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Category: Standards-setting organizations


FDA Releases First "Purple Book" for Biosimilar Products
October 01, 2014
Post by Blog Staff
The Biosimilars Act (BSA) was passed into law on March 23, 2010 with the goal of encouraging the market entry of generic products, similar to the system that exists for generic drugs under the Hatch-Waxman Act. The BSA sets forth an abbreviated approval pathway for biologics through a regulatory demonstration of biosimilarity (i.e. interchangeability). More than 4 years after the BSA went into effect, the FDA h.......
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USPTO Glossary Pilot Program
June 16, 2014
Post by Blog Staff
The USPTO has instituted a new program, the Glossary Pilot Program, which began June 2, 2014. The program will allow applicants for computer-related inventions to petition to make special entry into the Glossary Pilot Program with the filing of an application. Applications accepted into this pilot program will receive expedited processing and be placed on an examiner’s special docket prior to the first offic.......
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USPTO Proposes Rule Changes for International Design Applications
December 02, 2013
Post by Blog Staff
The U.S. Patent and Trademark Office is seeking comments on it proposed rules for implementing the provisions of Title I of the Patent Law Treaties Implementation Act of 2012. The law is the implementing legislation for the 1999 Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs (“the Hague Agreement”). The rules proposed rule changes under the law will.......
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Failure to disclose patents to SSO results in unenforceabilty against products using standard
March 23, 2009
Post by Blog Staff
In a recent decision, the Federal Circuit affirmed-in-part a district court decision that a patentee had breached a duty to disclose relevant video-compression technology patents while participating in a joint video team standards-setting organization (SSO). The Federal Circuit, however, reversed in part the district court decision finding the patents unenforceable against the world, instead holding the patents .......
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The attorneys of McKee, Voorhees & Sease, P.L.C. designed this blog as an informational and educational resource about intellectual property law for our clients, other attorneys, and the public as a whole. Our goal is to provide cutting-edge information about recent developments in intellectual property law, including relevant case law updates, proposed legislation, and intellectual property law in the news.

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