IN A LANDMARK decision, the Supreme Court of Appeal (SCA) in South Africa has ruled that the generic prostate cancer medication Enzutrix will remain available at an affordable price, ensuring access for patients in need.
Image: PEXELS
IN A LANDMARK decision, the Supreme Court of Appeal (SCA) in South Africa has ruled that the generic prostate cancer medication Enzutrix will remain available at an affordable price, ensuring access for patients in need.
This followed an order by the SCA delivered this week in a fierce patent-related battle between the Regents of the University of California (UC), which owned a South African patent for the prostate-cancer drug Xtandi, and Eurolab, which introduced the generic product Enzutrix.
Eurolab was earlier granted the right to continue making and selling the generic prostate cancer medication following an order by the Commissioner of Patents, which sat at the Gauteng High Court in Pretoria.
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.
The product is distributed through the Dis-Chem companies. It was discovered that UC and Astellas Pharma Inc., Astellas Pharma Europe Ltd, and Astellas Pharma (Pty) Ltd were registered licensees of the Xtandi patent, used for the treatment of prostate cancer.
As soon as Astellas became aware of Eurolab’s registration of Enzutrix with the South African Health Products Regulatory Authority (SAHPRA), Astellas, along with UC, threatened Eurolab with legal action on the basis that Enzutrix is identical to Xtandi and would infringe on the patent if launched.
Following unfruitful consultations with Astellas, Eurolab decided to launch Enzutrix 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 Enzutrix from marketing and selling Enzutrix before the patent infringement case had been disposed of.
The issue under the legal spotlight was whether UC, as the patentee, was entitled to apply for the patent, as it had. The court earlier ruled in Eurolab’s favour.
The commissioner found that UC had not secured assignments from all inventors prior to the filing of its patent application. Consequently, UC was deemed not to have met the entitlement requirement at the critical time.
Therefore, the commissioner dismissed UC’s request for interim relief and granted the applications brought by Eurolab and Dis-Chem.
UC subsequently turned to the SCA, in which it, among others, asked for the interim interdict against the selling of the generic version of the medication.
The SCA, in a majority judgment, upheld UC’s grounds for appeal, but it turned down the application for an interim interdict against the use of the generic drug.
The court accepted that on the face of it, UC had a right to enforce its patent rights, but it reasoned that at this stage, the public’s interests weighed more heavily. It said Enzutrix is far cheaper and essential to cancer patients who are not covered by medical aids.
The court also pointed out that the patent will expire within weeks. “If the sale of Enzutrix were enjoined, the consequences for cancer patients using it would be serious and immediate," Judge John Smith said.
He pointed out that Xtandi is substantially more expensive than Enzutrix and will be unaffordable to many.
The court found that withdrawing the generic from the market would have direct and serious consequences for the patients who depend on it.
The court acknowledged UC’s arguments that it would occur irreparable financial loss if the generic is to remain on the shelves, but Judge Smith pointed out the potential harm is financial as opposed to the harm of the patients. The court also commented that this financial harm can later be addressed.