5 March 2025
Regents of the University of California and Others v Eurolab (Pty) Ltd and Others (2024-039643; 2023-108509) [2025] ZACCP 1 (25 February 2025) – full judgment available here
Acting Judge Le Grange sitting as the Commissioner of Patents recently handed down judgment which considered various court applications concerning South African patent no. 2007/10870 (“the patent”) held by The Regents of the University of California (“UC”), directed to a prostate cancer treatment, Enzalutamide.
The judgment considered an application brought by Eurolab (Pty) Ltd (“Eurolab”) for a remedy for groundless threats of patent infringement proceedings made by UC and various Astellas entities, as licensees of the patent, together with an application for an interim interdict brought by UC and Astellas against Eurolab and Dis-Chem, and a counterapplication for revocation of the patent.
Background
Eurolab and Dis-Chem market and sell Eurolab’s generic prostate cancer treatment Enzutix which contains Enzalutamide as its active ingredient. In letters to Eurolab, UC and Astellas threatened to bring infringement proceedings on the basis that Enzutix infringed UC’s patent. In response, Eurolab brought an application for a remedy for groundless threats of infringement proceedings on the basis that the patent was invalid because, inter alia, the patentee, UC, was not a person entitled to apply for the patent in terms of the South African Patents Act, 57 of 1978 (“the Act”).
Following on from Eurolab’s subsequent product launch, UC and Astellas brought an urgent application for an interim interdict to restrain Eurolab and Dis-Chem from importing, marketing, and selling Enzutix. In this application Dis-Chem brought a counterapplication for the revocation of the patent.
Issues
Although numerous grounds of invalidity were raised in the various applications, the only issue which the court deemed necessary to consider was whether the patentee was a person entitled under the Act to apply for the patent. That is, the issue to consider was whether the applicant was a “person acquiring from [the inventor] the right to apply” for the patent, as is provided in section 27 of the Act.
The chain of title
The claimed invention was born out of collaborative medical research between UC and the Howard Hughes Medical Institute (“HHMI”). The patent cites 8 co-inventors – some of whom were employees of UC, and the rest of whom were employees of HHMI.
The court considered the various assignment agreements filed in support of the alleged assignment of the rights to the invention from the inventors. These included assignment agreements executed by the various inventors. Importantly, certain inventors, being the employees of HHMI, assigned their rights to HHMI, and only after the filing of the application for the patent, were there various attempts to rectify this chain of title. These attempts were not successful in the view of the court, which held that UC had failed to show that it was entitled to apply for the patent, at least at the date of making the application.
Interpretation of the Patents Act
To determine the issue in question and in light of its finding on the chain of title, the court needed to settle the correct interpretation of section 27 of the Act. That is, when does an applicant for a patent need to have the right to apply for the patent.
The court held that the time to consider whether an applicant for a patent is entitled to apply is at the time when the patent application is made. That is, at the time of applying for a patent, the applicant must have the right to apply. In the case where the applicant is not the inventor, such as the case here, the applicant must be able to furnish proof that it has taken assignment of these rights from the inventor(s).
Conclusion
In light of the court’s finding that the patent was invalid, the court dismissed UC and Astellas’ application for an interim interdict. The court also held that because the patent is invalid, the threats made by UC and Astellas were groundless, and they were accordingly interdicted and restrained from a continuance of these threats. Finally, the court also ordered that the patent was revoked.
This judgment has some important implications. Firstly, it is imperative to ensure that a patent is valid before threatening to enforce such a patent, for example in a letter of demand, as a party aggrieved by such threats can bring legal action against the party making the threats. Secondly, the judge accepted that it is possible to counterclaim for the revocation of a patent, being a final remedy, even in interim proceedings. Finally, this matter also highlights the importance of ensuring that the chain of title to an invention is in order at the time of making an application for a patent directed to that invention.
