In a long-awaited — and some would say long-feared — update in the regulatory pathway for FDA approval of follow-on biologics, the Senate’s Senate Health, Education, Labor and Pensions HELP Committee gave the thumbs up to the Biologics Price Competition and Innovation Act of 2007 (S. 1695), which will address the scientific, regulatory and legal […]

David Boundy of Cantor Fitzgerald and Mike Strickland of GlaxoSmithKline attended a meeting with the Office of Management and Budget (OMB) to discuss the USPTO’s Changes to Practice for Continuing Applications, Requests for Continued Examination Practice, and Applications Containing Patentably Indistinct Claims (Fed. Reg. 71: 48-61 (January 3, 2006)). The proposed regulations would limit an […]

While not as fundamentally important as Bong Hits 4 Jesus, the U.S. Supreme Court declined to hear a case profoundly important to the pharmaceutical industry. For the second time, the Court rebuffed a challenge to a “reverse payments” deal — this one where an AstraZeneca company paid off a Barr Pharmaceuticals company to delay marketing […]

Senators Kennedy, Hatch, Clinton, and Enzi announced legislation authorizing the FDA to approve a follow-on version of biologic therapies. The legislation, the Biologics Price Competition and Innovation Act of 2007, includes standards for the FDA to approve follow-on biologics as well as a period of exclusivity for the brand name drug company. The draft compromise […]

In a sign of “piling on”, more than 200 organizations and businesses have signed on to a letter to Chairman Leahy, Chairman Conyers, Chairman Berman, Senator Specter, Representative Smith, and Representative Coble of the Committee on the Judiciary regarding patent reform bill. The group voiced serious concerns with certain provisions of The Patent Reform Act […]

The U.S. Court of Appeals for the Federal Circuit held that claims with a means plus function limitation – here a “control means” — where there is no corresponding structure described in the specification, are invalid. See, Biomedino, LLC v. Waters Technologies Corporation (2006-1350). Biomedino, LLC had appealed from a lower court decision that claims […]

Jim Harlan, Patent Counsel at Siemens Automation and Drives, UGS PLM Software (and former Blawger Bowl III competitor), has gone wild and started a new patent blog, Patents Gone Wild. The site features Jim’s thoughts/musings on the business impact patents play as an intangible asset. One recent post asks about the ramifications of the Indian […]

After refusing to die easy on its bid to put out a generic version of Plavix, Apotex was handed its hat by the district court. Sanofi-Synthelabo v. Apotex Inc., 02cv2255, U.S. District Court, Southern District of New York. Granting a permanent injunction, U.S. District Judge Sidney Stein held that Apotex failed to prove by clear […]