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India Sets High Bar for Patent Protection, But Is it Too High?

By Ashby Jones

Be careful what you wish for.

It might be what multinational drug companies are thinking in regard to India’s recently overhauled patent system.

Let us explain, with a little help from this article, from the WSJ’s Geeta Anand. Until 2005, India’s patent regime recognized only process patents for making pharmaceutical products-and not the actual products, much to the chagrin of drug companies eager to jump into the world’s most populous democracy. When the country adopted an expanded patent law, it was widely hailed and multinational firms began moving in.

But, as Anand explains, little noticed at the time was that the new law sets a higher bar than Europe and the U.S. for approving patents. As a result, India’s patent office and courts have repeatedly declined to defend patents widely accepted in many other countries on some of the world’s best-selling medicines.

In the latest example, Bayer AG failed this week to persuade the Delhi High Court to direct India’s chief drug regulator to not give marketing approval to a competitor’s copy of its cancer medicine Nexavar. Other top-selling, life-saving medicines, including the anticancer treatment Glivec from Novartis; anticancer drug Tarceva from Roche; and HIV medicine Viread from Gilead Sciences all have failed to win protection from India’s patent office or the judicial system.

It’s a problem, say drug executives. “If this science and innovation can’t be patented, it is sending a very strong message about how limited India’s patent protections are,” says Gregg Alton, executive vice-president of corporate and medical affairs at Gilead Sciences.

In court and in interviews, Indian officials and companies contend the Indian system is fair and that, by contrast, international patent offices grant patents where there isn’t significant innovation or benefit. They say it is India’s duty to grant patents only when there has been significant innovation, and to foster a competitive environment that keeps prices low so the country’s vast and mostly poor population can afford medicines.

“The U.S. would grant a patent to a piece of toilet paper,” says Amar Lulla, chief executive of Cipla, the Indian generics drugmaker. “Just because the U.S. granted a patent, doesn’t mean it should be valid.”

Full post as published by Law Blog - WSJ.com on February 12, 2010 (boomark / email).