California headquartered Gilead Sciences will appeal the Indian patent office decision to reject a patent application that covers Hepatitis C drug sofosbuvir.

Earlier this week, the Indian patent office rejected a patent application on the base drug.

“We are pleased that the Patent Office found in favour of the novelty and inventiveness of our claims, but believe their Section 3(d) decision to be improper. Gilead strongly defends its intellectual property. The company will be appealing the decision as well as exploring additional procedural options,” Gregg Alton, Gilead’s Executive Vice President, Corporate and Medical Affairs, told BusinessLine in an email response.

Section 3 (d) of the amended Patents Act disallows patent protection on compounds that are seen as being a tweaked version of a known compound, unless it shows greater therapeutic efficacy. This feature of the Act has been contentious and has led to much acrimony in the IP relations between India and the United States. And the sofosbuvir decision comes ahead of a high-profile visit by US President Barack Obama, who is chief guest at the Republic Day celebrations later this month.

Breakthrough drug

Gilead’s sofosbuvir had hit global headlines last year over the pricing of the breakthrough medicine, one of the first of several oral Hepatitis C drugs. It costs $84,000 for 12 weeks in the US and is expected to be pegged at less than $1000 for the same period in India.

On this weeks patent rejection, Gilead clarified, “the main patent applications covering sofosbuvir are still pending before the Indian Patent Office. This rejection relates to the patent application covering the metabolites of sofosbuvir.”

But Tahir Amin, lawyer and director of US-based I-MAK (Initiative for Medicines, Access & Knowledge) told the paper that they were of the opinion that Gilead’s drug lacked in inventiveness as well. I-MAK is one of several who have opposed Gilead’s patent applications at the Delhi and Kolkata patent offices.

Others opposing Gilead’s patent application on sofosbuvir include Delhi Network of Positive People, the Indian Pharmaceutical Alliance (representing large domestic drugmakers) and Hyderabad-based drugmaker Natco.

Open competition

Intellectual property experts point out that the Patent office’s decision does not entirely open the flood gates for generic drug makers to produce inexpensive versions of the drug, just yet.

But it does open the possibility for companies across the world interested in making the Active Pharmaceutical Ingredient (API), explains Leena Menghaney, with international humanitarian organisation Doctors Without Borders/Médecins Sans Frontières (MSF).

Meanwhile, the Indian drug regulator has granted sofosbuvir regulatory approval in an unprecedented four months, Gilead said, making it the first country in Asia to approve sofosbuvir - recogni'sing the need to bring this innovative new medicine to patients in India as quickly as possible.

Amin observes that the patent rejection and regulatory approval will open up possibilities for “open competition” among generic drug makers to produce the drug, as opposed to “managed competition”.

His reference was to Gilead’s high profile alliance with seven Indian companies last year, allowing them to make sofosbuvir at reduced prices for certain markets. The Indian companies that entered into these non-exclusive licensing agreements included Cipla, Ranbaxy and Mylan.

Gilead, however, added, “These proceedings (patent application rejection) do not impact our commitment to enabling access to our hepatitis C medicines in India and other developing countries, and our generic licensing program with our Indian partners continues as normal.”

jyothi.datta@thehindu.co.in

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