India’s Decision About HCV Drug Patent Comes Under Fire

Ellen F.M. ‘t Hoen, a lawyer and activist for patients’ rights and more equitable pharmaceutical policies, slams recent decision by Indian Patent Office to grant sofosbuvir’s patent (a hepatitis C drug) to the US pharmaceutical giant, Gilead. She suggests to keep on fighting such an HCV drug patent which might restrict peoples’ access to essential medicines like sofosbuvir (available under the brand name Sovaldi.)

Drugs like sofosbuvir are considered ‘essential medications’, as they help us fight globally prevalent diseases. With an estimated 130 to 150 million people infected with chronic hepatitis C virus (HCV) worldwide, it has become essential to make medications which are affordable.

Indian government has recently amended its Patent Acts in 2005, which now allows pharmaceutical companies to apply for patents in India and acquire exclusive rights to manufacture drugs for the following two decades. The Patent Act was amended to comply with the intellectual property rules of the World Trade Organization. Before this, India was able to produce generic copies of the new drugs and able to offer those drugs at a much lower price which now would be impossible.

Gilead, however, has a special deal in place by which Indian companies can still produce generic copies of HCV medication sofosbuvir (as combinational tablets sofosbuvir/velpatasvir and ledipasvir/sofosbuvir combination tablet). The deal entails that the Indian companies can only supply their product in India, and 100 other low income and middle income countries.

The deal will provide potential medication to 100 million people with HCV. However, the companies cannot sell to middle income countries with high incidence of HCV and high income countries where ‘Gilead presumably wants to determine the price’ and establish a market for itself.

The medicine sofosbuvir has been added to WHO Model List of Essential Medicines and the current price of twelve week treatment course in United States is 84,000 dollars. Gilead has placed the price of one pill at 1,000 US dollars. Such a high price has resulted into rationing of the treatment in high income and low income countries where there is inaccessibility of the generic HCV medicines.

However, high Income and middle countries can give compulsory license to the Indian generic drug manufacturing companies which would allow them to make, sell, and import their product to those countries without any consent from Gilead.

Ellen F M ‘t Hoen, who also works as a researcher at Global Health Unit in the University of Groningen, asks an important question. “Whether this would allow countries to have access to cheap medication?” She answers with a resounding ‘no’.

Usually the decision to grant such license by middle income countries is met with ‘fierce opposition from wealthy nations and companies that vigorously defend the patent monopolies’.

Ms Hoen suggests that civil organizations should keep fighting such steps as essential medications should be kept in public domain for better and quick access and also reminds that governments should also take action if they are serious about implementing HCV treatment programmes.

A national human rights group in India, Delhi Network of Positive People (DNP+) and the US based non-profit group, Initiative for Medicines, Access & Knowledge (I-MAK) have filed a written challenge in the Delhi High Court against the Indian government which gave the patent to Gilead for the expensive hepatitis C drug, sofosbuvir.

The health activist groups are in favor of the Indian Patent Act before the changes, which did not allow companies’ patent protection for products whose patents are about to expire. This makes difficult to attain patents for newer versions of drugs in India (evergreen patenting) especially when generic and cheaper versions are available.

Loon Gangte, from Delhi Network of Positive People, said that it is a scary time for patients worldwide who rely on affordable generic medications from India. He also said that the Indian government’s ‘Make in India’ campaign seems only for foreign companies and not for Indian generic drug companies on whom people rely around the whole world.

The Controller General of Patents, Designs, and Trademarks of India granted the patent to Gilead for the HCV drug sofosbuvir on May 9, 2016, in a direct contradiction of an earlier order where the same patent was rejected as it lacked inventiveness and novelty.

The new reversal of policy step is seen as a potential block in access of the drug by the 50 million HCV infected patients in developing countries.

Doctors Without Borders (MSF) have also criticized the government over the patent approval. Leena Menghaney, a lawyer and manager of MSF Access Campaign in India, said that the move will “impact those domestic companies which were planning to enter the market independently to supply not just patients in India but also high-burden middle income countries that were not covered by the voluntary license”.

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