A South African pharmaceutical company has won the right to continue making cancer treatment more widely accessible and affordable for patients in the country.
The case before the Court of the Commissioner of Patents in Pretoria, concerned the validity of a patent held by the University of California for the pharmaceutical compound, enzalutamide.
Eurolab, a generic oncology company in South Africa, launched a generic enzalutamide product, called Enzutrix, which was distributed by Dis-Chem.
The patentee was the Regents of the University of California, with Astellas Pharma Inc., Astellas Pharma Europe Ltd, and Astellas Pharma (Pty) Ltd (collectively referred to as Astellas), registered licensees under this patent.
Astellas is a multi-billion-dollar company that sells the enzalutamide product, Xtandi, in South Africa.
According to the 15-page judgment by AJ Le Grange, the following order was made as the parties hosted two separate counter cases: “The application by Eurolab (Pty) Ltd is granted to the extent that the threats of infringement proceedings made by the Regents of the University of California, Astellas Pharma Europe Ltd, Astellas Pharma Inc and Astellas Pharma (Pty) Ltd in relation to South African Patent No. 2024-039643 are found to be unjustifiable.
“The Regents of the University of California, Astellas Pharma Europe Ltd, Astellas Pharma Inc and Astellas Pharma (Pty) Ltd are interdicted and restrained from a continuance of these threats.
“The counter application by Dis-Chem Oncology (Pty) Ltd, Dis-Chem Oncology Distribution (Pty) Ltd and Dis-Chem Pharmacies (Pty) under Case No: 2024-039643 is granted to the extent that Patent No. 2007/10870 is revoked in terms of section 61(1)(a) as read with section 27 of the Patents Act, No. 57 of 1978."
The court ordered the Regents of the University of California and Astellas to pay the costs of all the applications, including the costs of two counsel.
Lynne du Toit, CEO of Eurolab, said they are celebrating the judgment.
“This ruling has significant implications for the pharmaceutical industry and intellectual property law, particularly in patent enforcement strategies,” she said.
According to a statement by the company, 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."
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,” said 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 (University of California), threatened Eurolab with legal action on the basis that Enzutix is identical to Xtandi and would infringe on the patent if launched.”
After consultation with Astellas, Eurolab said they decided to launch Enzutix in early 2024.
“It brought an expected barrage from UC and Astellas”, said 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, said 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.”
She said the issues that were considered were whether UC, as the patentee, was entitled to apply for the patent.
“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,” she explained.
“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.”
They said the ruling had significant implications for the pharmaceutical industry and intellectual property law, particularly in generic drug manufacturing and patent enforcement strategies.
“Simply stated, UC did not comply with the requirements of South African law.”
“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."
Cape Argus