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India revokes Roche pegasys patent

Roche Pegasys

The judgment is considered to be a major victory for health rights activists in India who have been fighting for affordable medicines

By Team FI

In a landmark judgment, the Intellectual Property Appellate Board (IPAB) has set aside the first ever product patent on a medicine granted in India to Roche for Pegasys, a medicine used to treat Hepatitis C.

The judgment was delivered by Justice Prabha Sridevan last week while hearing an appeal filed by a Mumbai-based non-profit organization, Sankalp Rehabilitation Trust.

In 2005, to comply with its international trade obligations, India re-introduced a system of granting product patents on medicines. In 1970, it had changed its patent law to disallow such patents precisely because they had resulted in high prices of medicines in India. This was the first product patent granted under the amended 2005 patent law.

The Indian patent law provides for several tiers of protection to ensure that only genuine inventions are protected by patents. For instance, it allows “any person” to file an opposition challenging its grant. This could prevent a patent from being wrongfully granted in the first place. If a patent is granted, it can still be challenged by a “person interested” in a post-grant opposition or in a revocation proceeding.

Sankalp had filed a post-grant opposition, which was rejected by the Patent Office. In the appeal filed by Sankalp before the IPAB, Roche sought to place a narrow interpretation on who a “person interested” could be. It argued that Sankalp is not a “person interested” because it was not a business competitor or a researcher. This issue probably arose for the first time before the IPAB. Rejecting Roche’s contentions, the IPAB held that a patients’ group that is a “person interested” in whether a patent is revoked or not.

Justice Sridevan noted that the revocation of a patent could bring down the costs of the medicine as well as increase supply. She also held that public interest is persistently present in intellectual property law.

On the merits, the IPAB revoked the patent on the ground that Roche’s claim of combining interferon (a protein known to treat Hepatitis C) with an inert PEG structure using conventional methods to obtain predictable results was obvious to a person skilled in the art. The IPAB also held that Roche failed to prove that the medication showed enhanced efficacy over other known pegylated interferons – a requirement under section 3(d) of India’s patent law.

According to Lawyers Collective, the group that represented Sankalp, the judgment now paves the way for Indian companies that may decide to launch biosimilars of the Pegasys medicine in India

Headquartered in Basel, Switzerland, Roche has been operating in India since 1993.

Featured Photo courtesy: Roche