Patent laws will be under the spotlight in what is said to be a first-of-its-kind application in South Africa, with a US-based pharmaceutical company being accused of “patent abuse” relating to a lifesaving drug it developed to treat cystic fibrosis, writes Tania Broughton.
The applicants in the case pending before the high court, sitting as the Commissioner of Patents, are cystic fibrosis sufferer Cheri Nel and the Cystic Fibrosis Association. They want the court to grant a “compulsory licence” which allows others to produce and sell similar drugs without the patent holder’s consent. The application is being opposed by Vertex Pharmaceuticals.
Cystic fibrosis is an inherited condition that primarily affects the lungs. Most sufferers do not live beyond the age of 25.
The development of cystic fibrosis transmembrane conductance regulator (CFTR) modulators by Vertex, sold as Trikafta and Kalydeco, are considered “miracle drugs” which significantly improve the quality of life and life expectancy of patients. While Vertex has patented them in South Africa, it does not sell them in that country. And even if it did, it would be unaffordable.
The Treatment Action Campaign (TAC) and Doctors Without Borders (MSF), represented by Section 27, have applied to be amicus curiae (friends of the court), in the application.
Section 27’s Pearl Nicodemus said Vertex, despite having already enjoyed massive profits from the drugs, continued to price it at “the impossible amount” of $311 000 (approximately R5,7 million) a year, per patient in America.
“Even if someone could pay this excessive price, the drug is not available in South Africa. Vertex registered patents in South Africa in 2019 but has not brought the drug to the South African market, so cystic fibrosis patients in the country cannot access the drug. There is a generic version known as Trixacar, produced by Gador, a company based in Argentina. The generic costs a tenth of the price of Trikafta but is not available in South Africa due to Vertex having registered patents here,” she explained.
“As a result, the applicant (Nel) seeks a compulsory licence, which would allow her to use the patented drug without Vertex’s authorisation, and allow her to use other legal remedies, to facilitate access to the more affordable generic Trixacar.”
She said the TAC and MSF want to demonstrate to the court the public health and public interest implications of the case and the value of compulsory licences as a mechanism for ensuring that patents do not violate people’s right to health, which includes the right to access medicines.
They will also demonstrate why a compulsory licence, a remedy that has never been granted in South Africa, should be granted in this particular case, she said.
Nel, in an affidavit in the court application, said much suffering could be avoided by supplying the drugs to South Africans at reasonable prices.
While not commenting specifically on the case, Vertex said it believed in the importance of upholding intellectual property rights to drive innovation in tackling the unmet medical needs across the world, including in South Africa.
It said it was working towards bringing its cystic fibrosis medicines to eligible patients in South Africa, “as has been achieved in more than 40 countries around the world, including countries with smaller economies”, and as part of this it had signed an agreement with a local distribution partner and was in discussions with stakeholders in the private insurance system.
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