Safeguards for generics in UK FTA: Govt

New Delhi: The India-UK free trade agreement (FTA) does not mandate patent term extensions or data exclusivity, which are two common tools of evergreening of patents, the commerce and industry ministry said Monday, adding that this would protect the interests of the domestic generic drugs industry. Data exclusivity provides protection to the technical data generated by innovator companies to prove the usefulness of their products."The FTA does not mandate patent term extensions or data exclusivity-two common tools of evergreening. India's patent law provisions on patentability criteria under Section 3(d) (of Indian Patent Act) remain fully protected," the ministry said. It prohibits the grant of 'evergreening' patents, which are additional patents for a drug with no therapeutic benefit and are seen to increase the term of a patent monopoly.The UK was demanding for inclusion of "data exclusivity" provision in the agreement.India had earlier rejected a similar demand on data exclusivity from the four-nation EFTA bloc in their free trade agreement negotiations. The India-UK comprehensive economic and trade agreement (CETA) was signed on July 24.India's generic drug industry is estimated to be about $25 billion and it exports 50% of its produce."The FTA does not require India to provide patent term extensions for regulatory delays and data exclusivity for pharmaceuticals or agrochemicals," it said, adding that this ensures that generic manufacturers can enter the market without unnecessary delay, once the patent has expired or is challenged. CETA, it said, does not alter India's ability to refuse patents for minor modifications of known substances; and prevent frivolous or repetitive patent filings blocking generics.Farm accessThe ministry also said India is giving duty concessions to niche British agricultural products like cranberries, durians, certain varieties of mushrooms, leeks, lettuce, and artichokes under the trade pact. These products have negligible production in India,it said.However, India is not giving any concession on sensitive items like apples, pineapples, oranges, and pomegranates in the CETA.Over 95% of Indian tariff lines or product categories in the agri sector will now enjoy zero-duty access to the UK market."India-UK CETA will allow Indian farmers to fetch premium prices for their products in the UK market, thereby granting parity with major EU exporters like Germany and Netherlands, who currently enjoy zero tariffs," it said.It said major gains are estimated for fresh grapes; bakery items, onions and mixed vegetables.ServicesCompanies from the UK will be able to offer services in telecom and construction in India without setting up a local presence and British firms will be treated on par with Indian firms.