The scope of the recently concluded Trans-Pacific Partnership Agreement (TPPA) goes well beyond conventional trade concerns. It includes extensive obligations on intellectual property (IP) exceeding the minimum standards of the World Trade Organisation (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
Viewed against the backdrop of India’s disappointment at certain outcomes of the WTO talks in Nairobi — countries like India will need to examine TPPA implications especially on non-violation complaints. Particularly as developed countries like the US can take developing countries like India to the WTO dispute settlement body for using TRIPS flexibilities contained in Section 3 (d) of Indian Patent Act. A number of flexibilities are not part of the TPPA.
Instead, the TPPA has adopted several TRIPS–plus provisions which effectively extend monopoly rights. Although India is not a party to the TPPA, these TRIPS-plus provisions are significant for the Indian pharmaceutical industry as they will be applied to its exports to TPPA members. This could impact and delay the entry of generic drugs, threatening access to medicines for all.
Some worrisome IP-plus features in the TPPA include patent criteria and term extension. TPPA aims to grant patents for inventions which are merely variations and not entirely new or novel. This dilutes patentability requirements leading to their “ever-greening” and extension of monopoly by at least five years. This will delay entry of a generic version of a medicine, impacting its affordability and access.
Further, it provides for extension in patent term for ‘unreasonable’ delay in processing applications, which is a TRIPS-plus standard enabling the rights holder to delay launch of the product in relatively low-priced markets, particularly developing countries, again hampering access to new medicine.
Third parties are not permitted to market the same or similar products using the same or other data regarding its safety and efficacy. Even if the parties accept applications for generic medicines within those five years, marketing approval can be provided after the five-year period.
Patent linkages are the other concern for developing countries like India as this could extend the period of additional monopoly in other markets that do not have a formal system, similar to the Orange Book in the US (that binds the drug regulator to approve a generic product within the stipulated time frame), thus delaying the introduction of generics.
The list of concerns do not end there. There is, for instance, the restriction on the government’s ability to utilise a compulsory licence as a means to negotiate price with the patent holder as was done by Brazil for antiretroviral medicines; and allowing private rights-holders to review and arbitrate the meaning of the WTO TRIPS Agreement.
Inclusion of path-breaking provisions such as covering IP as an asset in the investment chapter and giving customs officials powers to impound legitimate generic medicines, including for goods-in-transit, will further limit the reach of generic companies to many markets.
TPPA grants additional monopoly of at least ten years to innovators through provisions that go beyond the TRIPS Agreement. This could impact society by disincentivising innovators to carry out research and development on new drugs, and force patients to pay more for ten more years.
(The writer is Associate Secretary-General, Indian Pharmaceutical Alliance. The views are personal.)