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  • Regulatory NewsRegulatory News

    BIO Highlights IP Challenges Around the Globe

    As part of an effort to help the US Trade Representative understand and preserve strong intellectual property (IP) protections for US companies, the Biotechnology Innovation Organization (BIO) recently put together a report highlighting challenges worldwide and noting that IP reforms outside the US could improve conditions for exporting biotech products. "These challenges hinder or prevent innovators from securing patents (patent backlogs and restrictive patentabil...
  • Feature ArticlesFeature Articles

    Strategies Adopted by Innovator Companies in Response to Biosimilars Competition

    This article examines key strategies being adopted by the innovator companies and discusses the impact these strategies are likely to have on the future market for biosimilars. Introduction Over the last 25 years, biologic medicines have transformed how several chronic and life-threatening diseases are treated. Because of the great value of these innovative biologic medicines and the capital required to bring them to market, they are able to command high prices. For e...
  • Regulatory NewsRegulatory News

    Sovaldi Patent Rejected in China Following Third-Party Challenge

    China's patent office has rejected a patent related to Gilead Science's blockbuster hepatitis C (HCV) drug Sovaldi. Background The rejection comes one month after the Initiative for Medicines, Access & Knowledge (I-MAK) filed several patent challenges against Gilead in China. I-MAK has also filed similar challenges in Argentina, Brazil, Russia and Ukraine, all citing Sovaldi's high price as a barrier to access in many middle-income countries where licensed generic ve...
  • Regulatory NewsRegulatory News

    US, Switzerland Campaign to End 20-Year Moratorium on Non-Violation Complaints to WTO

    At the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) meeting last week, the US and Switzerland called on the Council to end a 20-year moratorium on what are called "non-violation complaints," LiveMint reports. While non-violation complaints were rare even before the moratorium, they could provide a way for countries to challenge controversial intellectual property provisions such as Section 3(d) of India's Patents Act . Background Non-v...
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    Biologics Exclusivity Still Central in Trade Talk Debate

    The length of data exclusivity for biologics remains one of the most controversial aspects of the Trans-Pacific Partnership (TPP), which is poised to be the largest free-trade deal in history. While the US Trade Representative (USTR) and the biopharmaceutical industry have publicly called for a 12-year exclusivity period, Politico reports that some industry lobbyists are tempering their expectations. Background Among the 12 parties to TPP, the United States is the on...
  • 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

    After Court Rulings, Canada Proposes Changes to Combination Drug Requirements

    Canada is looking to amend its Patented Medicines (Notice of Compliance) Regulations after two high-profile court rulings took a strict interpretation of the regulations that would make it more difficult to protect combination drugs under the regulations. Background In Canada, a notice of compliance is issued to a drug company when its product has been authorized. The requirements for a notice of compliance to be issued can be found in C.08.004 of the Food and D...
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    After Being Sued for Patent Infringement, Cipla Offers to License Novartis Drug

    In the midst of arguments before a prominent court in India, generic drug maker Cipla has offered to pay a "reasonable" royalty to Swiss multinational Novartis, The Economic Times reports. The case will test a number of issues, including how licensing arrangements could work out when a company has already launched a generic version of a patented medicine and India's stance on the controversial practice of compulsory license. Intellectual Property: Background Novartis...
  • Regulatory NewsRegulatory News

    Indian Court Sides with Merck in Patent Dispute

    A prominent court in India has issued an interim injunction, overturning a previous ruling, in favor of US drug maker Merck in a patent dispute with Glenmark Pharmaceuticals over an active ingredient used in two of Merck's diabetes medicines, Januvia and Janumet. Background India’s patent system has been a source of frustration for western drug makers, which have argued for intellectual property (IP) reform in the country. While there have been several high-profile ...
  • 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...
  • Regulatory NewsRegulatory News

    Trade Group Wants to See Stricter Limits on Compulsory Licensing

    A US-based trade group wants to see the United States Trade Representative (USTR) pursue stricter limits on the ability of countries to bypass patent protection. In its Special 301 Submission 2015 , the Pharmaceutical Research and Manufacturers of America (PhRMA) argues that compulsory licenses should only be issued in “exceptional situations,” where there is a pressing public health need. What is a Compulsory License? Compulsory licensing (CL) is a legal provisi...
  • Regulatory NewsRegulatory News

    US, India Commit to ‘Collaboration’ in Health Sector

    The governments of the US and India released a joint statement affirming the two countries’ commitment to work together in a number of key areas, including intellectual property rights and healthcare-related trade. The statement comes after US President Barack Obama met with Indian Prime Minister Narendra Modi during with India’s his visit coinciding 66th Republic Day celebrations. The Statement The 59-paragraph statement, released 25 January 2015, discusses the two c...