Tag Archives: federal circuit

IP Sessions at BIO 2015: The Evolving Landscape of Patentable Subject Matter

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The IP Track at BIO 2015 had a number of incredible educational sessions concerning the most relevant topics in the biotech sector. Let’s look back at what top experts in the IP field had to say about the changing nature of patentable subject matter: Panelists included: Jennifer Swan and Howard Levine, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP Raul Tamayo, USPTO P. Michael Walker, E.I. du Pont de Nemours and Company Panelists focused on the increasingly restrictive interpretation of patent eligibility, Read More >

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Biosimilars at the Federal Circuit – Can the Parties Be Compelled to Dance?

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In 2009, Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”), which for the first time provided for biosimilar or interchangeable biological drug products.  But it was not until March 6, 2015, that the FDA approved the first biosimilar application – an application by Sandoz to market a version of Amgen’s NEUPOGEN® (filgrastrim) biologic drug product.  Nevertheless, there is still a question as to when Sandoz will be able to begin selling its drug product, Read More >

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Nautilus v. Biosig, Baxter v. Fresenius and Limelight v. Akamai

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BIO weighed in on three Supreme Court cases in the last few months whose outcome could change the IP landscape for biotechnology companies. BIO’s amicus brief in Nautilus v. Biosig Instruments argues that the petitioner misrepresents the Federal Circuit’s definiteness test and seeks to litigate an issue not properly before this court.  Petitioner’s approach radically departs from established law and practice.  Finally the petitioner’s approach would destabilize the patent system as it would inject substantial Read More >

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Fresenius v. Baxter: BIO files Amicus Brief in Federal Circuit

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The Biotechnology Industry Organization filed an amicus brief at the Federal Circuit in the case of Fresenius v. Baxter: BIO is concerned that the panel decision could have a number of unintended consequences, such as incentivizing defendants (or declaratory judgment plaintiffs) to employ dilatory tactics in the federal courts while re-arguing already-decided issues under claim construction more favorable to the patent challenger and lower burden-of-proof standards in the PTO.  Courts and parties may be forced Read More >

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