
Isaac Asimov was a biochemist. He once sent a story to his editor and it was returned, with C(4)H(9)SH written on the copy. That molecular formula stood for butyl mercaptan and is a chemical compound that gives the skunk its smell. Thanks to Asimov, non-chemist science fiction readers learnt about this obscure compound. Something similar is happening with CGP57148B or STI571, imatinib mesilate. Most anti-cancer drugs inhibit division of cells. Imatinib mesilate inhibits tyrosine kinase enzymes (catalysts). As an anti-cancer drug, it belongs to a slightly different category and can be used to treat leukaemia, tumours and other malignancies. Novartis chemists, particularly Brian Druker, identified imatinib in the late nineties and, having obtained US FDA approval in 2001, Novartis markets imatinib as Gleevec in the US and Glivec in Europe and Australia. In 1998, Novartis filed a patent application for
Gleevec/Glivec in India. Then, because we used 10-year transitory provisions of TRIPs (trade-related intellectual property rights), India didn’t have product patents for pharmaceuticals. But we had a system of exclusive marketing rights (EMRs) and Novartis got an EMR in November 2003. There were delays in changing legislation and the first amendment to Indian Patents Act was in 1999, with a second amendment in 2002. The third amendment, with a complete product patent regime, was in 2005.
There are various strands in the tangled web floating around. First, patent protection, or intellectual property protection (IPR) in general, is about temporary monopolies granted to persuade inventors to place information about inventions in the public domain, so that there is access to information and frontiers of human knowledge can be pushed forward by others. Contrast this with a situation where information about inventions is retained in the private domain. The temporary monopoly, qualified by the existence of substitutes and use of competition policy instruments, is reward. More importantly, there is a trade-off between short-term static objectives and a long-term dynamic ones. If a patent regime is lax, short-term prices will be lower. But, in the long-term, there won’t be research and development, investments or supply-side changes that would have kept prices in check through new drugs and substitutes. TRIPs agreement only sets minimum standards of protection that every WTO member has to satisfy. Beyond the threshold, one can do what one wishes. It is difficult to dispute that the US went overboard in granting patents and progressively weakened criteria in gauging whether something was patentable. What do you expect in a country where the right to patent/ copyright is enshrined in the Constitution (Article I, Section 8)?
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