Patients in South Africa, India, Brazil and Ukraine have petitioned to revoke or suspend Vertex's patents on cystic fibrosis drugs.
Cheri Nel, a Johannesburg woman with cystic fibrosis, and the Cystic Fibrosis Association have now launched a legal challenge to Vertex’s patents for Trikafta and Kalydeco.
They say Vertex is abusing the rights it enjoys in terms of its patents and that the rights of cystic fibrosis patients - and especially children - are being violated.
They want the court to issue a “compulsory licence”, which would ultimately allow them to bypass the patent protections to make more cost effective generics - already manufactured in Argentina - available on the South African market. They also want Vertex ordered to register the drugs with the South African Health Products Regulatory Authority (SAHPRA) to facilitate this.
Why are Vertex drugs better than others?
A new class of drugs for cystic fibrosis are so effective because they address the underlying cause of cystic fibrosis symptoms – a malfunctioning protein made by the CFTR gene.
The new therapy has already been hailed as a “miracle” for people with CF.
CFTR modulator therapy transforming cystic fibrosis from a progressive, life-threatening illness into a chronic, manageable condition.
The researchers called CFTR modulators like Trikafta an “unparalleled opportunity to increase quality and length of life for almost all CF patients,” but cautioned that “the medicines are so expensive they are essentially unavailable unless reimbursed by the government or health system authorities.”
Vertex has secured a global monopoly over CFTR modulator therapies by aggressively pursuing patents related to the class of drugs around the world. These patents prevent other companies from manufacturing and marketing CFTR modulator therapies and give Vertex wide latitude in setting prices. Vertex charges over $322,000 annually for its most effective CFTR therapy, Trikafta (which must be taken as a life-long treatment) in the United States.The company is – for the most part – not registering or marketing its CFTR modulator therapies in developing countries.
Last year, these medications generated $8.9 billion in revenue for the company, an 18% increase from the year prior. The gain was due to a big jump in sales of Trikafa, since the medicine is much more effective than older cystic fibrosis medicines and, therefore, has become more widely prescribed.
Patients vs. monopolist
Between 2007 and 2016, Vertex filed six patents in South Africa related to the CFTR modulator therapies, Kalydeco and Trikafta. While Vertex received marketing approval to sell Kalydeco and Trikafta to treat CF in the United States in 2012 and 2019, respectively - it has still not applied for registration of either product in South Africa. What this means is that Vertex does not supply drugs to South Africa and blocks any other companies from supplying the medicines to CF patients in the country, citing its patents.
“[Vertex] exploits its intellectual property monopolies to protect itself from competition, not in the name of reasonable profit or to recoup its research costs but to gouge patients, medical aids and state funders. It can do this because it holds the key to so many lives,”
Cheri Nel said.
Nel and the Cystic Fibrosis Association are seeking a compulsory license on the grounds that the patents held by Vertex are being abused. Nel’s lawyers argue that by failing to register or supply their CF medicines in South Africa, make them available in South Africa at reasonable prices, or license other companies to supply the medicines, Vertex is abusing its patents. They further argue that Vertex’s actions are violating the Constitutional rights of people with cystic fibrosis in South Africa, including the right to health care.
The average age of death of people with CF in South Africa was 27.5 in 2020. The life expectancy of people living with cystic fibrosis in the United States is now 50.
If granted, a compulsory license in South Africa would effectively override Vertex’s monopoly and allow the importation of generic cystic fibrosis medicines into South Africa, as well as their manufacturing in the country.
Earlier in February, patients in India, Brazil and Ukraine also petitioned their governments to revoke or suspend Vertex’s patents.
Families of cystic fibrosis patients in India pointed out that individual components of Orkambi and Trikafta were under patent protection in India, preventing generic manufacturers from making it.
Vertex, for its part, believes “intellectual property rights are critical to encourage and protect innovation," the company's spokesperson said.
“The revocation of the patent is justified on at least two counts, including Vertex’s failure to work their patents (i.e. supply the relevant medicine) in the Indian market, and their unaffordable high prices,”
the petition by cystic fibrosis patients and their families explains.
The way Argentina does it
Some cystic fibrosis patients have joined together to start a CF Buyers Club. The Buyer’s Club supports CF patients from around the world in buying generic versions of CFTR modulators from Argentina.
Argentina has taken steps to set strict criteria for granting patents and limit the granting of patents on certain types of claims related to pharmaceutical products. As a result, Vertex has not been granted patents on its CFTR modulator treatments in Argentina, and two Argentinian pharmaceutical companies, Gador and Tuteur, are legally manufacturing generic versions of these medicines.
The annual cost of generic Trikafta from Argentina is almost R1 million ($60,000). Other CFTR modulator therapies can be bought from Argentina for around R245 thousand ($15,000) annually.
While the Argentinian companies producing these medicines are unwilling to export them to South Africa for fear of facing patent infringement challenges from Vertex, Argentinian pharmacies will supply medicines to CF patients from South Africa visiting Argentina. Patients holding authorisations from SAHPRA can legally travel with up to six months’ medicine supply on them.
This method of obtaining medications is still prohibitively expensive for most South Africans. The medicine costs, combined with the costs of biannual travel to Argentina, are simply unaffordable for most.
Why is the case of Nel v. Vertex so important?
Both developing and developed countries have subsequently used compulsory licensing to improve access to critical health tools under patent including for HIV, cancer, and more recently, COVID-19.
The Fix the Patent Laws coalition, a coalition of over forty patient groups in South Africa, has long called on government to amend South Africa’s patent laws to improve the usability of compulsory licensing provisions to address health challenges in the country. The landmark court case of Nel vs Vertex will provide important insight into the ongoing need for these reforms in the country.
BRICS Competition Centre expert Mikhail Shikhmuradov notes:
"The intensification of generic competition in Argentina further highlights the benefits of competition in lowering drug costs, and the fact that Vertex did not obtain patents in Argentina raises questions about the effectiveness and fairness of patent laws in different jurisdictions."
A landmark court case challenging Vertex's monopoly in South Africa could set a precedent for similar situations in the future and potentially have global implications for compulsory licensing initiatives, the expert believes.
The case also raises questions about the balance between intellectual property rights and public health, highlighting the need for regulators to carefully consider the impact of patent law on competition and the availability of medicines.
In the Vertex situation in South Africa, the expert suggests action on several fronts:
- Encouraging generic drug manufacturers to enter the market to increase competition and lower drug prices, which could be achieved through compulsory licensing;
- improving access to essential medicines regardless of the ability to pay, which can be achieved by controlling prices through subsidies and public procurement programs;
- strengthening of anti-monopoly regulation, including through limiting the validity of patents or increasing penalties in the event of anticompetitive practices;
- increasing the transparency of pricing;
- cooperation with international organizations to develop coordinated approaches, efforts to improve drug distribution systems and increase funding for research on neglected diseases.
Sources: EWN, Spotlight, Fierce Pharma