Stop abuse of patent monopolies in rare diseases, say patient representatives and treatment activists 

They seek urgent intervention by government, courts, and lawmakers into the issue  

Roche, a Swiss multinational healthcare company, is seeking a permanent injunction against Natco Pharma to prevent the introduction of a generic version of Risdiplam, a Spinal Muscular Atrophy (SMA) drug, citing patent infringement.

Health groups on Tuesday (November 5, 2024) argued that Roche’s legal action to block generic supply jeopardises public interest by limiting access to affordable medication. Roche’s patent for Risdiplam is effective until 2035, allowing them to charge approximately ₹6 lakh per bottle, while production costs suggest the drug could be made available for as low as ₹3,024 annually.

Patient representatives and treatment activists have come together stating that government, courts, and lawmakers need to take urgent action to address the abuse of patent monopolies in rare diseases.

They also noted that the monopoly on the drug could hinder the Indian Ministry of Health and Family Welfare’s efforts to benefit from domestic production and competitive pricing through pooled procurement (tendering) strategies.

Also, the Delhi High Court has been addressing SMA-related petitions since early 2021, highlighting the need for a coordinated treatment framework amid ongoing challenges posed by high drug costs and limited access.

However, the problem isn’t just about the SMA drug alone, note experts, speaking at a press conference on Tuesday about access to medicines.

They said that for patients with cystic fibrosis, patent barriers are similarly overwhelming, with no options for the drug becoming available to patients in India in sight.

The drug for CF (CFTR modulators), while under monopoly, continues to be unavailable in the country due to a lack of registration by Vertex (the patentee) with the Indian FDA and is priced at one crore annually for those patients importing the drug under a personal use licence.

Patent infringement

The CF drug (elexacaftor/tezacaftor/ivacaftor) is already in generic production and supply in Argentina. Still, the generic manufacturer from Argentina could not supply Indian patients as tezacaftor and ivacaftor are patented. Selling the combination of elexacaftor/tezacaftor/ivacaftor in India would amount to patent infringement.

CFTR modulators’ production costs could be 90% lower than current prices if the government addressed patent barriers to open supply.

Health groups and patient representatives are seeking the government to incentivise generic manufacturing to play its crucial role as the pharmacy of the developing world by producing and supplying drugs to rare disease patients in India and other LMICs.

Company’s statement

Meanwhile, in a statement, Roche said: “At Roche, drug innovation and its access to patients is foremost. We are committed to delivering healthcare innovations that significantly improve patient lives in the country while ensuring that as many patients as possible have access to our products.”

It added that the company’s focus remains on discovering and developing innovative medicines and diagnostics that will change standards of care in the future.

“At the same time, we are also committed to protecting our innovations within the scope of applicable laws in the countries we operate and believe that laws provide sufficient safeguards for protection of innovation,” said the statement.

Published - November 05, 2024 07:17 pm IST