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    Biosimilar ‘Patent Dance’: Federal Circuit Rules 180-Day Notice is Mandatory

    The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration (FDA) review. The ruling has major implications for when biosimilars can be launched and it follows the US Supreme Court’s request in late June that th...
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    India's Supreme Court Denies Petitions Challenging CDSCO

    • 11 March 2016
    Dinesh Thakur, the now-famous Ranbaxy whistleblower who won more than $48 million for calling out the company’s drug safety issues to the US Department of Justice, failed on Friday to get the Supreme Court of India to hear two petitions seeking to challenge the law under which India’s drug regulator Central Drugs Standard Control Organization (CDSCO) operates. Thakur told Focus that the petitions “challenge how CDSCO works and the commitments it makes” to keeping subst...
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    Sandoz Petitions Supreme Court to Rule on Biosimilars

    Novartis' Sandoz has called on the US Supreme Court to review a lower court ruling that found biosimilar makers must wait an additional six months after US Food and Drug Administration (FDA) approval before they can bring their product to market. The petition for the Supreme Court’s review deals with Sandoz’s Zarxio (filgrastim-sndz), which came to market as a biosimilar version of Amgen’s Neupogen (fligrastim). Although FDA approved Zarxio in March 2015 as the first bio...
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    New Fundamentals of US Regulatory Affairs Book Now Available

    RAPS has just published the updated, ninth edition of Fundamentals of US Regulatory Affairs , the book that has become one of the most essential references for regulatory professionals working with healthcare products for the US market. The new edition is now available  in a print, hardcover edition or as an e-book. RAPS currently is offering free shipping for the book and for all orders from the RAPS Store through 31 August. Fundamentals of US Regulatory Affa...
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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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    European Court Says French Decree Violated Transparency Rules

    The European Court of Justice (ECJ) has issued a judgment clarifying EU transparency rules for products covered by national health insurance as they apply to ongoing legal battles in France. The judgement pertains to two complaints filed against France's Minister for Finance and Public Accounts and the Minister for Social Affairs and Health over the removal of two medicines from the list of products covered by the country's health insurance scheme. Background The medic...
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    Are Notified Bodies Responsible for the Failure of Companies They Oversee?

    A legal battle in Germany to determine responsibility in the aftermath of the Poly Implant Prothese (PIP) breast implant scandal will be put on hold while a German court asks for clarification from the European Court of Justice (ECJ), Deutsche Welle reports. Background For many years, PIP was one of the largest producers of silicone breast implants. However, after it came to light that the company used industrial-grade silicone in its implants, the company shut ...
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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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    EU Court Rules on Orphan Product Exclusivity

    A European Court has issued a ruling in an unlikely scenario dealing with overlapping periods of orphan product market exclusivity. In its ruling, which has the potential to influence how companies develop orphan products, the court found that authorized orphan products are entitled to market exclusivity, even when they are similar to an already approved product. Background Orphan product designation was first introduced in the EU in 2000 under Regulation (EC) No 141...
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    Boston Scientific Ordered to Pay Surgical Costs for Faulty Pacemakers

    A prominent European court has ruled that Boston Scientific’s German branch is responsible for paying the surgical costs associated with replacing faulty implantable devices made by one of the company’s subsidiaries. In 2005, Guidant Corporation – which was acquired by Boston Scientific in 2006 – informed doctors it had identified potentially faulty components in three of its implantable products, two pacemakers and an implantable cardioverter defibrillator. Main Proc...
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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...