The last two-odd weeks witnessed three significant developments aimed at improving access to affordable medicines, playing out in India, South Africa and the US.
All developments involved patents, and signal a change in the way governments increasingly view the practice of drugmakers filing multiple patents through the life of a drug, say legal experts.
Early July, the Indian Patent Office (IPO) rejected Johnson and Johnson’s (J&J) patent application on the paediatric version of its break-through tuberculosis (TB) drug bedaquiline. The move is expected to pave the way for generic drugmakers to make similar versions of this drug at lower prices. In March 2023, the IPO had rejected J&J’s attempt to patent the salt form of bedaquiline, stopping efforts to add four more years to the drug’s life, even as the primary patent was to expire (July 2023). Civil society and patients fought both cases, with support from Médecins Sans Frontières/Doctors Without Borders.
In South Africa, its Competition Commission ended an investigation into alleged “anti-competitive” actions involving bedaquiline this month. J&J agreed to not pursue secondary patents on the drug in 134 low and middle income countries and they dropped prices in S Africa by 40 per cent, the Commission said.
Separately, in the US, “patent thickets” were targeted through the Affordable Prescriptions for Patients Act (APPA), sponsored by two US Senators. It was passed unanimously. Patent thickets involve multiple patents filed on a single drug by a company. They tend to block out competition for a long time.
“Some pharmaceutical manufacturers have been deliberately abusing the patent system to prevent potential competitors from entering the marketplace using tactics like erecting patent thickets, which slow the entry of lower-cost biosimilars,” they said in a note.
This bill puts a “reasonable limit on the number of patents a manufacturer can contest, preventing a “patent thicket,” the note explained. The move would “deter branded manufacturers of biologics from gaming the system to increase the number of patents they assert, while preserving the incentives provided by the patent system to encourage the core innovation that produces new biologic treatments in the first place,” it added.
Connect the dots
“Patent reforms have started to find a voice... pushing big pharma to make concessions, the bedaquiline saga in South Africa being an example,” observes Krishna Sarma, Managing Partner, Corporate Law Group. The consequence would mean “higher threshold for patentees to maintain their core patent pharma/biopharma portfolio, and at the same time, giving leeway to the generics to chip away at the patent thickets resorted to by innovator companies,” she added.
On limiting patent filings, she explained, “As per APPA, 2023, only up to 20 patents (the core patents) can be asserted by biologic companies in a court of law, with the possibility of raising the cap in the interest of justice. At present, on an average, a major drug is protected by around 74 patents.” With the number of patents protecting a drug significantly going down, “the entry of generics into the market would be much earlier,” she said.
As a result, she said, “patent filings on pharmaceuticals and biopharmaceuticals would reduce significantly and the present strategy to cover a particular drug with numerous patents (patent thickets leading to evergreening) could see a radical change.”
Innovation interrupted?
The Pharmaceutical Research and Manufacturers of America (PhRMA) counter saying that they’ve always supported the full lifecycle of medicines — from innovation to generic and biosimilar uptake. “We do however have concerns with (US) Congress prohibiting innovators from enforcing lawfully granted patents,” they added.
“Innovation shouldn’t stop once a new medicine becomes available to patients. IP protections incentivise researchers to continue R&D after a product’s initial FDA approval to improve the medicine, make it more effective and expand treatment options,” they explained.
Public health lawyer Leena Menghaney disagrees that disallowing secondary/follow-on patents stifles innovation. Companies get 20 years of patent protection (with no competition) on their innovative basic patent. Crediting civil society in pushing for change, she points to the watershed Glivec case in India (where patent protection was disallowed on the blood cancer drug for not being a new invention or more efficacious). The access fight has been case by case, she says, recalling HIV/AIDS, Hepatitis C, breast cancer and TB drugs. Unless the US system changes, other world systems will continue to be under pressure, she observed.
“The pharmaceutical industry has to stop using patents as tools to manage competition. Otherwise governments will step in,” says KM Gopakumar, an IP (Intellectual Property) expert, with Third World Network. In India, the IPO should be consistent in reviewing patents and follow the law in letter and spirit, he says. Besides, he adds, “India has imported oil from Russia; similar political willingness can be shown in addressing anti-competitive practices involving medicines.”