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Here we'll explore the nexus of legal rulings, Capitol Hill policy-making, technical standards development, and technological innovation that creates -- and will recreate -- the networked world as we know it. Among the topics we'll touch on: intellectual property conflicts, technical architecture and innovation, the evolution of copyright, private vs. public interests in Net policy-making, lobbying and the law, and more.

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

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March 8, 2012

Indian Court Decision May End Cheap Generics

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Posted by Alan Wexelblat

It's sad and ironic that these stories always seem to appear around the same time of year. Last March I noted it was three years, and now it's four in which we've been unable to break the logjam around drug patents, pricing, profits, and people dying.

None of the issues have changed: patents are still a government-created monopoly that is limited in some ways and very broad in others. Drug companies still use patents to ensure they have monopolies on money-making medicines. And people still need medicines in order to stay alive with serious conditions such as HIV/AIDS or in this case a particularly nasty form of leukemia.

As Vikas Bajaj and Andrew Pollack wrote in The Times this week, a case has slowly wound its way through the Indian court system around drug giant Novartis's patents on a medicine known as Gleevec. This medicine treats one of the most deadly forms of lukemia and like many life-saving medicines it has been remade as a cheap generic by companies in India and elsewhere. The purpose of the suit is to force the government of India to recognize Novartis's patent as valid in India and thereby shut down the production of generics - which would be in violation of this patent if it was recognized.

Of course it's not just this patent that's at stake. If the Gleevec patent is recognized then the law under which India has barred recognition to a whole host of drug patents will fall, and those generics will go away. And it's not just India - the US and the drug lobbyists are so afraid that other countries might follow India's lead that they've begun high-pressure moves in trade negotiations to prevent this from happening.

It's worth noting that India's law is not a wholesale blind invitation to piracy. What the law says is that you can get a patent on a new drug, but you can only get a patent on a modification of that basic drug if you do something that improves its efficacy. In the US you can get patents based on slight reformulations, or patents to cover different delivery methods even though the underlying drug remains identical. So while it's clear that US and Indian patent laws differ, it's not obvious to me that one is inherently superior.

I've never been shy about where I stand on this sort of thing and my position hasn't changed. I believe that the patent monopoly power ought not to be absolute, that a new equitable bargain should be reached, if the damned drug companies will stop blocking it. Indian law may be too restrictive in that companies would not be properly enticed to spend the money to develop better delivery systems or refinements if they can't be sure it would meet some (currently undefined) standard of efficacy improvement. But we must weigh the lifesaving necessity of cheap versions of these drugs against the business needs. Right now, particularly in the US, the scales are tipped over far too much to one side. Let's hope India doesn't end up the same way.

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