IN A MAJOR victory for cancer treatment in South Africa, Eurolab was granted the right to continue making and selling generic prostate cancer medication in the country at an affordable price, following a legal victory against the international patentee of the medication.

Lynne du Toit, CEO of Eurolab Pty Ltd, said they were celebrating the judgment handed down by Judge AJ Le Grange in the Court of the Commissioner of Patents, which sat at the Gauteng High Court, Pretoria.

“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 said it 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 a South African Patent 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, which 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 established that the patent was invalid.

“As a result, despite the rather daunting prospect of litigation 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,” Du Toit explained.

"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 said.

Following unfruitful consultations with Astellas, Eurolab decided to launch Enzutix early last year. This resulted in litigation.

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, Du Toit said, 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 often not considered in much depth, by the court".

"Thus, 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," Du Toit said.

The issue under the legal spotlight was whether UC, as the patentee, was entitled to apply for the patent, as it had. They were not, Acting Judge AJ Le Grange ruled, because the inventors of the medicine had not signed over their rights to UC. This meant 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,” Du Toit said.

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

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,” said Du Toit.

Cape Times