The University of California’s (UC) governing board has suffered a legal setback in South Africa after a High Court revoked its patent over a lucrative life-extending prostate cancer drug.
The drug is marketed and sold in SA as Xtandi by Japanese pharmaceutical major Astellas Pharma.
Xtandi was developed at the UC with grant support from the National Institutes of Health and the US Army, reports BusinessLIVE.
Eight UC academics, including Michael Jung and Charles Sawyers, are the brains behind Xtandi, which, according to Astellas’ 2023 financial results, raked in R93bn in sales.
The drug, which Astellas describes as medication used to treat men with prostate cancer that no longer responds to hormone therapy or surgical treatment to lower testosterone, among other things, has been sold in South Africa since March 2017.
The drug is prescribed for certain forms of prostate cancer in adult men, including more specifically hormone refractory prostate cancer and hormone-sensitive prostate cancer.
UC and Astellas made an unsuccessful attempt to interdict SA generic oncology firm and JSE-listed pharmacy chain Dis-Chem from infringing its patent.
Recently, Johannesburg-based Eurolab launched a drug called Enzutrix, a generic enzalutamide-containing medicine approved for the treatment of certain kinds of prostate cancer – and which is also distributed by Dis-Chem.
Eurolab did not dispute that making, using, importing, marketing, distributing and selling Enzutix constituted an act of infringement of the patent in SA.
However, the company argued that UC was not entitled to apply for the patent because it had not acquired the right to do this from the inventors of the patent at the date on which the patent was filed in 2006.
The generic oncology drugmaker also argued that there had been a material misrepresentation regarding the priority date in applying for the patent, which makes the patent liable to be revoked under SA’s patents regime.
The Gauteng High Court (Johannesburg) dismissed UC’s counter-argument that the wording of the Patents Act opened the door for it to apply for the patent.
The court found that for UC to have had the right to apply for the patent, it needed to have acquired the right to do so from all of the inventors before launching the application.
“Under UC’s interpretation, any person could apply for a patent as long as it ‘(is) acquiring’ the right at some point in the future,” reads the judgment.
“This would lead to an absurd result: a patentee who obtained a patent under such circumstances could simply argue, when challenged, that it is still in the process of acquiring the right (the test to be applied, I have not even tried to consider), all while benefiting from the invention to the detriment of both the inventor (if the latter ever intended to secure a patent) and the public, who would be forced to pay a monopoly price,” it said.
The court accepted Dis-Chem’s counter application to have UC’s patent revoked.
Eurolab, founded in 2011 has quickly grown to be the one of the largest generic oncology companies in SA.
UC has no role in the marketing or sale of Xtandi. By virtue of patent and licensing agreements administered by UC, the university, the researchers and Howard Hughes Medical Institute share a royalty interest in worldwide net sales of Xtandi.
According to the 2022 National Cancer Registry, the lifetime risk for prostate cancer in men in SA is one in 15.
UC and Astellas in October fended off a nullity bid brought in the UK by Accord, Sandoz and Teva. The generic drug manufacturers wanted a UK court to allow them to launch their copycat products of Xtandi in the UK market.
The price of Xtandi in the US, where it is co-licensed by Astellas Pharma and Pfizer, has come under scrutiny over the years. It is said to cost US patients more than $150 000 a year on average.
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