6 March 2023, Johannesburg – SECTION27 has sought consent on behalf of its clients, the Treatment Action Campaign (TAC) and Doctors Without Borders (MSF), to intervene as amici curiae (friends of the court) in a compulsory licence application relating to a lifesaving drug to treat cystic fibrosis, called Trikafta, in the High Court of South Africa sitting as the Commissioner of Patents.
A compulsory licence allows third parties to produce a patented product without the patent holder’s consent. TAC and MSF seek 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.
The case is against Vertex Pharmaceuticals and is brought by Cheri Nel, (a South African cystic fibrosis patient), and the Cystic Fibrosis Association. In 2019, Vertex invented and patented Trikafta, an effective new drug that changes the trajectory and impact of cystic fibrosis for patients diagnosed with the illness. Cystic fibrosis comes from a genetic mutation and causes mucus overproduction. The excessive mucus makes people with cystic fibrosis susceptible to infection, causing lung scarring, which necessitates a plethora of treatments and interventions including lung transplants. Cystic fibrosis often results in early death. The drug that Vertex has invented is therefore very significant, but despite already having enjoyed massive profits from the drug, Vertex continues to price it at the impossible amount of 311,000.00 USD per year, per patient in America (approximately 5,722,400.00 ZAR).
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.
As a result, the applicant seeks a compulsory licence, which would allow her to use the patented drug without Vertex’s authorization, and it allow her to use other legal remedies, to facilitate access to the more affordable generic Trixacar.
TAC and MSF’s intended intervention
TAC and MSF have long histories as advocates for access to medicines and the appropriate balance of intellectual property interests and the right to access health care services. This advocacy history and experience will be brought to bear in this case.
If admitted as amici curiae, TAC and MSF will present arguments showing how the denial of a compulsory licence may infringe the right to access medicines and how access to medicines is an integral component of the right to access health care services, and the right of all children to access basic health care services.
TAC and MSF will focus on how to interpret the Patents Act 57 of 1978 in a constitutional manner, and the obligations the Act imposes on patent holders. Specifically, they intend to show that courts should interpret compulsory licencing as a legislative measure that contributes to the progressive realisation of the right to access medicines in section 27(2) of the Constitution. Furthermore, TAC and MSF will show that compulsory licences are envisaged and permitted under the WTO Agreement in Trade-related Aspects of Intellectual Property (TRIPS agreement) and the state’s obligations under international human rights law.
Finally, TAC and MSF will demonstrate the public health and public interest implications of this matter, and why a compulsory licence, a remedy that has never been granted in South Africa, should be granted in this particular case.
The parties to the case have until 15 March 2023 to respond to the request for consent to TAC and MSF’s intervention as amici curiae, following which an application will be made to court for their admission.
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