India's Supreme Court wrapped up hearings in the big Novartis ($NVS) patent case yesterday. But don't expect a decision very soon. The Swiss drugmaker, fighting for patent protection for its cancer drug Glivec, says it's not expecting a verdict till the first quarter of next year.
It's been one of the most closely watched--and long-drawn-out--drug-patent cases ever. Denied a patent on the blood cancer drug, Novartis appealed to the Intellectual Property Appellate Board--and lost. It then took its fight to Indian court. Hearings were repeatedly postponed. When the high court did finally sit for arguments, the hearings lasted 12 weeks.
Glivec, sold as Gleevec in other markets, has been considered a breakthrough treatment for some blood cancers. But Indian patent authorities decided it didn't meet stipulations of two sections of their IP laws--one of which involves patents on already known drugs and another that involves patents "against the public interest."
As the Glivec case played out, the Indian government has grown increasingly skeptical of foreign drugmakers' patent claims and protections. Over the past few months, officials have pulled patents on Pfizer's ($PFE) kidney cancer drug Sutent and Roche's ($RHHBY) hepatitis C remedy Pegasys. The Indian government also forced Bayer to license its cancer drug Nexavar to Natco Pharma, a domestic drugmaker that's now selling its generic version for a fraction of the branded price.
The patent changes aren't the only signs of shifting attitudes. Spooked by Big Pharma's acquisitions of some big domestic pharma players, the government is now requiring review of foreign investments in the drug industry. Deals have to clear a government panel before they can close.
So, the Supreme Court's ruling will either continue the erosion of intellectual property protections in India or signal the rest of the world to expect more of the same. Legal details aside, the essential argument is whether patent protections and foreign ownership drive prices up and restrict access to medicines. Novartis has posted its side of the story in a 6-page fact-or-fiction discussion; it includes the usual links between patent protections and innovation, as well as a deconstruction of India's "pharmacy to the poor" self-image. Domestic pharma and access-to-medicine advocates have their own points to debate.
The company, in any case, can see the end of this legal battle. "Novartis deeply appreciates the opportunity to present the case before the Court and will look forward to the outcome," the company said in a statement. Stay tuned next quarter.
- read the Novartis statement
- get the Bernama story
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