Orange Book Blog

At the intersection of Patent and FDA Law

Recent Posts

Month: June 2006

  • FTC Files Supplemental Brief in FTC v. Schering, in Supreme Court

    The FTC last week filed a supplemental brief in the Supreme Court, in response to the Solicitor General’s brief, in FTC v. Schering.  The case involves the legality of "reverse payment" settlements–those from an innovator drug company to a generic drug company–in Hatch-Waxman cases.  The Solicitor General, whose views on the case were requested by…

  • Supreme Court Denies Certiorari in SKB v. Apotex

    Following the Solicitor General’s advice, the Supreme Court today denied SmithKline Beecham’s petition for certiorari in SKB v. Apotex, No. 05-489.  The issue presented was whether inherent anticipation occurs only when one of skill in the art recognizes the prior creation of the invention.  The Federal Circuit had held that inherent anticipation may occur regardless…

  • SDNY: Orange Book Listing Does Not Provide Notice Under Patent Marking Statute

    In a case of first impression, the U.S. District Court for the Southern District of New York held, on cross motions for summary judgment regarding available remedies, that an Orange Book listing of patents protecting an approved drug was not effective public notice under the patent marking statute, 35 U.S.C. 287(a).  Merck & Co. v.…

  • Merck and Integra Submit Post-Hearing Letters to Federal Circuit, Urging the Court Not to Address Research Tools Issue

    As reported in a post last week, the Federal Circuit recently heard oral arguments in Merck KGaA v. Integra LifeSciences following remand from the Supreme Court.  Since the hearing, both Merck and Integra have submitted letters to the Federal Circuit, urging the court not to decide the issue of whether Merck’s use of Integra’s patented…

  • Barr Labs Pays $22.5 Million to Sandoz to Settle Antitrust Case Involving Warfarin

    Barr Labs announced today in a press release that it has paid $22.5 million to settle antitrust claims brought in 1998 by Invamed and Apothecon, both of which are subsidiaries of Sandoz.  The settlement comes on the same day that a trial in the case was scheduled to begin in the Southern District of New…

  • FTC Publishes Public Comments on its Authorized Generics Study

    The FTC has begun posting public comments relating to its proposed authorized generics study on its website.  The public comment period ended Monday. In addition to the comment by the Ohio Public Employees Retirement System, available on the FTC website, a helpful reader provided comments from the following consumer and public interest groups: AAI, CFA,…

  • Federal Circuit Hears Oral Arguments in Integra v. Merck, After Remand from Supreme Court

    A Federal Circuit panel of Judges Newman, Rader, and Prost heard oral arguments Monday in Integra LifeSciences v. Merck KGaA, No. 02-1052.  An mp3 audio file of the 45-minute session is available here (be patient when downloading this; it’s a 40 mB file). The case involves the scope of the "FDA exemption" under 35 U.S.C.…

  • Teva’s Victory Over Apotex in Fight for Generic Pravachol Exclusivity Survives Appeal

    The Court of Appeals for the D.C. Circuit today upheld an FDA rule stating that a district court order dismissing a patent suit for lack of subject matter jurisdiction is not a "court decision" under the Hatch-Waxman Act, and is therefore insufficient to trigger the first ANDA filer’s 180-day exclusivity period.  The case is Apotex…

  • FDA Releases Omnitrope Citizen Petition Response

    Last Tuesday, on the same day the FDA approved Sandoz's application for Omnitrope, a recombinant human growth hormone (rhGH) that Sandoz is calling the first-ever "biogeneric" drug, the FDA also released a 53-page response to a series of citizen petitions that had opposed FDA approval of Omnitrope.  Consistent with its approval of Sandoz's Omnitrope application,…

  • FDA Approves First Biogeneric Drug–Or Does It?

    Sandoz announced Wednesday that the FDA has approved Omnitrope, Sandoz’s recombinant human growth hormone drug product.  According to Sandoz’s press release, the FDA approval is “precedent-setting” because Omnitrope is the first “follow-on version of a previously approved recombinant biotechnology drug” (or “biogeneric”).  Omnitrope is similar to Pfizer’s Genotropin. The FDA, however, disputes Sandoz’s claim.  According…