Civil society groups dejected, mull PIL; setback also for Wockhardt.
The patent office has upheld the validity of Roche’s patent rights over Pegasys (pegylated interferon alfa2a), a Hepatitis C medicine.
In a decision taken last month, the patent office quashed the post-grant oppositions filed by drug major Wockhardt and a Mumbai-based civil society group, Sankalp, against Roche’s biotech drug.
Pegasys was the first medicine to be awarded a product patent here after changes to the domestic patent law four years earlier.
The decision ends Wockhardt’s hope of developing a low-cost “biosimilar” version of Pegasys. For Sankalp and other civil society groups, the decision means a setback to their campaign on lack of access to cheaper alternatives. The medicine is considered crucial for HIV positive patients who are co-infected with hepatitis
Some of these groups are considering filing a public interest suit on the issue.
Lawyers Collective, an advocacy group that supported the patent opposition, said the decision provided Roche a monopoly over the drug.
“Patients with chronic Hepatitis C, who need a six-month course of treatment of pegylated interferon alfa2a, have to purchase it at for approximately Rs 4,36,000 (available at a discounted price of Rs 3,14, 496). Again, Pegasys has to be taken in combination with Ribavarin, which alone costs Rs. 47,160,” said the group.
Lawyers Collective also complained that the patent was upheld even after members of the Opposition Board, which looked into the post-grant opposition, were not unanimous in their opinion favouring Roche.
Roche and Wockhardt declined comment.
“Roche’s patent for Pegasys involves combining interferon alfa2a – a naturally occurring protein with known antiviral effects – with a structure called polyethelyene glycol (PEG), a known inert substance that prevents interferon from being broken down by the body, thus allowing it to remain in the blood stream longer. This technology of combining interferon and other biologically active proteins with PEG had been known for years prior to Roche’s claim for the patent,” said Lawyers Collective.
Sankalp Rehabilitation Trust, a Mumbai-based NGO that works with drug users, in its post-grant opposition filed in 2007, had argued that the patent was wrongly granted because, given what was known when Roche filed its patent application, the invention that Roche was claiming was neither new nor inventive.
“The high price of the medicine makes the 48 weeks treatment for patients co-infected with HIV and Hepatitis C unaffordable and inaccessible. Urgent steps need to be taken to allow generic production of interferon alpha2a so that its price can be brought down,” said Leena Menghaney of Medicines Sans Frontieres.