KEY POINTS
- Eurolab wins the legal right to sell generic prostate cancer medication.
- South African court invalidates patent held by UC and Astellas.
- The ruling benefits South African patients with affordable access to treatment.
After winning a lawsuit against the drug’s international patent holder, Eurolab was given permission to continue producing and distributing generic prostate cancer medication at a reasonable cost, marking a significant victory for cancer treatment in South Africa.
Eurolab’s legal victory grants access to affordable cancer medication
The CEO of Eurolab Pty Ltd, Lynne du Toit, praised the ruling rendered by Judge AJ Le Grange in the Gauteng High Court’s Court of the Commissioner of Patents in Pretoria. “This decision has important ramifications for intellectual property law and the pharmaceutical industry, especially in terms of patent enforcement tactics,” Du Toit stated.
The lawsuit started when Eurolab discovered the potential of enzalutamide, a South African androgen receptor inhibitor used to treat prostate cancer.
According to Eurolab, it respects intellectual property rights and thoroughly examined any patents that would prevent the release of a product containing enzalutamide. “A South African patent for enzalutamide and its use was identified as a potential issue by this research,” Du Toit stated.
The University of California (UC) Regents held the patent, and Astellas Pharma Inc., Astellas Pharma Europe Ltd., and Astellas Pharma (Pty) Ltd. were registered licensees.
According to Iol, Astellas threatened legal action after discovering that Eurolab had registered its medicine, Enzutix, with the South African Health Products Regulatory Authority (SAHPRA). The company claimed that Enzutix was a copy of Xtandi and would violate the patent.
Following fruitless negotiations with Astellas, Eurolab proceeded with the launch of Enzutix last year, which led to a legal dispute. To stop Eurolab and distributors from promoting or selling Enzutix until the dispute was settled, Astellas filed a lawsuit alleging patent infringement and requested a temporary injunction.
Given that these patent cases frequently don’t go into great detail about the merits, Eurolab persisted despite the possibility of a court order, according to Du Toit. In order to maintain high drug prices, “big pharma companies often get their way, blocking competitors even if temporarily,” she continued.
The ruling has major implications for pharmaceutical industry
“This decision has important ramifications for intellectual property law and the pharmaceutical industry, especially in the areas of patent enforcement and generic drug manufacturing,” Du Toit stated. “UC did not adhere to South African law, to put it simply.”
Due to the positive verdict, Eurolab is able to keep using pharmacies and distributors to market and sell Enzutix in South Africa.
“It’s a win not only for Eurolab, but also for South African patients in need of affordable access to the drug,” Du Toit said.
