Momentous court victory for SA pharmaceutical company against multinational giant

In the face of a legal challenge by a multi-national pharmaceutical giant, a South African pharmaceutical company has fought for and won the right to continue making cancer treatment available at an affordable price for South African cancer patients. Lynne du Toit, CEO of Eurolab Pty Ltd, said they are celebrating the judgment handed down by Judge AJ Le Grange in the Court of the Commissioner of Patents last week. “This ruling has significant implications for the pharmaceutical industry and intellectual property law, particularly in patent enforcement strategies,” said Du Toit. The matter arose after Eurolab identified the potential of enzalutamide, an androgen receptor inhibitor, used in the treatment of prostate cancer patients in South Africa. “Eurolab respects intellectual property rights and undertook a thorough analysis of any patents that could pose a bar to the launch of an enzalutamide product. This research identified South African Patent No. 2007/10870 directed to enzalutamide and its use, as posing a potential problem,” said Du Toit.

The patentee was the Regents of the University of California (UC), and Astellas Pharma Inc., Astellas Pharma Europe Ltd and Astellas Pharma (Pty) Ltd (collectively referred to as Astellas) were registered licensees under this patent. Astellas is a multi-billion-dollar company that sells the enzalutamide product, Xtandi, in South Africa.

Eurolab and its attorneys, Von Seidels, established that the patent was invalid.

“As a result, despite the rather daunting prospect of litigating against a multinational giant, Eurolab stuck to its vision of making oncology treatments more widely accessible and affordable, and put into process plans to launch its enzalutamide product, Enzutix,” says Du Toit.

“As soon as Astellas became aware of Eurolab’s registration of Enzutix with the South African Health Products Regulatory Authority, (SAHPRA), Astellas, along with UC, threatened Eurolab with legal action on the basis that Enzutix is identical to Xtandi and would infringe on the patent if launched,” Du Toit explains.

Following unfruitful consultations with Astellas, Eurolab decided to launch Enzutix in early 2024. It brought “an expected barrage from UC and Astellas”, says Du Toit. Apart from suing for patent infringement, Astellas also sought a temporary interdict to stop both Eurolab and all distributors holding stock of Enzutix, from marketing and selling Enzutix before the patent infringement case had been heard in court.

Eurolab was undeterred, says Du Toit, even though they knew there was a chance that such an order could follow because “the merits of attacks on the validity of patents are, surprisingly, often not considered in much depth by the court” and so big pharma companies can get their way and continue selling their product at much higher prices and block any competitor product from entering the market – even if just temporarily.

The court addressed the matter directly: the only issue to be considered was whether UC, as the patentee, was entitled to apply for the patent, as it had. They were not, the Judge ruled because the inventors of the medicine had not signed over their rights to UC, which means the intellectual property did not belong to UC.

“As a result, the patent was revoked in line with the advice Eurolab had received. UC and Astellas were also prohibited from directing any further threats of patent infringement to Eurolab or any wholesaler or distributor dealing with Enzutix,” says Du Toit.

The ruling has significant implications for the pharmaceutical industry and intellectual property law, particularly in generic drug manufacturing and patent enforcement strategies, Du Toit explains. “Simply stated, UC did not comply with the requirements of South African law.”

Eurolab is committed to making quality, affordable cancer treatments available to all South Africans. Because of the favourable ruling, Eurolab can continue to market and sell Enzutix in the South African market through wholesalers and all pharmacy chains.

“It’s a win not only for Eurolab, but also for all the South African patients who are desperately in need of the product at an affordable price.” says Du Toit.

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