By Rupali Mukherjee, The Times of India
MUMBAI: Healthcare aid and patient groups have come together in patent courts to fight against “abusive strategies” of Big Pharma, to ensure access to affordable treatment in hepatitis C. The Initiative for Medicines, Access & Knowledge (I-MAK) together with Delhi Network of Positive People and international medical humanitarian organisation, Medecins Sans Frontieres filed three cases on crucial new hepatitis C medicines: two patent challenges on daclatasvir, one on velpatasvir and a further challenge on sofosbuvir. The patent challenges could remove barriers to production and distribution of affordable generic versions of direct-acting antiviral (DAA) medicines, including Gilead’s sofosbuvir and velpatasvir, and Bristol-Myers Squibb’s daclatasvir.
Sofosbuvir (brand name Sovaldi) is Gilead’s blockbuster drug for hepatitis C, also embroiled in another patent challenge, which comes up for hearing today. The Indian Patent Office granted a patent on the drug last year, with the decision challenged by patient groups.
In the present challenge, the two cases oppose crystalline forms of sofosbuvir and daclatasvir and should be rejected for not being in compliance with Indian law, a statement from MSF said. India’s law recognizes that crystalline forms of known medicines are not inventions and should not be awarded patents. This was confirmed by Supreme Court on April 1, 2013, which refused a patent on Novartis cancer drug, Gleevec by holding that a crystalline form of a known pharmaceutically active compound cannot be regarded as involving an inventive step.
A critical third opposition shows that the patent on velpatasvir is an obvious structural change to an earlier hepatitis C drug, ledipasvir. This is a classic example of Gilead gaming the patent system in order to strengthen its control on the hepatitis C market. The fourth opposition also seeks to open up supply of raw materials from India by challenging the patent on intermediate form of daclatasvir.
Patent challenges, also called patent oppositions are one strategy to open up access to millions of people left without affordable treatment options, after other strategies to directly engage pharmaceutical companies have largely failed.
It is time to challenge the unchecked power that pharmaceutical corporations hold through abuse of the patent system.