The Department of Industrial Policy and Promotion (DIPP) has rejected all suggestions made by the multinational drug majors’ lobby group – Organisation of Pharmaceutical Producers of India (OPPI) – before the Prime Minister’s Office in August.
The association had sought amendments to the Indian Patent Act to introduce some controversial provisions kept out from the Act in its previous amendment five years ago. Responding to OPPI suggestions, PMO had sought the opinion of the stakeholder departments like health, pharmaceuticals, legal affairs and DIPP.
DIPP, being the administrative department for patent-related matters, has a key role in deciding the future of intellectual property regulations in India. A point-by-point rebuttal of OPPI’s claims has sealed the hopes of immediate proposal to amend the laws.
Opposing the OPPI suggestions, DIPP, in its reply to the PMO note said the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement of the World Trade Organization did not mandate OPPI’s key demand for “data exclusivity”. According to DIPP, the downsides of data exclusivity include providing unnecessary protection to non-patented or off-patented medicines. It will also create barriers for compulsory licensing, as it prevents local manufacturers from relying upon the innovator firm’s clinical trial data to get approval for low-cost generic alternatives.
The department also opposed further amendments to the Patent Act, saying the current provisions contained the best possible methods to prevent ever greening of patents.
DIPP did not favour any linkage between the drug approval process and the patent status as it would lead to indirect “patent linkage” that can delay the development of low-cost medicines.
OPPI, the association representing the global pharmaceutical industry in India had sought a review of the scope of a specific section of the Indian Patent Act that disallows patenting of incremental innovations without significant advantages.
The department’s response is significant, as it has initiated a dialogue on the benefits and pitfalls of invoking compulsory licensing provisions under the Patents Act to make low-cost variants of patented medicines available in adequate quantities.
