Join Our Telegram Channel _http//t.me/UPSCMaterials RIRAM’s (Generic medicines are unbranded drugs. They have the same active chemical content as the patented drug. They can be produced for drugs for which either there is a process patent or the product patent expired.) TRIPS and Public Health Safeguards While the TRIPS provisions are good in the long term for development of new medicines, they may go against availability of affordable medicines when there is a public health emergency. Therefore, there are two safeguards in TRIPS law that are incorporated into Indian law as well: © compulsory licensing and + parallel imports Compulsory licensing means Government of the country facing public health crisis can ask for production and sale of the drugs in the country at concessional price based on @ compulsory license that it issues. If the patent holder is ready, it gets the license. If not, it allows a government to temporarily override a patent and give license to another company. This allows generic copies of a patented product to be produced domestically, with compensation paid to the patent holder. Generic copies of patented drugs are much cheaper than the branded drugs thereby ensuring an adequate, affordable stock of the essential drugs. It works without the consent of the patent owner. Multinational drug companies had demanded strong safeguards against the liberal use of the ne a ne the, pied India's first ever compulsory Ili iene? De J ial Property Appellate Board (IPAB) in 2012 to Natco Pharm: the Sod sion of Bayer’s Nexavar, an anti-cancer agent used in the treatment of liver and kidney cancer. Health experts and NGOs have welcomed the order saying it would deter innovator companies from selling their drugs at exorbitant prices. It was the only case when compulsory licensing was invoked. US did not like it and so India was placed on the ‘Priority Watch List’ in the US Trade Representative’s (USTR) Special 30] Review. Special 30lis a section in, the US trade law that seeks to penalise the countries whose JP laws, go against US interests. Incremental Innovations Section 3(d) of the Indian Patents Act disallows ever-greening of patents unless it differs significantly in properties with regard to therapeutic efficacy. In 2013, the Supreme Court in a landmark ruling rejected Swiss drug-maker Novartis’ plea for a patent for its anti-cancer drug Glivec — beta crystalline of a known molecule called imatinib mesylate — saying it lacked novelty and failed to meet the country’s patenting standards. Novartis enjoyed the patent for Glivec for 20 years and later without adequate value addition, applied for a new patent for the same drug with mere incremental innovation. It upholds India’s policy stance that incremental innovations lacking "enhanced therapeutic efficacy” as assessed by the patenting authorities will not qualify for patents. (SSDEMIRAIAS! 184 alee