Category Archives: Patently BIOtech

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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11 Days Until BIO 2015: IP Networking and Meetup Opportunities

BIO Convention Networking

This year’s BIO International Convention is fast approaching, with plenty of opportunities for the best and brightest in the biotech IP sector to meet and discuss the most pressing issues affecting the industry today. Here are some of the receptions, networking, and meet-up opportunities for the Intellectual Property Track at this year’s convention: Monday: Kickoff Concert (Open to Convention Access registrants and higher) 6:30 p.m.-9:30 p.m. Liacouras Center Philadelphia is home to a rich musical Read More >

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IP Sessions at the 2015 BIO International Convention

BIO International Convention

This year’s BIO International Convention will be host to educational sessions on the latest issues in the biotech IP sector.  The world’s largest biotechnology gathering, the convention offers attendees the chance to come together to hear, discuss, and learn about current issues affecting the biotech community. Here’s a look at the Intellectual Property Track at this year’s convention: Sessions* Intellectual Property Opening Plenary Antibody Therapeutics: May I Have Them All? The Impact of USPTO Inter Read More >

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BIO Deputy General Counsel Testifies on Patent Reform

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On Wednesday, March 18, BIO’s Deputy Counsel for Intellectual Property, Hans Sauer, testified in front of the U.S. Senate Judiciary Committee regarding proposed reforms to the current U.S. patent system. The hearing was a chance for the Judiciary committee to listen to experts on what should be done to halt misuse of the patent system. In his remarks, Mr. Sauer noted that while BIO appreciates efforts by Congress to curb patent troll abuses, some of Read More >

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