The Court of the Commissioner of Patents in South Africa has dismissed an application by the Regents of the University of California and its corporate affiliates to uphold a patent for a prominent prostate cancer treatment.
The judgment revolves around South African Patent No. 2007/10870, which pertains to the pharmaceutical compound Enzalutamide, known commercially as Xtandi. This compound has been pivotal in treating specific forms of prostate cancer since its market entry in March 2017, but the legality of the patent was challenged by Eurolab (Pty) Ltd and various entities under the Dis-Chem brand.
The case centres on multiple applications, including an interim interdict and allegations of groundless patent infringement threats. Despite the complexity of the litigation, the core issue remained clear: the validity of the patent itself. In a ruling marked by detailed analysis, the Commissioner of Patents, Judge A Le Grange, ultimately concluded that the patent was invalid based on key statutory provisions within the South African Patents Act of 1978.
At the heart of the ruling was a dispute regarding the rightful entitlement to apply for the patent. Section 27 stipulates that any individual filing for a patent must possess the right to do so, a right that must be secured from the original inventor. However, the court found that the University of California did not provide sufficient evidence to prove they had acquired the necessary rights from the named inventors prior to the patent application date on 29 March 2006.
Eurolab, a generic oncology firm that had recently launched its version of the drug known as Enzutrix, argued convincingly that the patent application was flawed. Its claims were anchored in purported breaches of assignment agreements and misrepresentations about the priority date of the patent.
The court found that key inventors had assigned their rights to the Howard Hughes Medical Institute (HHMI), raising doubts about the University of California's ownership claims. The judgment reinforces the notable expectation that patent applicants must demonstrate clear proof of entitlement at the time of their application. In a comprehensive evaluation of numerous documents, the court determined that neither assignment nor agency agreements were adequate to validate UC's claim over the patent, thereby stripping it of its legal standing.
Furthermore, the court ruled against UC's assertions regarding its supposed ability to acquire rights to apply for the patent at a later date, emphasising that this would create unnecessary ambiguity and undermine the integrity of the patenting system. The finding established that the compliance with statutory requirements isn't merely procedural but fundamental to uphold the legitimacy of patent rights.
As a result, the court dismissed the applications put forth by the university and its affiliates, declared the alleged patent infringement claims by UC as unjustified, and imposed a hefty legal cost burden on them.
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