Tag Archive for Health Rights

India’s Supreme Court rejects Novartis patent claim

Novartis

Health rights activists hail judgment as a major victory for the world wide campaign for affordable medicines

By Team FI

In a landmark judgment the Supreme Court of India rejected Novartis AG’s plea to patent its cancer drug, Glivec. The drug was developed in the 1990s and is considered beneficial for treating chronic myeloid leukemia and gastrointestinal tumors.

The Swiss company’s legal fight began after the Chennai patent controller rejected its application for a patent for Glivec in 2006. According to health rights activists, Novartis tried to get an Indian patent for a ‘new’ version of the drug which was just the same old molecule with a tiny cosmetic change. India’s patent law applies strict standards for granting patents.

Glivec costs INR 120,000 (around USD 2400) per dose. This judgment opens the door for generic production of the drug and the generic version is expected to be at least 95% cheaper. The court decision is also expected to facilitate early entry of generic medicines into the market for other diseases too. India’s generic drug industry supplies much of the cheap medicine used in the developing world.

Rejoicing at the decision, Mr. Y. K. Sapru of the Cancer Patients Aid Association (CPAA), which had opposed Novartis’ patent application, said, “Our access to affordable treatment will not be possible if the medicines are patented. This judgment is a huge victory for human rights.”

According to Anand Grover of the Lawyers Collective, who had represented the CPAA in the court, the ruling “gives life to Parliament’s intent of facilitating access to medicines and of incentivizing only genuine research”.

The judgment is considered to be a great boost for India’s health rights movement. A similar case is being fought in the Supreme Court by activists who are campaigning for affordable Trastuzumab drug. In another boost to India’s health rights movement, the Supreme Court admitted a public interest writ petition against licensing and trials of cervical cancer vaccines in January this year.

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