Category Archives: Patently BIOtech

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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This Independence Day, Let’s Thank the Inventors

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Happy Birthday AMERICA! That’s right, this Saturday is July 4. And yes, that means what you think it means. Prepare yourself for Facebook posts of your old college roommate in an American flag t-shirt, Instagrams from your sister who makes the world’s GREATEST potato salad and texts from your cousin about prime firework viewing in D.C. (Hint: Avoid the crowds and head to the Marine Corps War Memorial and Netherlands Carillion in Rosslyn – you Read More >

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IP Sessions at BIO 2015: The Impact of the Inter Partes Review on (BIO)Pharma

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The Intellectual Property Track at the BIO International Convention was a chance for IP thought leaders in the biotech sector to discuss some of the most pressing issues impacting the industry. Let’s recap what we learned from one of the IP sessions at BIO 2015: The Impact of IPRs on (BIO)Pharma On Tuesday, patent litigation experts met to discuss inter partes review proceedings and how they are impacting biotechnology. Panelists from The Impact of IPRs Read More >

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FDA Acts on Biosimilars

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The Biologics Price Competition and Innovation Act (BPCIA) deferred to the Food and Drug Administration with regard to implementing the particulars of how the biosimilar approval pathway would be implemented.  The U.S. Food and Drug Administration has issued a series of draft Guidances indicating how it was considering implementing the biosimilar approval pathway contained in the Act.  The Guidances were expressly “draft” in nature, and were the subject of public hearings with the Agency welcoming 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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