Health activists are lobbying the Supreme Court of Appeal to consider the broader issue of the constitutional right to health when it weighs up commercial interests in a legal fight between two pharmaceutical companies next month.
The battle is over the patent for a blockbuster cancer drug.
Local generics company Cipla Medpro and Aventis Pharma, a subsidiary of French pharmaceutical firm Sanofi Aventis, are tussling over Aventis’s patent on docetaxel, which Cipla maintains is invalid. The drug is Aventis’s biggest oncology product in SA and global sales in 2010 topped €2bn, according to court papers.
It is also an important drug for Cipla, which last year announced plans to move into the oncology market. The drug is used to treat a range of cancers, including prostate and breast cancer, and Kaposi’s sarcoma.
While legal tussles between generic drug makers and the companies that own the patents are fairly common, this case could have wider legal implications for patients’ access to medicines, says Umunyana Rugege, an attorney with lobby group Section 27.
The organisation is representing the Treatment Action Campaign (TAC) in an application to be admitted as a friend of the court when the matter is heard.
"Our argument is that the court should take into account certain public interest issues, including the right to health guaranteed in the constitution. It should consider public access to medicines, whether or not it is a life-saving drug, and if there is need for the law to be developed to take this into account," Ms Rugege said on Friday.
Cipla sells its generic, Cipla Docetaxel, to the private sector at R1021 for 20mg and R3575 for 80mg. Aventis sells its brand, Taxotere, at R2092 for 20mg and R7693 for 80mg. It also sells its own generic, Docetere, at a price similar to Cipla’s.
The court will consider an appeal lodged by Sanofi after it failed to get the patents commissioner to interdict Cipla from selling its generic for patent infringement.
SA’s patent office does not examine the detail of patent applications, so it is up to interested parties to challenge their validity once they are registered. One way to challenge a patent is to launch a rival product, and leave it to the holder to take legal action. This is what happened in the case of docetaxel. Cipla considered Aventis’s patent to be invalid and launched its own version of the drug in January, Cipla medical director Nic de Jongh said. The patent in question expires in SA next year.
Aventis then asked the patents commissioner to interdict Cipla from selling the drug, arguing it had infringed its patent. The commissioner ruled on October 20 last year that Aventis’s patent was ambiguous and therefore unenforceable.
Aventis subsequently appealed to the court to have the ruling scrapped. The case will be heard on May 15.
Sanofi SA’s head of communications, Prudence Mahapa, said the company had no objection to the TAC being admitted as a friend of the court. "Sanofi has always been committed to endeavouring to ensure that as wide a section of patients as possible have access to (its) products and as such has been supplying Taxotere to the public sector at a price 33% below Cipla Docetaxel.
"The unit sales growth over the past four years has been exponential, confirming the commitment of Sanofi to make this drug available to all patients," she said.