• 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 ...
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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...
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    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 ...
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    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...
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    Follow the Rules, Indian Court Tells Patent Office in Sovaldi Case

    A prominent Indian court has ruled that India's patent office erred when it invalidated a patent application owned by the pharmaceutical company Gilead, giving the company another chance to save its patent on the hepatitis C drug Sovaldi while the patent office revisits the application. Monday, Regulatory Focus  reported the outcome and major themes of the court’s decision. In this article Focus will take a closer look at the facts of the case and the court’s judg...
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    Indian Court Sides with Gilead in Patent Dispute

    The Delhi High Court has ruled that India’s patent office failed to follow proper procedures in evaluating Gilead’s patent application, LiveMint reports. The ruling invalidates the Patent Office’s recent decision to reject Gilead’s patent application for one of the active metabolites of its hepatitis C drug Sovaldi. Background On 13 January 2015, India’s Patent Office rejected a patent application for a compound produced by the body as it metabolizes Sovaldi. Gi...
  • GMP Deficiencies in Spotlight in Warning Letters to Amgen, Baxter

    Life science manufacturing giants Baxter Healthcare and Amgen were each sent Warning Letters by the US Food and Drug Administration (FDA) in January 2014 chiding them for medical device manufacturing problems at their respective facilities. Amgen Letter The Amgen letter refers to a June 2013 inspection of the company's Thousand Oaks, CA facility where it makes three products: Prolia with prefilled syringe and manual needle guard Enbrel lyophilized vial and diluent ...
  • Amgen's Aranesp Target of OPDP Letter, Agency's Seventh in as Many Weeks

    Biopharmaceutical manufacturer Amgen is the latest company to receive an Untitled Letter from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP), the latest in a flurry of letters sent by the office in recent weeks regarding allegedly deficient marketing practices. The 19 November 2013 letter to Amgen, made public on 22 November, references a direct mailer used by the company to market its anemia drug Aranesp (darbepoetin alfa). Regu...
  • Landmark Ruling Clears Way for Use of Compulsory License in India

    In a decision upholding a landmark ruling, India's Intellectual Property Appellate Board (IPAB) has upheld a compulsory license granted by the controller of patents earlier in 2012, clearing the way for generics manufacturers to introduce low-cost versions of German pharmaceutical manufacturer Bayer's cancer drug Nexavar (sorafenib). At issue for Bayer was the country's use of the compulsory license-a concept first established under the Trade-Related Aspects of Intelle...
  • Brazil: Anvisa Issues New Technology Transfer Regulation for Local Companies

    Local Brazilian companies will be the beneficiaries of a new technology transfer  regulation that is intended to reduce the country's dependence on foreign drug imports and technology.  The regulation, approved by the Board of Brazil's national regulatory agency, Anvisa, on 13 September 2012, establishes procedures for local companies to enter into drug development and technology transfer partnerships with the National Health Service (SUS).  The regulatio...
  • UK: NICE Revises Guidance on Amgen's Denosumab

    The UK's National Institute for Health and Clinical Excellence (NICE) has reversed an earlier decision and now plans to recommend the use of Amgen's new cancer drug denosumab, used in the treatment of bone metastases from solid tumors, to the National Health Service (NHS). Physicians would be prohibited from prescribing the drug under the recommendation unless Amgen agrees to a cut in the price of the drug. The original recommendation not to use the drug was r...
  • Supreme Court Prepares to Hear Amgen's Challenge to Securities Fraud Lawsuit

    • 12 June 2012
    The Supreme Court of the United States (SCOTUS) said it agreed to hear a challenge from life sciences manufacturer Amgen regarding a lawsuit alleging the company inflated its stock price by misleading investors about the safety of its anemia drugs, Aranesp and Epogen. Amgen is reportedly contesting the class-action nature of the lawsuit, which it says could have the perverse effect of placing severe financial pressures on companies if allowed to stand. "At issue," expla...