines;
however, if it achieves its purpose more effectively or in a sufficiently distinct manner, it
may still be considered inventive, even if it is not categorically better in every respect.22
[105] As counsel for UC has correctly pointed out, there is no evidence that RD162 was
tested in clinical trials to determine its efficacy in treating HRPC. Enzalutamide, on the
contrary, has been proven to be effective and has been recognised as a ground-breaking
drug and a huge advancement in the treatment of prostate cancer. This, in my view, is a
drug and a huge advancement in the treatment of prostate cancer. This, in my view, is a
secondary consideration which also weighs against a finding that the inventive step was
obvious to the skilled person.
20 Accord Healthcare Ltd and Another v The Regents of the University of California C/09/654970/HAZA 23
-903; Sandoz AG v The Regents of the University of California C/09/654975.
21 Hexal AG v The Regents of the University of California 3 Ni 20/23 (EP) BPatG (8 April 2025).
22 Ausplow op cit fn 17 above, para 31.
33
[106] For all the above reasons, I find that the invention of RD162’ would not have been
obvious to a person skilled in the art, having regard to matter s which formed part of the
state of the art, immediately before the priority date of the invention.
Did UC establish all the requirements for an interim interdict?
[107] It is trite that an applicant for interim relief must establish: (a) a prima facie right,
though open to some doubt; (b) that there is a well-grounded apprehension of irreparable
harm if the interim relief is not granted; (d) the balance of convenience favours the
granting of interim relief; and (e) it has no other satisfactory remedy.
[108] The prima facie right does not have to be established on a balance of probabilities.
In Webster v Mitchell the legal position was explained as follows:23
‘The proper manner of approach…is to take the facts as set out by the applicant, together with
any facts set out by the respondent which the applicant cannot dispute, and to consider whether,
having regard to the inherent probabilities, the applicant could on those facts obtain final
relief…The facts set up in contradiction by the respondent should then be considered. If serious
doubt is thrown on the case of the applicant, he could not succeed in obtaining temporary
relief…But if there is mere contradiction, or unconvincing explanation, the matter should be left
to trial and the right be protected in the meanwhile, subject of course to the respective prejudice
in the grant or refusal of interim relief…the position of the respondent is protected because…the
test whether or not temporary relief is to be granted is the harm which will be done…’
[109] An applicant must also establish that the prima facie right is being threatened by
an impending or imminent irreparable harm. The Constitutional Court held in National
Treasury and Others v Opposition to Urban Tolling Alliance and Others:24
Treasury and Others v Opposition to Urban Tolling Alliance and Others:24
‘…[T]he prima facie right a claimant must establish is not merely the right to approach a court in
order to review an administrative decision. It is a right to which, if not protected by an interdict,
irreparable harm would ensue. An interdict is meant to prevent future conduct and not decisions
already made. Quite apart from the right to review and to set aside impugned decisions, the
applicants should have demonstrated a prima facie right that is threatened by an impending or
imminent irreparable harm.’ (Citations omitted.)
23 Webster v Mitchell 1948 (1) SA 1186 (W) at 1189-1190.
24 National Treasury and Others v Opposition to Urban Tolling Alliance and Others 2012 (6) SA 223 (CC);
[2012] ZACC 18; 2012 (11) BCLR 1148 (CC) para 50.
34
[110] However, even if all the foregoing requirements are met, the Court still has a
discretion whether to grant the interim interdict. 25 Holmes J explained in in Olympic
Passenger Service (Pty) Ltd v Ramlagan26 how that discretion is to be exercised:
‘In such cases, upon proof of a well-grounded apprehension of irreparable harm, and there being
no adequate ordinary remedy the Court may grant an interdict – it has a discretion, to be exercised
judicially upon a consideration of all the facts. Usually th is will resolve itself into a nice
consideration of the prospects of success and the balance of convenience – the stronger the
prospects of success, the less the need for such balance to favour the applicant: the weaker the
prospects of success, the greater the need for the balance of convenience to favour him.’
[111] The decision on the revocation application indicates that UC has demonstrated a
clear right and strong prospects of success in the enforcement proceedings . The
respondents acknowledge that the ongoing production and sale of Enzut rix is causing
harm to UC, though they argue that the harm is not irreparable. Eurolab began selling
Enzutrix in April 2024 and has continued to increase its market share as the first producer
of the generic drug. UC references the case of Zytiga, another prostate cancer treatment,
which lost approximately 83 percent of its market share within a year of the generic
product entering the market. UC asserts that this example demonstrates that an
originator’s market share typically declines rapidly and significantly after a generic is
introduced. It is agreed that Enzut rix has secured a notable portion of the market share
in its initial month.
[112] UC contends that damages cannot adequately compensate for its harm, as
quantifying losses is challenging due to the complex prostate cancer drug market.
Xtandi’s market growth before Enzut rix’s launch is hard to project, and competition
Xtandi’s market growth before Enzut rix’s launch is hard to project, and competition
involves multiple drugs, making it unlikely that each lost sale by Xtandi directly benefits
Enzutrix. Additionally, Enzutrix’s entry affects other drugs’ sales, so losses suffered by UC
and Astellas cannot be precisely measured.
[113] In addition, UC contends, Eurolab’s conduct is likely to lead to job losses at Astellas
SA. The sale of Xtandi is one of the major contributors to its revenues , and if losses
25 Setlogelo v Setlogelo 1914 AD 221.
26Olympic Passenger Service (Pty) Ltd v Ramlagan 1957 (2) SA 382 (D) at 383E-F.
35
continue at the current rate, it stands to lose close to a third of its revenue. The harm that
they will suffer if interim relief is not granted is both substantial and irreparable.
[114] UC further asserts that its clear entitlement and strong likelihood of prevailing in
the patent enforcement action significantly diminishes the relevance of the balance of
convenience. In any case, the balance of convenience strongly favours UC, as it will
experience substantial harm if interim relief is not granted, while Eurolab’s potential harm
is minimal. UC has invested nearly USD 1.5 billion in developing Xtandi, whereas Eurolab
bears no comparable development costs. Furthermore, as previously o utlined, losses
incurred by UC and Astellas would be difficult to quantify precisely, while those suffered
by Eurolab are limited to loss of profits and are therefore more readily ascertainable.
Additionally, Astellas SA has offered to compensate Eurolab a nd Dis -Chem for any
damages they may demonstrate, should it be determined that the interim interdict was
improperly issued.
[115] It is undisputed that the interim relief requested by UC may result in cancer patients
without medical aid being unable to afford Enzulamide treatment. This potential outcome
of the interim interdict should be acknowledged. The issue to consider is the deg ree of
significance this factor holds when evaluating the balance of convenience.
[116] In Cipla Medpro (Pty) Ltd v Aventis Pharma SA and Related Appeal 27 (Cipla) the
amicus, namely the Treatment Action Campaign (TAC) , founded its opposition to the
granting of an interdict on s 27(1) of the Constitution, which guarantees to everyone the
right to have access to health care services, includ ing the right to have access to
affordable medicines. Although the Court found no merit in that argument, it considered
the TAC to be ‘on stronger ground when it advances factors to be taken account such as,
the TAC to be ‘on stronger ground when it advances factors to be taken account such as,
the broader public interest s, and not only the interests of the litigating parties, must be
placed in the scales when weighing where the balance of convenience lies’28.
[117] The Court reviewed relevant local and foreign cases , including those from the
United States, where injunctions against patent infringements were denied due to public
27 Ibid.
28 Ibid.
36
interest reasons. It concluded that while interim interdict requirements here are more
flexible than permanent injunctions in the U.S., public interest considerations should still
influence the court’s discretion. However, counsel for Aventis showed these concerns do
not apply to that case. 29
[118] The Court was not convinced that the evidence demonstrated serious negative
outcomes for patients if the sale of the infringing product was prohibited. Concluding that
an interdict would not cause significant disruption to patients, and that the TAC’s
opposition was primarily against the patent holder’s monopoly rather than the interdict
itself, the Court proceeded to grant the interdict.
[119] While UC correctly submitted that Eurolab’s opposition to the granting of an interim
interdict has little to do with the public interest s and more with its desire to secure its
advantage as the first producer of the generic product on the market, it is indisputable
that if the sale of Enzutix were enjoined, the consequences for cancer patients using it
would be serious and immediate. As mentioned, it is common cause that Xtandi is
substantially more expensive than Enzutix and will be unaffordable for those patients who
do not have medical aid.
[120] The patent is scheduled to expire within a few weeks. The primary harm anticipated
for UC and Astellas should interim relief be denied, is financial. They maintain that this
harm w ill be irreparable due to the challenges associated with quantifying losses, as
previously outlined. While these challenges may exist, they have been substantially
mitigated by the respondents' undertaking that each sale of Enzutix will be considered
equivalent to a lost sale for UC and Astellas.
[121] It is important to acknowledge, as highlighted by this Court in Cipla, that (a) patent
protection ordinarily results in the public being denied access to generic drugs for the
duration of the patent term, and (b) given the commercial benefit associated with being
duration of the patent term, and (b) given the commercial benefit associated with being
first to market among generics, it is common practice for the patentee of a pharmaceutical
29 Ibid para 52.
37
product to introduce an alternative competing product shortly before patent expiration, in
anticipation of generic competition. 30
[122] Counsel for UC correctly submitted that the protection of patents advances the
public interest by fostering investment in the development of new pharmaceuticals.
Pharmaceutical companies are incentivized to invest in research and the creation of
improved medications only when they have confidence that the judiciary will uphold patent
rights throughout their duration. As Nugent JA observed in Cipla, refusing an interdict
solely to diminish a patentee’s lawful monopoly would constitute an improper exercise of
judicial discretion. 31
[123] I, however, believe that in this case, there are compelling reasons to deny the
interdict, namely: the immediate impact on cancer patients using Ezutix; the respondents'
tender, which simplifies loss calculation for UC and Astellas, and the patent's imminent
expiration in March 2026.
Summary and costs
[124] For the reasons stated above, all three applications fall to be dismissed. Regarding
both Eurolab’s groundless t hreat application and Dis -Chem’s counterapplication, costs
will be determined in accordance with the outcome. However, separate considerations
apply to the costs relating to the interim interdict proceedings.
[124] As I explained above, the refusal of interim relief is based primarily on public
interest considerations , not the respondents’ case. The respondents’ opposition was
driven by their own financial interests, while UC and Astellas acted within their rights to
protect the patent. UC and Astellas should, therefore, not be mulcted with costs. It is thus
fair for the parties to bear their own costs in respect of the interim interdict proceedings.
There is no reason why the respondents should not be ordered to pay all related costs,
including those of two counsel where applicable, in the other two applications.
30 Ibid para 53.
31 Ibid para 56.
38
[125] In the result, the following order is made:
1 The appeal is upheld with costs, including the costs occasioned by the employment of
two counsel.
2 The order of the Court of the Commissioner of Patents is set aside and replaced with
the following order:
‘(a) The application by first respondent, Eurolab (Pty) Ltd, brought under the provisions
of s 70 of the Patents Act 57 of 1978, is dismissed with costs on Scale C, including
the costs of two counsel where so employed, and the qualifying fees of the
applicants’ (the Regents of the University of California; Astellas Pharma Europe
Ltd; Astellas Pharma Inc and Astellas Pharma (Pty) Ltd, respectively), expert
witnesses.
(b) The counterapplication for revocation of patent no 2007/10870 instituted by the
second to fourth respondents (Dis-Chem Oncology (Pty) Ltd; Dis-Chem Oncology
Distibution (Pty) Ltd; and Dis -Chem Pharmacies (Pty) Ltd, respectively) is
dismissed with costs on Scale C, including the costs of two counsel where so
employed, and the qualifying fees of the applicants’ expert witnesses.
(c) The application for interim relief instituted by the applicants is dismissed. Each
party shall pay its own costs.’
____________________
J E SMITH
JUDGE OF APPEAL
Molemela P
[126] I agree with the reasoning and conclusion of my brother, Justice Smith (the first
judgment), except for the conclusion he reaches in para 43 of the judgment where he
finds that ‘UC is precluded from relying on the 2009 assignment to resist an attack on the
finds that ‘UC is precluded from relying on the 2009 assignment to resist an attack on the
validity of the patent based on s 61(1)(a) because the assignment did not exist at the time
39
of the patent application.’ I respectfully disagree with the conclusion reached by my sister,
Justice Baartman (the second judgment). I agree with the first judgment’s finding that the
orders granted by the Commissioner ought to be set aside. Furthermore, from my point
of view, the Commissioner erred in granting Eurolab the order granted in respect of the
application founded on groundless threats.32 This is because, by the time the applications
were heard, UC had already instituted action for damages against Eurolab. It goes without
saying that once the damages claim was instituted, Eurolab could no longer be granted
relief on the basis that UC had made groundless threats against it. It follows that it was
no longer necessary for the Commissioner to consider granting the interdict sought,
except for addressing himself to an appropriate costs order.
[127] It is correct that the disposed of the matter on the basis that the crux of the matter
was whether UC, as the patentee, had been entitled to apply for the patent as provided
in s 27 of the Act; specifically, whether UC was a ‘person acquiring from [the inventor] the
right to apply’ for the patent. In finding that there was no such entitlement, the second
judgment finds that in the Power of Attorney filed at the Registrar of Patents, Ms Silverman
named the eight inventors but failed to file the 1986 Collaboration Agreement concluded
between HHMI and UC, which purportedly evidenced the assignment of the rights of the
HHMI inventors to UC.
[128] The second judgment posits that because the HHMI inventors were never in UC’s
employ, they could not conceivably have assigned the intellectual property rights
pertaining to their inventions to UC in terms of their employment contracts. It is on that
basis that the second judgment concludes that UC was not entitled to register the patent
in the absence of a proper deed of assignment from the HHMI inventors, as UC had not
in the absence of a proper deed of assignment from the HHMI inventors, as UC had not
declared any o ther mechanism through which it had obtained the rights of all the
inventors. I disagree. In the succeeding paragraphs, I will illustrate that, although the 1986
Collaboration Agreement was not submitted to the South African Patents Office, the other
32 The orders read as follows: ‘3.The application by Eurolab (Pty) Ltd brought under Case No:2023-108509
is granted to the extent that the treats of infringement proceedings made by The Regents of the University
of California, Astellas Pharma Europe Ltd, Astellas Pharma Inc and Astellas Pharma (Pty) Ltd in relation to
South African Patent No. 2024-039643 are found unjustifiable.
4.The Regents of The University of California, Astellas Pharma Europe Ltd, Astellas Pharma Inc and
Astellas Pharma (Pty) Ltd are interdicted and restrained from a continuance of these threats. ’
40
documents filed, when considered in their entirety, clearly establish a chain of title that
entitled UC to file the PCT application and also register the patent at the South African
Patents Office.
[129] It is noteworthy that the deponent to Eurolab’s affidavit in the application
concerning groundless threats did not contest the fact that Mr Sawyers, Mr Tran, and Mr
Wongvipat were employed by HHMI when they made the inventions central to the dispute
between the parties. In that affidavit, Eurolab admitted that a copy of the patent file from
the South African patent office ‘includes several documents relating to the assignment of
rights from the inventors , including the Patents Agreement dated 1 Januar y 1987.
However, Eurolab asserted that none of those documents, read alone or together with
documents later attached to correspondence, were ‘sufficient to give UC the rights to the
invention at either one of the filing date[s] of the PCT application or the lodging date of
the pat ent at the South African patent office’. This assertion is not borne out by the
documents attached to Eurolab’s founding affidavit. It is to these documents that I now
turn.
[130] In terms of a Patent Agreement concluded between HHMI and UC dated 1 January
1987, HHMI was required to assign to UC the rights to all patentable inventions that were
conceived at UC’s facilities by any HHMI employee pursuant to a programme financed by
HHMI. The same agreement recorded that, subject to the sharing of patent costs and
royalties, HHMI shall assign to UC all of its rights, title, and interest in HHMI patentable
inventions.
[131] The key elements of a document titled ‘Statement of Policy on Intellectual Property’
outlined its primary objectives as follows:
‘(a) The primary purpose of the Howard Hughes Medical Institute ( “the Institute”) is the
promotion of human knowledge within the field of basic sciences and the effective
promotion of human knowledge within the field of basic sciences and the effective
application thereof for the benefit of mankind. To carry out these papers, the Institute has
established this policy to promote disclosure of, and make available to the public on a
nondiscriminatory basis, the results of Institute research, to define and protect the rights
of institute personnel, to provide for an equitable distributi on of the rewards and
responsibilities attendant upon inventions, discoveries, improvements and other
41
intellectual property, and to provide that income of the Institute from such intellectual
property be used for the purpose of promoting Institute research.
(b) This policy applies to any invention, discovery, improvements or other intellectual
property, whether or not patentable or copyrightable, developed directly or indirectly as a
result of a program of research financed by institute funds or by funds under the control
of the institute (each a “subject property ”). All salaried or hourly full -time or part -time
Institute employees and the volunteers, including students, and all other persons who
provide services to the Institute or use the Institute’s facilit ies and equipment (“Institute
personnel”) shall be subject to this policy. The share of royalties of Institute personnel
who develop a subject property as a result of their endeavors on behalf of the Institute
(“inventors”) shall be determined in accordance with this policy.’ (Own emphasis.)
The same document further provides that any member of the committee established by
the Chief Executive Officer of HHMI may sign documents and contracts on HHMI’s behalf.
It also makes provision for collaboration with affiliated institutions.
[132] Among the documents filed with the Registrar are three documents signed by the
three HHMI inventors in 2003, titled ‘Intellectual Property Statement of Agreement’. These
documents outline a range of terms to which these inventors mutually consented. Among
these terms are the following: (i) to abide by the HHMI Policy of Statement and any
amendments thereto; (ii) to assign to HHMI ‘all rights I may have or hereafter acquire in
any and all subject property’; and (iv) to abide by the terms of any agreement entered into
by HMMI with the government of the USA or another entity as a condition of receiving
research materials, in connection with a research collaboration, or otherwise in
connection with institute research.
connection with institute research.
[133] It is important to note that, in the Deed of Assignment entered into between
Mr Sawyers and HHMI on 17 August 2005, Mr Sawyers recognised himself as both an
inventor and an HHMI employee. It is equally crucial to note that, according to that
document, he was not only assigning his rights to one specific invention to HHMI, but he
was also doing so with respect to ‘any invention, d iscovery, improvement, or other
intellectual property, regardless of whether it is patentable or copyrightable’. He
acknowledged that he was assigning his entire right title and interest not only in respect
of the invention entitled ‘Novel Androgen Receptor Inhibitors with Minimal Agonistic
42
Activities’ issued from the United Patent and Trademark Office but also in relation to ‘any
and all patents issued therefrom; and all patents which are directed to the invention and
which may be contained in continuation -in-part applications or in patents which issue
therefrom’.
[134] Mr Sawyers also agreed to execute, upon request further documents that may be
required for purposes of assigning his entire right, title and interest in the invention to
HHMI or others, upon the direction of HHMI for purposes of applying for, obtaining, and
enforcing patents, copyrights, or other rights in the United States and in any foreign
country with respect to the invention. He also affirmed that he had not entered into any
other agreement or assignment that conflicts with that Assignment. A sim ilarly worded
Deed of Assignment was signed by the inventors between 24 May 2006 and
12 June 2006 in relation to the Diarylhydantoin compounds. This assignment was in
relation to P1, P2, P3, and RD162.
[135] Much was made about the fact that some of the assignment instruments were
signed after the patent application date of 29 March 2006. This, however, fails to take into
account that by virtue of their employment contracts, all employees of UC and HHMI had
agreed to grant ownership rights of all conceived and to -be-conceived property to HHMI
and UC as employers, and by the t ime the patent application was filed, such rights had
already become vested in both HHMI and UC. The fact that other documents were
subsequently signed by the same inventors does not detract from this, given that they
had agreed to sign any documents their employers required. In my view, the collaboration
between UC and HHMI and assignment of HHMI’s rights to the inventions of its
employees is implicit in the Assignment signed by Mr Sawyers on 17 August 2005.
[136] Du Pont and subsequent judgments that refer to it with approval 33 make it plain
[136] Du Pont and subsequent judgments that refer to it with approval 33 make it plain
that it is not unusual for employers to include employment agreements with assignment
clauses that unequivocally indicate an intention to grant the employer rights in inventions
made by the employee during the period of employment. In the same vein, an assignment
33 Du Pont was confirmed in Firm Construction Co Ltd v PG Kusel 1997 BIP 25 (CP), where it was held that
an employment contract can be submitted as proof of ownership of the invention by the employer and
lodged in the place of a formal assignment.
43
clause may unequivocally indicate an intention to transfer ownership of a future invention
without the need for any subsequent agreement, with the effect that ownership transfers
immediately upon the invention’s creation . What is critical and decisive is t he language
that is used in the assignment clause.
[137] In this matter, the rationale for applying that approach is justified by the terms of
the various agreements signed by the inventors, seen against the backdrop of the
Statement of Policy as articulated in para 130 of this section of the judgment. The phrases
‘hereby agree to assign and assign’ constitute a present assignment clause intended to
ensure that the transfer of ownership is immediate and effective. Similarly, the broad
definition of intellectual property in phrases such as ‘to assign to [HHMI] ‘all rights I may
have or hereafter acquire in any and all subject property’, and to assign ‘ any invention,
discovery, improvement, or other intellectual property, whether or not patentable or
copyrightable’ as set out in the documents alluded to above, signal an intention to have
an all-encompassing assignment of all rights title and interest to all inventions made by
these employees in the course of their employment.
[138] Provisions requiring the inventor to sign additional documents to perfect the legal
title in the future are phrases that are indicative of an intention to affect a valid transfer of
ownership of the inventions made in the course of employment without requiring an
employer to take further steps to obtain a valid assignment before applying for a patent.
Therefore, the fact that the inventors agreed to sign further documents that were furnished
to them must be considered against the backdrop of contractu al arrangements that
already permit such filings, and not as signalling an intention to correct what was legally
impermissible. What is important to observe is that none of the documents subsequently
impermissible. What is important to observe is that none of the documents subsequently
signed by these inventors conflict with any of the contr actual agreements to which they
had committed themselves.
[139] As regards the 1986 Collaboration Agreement, sight must not be lost of the fact
that neither Eurolab nor Dis -Chem disputed its authenticity. Eurolab contended that the
agreement obligates HHMI to execute future assignments in favour of UC. At the same
time, Dis-Chem posited that the agreement in question conferred a personal right on UC
to acquire assignments from HHMI. Neither Eurolab nor Dis-Chem pleaded that the rights
44
to assignment as embodied in the 1986 Collaboration Agreement were conditional. The
first judgment thus correctly concludes that the rights to assignment as embodied in the
1986 Collaboration Agreement were unconditional.
[140] As regards the assignment by HHMI to UC, t he document ostensibly signed by
HHMI on 31 August 2005, titled ‘Appointment of Investigator as Agent’, appoints
Mr Sawyers to act as UC’s agent for purposes of assigning to UC ‘the rights [HHMI] has
or may acquire in the Invention by reason of the research program conducted at UC’. In
this regard, it is of significance that neither HHMI nor any of the inventors disputes the
validity of the agreements concluded between the parties in 1986 and 1987. It is therefore
opportunistic for Eurolab and Dis-Chem, which have not disputed the authenticity of any
of these documents, to attack their legal force and effect on speculative grounds. In
circumstances where one of the undisputed documents is a policy statement of HHMI,
which stipulates that any member of the committee established by the Chief Executive
Officer of HHMI may sign documents and contracts on behalf of HHMI and also allows
collaboration with affiliated institutions, there is no basis for rejecting the validity of any of
these agreements.
[141] It is not surprising that Eurolab did not join issue with Dis -Chem's challenge to
Sawyers' authority in finalising the 2005 agreement. The assignment instrument clearly
evinces a valid assignment. Furthermore, the agency document authorised Mr Sawyers
to act as HHMI’s agent in relation to the assignment of its rights, title, and interests in its
inventions to UC. The authenticity of the document has not been disputed. However, Dis-
Chem contends that this agency document cannot come to UC’s aid because one cannot
validate one's own agency. I disagree because the authenticity of the remaining
documents has not been questioned.
documents has not been questioned.
[142] Notably, Mr Sawyers has deposed to an affidavit which aligns with the respondents'
account of events. Moreover, the two other inventors who were employed by HHMI under
similar contracts basically confirmed his version. Although the facts of cases involving the
same patent in three different countries are not analogous to those of this matter, it is
important to note that HHMI never challenged any of UC's claims during the 18 years the
patent was registered. During this time, HHMI continued to receive royalties from the
45
patent, which, in my view, is a significant consideration. The Patent Agreement dated
1 January 1987; the assertions made by the three HHMI inventors in their affidavits; the
undisputed assignment instrument executed by Mr Sawyers and HHMI , authorising
Mr Sawyers to sign the assignments; the Statement of Policy on Intellectual Property
endorsed by HHMI, which permits delegation of authority to sign agreements and
documents to senior employees; the absence of demur from HHMI in ongoing litigation
concerning these patents; and the continued receipt of royalties by HHMI, are all factors
that, considered as a whole, reasonably support the conclusio n that Mr Sawyers
possessed the authority34 to assign HHMI inventions in favour of UC.
[143] In any event, b earing in mind that both Eurolab and Dis -Chem bore the onus of
establishing invalidity of the patent, 35 the inference Dis -Chem seeks to draw regarding
Mr Sawyers’ alleged lack of authority is not a reasonable one when the conspectus of the
facts is considered. In my opinion, the evidence suggests that Mr Sawyers can be deemed
competent to attest to the existence of the agency, define the scope of his authority, and
confirm the contract executed on behalf of the principal.
[144] Since the patent under consideration falls in the category of PCT patents, there
can be no reason why the documents furnished to the Registrar, along with the Patent
Agreement dated 1987, cannot be regarded as adequately demonstrating UC's
entitlement to apply for patents P1, P2, P3, and RD162. In my opinion, all the documents
mentioned in the preceding paragraphs , considered together through the lens of the
Endumeni interpretive exercise, reveal a clear intention (i) to automatically transfer
ownership of inventions to HHMI and UC by their respective employees; and (ii) by HMMI
to transfer its rights to UC in terms of the 1987 Patents Agreement. Considered as a
whole, these agreements reveal a clear chain of title that entitled UC to apply for patent
whole, these agreements reveal a clear chain of title that entitled UC to apply for patent
registration even in the absence of the 1986 Collaboration Agreement or the 2009
assignment. This aligns with the provisions of s 27(1) of the Act, which permit either the
inventor or any other person acquiring the right from the inventor to apply for the patent.
34 Compare Makate v Vodacom (Pty) Ltd [2016] ZACC 13 para 165.
35 In Gentiruco AG v Firestone SA (Pty) Ltd 1972 (1) SA 589 (A) at 629 E -F, it was held that the person
attacking the validity of the patent bears the burden of proof. Also see Roman Roller CC and another v
Speedmark Holdings (Pty) Ltd 1996 (1) SA 405 (A) at 412 F-G.
46
[145] For all the reasons stated above, I too conclude that the Commissioner erred in
finding that UC’s registration of the patent did not satisfy the requirements of s 27 of the
Act.
________________________________
MB MOLEMELA
PRESIDENT OF THE APPEAL COURT
Baartman JA
[146] I have had the benefit of reading the first and second judgments. I concur with both
judgments in respect of the issues for determination and conclusion in all but one issue.
I respectfully differ in respect of the effect of s 61(1) (a) read with s 27 of the Patents Act
on the facts in this matter. I deal with that issue below.
[147] The first appellant, the Regents of the University of California (UC), is the
registered proprietor of South African patent No. 2007/10870 titled Diarylhydantoin
Compounds and claims the compound enzalutamide ( ‘RD162’) used in the treatment of
prostate cancer (the patent). The second to fourth appellants (Astellas) are the licensees
under the patent. I shall refer to UC and Astellas collectively as the appellants. On 24
February 2025, the Court for the Commissioner of Patents for the Republic of South
Africa, Pretoria, per Le Grange AJ, (the Commissioner) revoked the patent and granted
ancillary relief. The appeal is with leave of the Commissioner of Patents.
[148] It was common cause that UC, in collaboration with the Howard Hughes Medical
Institute (HHMI), invented the compound RD162’. Eight inventors were involved in the
research, five of whom were UC employees (the UC inventors) and the remaining three
were HHMI employees (the HHMI inventors). The patent, a national phase filing, was filed
on 29 March 2006 under application number PCT/US2006/011417 (the PCT application).
47
The lodging date of the national phase patent application at the South African Patent
Office was 13 December 2007, in terms of the Patents Act, 57 of 1978 (the Patents Act).
It will expire on 29 March 2026. UC filed a declaration36 claiming the earliest priority is US
60/680.835 dated 13 May 2005 (P1).
[149] Each UC inventor had signed a patent acknowledgement in favour of UC in their
respective employment contracts. Similarly, in 2003, the HHMI inventors had assigned
their rights in the invention to HHMI. In 1986, UC and HHMI entered into a Collaboration
Agreement (the 1986 Collaboration Agreement). The admissibility of this agreement is in
dispute; I deal with it below.
[150] On 23 April 2008, Cheryl Silverman (Ms Silverman), at the time UC’s Patent
Prosecution Manager, filed a declaration and power of attorney 37 with the South African
Patent’s Registrar claiming that ‘the inventors of the abovementioned invention are the
persons named above and the applicant has acquired the right to apply by virtue of an
assignment from the inventors;’. Ms Silverman named the ei ght inventors and made no
mention of the collaboration agreement or any transfer of rights from HHMI. In respect of
the HHMI inventors, the declaration was false. UC declared no other mechanism in the
prescribed declaration through which it had obtained the rights of all the inventors.
[151] In 2003, the first respondent, Eurolab (Pty) Ltd (Eurolab) obtained regulatory
approval from the South African Health Products Regulatory Authority (SAHPRA) for
Enzutrix, a generic of RD162’ that fell within the scope of the patent. This concerned the
appellants to the extent that they demanded Eurolab undertake neither to launch its
product nor to give the rights to do so to a third party for the remaining life of the pat ent,
failing which litigation would follow. In response, Eurolab denied that reg istration was a
ground on which to threaten infringement proceedings38 and alleged that the patent was,
ground on which to threaten infringement proceedings38 and alleged that the patent was,
in any event, liable to be revoked. The parties were unable to resolve their differences.
Therefore, on 19 October 2023, Eurolab launched proceedings (the groundless threats
application) in terms of s 7039 of the Patents Act, claiming the following relief:
36 In terms of regulation 22(1) of the Patent Regulations, 1978 (the Regulations).
37 Section 30 of the Patents Act and regulations 8(1), 22(1) (c), 33 and 67B of the Regulations.
38 Sections 45 and 69A of the Patents Act.
39 Section 70 provides: ‘Remedy for the groundless threats of infringement proceedings
48
‘1. that the threats of infringement proceedings made by the respondents in relation to the South
African Patent … are unjustifiable;
2. that the respondents are interdicted and restrained from the continuance of these threats…’
[152] In the groundless threats application, Eurolab alleged that the patent was liable to
be revoked and indicated that it was applying for the revocation of the patent. Eurolab
relied on the misrepresentations contained in the Silverman declaration for its cl aim that
UC was not entitled, in terms of s 61(1) (a) read with s 27, to have applied for the patent
when it did. Eurolab further alleged that UC had made material misrepresentations on the
form P3 in the patent application, which also rendered the pat ent liable to be revoked in
terms of s 61(1)(g) of the Patents Act.
[153] Astellas is the registered licensee of RD162’ and sells Xtandi, the active ingredient
in RD162’, commercially known as enzalutamide’ and its generic Enzut rix. In 2024, in
contravention of Astellas’ licence, the second to fourth respondents (collectively Dis -
Chem) started distributing Enzut rix in South Africa. Disputes between Dis -Chem and
Astellas arose which le d to Astellas and UC launching interim interdict proceedings in
which they sought to interdict Eurolab and Dis -Chem from infringing the patent (the
interim interdict application). Dis-Chem responded by launching a counter-application for
the revocation of the patent (the revocation application). Dis-Chem alleged that the patent
was liable to be revoked for the reasons Eurolab had advanced and additionally attacked
the novelty of the patent under s 61(1)(c) of the Patents Act.
[154] The three applications, the interim interdict, the groundless threats application, and
the revocation application, served before the Commissioner simultaneously. The
Commissioner held that in compliance with ss 61(1) (a) and 27 of the Patents Act, UC
Commissioner held that in compliance with ss 61(1) (a) and 27 of the Patents Act, UC
(1) Where any person, by circular, advertisement or otherwise, threatens any other person with proceedings
for infringement of a patent, a person aggrieved thereby may, whether the person making the threats is or
is not entitled to or interested in a patent, o r an application for a patent, institute proceedings against him
and obtain a declaration to the effect that such threats are unjustified and an interdict against the
continuance of such threats, and may recover such damages, if any, as he has sustained thereby, unless
the person making the threats proves that that the acts in respect of which the proceedings are threatened,
constitute or, if done, would constitute an infringement of the patent in respect of a claim in the specification
which is not shown by the Plaintiff to be invalid: Provided that a circular, advertisement or communication
addressed to any person , which comprises only a notification of the existence of a particular patent upon
which the proprietor relies for the protecting of his interest shall not, by itself, be deemed to be a threat of
proceedings for infringement.’
49
should have obtained from all the inventors the right to apply before it made the patent
application. As the HHMI inventors had assigned their rights to HHMI and the latter had
not ceded those rights to UC before it applied, the patent was liable to be rev oked.
Therefore, the Commissioner held that UC had not established the prima facie right
contended for in the interim interdict application. The Commissioner considered that
finding dispositive of the three applications and made the following order:
‘1. The non-compliance by the parties with the provisions relating to forms and services are
condoned.
2. The application by The Regent of the University of California, Astellas Pharma Europe Ltd,
Astellas Pharma Inc and Astellas Pharma (Pty) Ltd brought under Case No: 2024-039643
is dismissed.
3. The application by Eurolab (Pty) Ltd brought under Case No:2023 -108509 is granted to
the extent that the treats of infringement proceedings made by The Regents of the
University of California, Astellas Pharma Europe Ltd, Astellas Pharma Inc and Astellas
Pharma (Pty) Ltd in relation to South African Patent No. 2024 -039643 are found
unjustifiable.
4. The Regents of The University of California, Astellas Pharma Europe Ltd, Astellas Pharma
Inc and Astellas Pharma (Pty) Ltd are interdicted and restrained from a continuance of
these threats.
5. The counter application by Dis-Chem Oncology (Pty) Ltd, Dis-Chem Oncology Distribution
(Pty) Ltd and Dis-Chem Pharmacies (Pty) under Case No: 2024-039643 is granted to the
extent that Patent No.2007/10870 is revoked in terms of section 61(1)(a) as read with
section 27 of the Patents Act, No.57 of 1978.’
[155] The Commissioner did not deal with the other grounds of invalidity raised by
Eurolab and Dis-Chem. At the hearing, in accordance with this Commissioner’s ruling, all
the issues in dispute were fully canvassed. While I agree with the majority judgment’s
the issues in dispute were fully canvassed. While I agree with the majority judgment’s
finding regarding when the right to file must exist, I respectfully differ in respect of the
effect of s 61(1)(a) read with s 27 of the Patents Act on the facts in this matter. I turn to
that issue. Section 61(1)(a) provides as follows:
‘(1) Any person may at any time apply in the prescribed manner for the revocation of a patent on
any of the following grounds only, namely-
(a) that the patentee is not a person entitled under section 27 to apply for the patent.’
Section 27(1) of the Patents Act provides as follows:
50
‘(1) An application for a patent in respect of an invention may be made by the inventor or by any
other person acquiring from him the right to apply or by both such inventor and such other person.’
[156] Sections 61(1) (a) and 27 must be read together. The approach to statutory
interpretation is now well established. The courts have repeatedly stressed that
commercial and legal documents must be interpreted contextually and purposively. In
Cool Ideas 1186 CC v Hubbard and Another40 the Constitutional Court held that:
‘A fundamental tenet of statutory interpretation is that the words in a statute must be given their
ordinary grammatical meaning, unless to do so would result in absurdity. There are three
important interrelated riders, namely:
(a) that statutory provisions should always be interpreted purposively;41
(b) the relevant statutory provision must be properly contextualised42; and
(c) all statutes must be construed consistently with the Constitution, that is, where reasonably
possible, legislative provisions ought to be interpreted to preserve their constitutional validity. This
proviso to the general principle is closely related to the purposive approach referred to in (a).43’
[157] The interpretative exercise starts with the language of the sections. The appellants
submitted that the reference to ‘acquiring’ is important as it indicates that a person may
apply while in the process of acquiring the right from the inventor and that the time for
consideration of the right to apply is the date when the application for revocation is made.
The circumstances of this matter underscore the danger of accepting that proposition. To
date, an unambiguous transfer of rights from HHMI to UC has not been filed with the
registrar and the 20-year patent monopoly has a few weeks left before expiry.
[158] There is no ambiguity in the provisions of s 61(1) (a) read with s 27; it envisages
an enquiry into the applicant’s entitlement to have applied for registration of a patent as
an enquiry into the applicant’s entitlement to have applied for registration of a patent as
40 Cool Ideas 1186 CC v Hubbard and Another [2014] ZACC 16; 2014 (4) SA 474 (CC);2014 (8) BCLR 869
(CC) para 28; Natal Joint Municipality Pension Fund v Endumeni Municipality [2012] ZASCA 13; [2012] 2
All SA 262 (SCA); 2012 (4) SA 593 (SCA) (Endumeni).
41 Dengetenge Holdings (Pty) Ltd v Southern Sphere Mining and Development Co Ltd and Others 2014 (3)
BCLR 265 (CC); [2013] ZACC 48 paras 84 – 86; and Department of Land Affairs and Others v Goedgelegen
Tropical Fruits (Pty) Ltd 2007 (6) SA 199 (CC); 2007 (10) BCLR 1027; [2007] ZACC 12) para 5.
42 North East Finance (Pty) Ltd v Standard Bank of South Africa Ltd 2013 (5) SA 1 (SCA) ; [2013] ZASCA
76 para 24; KPMG Chartered Accountants (SA) v Securefin Ltd and Another 2009 (4) SA 399 (SCA) ([2009]
2 All SA 523; [2009] ZASCA 7) para 39; and Jaga v Dönges NO and Another; Bhana v Dönges NO and
Another 1950 (4) SA 653 (A) at 664E – H.
43 SATAWU and Another v Garvas and Others 2013 (1) SA 83 (CC); 2012 (8) BCLR 840; [2012] ZACC 13)
para 37.
51
at date of the application. Only after the application is granted is an applicant referred to
as a patentee. Therefore, s 27 is concerned with the entitlement of an applicant before
the patent is granted. This accords with the purpose of the Patents Act - protection of an
inventor’s right to exploit his or her invention. The patentee has a monopoly for the period
of the patent's validity. This, as the facts in the matter show, can have far -reaching
consequences for the public. In this instance, it is those suffering from prostate cancer
who are denied access to a cheaper generic version of the patented compound.
[159] A register is kept to inform the public of the status of a patent and the restrictions
it imposes on a particular industry. In Ascendis Animal Health (Pty) Ltd v Merck Sharpe
Dohme Corporations and Others,44 the Constitutional Court held:
‘[100] …We must not lose sight of the fact that testing the validity of patents is in the public interest
because patents create artificial monopolies. Currently, South Africa completely relies on private
parties to regulate this artificial monopoly system because the government does not examine a
patent’s validity upon registration. Instead of deterring litigants, who are working both in a private
capacity and for the public interest, there should be an inclination to encourage them to bring
more revocation challenges, not to create extensions in common law that increase the costs and
risks of doing so.’ (Citations omitted.)
[160] It is in the public interest that inventors be encouraged to invest in research,
knowing that their rights will be protected. However, a patent applicant engages in a
specialised field and has the obligation to acquaint herself/himself/itself with the
applicable legislative requirements before venturing into the field. 45 It requires the
applicant to act with diligence to protect its invention. The responsibility for the accuracy
applicant to act with diligence to protect its invention. The responsibility for the accuracy
of a declaration in an application for a patent rests fairly and squarely upon the applicant.46
South Africa has mundane requirements for the registration of a patent. The system is
dependent on the bona fides of applicants. UC engages in patent applications
internationally and is experienced in the field. Ms Silverman is not an administrative clerk
whose errors can be excused as such; instead, she was Patent Prosecution Manager
44 Ascendis Animal Health (Pty) Ltd v Merck Sharpe Dohme Corporation and Others [2019] ZACC 41; 2020
(1) SA 327 (CC); 2020 (1) BCLR 1 (CC); 2019 BIP 34 (CC) para 100.
45 In Biogen v Celltrion ECLI:NL:GHDHA :2019:1962 para 4.7, a matter in the Court of Appeal of The Hague
the following was stated: ‘…the conditions for granting and revoking patent for a particular country are
determined by the law of that country- the lex loci protectionis.’
46 Bendz Ltd and Another v South African Lead Works Ltd 1963 BP 409 (A);1963 (3) SA 797 (A).
52
and could reasonably be expected to have known about the collaboration agreement
between UC and HHMI. It is inconceivable that Ms Silverman did not know that the HHMI
inventors had assigned their rights to their employer.
[161] As indicated above, the lodging date of the national phase patent application at the
South African Patent Office was 13 December 2007. The application date for purposes of
s 27 was 29 March 2006. 47 At that time, UC had obtained from the UC inventors their
rights in the patent but not from the HHMI inventors. In 2006, the rights of the HHMI
inventors vested in their employer. As indicated above, the Silverman declaration did not
mention HHMI nor the collaboration agreement. That does not mean that UC was not
vested with the rights to make the application, even though it does not appear from the
documents filed in the register as the court in Du Pont correctly found.
[162] In Du Pont, the court dealt with an application for rectification under the Patents
Act, 57 of 1952. It was alleged that the patent was liable to be revoked because the name
of one inventor, Mr Gay, had been omitted from the application. The court held:
‘When the relevant facts are considered, it seems clear that there is no question of a
misrepresentation, let alone a material misrepresentation in the present case. The applicant was
at all relevant times the holder of all the rights, including those of Gay, to the invention. It could
not, therefore, by omitting Gay’s name as an inventor, obtain anything to which it was not entitled.
…
The patent in suit is a document lodged in pursuance of an application for a patent and the
omission is an error in such document for the amendment or rectification of which no provision is
made elsewhere in the Act. The fact that the patent has expired, is irrelevant. It remains filed with
the Registrar and the public is entitled to have access to it at any time, for example for purposes
of establishing the state of the art or a possible anticipation of a later patent. The delay in bring
this application is also irrelevant. There is no indication of bad faith or blameworthiness on the
part of the applicant, and there can certainly not be any prejudice to anyone if the rectification
should be effected. On the contrary, it will benefit the public and the art should the register be
corrected in order to reflect the proper state of affairs. There is hence no valid objection to
…rectification….’48 (Own emphasis.)
47 The date of filing of the international application number PCT/US2006/011417.
48 Ibid at 289A-290C.
53
[163] The facts in this matter differ from those in Du Pont. Mr Gay had in his employment
contract with the applicant ceded his rights in the invention to his employer. Therefore,
the UC inventors are in the position of Mr Gay and UC always held all their rights in the
invention. Not so with the HHMI inventors. UC had an enforceable contractual right
against HHMI to transfer to it the rights of the HHMI inventors as per the collaboration
agreement. Until HHMI transferred the rights of its inventors, HHMI wa s the holder
thereof, not UC.
[164] In Du Pont, the court granted rectification on application. The court considered that
‘there was no bad faith or blameworthiness on the part of the applicant, no prejudice to
anyone, and that it was in the public interest that the register be correct.’ I accept that
errors in the register can be corrected. Section 50 49 deals with the correction of clerical
errors. Ms Silverman’s false declaration cannot be ascribed to clerical error as she was
the patent prosecution manager when she made the declaration. Evidently, the section is
not applicable.
[165] In the groundless threats application, UC relied on several documents it claimed
had corrected its title in the register. I deal briefly with the futile 2017 attempt to amend
UC’s ‘chain of title’. On 13 February 2017, UC applied in terms of regulation 39 50 of the
Regulations to amend its title as follows:
‘In terms of section 50(1)(a) of the Act and regulation 11 of the Patent Regulations, the applicant
hereby requests the following:
That the application be corrected in that the assignment on file be replaced with the attached
assignments showing the following chain of title: The applicant acquired the right to apply for a
patent by virtue of an assignment from the inventors …[the UC inventors] to the applicant and by
virtue of an assignment from the inventors SAWYERS, Charles L, TRAN, Chris and WONGVIPAT,
49 Section 50(1) provides: ‘The registrar or the commission may authorise-
49 Section 50(1) provides: ‘The registrar or the commission may authorise-
(a) The correction of any clerical error or error in translation in any patent, application for a patent or
document lodged in pursuance of such an application, or in the register;
(b) The amendment otherwise of any document for the amending of which no express provision is made in
the Act.’
50 Regulation 39 provides: ‘Requests and application to registrar
Unless otherwise provided, any request or application to the registrar shall be made on form P4 in duplicate
quoting the section or the Act or the regulation or both under which relief is sought and shall set out the
relief claimed. The duplicate of the form shall be returned to the applicant or his agent.’
54
John Howard Hughes Medical Institute, which subsequently assigned to the applicant.’ (Own
emphasis.)
[166] UC relied on the 31 August 2005 authorisation HHMI gave to Mr L Charles Swayers
(Mr Swayers), one of the HHMI inventors, to assert his authority to have assigned to it the
right to have applied for the patent. The authorisation was signed by HHMI’s Vice
President and Chief Scientific Officer and provides in relevant part as follows (the 2005
authorisation):
‘APPOINTMENT OF INVESTIGATOR AS AGENT
Appointment by [HHMI] (the “Institute”) of Charles L. Swayers, MD, an employee of the Institute,
as its agent for purpose of assigning certain rights to [UC].
WHEREAS, the Institute and [UC] collaborate in the active conduct of medical research pursuant
to an Agreement between them dated as of November 1, 1986 (the “Agreement”).
…
WHEREAS, research conducted pursuant to the Agreement by [Mr Swayers] while employed by
the Institute at [UC] has resulted in the invention of a certain Subject Property entitled “Novel
Androgen Receptor Inhibitors with Minimal Agonistic Activities,” which is the subject of a patent
application entitled “Novel Androgen Receptor Inhibitors with Minimal Agonistic Activities” filed in
the U.S. Patent and Trademark Office on May 11, 2005, and the Invention is a Subject Property;
and
WHEREAS, [HHMI] wishes [Mr Swayers] to act as its agent for the purpose of assigning to [UC]
the rights [HHMI] has in the Invention by reason of the research program conducted at [UC]
NOW THEREFORE, [HHMI] hereby appoints [Mr Swayer s] as its agent for the purpose of
assigning the rights [HHMI] has or may acquire in the Invention by reason of the research program
conducted at [UC] to [UC] with and subject to the conditions of the Agreement’
[167] Eurolab alleged that the 2005 authorisation was limited to the first priority
document, which did not include the invention that forms the subject of the three
document, which did not include the invention that forms the subject of the three
applications under consideration. It made that allegation in the founding affidavit in the
groundless threats application, paragraphs 5.30 - 5.30.2 as follows:
‘5.30 The sixth document is titled “Appointment of Investigator as Agent” …The document was
signed on 31 August 2005…
5.30.1 … The Swayers Agent Appointment thus appears to relate to P1.
55
5.30.2 The Swayers Agent Appointment was not sufficient to assign to UC the right to apply for
the patent prior to the date of filing of the PCT application, because it is not an assignment, but
simply appoints Swayers as HHMI’s agent to effect an assignment or assignments to UC.’
[168] In answer to the above, UC’s Chief Intellectual Property Office, Ms Charanjit Arora
said: ‘I admit these allegations’. Therefore, the Commissioner of Patents’s finding that Mr
Swayers’s authority was limited to P1 and ‘nowhere refers to any other or future
inventions…’ is unassailable. The appellants cannot in these proceedings rely on Mr
Swayers’s 2005 agency appointment.
[169] Nevertheless, in these proceedings, Mr Swayer s attested to an affidavit and said
that: ‘On 9 November 2009, acting for myself and in my capacity as HHMI’s agent, I
formalised the assignment of HHMI’s rights in the invention(s) (including all priority
documents and the PCT application) to UC.’ He annex ed a document entitled
‘ASSIGNMENT’ in which he claimed to be acting ‘for myself and as agent for [HHMI]…’
But at the time, Mr Swayer s had no entitlement to the invention as he had previously
assigned his rights to HHMI. At the hearing, counsel submitted that the part of the
‘ASSIGNMENT’ where Mr Swayers alleged that he was acting on his own behalf can be
ignored. That is contrary to the principles of interpretation referred to above. Counsel, on
behalf of Eurolab, submitted that the Commissioner of Patents was correct in holding that
Mr Swayers could not testify to his own authority. 51 In the circumstances of this matter,
Mr Swayers’s agency is problematic as UC had accepted that his 2005 authority was
limited to P1 and Mr Swayer s had relied on that authority for the 2009 Assignment. The
above was filed in the 2017 attempt to correct the ‘chain of title’. I am persuaded, for the
reasons stated above, that the 2017 attempt to correct the ‘chain of title’ was
unsuccessful.
unsuccessful.
[170] UC now proposes that its rights to the invention are derived from the 1986
Collaboration Agreement in terms whereof it owned HHMI’s rights. The shoe is pinching.
As indicated above, the collaboration agreement is not filed in the register; Eurolab and
51 MEC for Safety and Security, Eastern Cape v Mtokwana [2010] ZASCA 88; 2010 (4) SA 628 (SCA);
[2010] 4 All SA 583 (SCA) para 20 reads: ‘…In addition, the court below erred in inferring the agency of the
attorney from his own acts. See… Volkskas Bank Bpk v Bonitas Medical Aid Fund 1993 (3) SA 779 (A) at
789I-J and the cases there cited.’
56
Dis-Chem, relying on s 72(3), submitted that UC is barred from relying on the agreement.
Section 72(3) provides as follows:
‘Except for the purpose of 5252, a document or instrument in respect of which no entry has been
made in the register in terms of section 10, shall not be permitted in evidence in any proceedings
of proof of the title to a patent or application for a patent or to any interest therein unl ess the
commissioner or a court, on good cause shown, otherwise directs.’
[171] In my view, a court has discretion to have regard to a document not filed in the
register as the court did in Du Pont. I also make common cause with the factors that court
took into consideration, although that is list is not exhaustive. However, I respectfully
disagree with the court’s finding that the delay in bringing the application for rectification
is irrelevant. T he length and reason for the delay are factors to be considered, among
others.
[172] It is necessary to consider whether the collaboration agreement clothed UC with
the right to apply for the patent on behalf of HHMI. If it did, depending on the circumstance,
that might outweigh factors that militate against its inclusion at this late sta ge. The
collaboration agreement, in relevant part, provides as follows:
‘II. Assignment of Rights to University – Conditions
A. HHMI agrees that it will require all HHMI Personnel at HHMI at the HHMI UC Facilities to
execute a written agreement pursuant to which all such HHMI Personnel at the HHMI UC Facilities
to execute a written agreement pursuant to which all such HHMI Personnel shall agree therein to
assign to HHMI and to execute any document requested by HHMI regarding their rights, title, and
interests in or relating to any Patentable Invention conceived or developed, alone or together with
others, as a result of their employment by HHMI, or during the course of use of any funds, …HHMI
will retain and make available copies of all such agreements to the University upon the University’s
request.
52 Section 52 provides: ‘Rectification of the Register
The registrar may order the register to be rectified by making, amendment or deletion of any entry therein,
and such order may be made either on request in the prescribed manner or without such request: Provided
that where the registrar intends to make an order otherwise than upon a request, he shall give notice of his
intention to do so to the patentee or the applicant for the patent, as the case may be, and to any other
person who appears to him to be concerned, and shall give such patentee or applicant o r other person an
opportunity of being heard before making the order.’
57
B. Except as provided in paragraph F of this Article II, HHMI shall assign to the University all of
its rights, title and interest in HHMI Patentable Inventions, and HHMI further agrees that the
University’s policies and procedures, including the execution of Patent Agreement procedures,
including the execution of the Patent Agreement pursuant to the University’s Patent Policy,
pertaining to the management and disposition of such Patentable Inventions shall apply thereto
subject to the following conditions:
…
(vi) Except as otherwise required by law, or prevented by prior agreement between the University
and a third party, if the University declines or fails, after reasonable request and notice by HHMI,
to file for patent protection and prosecute diligently suc h application with respect to any HHMI
Patentable Invention for which patent protection can be obtained, the University shall, upon
request, assign back to HHMI all rights, title and interest assigned to the University pursuant to
this Agreement, and all r ights with respect to any patent issued thereon shall not be within the
scope of this Agreement….’
[173] When applying the applicable principles of interpretation, referred to above, it is
apparent that the agreement obliges HHMI to obtain the rights to future inventions from
its employees involved in research relevant to the collaboration agreement. UC coul d
request proof of the assignment of rights from the inventors to HHMI. Thereafter, HHMI
had an obligation, ‘shall’, to transfer its rights to UC on certain conditions. As is apparent
from the relevant section of the collaboration agreement quoted abo ve, UC is obliged to
protect HHMI’s patent rights.
[174] In terms of the 1986 Collaboration Agreement, UC has enforceable contractual
rights against HHMI. The latter, if called upon, would be obliged to transfer its right in the
patent to UC. That interpretation is also consistent with the way HHMI had, in 2005,
patent to UC. That interpretation is also consistent with the way HHMI had, in 2005,
transferred its rights in P1 to UC. As indicated above, HHMI transferred only its rights in
P1. Similarly, HHMI can call upon UC to institute a process to defend any threat or breach
of its patent rights. The interim interdict application is an example of UC complying with
that obligation. The obligations in terms of the collaboration agreement do not establish a
right to apply for the patent without any action on the part of HHMI. The 2005 transfer is
consistent with the interpretation of the collaboration agreement contended for above.
58
[175] Applying the Du Pont criteria to the facts in this matter, the following is apparent.
In Du Pont, the court found, correctly, that the applicant was vested with all the rights in
the patent and the correction would state the correct legal position. That is not the case
in the present matter; UC did not have the right as per its declaration. There is no apparent
bad faith in the delay; instead, the facts indicate incredible disregard for the basic
requirements of the law, which I find deplorable.
[176] The appellants’ counsel, submitted that the issue is between UC and HHMI. As the
latter has not raised any concerns, its consent should be inferred. Unfortunately, the
information in the register is for the public benefit, and those interested in that industry
are entitled to rel y on the information contained in the register. As the Constitutional
Court53 emphasised, we should encourage challenges to patent monopoly because
South Africa does not examine patent validity on registration. The opportunity for abuse
is obvious and, in certain circumstances, could have dire consequences for the public.
[177] I accept that Eurolab and Dis -Chem are pursuing commercial interests and
anticipate gaining from the advantage of being the first generic in the market. They are
entitled to do so; they sought legal advice before the alleged patent infringement. The
advantage cannot be underst ated. UC is the author of its own misfortune. As indicated
above, the only mechanism recorded in the prescribed declaration was that UC had
acquired its entitlement to make the application from the eight inventors. The submission
from the appellants that ‘the right to apply’ should be determined with reference to those
who had a contractual or other legally enforceable right at the time of making the
application, has no merit as it would defeat the purpose of ss 60(1)( a) and 27, as
discussed above. Section 27 envisages the applicant being the holder of rights at the date
of application.
of application.
[178] Members of the public are entitled to rely on the information filed in the register.
More importantly, patients have been on the impugned generic for several months. The
submission that those patients can change to the original product is a callous disrega rd
for the medical and financial implications for those patients who have not been dealt with
53 Op cit fn 11.
59
on these papers. The patent has only a few weeks left, and disrupting patient treatment
for that period with no evidence as to the effect of such interruption on the treatment is
not desirable. In the circumstances of this matter, the public interest militates against
granting rectification. In any even t, the collaboration agreement does not correct UC’s
title. In these circumstances, allowing the agreement would not change the legal position,
as it would only confirm the contractual relationship between UC and HHMI.
[179] If I commanded the majority, I would have dismissed the appeal with costs such to
include the costs of two counsel where so employed.
________________
E BAARTMAN
JUDGE OF APPEAL
60
Appearances:
For the appellants: G Marriott and A Molver
Instructed by: Adams & Adams Attorneys, Pretoria
Honey & Partners Inc, Bloemfontein
For the first respondent: A Franklin SC and CC Bester
Instructed by: Von Seidels c/o Smit & Van Wyk Inc, Pretoria
Webbers Attorneys, Bloemfontein
For the second to fourth respondents: RM Robinson SC and FW Landman
Instructed by: Margo Attorneys Inc, Johannesburg
Lovius Block Inc, Bloemfontein.