by, Prof. Brook K. Baker, Health GAP
Feb. 7, 2014
IP, health and trade activists expressed outrage in early 2011 when the proposed US IP Chapter for the Trans-Pacific Partnership Agreement was first leaked. Particularly concerning was the language of section 8.1, addressing standards of patentability, that that proposed a substantial weakening of patentability criteria, including required patenting of new forms and new uses of existing medicines: "[T]he Parties confirm that: patents shall be available for any new forms, uses, or methods of using a known product; and a new form, use, or method of using a known product may satisfy the criteria for patentability, even if such invention does not result in the enhancement of the know efficacy of that product."
Other TPP negotiators were reported to be uniformly opposed to the U.S. proposal and the unconfirmed reports 2012-13 were that the U.S. had dropped its demand that new forms be patented.
The Wikileak disclosures of more recent IP chapter positions has revealed that the US has not so much dropped the demand that patents be granted for new forms, but rather has hidden the same demand in new language: “The Parties confirm that: (a) patents shall be available for any new uses or methods of using a known product and (b) a Party may not deny a patent solely on the basis that the product did not result in enhanced efficacy of the known product when the applicant has set forth distinguishing features establishing that the invention is new, involves an inventive step, and is capable of industrial application.”
The identical language in both US proposals is that TPP members would not be permitted to assess enhanced efficacy in determining whether an alleged invention is patentable. This provision is a direct challenge to section 3(d) of India's Amended Patents Act, which was famously used by the Supreme Court of India to deny Novartis's application for a patent on Glivec. Section 3(d) has been used in other opposition proceedings and decisions of the Indian Patents Office to deny secondary patents on minor variations to existing medicines where the variations do not evidence significantly enhanced efficacy in treating humans (not just in terms of physical properties like stability). Other countries are beginning to mimic the Indian provision, e.g., the Philippines, and comparable reforms are being proposed in important pharmemerging markets including Brazil and South Africa.
But in other respects, the new section 8(1)'s language concerning products with "distinguishing features" is linguistically equivalent to the earlier version concerning "new forms." Something new is something that is distinguishable from what existed before. Thus, many of the unpatentable new forms specified in India's section 3(d), e.g., "salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance" would have "distinguishing features" under the US proposal and thus be patentable.
IP maximalist positions in US TPP proposals never go away. The only patent demand that seems to firmly have been dropped is the US position outlawing pre-grant opposition procedures. The US is also reported to be proposing a transition period for Vietnam, Peru, Mexico, and Malaysia with respect to some of its patent and data monopoly demands, but that freedom will be temporary and partial.
Granting patents on new forms of existing medicines – or under the new language on forms with distinguishing features – is the essence of low/weak patent standards that results in evergreening – successive and recursive patenting of a medicine to extend the period of monopoly protection. TPP trading partners should continue to reject this US proposal or their access to affordable generics will be seriously constrained.