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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 19, 2013

Indian Court Upholds Compulsory Licensing Scheme

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Posted by Alan Wexelblat

According to a Reuters story earlier this month filed by Anupama Chandrasekaran, an appeals board in India has upheld a scheme permitting a generic local version of a patented anti-cancer drug to be manufactured. The local maker, Natco Pharma, is required to pay the patent owner Bayer AG, a 7% royalty on its sales but will be allowed to continue vastly undercutting Bayer's monopoly prices.

Natco's manufacturing is protected under an Indian national compulsory licensing scheme that follows the guidelines set out under TRIPS, a WTO-governed international trade agreement. Bayer has said that it will continue to fight against Natco and other country-local producers who are targeting lower-income buyers and in the process disrupting big-pharma international monopolies.

As I've made clear in the past, my sympathies in these cases are divided. Development and testing of drugs is a socially valuable but intensely expensive undertaking. Until and unless governments are willing to shoulder the entire burden of this process we must rely on commercial companies to do it. These companies need to be compensated for their costs of research and development and they need to make profits to stay in business. It's not enough just to make money on some drugs - if companies only have incentives to produce certain kinds of drugs then treatments for important conditions will lag. The sad state of anti-malaria treatments versus, say, expensive first-world mental health medications demonstrates this clearly.

However, the reason these medicines are so socially valuable is that they are often life-saving. They may be the only thing standing between millions of people and significant suffering or even death. Companies that are granted special rights such as manufacturing monopolies (patents) need to be willing to give up something in exchange - likely that means giving up some of their possible profits in order to ensure that life-saving medicines are more affordable.

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