After a long campaign by right-to-health activists and TPP partners, it appears that the U.S. has finally dropped its efforts in TPP negotiations to require patent coverage for new forms of known products that lack evidence of enhanced efficacy. The most recent previous leaked draft TPP patent chapter contained Article QQ.E.1.2 which stated that a “patent may not be denied solely on the absence of enhanced efficacy of a known product where the applicant has set forth distinguishing features.” This provision – or any equivalent – is now absent from the draft text leaked by KEI yesterday.
The deleted provision had been proposed as a direct challenge a patent exclusion/standard-of-inventiveness used by India in section 3d of its Amended Patents Act to prevent ever greening of patent monopolies by minor changes to the chemical form of a known substance or by a mere new dosage, new formulation, or new combination of known substances in the absence of evidence of a significant therapeutic effect. This anti-evergreening standard is gaining traction in state practice elsewhere having been adopted by several other countries and under discussion in others.
The universal opposition to the U.S. “new form” proposal by other TPP partners, rich and poor, bodes well for the defense of India’s section 3d against ideological attacks by the U.S. and for further adoption of comparable provisions in law reform efforts in Brazil, South Africa, and elsewhere. Instead of being able to force this particular pro Big-Pharma, eased patentability criterion down the throats of TPP partners, the U.S. has become so isolated on the “new form” issue that it has actually dropped the demand. This retreat also bodes well for future progress on stricter standards of patentability even in the U.S. where the vast majority of pharmaceutical patents are granted on minor variations to known medicines with little, no, or even less therapeutic benefit – all in pursuit of longer profit-maximizing pharmaceutical monopolies.
Despite this partial victory, the most recent proposed test still includes demands from the U.S. concerning mandatory patents for new uses and methods of use of existing medicines. There is also language weakening the standard for industrial applicability to usefulness/utility. These relaxed standards could still result in ever greening, delayed generic entry, and higher prices for medicines. Thus, the struggle against U.S. IP fundamentalism continues.