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“The United States is concerned that the recent decision by India’s Supreme Court with respect to India’s prohibition on patents for certain chemical forms absent a showing of “enhanced efficacy” may have the effect of limiting the patentability of potentially beneficial innovations. Such innovations would include drugs with fewer side effects, decreased toxicity, or improved delivery systems. Moreover, the decision appears to confirm that India’s law creates a special, additional criterion for select technologies, like pharmaceuticals, which could preclude issuance of a patent even if the applicant demonstrates that the invention is new, involves an inventive step, and is capable of industrial application.” [pg 38]
As has been mentioned repeatedly, the Novartis decision does not prevent patenting of new uses but instead paves the way for genuine innovation rather than frivolous ‘evergreening’ – something perhaps that other countries could learn from. [See Shamnad’s elucidation here]
Regarding the IPAB’s Compulsory License decision:
In particular, India’s decision in this case to restrict patent rights of an innovator based, in part, on the innovator’s decision to import its products, rather than manufacture them in India, establishes a troubling precedent. Unless overturned, the decision could potentially compel innovators outside India – including those in sectors well beyond pharmaceuticals, such as green technology and information and communications technology – to manufacture in India in order to avoid being forced to license an invention to third parties.
To this, my first response is to question how exactly they define ‘respect’ when they earlier state:
Consistent with this view, the United States respects its trading partners’ rights to grant compulsory licenses in a manner consistent with the provisions of the TRIPS Agreement, and encourages its trading partners to consider ways to address their public health challenges while maintaining IPR systems that promote innovation.
And secondly to point out that the decision revolved mainly around ‘the excessive pricing of an anti cancer drug Nexavar, patented by Bayer’. Quoting Jamie Love in the Huff Post, “by focusing on India’s domestic drug production rules, neglected to admit it was trying to force India to accept a $65,000 annual price for a cancer drug.”
Also relevant to this is the rather arrogant natured exchange between the USPTO deputy director Teresa Rae and the US Congress on the same issue last year wherein “the Deputy Director of the USPTO testifies before Rep. Bob Goodlatte, in the House Subcommittee on Intellectual Property that the USPTO continues to actively try to ‘educate’ and persuade Indian officials to not grant any further compulsory licenses.” Her statement was heavily criticized and later retracted and ‘clarified’. See more in my previous post here.
Other issues that the report mentioned India required improvement included increasing TPM protection, increasing criminal enforcement, increased penalties and stronger actions against counterfeit goods. They also go on to refer to the ACTA and TPP agreements as positive developments – the dangers of which we have written about several times on this blog. [See here for KEI’s report on the rest of this year’s edition of the 301 report].
All in all, my opinion would be that any legitimacy that they may have hoped to develop through this Special 301 process is slowly getting eroded by the (ab)use of this process as such a blatant tool of representation of corporate America across the world without regard for the public interest in a number of developing countries.
