On April 11th, leading Indian drug makers banded under the collective “Indian Pharmaceutical Alliance” (IPA) to challenge 25 frivolous patent applications filed by several multinationals. For the past five years, since a massive transformation in Indian patent law (effectuated in 2005) that finally allowed the filing of pharmaceutical patents (before 2005, most pharmaceuticals were actually nonpatentable), the vast majority of drug patents have been granted to foreign multinationals. Until the IPA demanded its review of pharmaceutical patent grants, neither the names of the drugs for which patents had been awarded, nor the identity of their makers/patent holders, were known to the public public. With the recent disclosure by the Indian Patent Office, it was revealed that Novartis, AG, and Eli Lilly won roughly a third of the 81 contentious drug patents. Aside from these 25 challenged patents, another 51 were granted to other foreign drug makers (La Roche, Shering Corp., Merck, F. Hoffmann, etc…). Only five of the 81 pharmaceutical patents were given to local Indian drug makers.
The IPA alleges that the 25 contentious patents held by Novartis, AG and Lilly don’t merit patent protection under domestic law because they don’t enhance the efficacy of previously known drugs. The tactic, the IPA alleges, has been to “evergreen,” to extend the lifespan of an existing patent (for an indefinite period of time, à la copyright-extension) by tweaking the drug’s molecules a bit, without enhancing the drug’s function whatsoever. We’ll see how the suits play out, and whether the IPA will be successful in challenging the big multinationals’ patent extension efforts.
A large part of the problem with IP enforcement and practice in India, especially with regards to patent granting and infringement, has been the lack of transparency of patent records, which, for all the charges of corruption being thrown about, was really just due to a poor infrastructure.
It was only last year that extant patent records were finally digitized and uploaded to a central server, and only a few months ago, in October 2009, that the records were finally searchable online. In the same vein, a lack of patent examiners has hindered the patent-granting process (in the past) or, as is the precarious case today, granted patents when there was no justification for doing so.
But if “evergreening” patents was certainly aided by the poor IP oversight, it did not depend entirely on bad infrastructure to carry out its nefarious aims. Evergreening is symptomatic of the egregious overstep of patent granting, but is not its only occurrence. The massive 2005 change in Indian law that finally permitted for the patenting of pharmaceuticals was carefully to include a restriction on traditional and commons-based medicines, a section labeled 3(d), “which restricts protection being granted to already known and long-ago patented drugs and their combinations.” Even despite the new presence of pharma patents, Indian scientists are urging people to infringe on drug patents. Beyond that, on the more constructive end of things, a few scientists have recently mapped out the tuberculosis genome, and are refusing to patent the genome and freeing up future research through an open search approach: “Anyone can take advantage and develop a drug based on our research. The aim here is not patents but drug discovery for a neglected disease.” Open access to the tuberculosis genome will be useful for researchers working on solutions for combatting the disease. Anyone across the world is free to join the effort.
The restriction on the new patent law highlights the enormous frequency (and problematic nature) of patents on traditional drugs. In 1995, the US Patent Office (not the Indian one) granted a patent to the University of Mississipi’s Medical Center for the “Use of Turmeric in Wound Healing.” Since then, patents have been granted to US firms for Basmati rice and yoga postures. When pressed by the Indian government for explanations as to their ludicrous patent grants, the US’ answer was that “’India has not yet made available product patent protection for pharmaceuticals and agricultural chemicals, and thus has chosen to take advantage of at least part of the exclusive marketing rights.”
For Indians in India, the impact of an American patent on Turmeric use is much less significant than for Americans, especially considering that international enforcement and standardization of IP laws (under bodies like the WIPO) is far less strict than domestic enforcement by the US. But consider the case of an Indian émigré in the United States using Turmeric to heal scrapes and wounds – she would be violating the patent. Although it has been revoked, the US patent on Turmeric nonetheless highlights what seems to be the dominant (and quite problematic) strategy of the US Patent Office (which has since, sadly, been adapted by the Indian Patent Office as well), to grant patents, regardless of whether they meets the necessary standards, flaunting left and right the non-obviousness clause, or the efficacy-clause, and to revoke them only when under pressure to do so from external parties.
India is the greatest IP paradox. For all its notorious flouting of IP rights,l India is one of the preferred locations for the R&D labs of those same multinationals pressuring India to strengthen its IP policy and enforcement. IT giants Microsoft, Intel and Motorola have immense R&D operations in India, and pharmaceutical companies are beginning to establish research centers there as well. India is the ideal innovation center because of its sheer mass of low-cost, high-skilled knowledge workers. The average salary of a scientist or engineer in India is $20,000, a figure that pales compared to the $90,000 average in the United States. Whether IP maximization drives India’s stunning knowledge culture, or rather, whether the commons-based approach to knowledge that prevailed until recently is instead responsible for providing IP maximizers such as Microsoft with the R&D they need to function, is a question here left unanswered.