Month: October 2009

  •     By Donald Zuhn — In a Federal Register notice published on Wednesday (74 Fed. Reg. 54028), the U.S. Patent and Trademark Office announced that it plans to hold a roundtable discussion to "obtain input from diverse sources in the patent community and/or the public sector to evaluate views on work sharing."  The roundtable discussion…

  •     By Suresh Pillai — Infosint Awarded $15 Million Verdict in Lexapro® Suit A federal jury in the U.S. District Court for the Southern District of New York has awarded Infosint $15 million as a reasonable royalty in Infosint's patent dispute with Lundbeck A/S and Forest Laboratories, Inc. over the patent covering Lexapro®.  The patent-in-suit,…

  •     By Donald Zuhn –- On Monday, Counsel for Dr. Triantafyllos Tafas filed a reply to the joint motion to dismiss the appeal in Tafas v. Kappos and for a vacatur of the District Court's injunction and judgment filed by the U.S. Patent and Trademark Office and Appellee GlaxoSmithKline on October 9, 2009.  The joint…

  •     By Kevin E. Noonan — With fresh life being breathed into its patent "reform" bill by the new Commerce Secretary and PTO management, the Senate Judiciary Committee on Thursday acted on another "reform" measure, voting in favor of sending to the floor of the Senate a bill prohibiting "reverse payments."  These are payments by…

  •     By Donald Zuhn –- Earlier this month, four Senators sent a letter to Senate majority leader Harry Reid (D-NV) expressing their "strong support" for including an approval pathway for biosimilars in any health care reform package brought to the Senate floor for a vote.  The Senators — Orrin Hatch (R-UT), Barbara Mikulski (D-MD), Michael…

  •     By Donald Zuhn –- In a statement issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) earlier today, the advocacy group representing pharmaceutical and biotechnology research companies indicated that it "supports the development of a responsible, abbreviated approval pathway for biosimilars that includes a fair period of data protection that is critical for…

  •     By Kevin E. Noonan — Myriad Genetics, one of the preeminent gene-based diagnostics companies, has been targeted by the American Civil Liberties Union, Dan Ravicher’s PUBPAT Organization, a raft of medical researchers and their associations, and individual patients in a lawsuit filed in the Southern District of New York; the avowed aim of the…

  •     By Kevin E. Noonan — The principal debate involving follow-on biologics legislation has revolved around the length of the data exclusivity term granted to innovators.  The bill voted out of the Senate Health, Education, Labor and Pensions (HELP) Committee earlier this year has a 12-year data exclusivity term, which is shorter than the term…

  •     By Sherri Oslick — About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Shelbyzyme LLC v. Genzyme Corp.1:09-cv-00768; filed October 14, 2009 in the District Court of Delaware Infringement of U.S. Patent No. 7,011,831 ("Recombinant α-galactosidase…

  • October 20, 2009 – What the Federal Circuit Can Learn from the Supreme Court — and Vice Versa (American University Washington College of Law) – 6:00 pm (EST) October 20-21, 2009 – 17th Forum on Biotech Patenting (C5) – London, United Kingdom October 22-23, 2009 – Pharmaceutical Congress on Paragraph IV Disputes*** (Center for Business…