The Telegraph
Saturday , November 3 , 2012
Since 1st March, 1999
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Cheap hepatitis drug hope

New Delhi, Nov. 2: An appellate board in Chennai today overturned a product patent granted by India to a Swiss company on a medicine to treat hepatitis-C infections, raising hopes for patients looking for cheaper versions of the drug.

The Intellectual Property Appellate Board (IPAB) has, after five years of hearings, revoked India’s first product patent on a drug granted in 2006 to F Hoffman-La Roche for pegylated interferon-alpha2a.

Health activists say the patent effectively granted a monopoly to Roche and patients who require a six-month course of treatment with pegylated inteferon alpha2a currently have to pay about Rs 3.14 lakh at a discounted cost.

“We are hoping the removal of this patent barrier will encourage generic competition, and patients will have access to cheaper versions of the drug,” said Eldred Tellis, the director of Sankalp Rehabilitation Trust, which had challenged the patent in 2007.

In 2009, the IPAB had rejected the post-grant objections filed by Sankalp, but the NGO had appealed. “We believe the generic version of pegylated interferon will be available at one-fifth the cost of the original product,” Tellis said.

Sankalp provides treatment and rehabilitation support to intravenous drug users who are at high risk of acquiring the hepatitis C infection.

Doctors estimate that up to 12 million Indians are infected with the virus, which is picked up through contaminated needles or blood or sexual intercourse, and can eventually lead to chronic conditions such as cancer, liver cirrhosis or liver failure.

The IPAB observed that pegylated interferon was obvious to a person skilled in the pharmaceutical domain and noted that Roche had not provided any evidence to prove that its drug had enhanced efficacy.

“Our objection to the patent was that interferon was a molecule already known to medicine and the process of pegylation was also known to the pharmaceutical industry,” Tellis said.

Under Indian patent laws, a patent cannot be granted to an innovation that is obvious. However, the IPAB held that while Roche’s drug had novelty, it did not meet other conditions for grant of a product patent. Roche may still challenge the ruling in court.

“The IPAB has rightly observed that the patentee had used conventional methods to pegylate interferon and obtained predictable results,” Anand Grover, a senior counsel and director of the HIV-AIDS unit within Lawyers Collective, said in a statement today. Lawyers Collective is a group of lawyers fighting for patients’ rights.

“We hope patent offices will follow these standards (set by the IPAB) while deciding on other applications,” Grover told The Telegraph later. Pegylated interferon was the first product patent on a medicine granted after India changed its patent law to allow product patents in 2005.

Between 1970 and 2005, India allowed only process patents, which facilitated the growth of the generic drug industry that reverse-engineered molecules and sold them at much lower prices than the original products.