U.S.-India to Create Intellectual Property Working Group; Brand Drugmakers Hope to Resolve IP Concerns

Branded drugmakers have expressed guarded optimism at the announcement of high-level intellectual property talks between the U.S. and India, hoping the discussions will resolve long-standing worries over a lack of effective patent protection by the Indian government. 

President Obama and India’s recently elected Prime Minister, Narendra Modi, last week said they would establish an annual Intellectual Property Working Group to hold decision-making and technical-level meetings as part of the two countries’ bilateral Trade Policy Forum.

The working group represents a positive first step in resolving intellectual property issues, PhRMA Deputy Vice President for Public Affairs Mark Grayson said.

However, Grayson cautioned that “just having a working group is not enough;” there must also be direct action to alleviate concerns over how India protects pharmaceutical IP. At such an early juncture, brandmakers will just have to wait and see what the working group accomplishes, he added. 

U.S. brand drugmakers and Indian generics makers have been at loggerheads in the past over intellectual property.

U.S. manufacturers have lashed out at India’s pharmaceutical policies, such as compulsory licensing, which, in at least one instance, allowed Indian generics makers to produce copies before the brand drug’s patent expired. Indian generics firms have gone so far as to hire a U.S. lobbyist to represent their interests on Capitol Hill, aiming to ward off FDA import bans and fears of a trading status downgrade for India.

If nothing else, the working group represents another chance for U.S. brandmakers to continue pressuring the Indian government to step up its protection and enforcement of IP, India advisory firm TwoFour Insight Group founding partner Vince Suneja said.

Suneja expects a variety of IP issues to come up in working group discussions. Those issues include incremental innovation, regulatory data protection, patent linkage and pre-grant oppositions. Any major changes in these areas are unlikely in the short to medium term because of how important India’s generics companies are to its economy, Suneja said, especially because of their outsized presence in foreign drug markets like the U.S. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.