News APP

NewsApp (Free)

Read news as it happens
Download NewsApp

Available on  gplay

This article was first published 16 years ago
Rediff.com  » Business » Roche's Hepatitis C drug patent challenged

Roche's Hepatitis C drug patent challenged

By P B Jayakumar in Mumbai
June 12, 2007 07:58 IST
Get Rediff News in your Inbox:

Swiss pharmaceutical major Hoffmann-La Roche's patents rights over Hepatitis C drug Pegasys has been challenged by public interest groups at the Indian Patent Office.

This is the second post-grant opposition filed against Pegasys, after Wockhardt, a domestic drug firm, approached the patent office with a similar plea two months ago.

Pegasys was the first drug to receive patent production and subsequent market monopoly according to the changed patent law of 2005. Its patent is valid in India until May 16, 2017.

The public interest groups have said that patent protection and the resultant high price of the drug is making it unaffordable for an estimated 12.5 million Hepatitis C infected people in India. The groups also argued that the product was not an innovation and hence not eligible for patent protection.

Sankalp, a Mumbai-based non-governmental organisation that provides treatment and rehabilitation support to injecting drug users, backed by a group of NGOs led by Lawyers Collective, filed the opposition with the Patent Office on May 18, citing that Roche sells the drug at a price of Rs 225,000 for a 6-month treatment course.

Absence of patent protection could help Indian pharmaceutical companies develop cheap reverse-engineered versions of Pegasys, it said.

Roche India said its parent company Roche was assessing the post-grant opposition filed by Sankalp and would reply to the Indian Patent Office within the stipulated time.

India amended the Patent Act in 2005 to bring in a new product patent regime, instead of the earlier process patents which legalised copying of drugs. By the new rules, generics drugs cannot be manufactured by changing the process and the product patent holder gets exclusive right to sell the product in the country.

Under the amended Indian Patent Act 2005, an application for a patent can be challenged within 12 months of publicising the application (pre-grant opposition) and after grant of the patent (post-grant opposition). The company has to respond to the challenge within a month.

Girish T Telang, managing director of Roche India, told Business Standard that the introduction of Pegasys has seen treatment costs for Hepatitis C patients drop to about one-third and the rate of cure has gone up to 80-95 per cent from 30-35 per cent earlier with normal interferons (a naturally occurring protein with antiviral effects).

"We also give Ribavirine (an anti-viral drug) free to patients as part of the total package. Pegasys is a technological advancement from Roche. The drug was launched in Switzerland in 2001, in US and Europe in 2002 and in the very next year, we made it available to Indian patients," he said.

It is not fair to demand it should not be given patent protection in India," Telang said.

Earlier, in a much-publicised similar case, multinational pharma major Novartis is fighting a case with the Indian government for denying it exclusive rights to market its cancer drug Gleevec in the country.

A few months ago, Indian drug maker Cipla had filed a pre-grant opposition against granting of patent for Gilead Life Science's Viread, an HIV/AIDS drug. The NGOs also had filed opposition to the Virea patent.

Sankalp alleges that Pegasys, a new-generation Hepatitis drug that helps to reduce the normal three injections per week to one injection per week, involves combining interferon with a structure called polyethelyene glycol, which helps the interferon to remain in the bloodstream.

The technology of combining interferon and other biologically active proteins with PEG had been known for years prior to this patent, the NGO says.

NGO sources said patent protection is only granted to inventions that are new and involve an inventive step. Under some legal provisions that are unique to Indian patent law, they said, "Roche's 'invention' is at most a 'mere admixture' of known substances and thus unpatentable under section 3(e) of the Patents Act, and it is just a 'new form of a known substance' and not patentable under section 3(d) of the Act. The patent is an attempt to obtain a monopoly over technology that existed in the public domain," they said.

Get Rediff News in your Inbox:
P B Jayakumar in Mumbai
Source: source
 

Moneywiz Live!