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Time of India
2 days ago
- Business
- Time of India
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. Explore courses from Top Institutes in Please select course: Select a Course Category Cybersecurity Technology Digital Marketing MCA Finance Operations Management Project Management Public Policy Management Artificial Intelligence CXO Data Science Healthcare Data Science Others healthcare others MBA Data Analytics Degree Leadership Design Thinking Product Management PGDM Skills you'll gain: Duration: 10 Months MIT xPRO CERT-MIT xPRO PGC in Cybersecurity Starts on undefined Get Details The UK was demanding for inclusion of "data exclusivity" provision in the agreement. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Why Your Current Make-Up Routine Might Be Aging You Learn More Undo 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. Live Events "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 access The 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. Services Companies 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.
Economic Times
3 days ago
- Business
- Economic Times
India, UK trade pact does not mandate patent term extensions or data exclusivity
Representative image 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, according to a commerce ministry document. The move would protect the interests of the domestic generic drugs industry. The UK was demanding for inclusion of "data exclusivity" provision in the agreement. "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. Section 3(d) of the Indian Patents Act, 1970, restricts patents for already-known drugs unless the new claims are superior in terms of efficacy, while Section 3(b) bars patents for products that are against public interest and do not demonstrate enhanced efficacy over existing products. Certain multinational firms have asked India to amend these laws, which were strongly opposed. The agreement, signed on July 24, may take about a year to come into force. Data exclusivity provides protection to the technical data generated by innovator companies to prove the usefulness of their products. In the pharmaceutical sector, drug companies generate data through expensive global clinical trials to prove the efficacy and safety of their new medicine. By gaining exclusive rights over this data, innovator companies can prevent their competitors from obtaining a marketing licence for low-cost versions during the tenure of this exclusivity. Earlier, India had also rejected a similar demand from the four-nation EFTA bloc in their free trade agreement negotiations. The European Free Trade Association (EFTA) members are Iceland, Liechtenstein, Norway, and Switzerland. The pact was signed in March 2023 and will be implemented later this year. The UK (AstraZeneca and GSK) and Switzerland (Novartis and Roche) have some of the major pharma firms of the world. India's generic drug industry is estimated about USD 25 billion, and the country exports 50 per cent of its produce. An expert said data exclusivity is beyond the provisions of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement under the World Trade Organization (WTO). Evergreening of patent rights is a strategy allegedly adopted by the innovators having patent rights over products to renew them by bringing in some minor changes, such as adding new mixtures or formulations. It is done when their patent is about to expire. A patent on the new form gives the innovator company a 20-year monopoly on the drug. "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. The agreement, it said, does not alter or dilute India's ability to refuse patents for minor modifications of known substances; and prevent frivolous or repetitive patent filings that block generics. "There is no obligation for patent linkage or automatic injunctions either-key tools used to delay generics in other jurisdictions," the ministry said.
Time of India
3 days ago
- Business
- Time of India
India, UK trade pact does not mandate patent term extensions or data exclusivity
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 , according to a commerce ministry document. The move would protect the interests of the domestic generic drugs industry. Explore courses from Top Institutes in Please select course: Select a Course Category Operations Management Healthcare MBA Data Analytics healthcare Others Public Policy Data Science MCA CXO Data Science Leadership Product Management Technology Project Management Artificial Intelligence others Digital Marketing PGDM Degree Finance Design Thinking Management Cybersecurity Skills you'll gain: Quality Management & Lean Six Sigma Analytical Tools Supply Chain Management & Strategies Service Operations Management Duration: 10 Months IIM Lucknow IIML Executive Programme in Strategic Operations Management & Supply Chain Analytics Starts on Jan 27, 2024 Get Details The UK was demanding for inclusion of "data exclusivity" provision in the agreement. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Fed Just Quietly Took Control of Your Money Priority Gold Read More Undo "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. Section 3(d) of the Indian Patents Act, 1970, restricts patents for already-known drugs unless the new claims are superior in terms of efficacy, while Section 3(b) bars patents for products that are against public interest and do not demonstrate enhanced efficacy over existing products. Live Events Certain multinational firms have asked India to amend these laws, which were strongly opposed. The agreement, signed on July 24, may take about a year to come into force. Data exclusivity provides protection to the technical data generated by innovator companies to prove the usefulness of their products. In the pharmaceutical sector, drug companies generate data through expensive global clinical trials to prove the efficacy and safety of their new medicine. By gaining exclusive rights over this data, innovator companies can prevent their competitors from obtaining a marketing licence for low-cost versions during the tenure of this exclusivity. Earlier, India had also rejected a similar demand from the four-nation EFTA bloc in their free trade agreement negotiations. The European Free Trade Association (EFTA) members are Iceland, Liechtenstein, Norway, and Switzerland. The pact was signed in March 2023 and will be implemented later this year. The UK ( AstraZeneca and GSK ) and Switzerland ( Novartis and Roche) have some of the major pharma firms of the world. India's generic drug industry is estimated about USD 25 billion, and the country exports 50 per cent of its produce. An expert said data exclusivity is beyond the provisions of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement under the World Trade Organization (WTO). Evergreening of patent rights is a strategy allegedly adopted by the innovators having patent rights over products to renew them by bringing in some minor changes, such as adding new mixtures or formulations. It is done when their patent is about to expire. A patent on the new form gives the innovator company a 20-year monopoly on the drug. "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. The agreement, it said, does not alter or dilute India's ability to refuse patents for minor modifications of known substances; and prevent frivolous or repetitive patent filings that block generics. "There is no obligation for patent linkage or automatic injunctions either-key tools used to delay generics in other jurisdictions," the ministry said.
News18
3 days ago
- Business
- News18
India, UK trade pact does not mandate patent term extensions or data exclusivity
New Delhi, Jul 28 (PTI) 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, according to a commerce ministry document. The move would protect the interests of the domestic generic drugs industry. The UK was demanding for inclusion of 'data exclusivity" provision in the agreement. '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. Section 3(d) of the Indian Patents Act, 1970, restricts patents for already-known drugs unless the new claims are superior in terms of efficacy, while Section 3(b) bars patents for products that are against public interest and do not demonstrate enhanced efficacy over existing products. Certain multinational firms have asked India to amend these laws, which were strongly opposed. The agreement, signed on July 24, may take about a year to come into force. Data exclusivity provides protection to the technical data generated by innovator companies to prove the usefulness of their products. In the pharmaceutical sector, drug companies generate data through expensive global clinical trials to prove the efficacy and safety of their new medicine. By gaining exclusive rights over this data, innovator companies can prevent their competitors from obtaining a marketing licence for low-cost versions during the tenure of this exclusivity. Earlier, India had also rejected a similar demand from the four-nation EFTA bloc in their free trade agreement negotiations. The European Free Trade Association (EFTA) members are Iceland, Liechtenstein, Norway, and Switzerland. The pact was signed in March 2023 and will be implemented later this year. The UK (AstraZeneca and GSK) and Switzerland (Novartis and Roche) have some of the major pharma firms of the world. India's generic drug industry is estimated about USD 25 billion, and the country exports 50 per cent of its produce. An expert said data exclusivity is beyond the provisions of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement under the World Trade Organization (WTO). Evergreening of patent rights is a strategy allegedly adopted by the innovators having patent rights over products to renew them by bringing in some minor changes, such as adding new mixtures or formulations. It is done when their patent is about to expire. A patent on the new form gives the innovator company a 20-year monopoly on the drug. '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. The agreement, it said, does not alter or dilute India's ability to refuse patents for minor modifications of known substances; and prevent frivolous or repetitive patent filings that block generics. 'There is no obligation for patent linkage or automatic injunctions either-key tools used to delay generics in other jurisdictions," the ministry said. PTI RR TRB view comments First Published: July 28, 2025, 17:15 IST Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy.
