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  • Regulatory NewsRegulatory News

    WTO Reviews India's Trade Policies, Including Drug Patents, Compulsory Licensing

    The World Trade Organization (WTO) is conducting its sixth review of India's trade policies this week. To coincide with the review, the WTO Secretariat has released a report on India's trade and related policies, which highlights areas of many areas of progress, while noting some areas of concern related to India's policies on drug patents. Background The WTO routinely reviews its members' trade-related policies in order to track developments that may affect global ...
  • Regulatory NewsRegulatory News

    Bayer, Boehringer Latest to be Hit by Indian Patent Office Decisions

    In two recent decisions, India’s patent office struck major blows to German drug makers Bayer and Boehringer Ingleheim, saying their respective patents for Nexavar and Spiriva fail to meet the inventiveness requirements under the country’s controversial Patents Act . Background India’s patent system has been a source of frustration for western drug makers, who have argued for intellectual property (IP) reform in the country. India is also listed on the US Trade Repre...
  • In Landmark Ruling, Indian Generics Manufacturer Obtains Compulsory License

    In a landmark ruling, the Indian Patent Office (IPO) has granted generics manufacturer Natco a compulsory license to manufacture Bayer's oncology drug Nexavar, reports Pharmalot . The 9 March ruling has the could revolutionize the pharmaceutical industry in India by potentially allowing any number of generic manufacturers to challenge patented medicines so long as they pay royalties to the original manufacturer and seek to lower the price of the drug in order to make it...