Ever-greening of Patents in the Context of Trans – Pacific Partnership Agreement: Implications for South Asian Countries

Abstract

Patents are monopolies granted by state to inventors for a limited period of time. Disclosure of invention and technology transfer are the raison d etre for patents. The Intellectual property balancing is well in place in the multilateral WTO TRIPS regime through patentability criteria’s, flexibilities, limitations and exceptions. But the recent mega Regional Trans Pacific Partnership Agreement establishing Gold standards for Intellectual property generates great IP imbalance between private and public interest. The Pharmaceutical patents is one of the controversial area even within the multi lateral trade agreement is further becomes murkier beyond the imagination of TPPA Negotiators, activists, even WTO. The most controversial issues in pharmaceutical patents are patent linkages should be allowed in chemicals, pharmaceutical products. Data exclusivity should be given for minimum 10 years and biologics for 8 years, Ever greening should be allowed for new process, use, indication, and improvement of known product. Patent term adjustments and patent term extensions for administrative reasons and through ever greening will be very common. Compulsory licensing provisions of chapter 9 and chapter 18 limiting government use and the incorporation of ISDS dispute mechanism will have adverse effects taking each ground individually and collectively. The present concern is to analyze the patent ever greening or incremental innovation as dealt in article 18.37 (2) of Chapter 18 of TPPA which categorically states that ever greening should be allowed under three criteria’s new use of known product, new methods of using a known product, or new processes of known product provided the parties can limit the last criteria with process patent and exclude product patents. The author argues that ever greening provisions is never leading to innovations rather extending undue monopolies when issued without improved efficacy. The author further argues that ever greening is bad for generics as the period of patent goes uncertain and it delays the entry of generics and will impact market power. Ever greening is bad for patients as it raises affordability issues. The Indian supreme court in Novartis II (2013) also states that there needs to be 3(d) because to curb undue monopolies and this does not in any way intended to stop incremental innovations.