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  • Orange Book Blog is published for informational purposes only; it contains no legal advice whatsoever. Publication of Orange Book Blog does not create an attorney-client relationship. Orange Book Blog is Aaron Barkoff's personal website and it is intended primarily for other attorneys. Orange Book Blog is not edited by McDonnell Boehnen Hulbert & Berghoff LLP ("MBHB") or its clients. Therefore, no part of Orange Book Blog--whether information, commentary, or other--may be attributed to MBHB or its clients. Readers should be aware that MBHB represents many companies in the pharmaceutical and biotechnology industries, and therefore Orange Book Blog may occasionally report on news that relates to MBHB clients. Orange Book Blog will always strive to be unbiased in its reporting. All information on Orange Book Blog should be double-checked for its accuracy and current applicability. -- © Aaron F. Barkoff 2006-08

« Lovenox Patent Case Back at Federal Circuit; Generic Versions Still Not Yet Approved | Main | District Court Upholds Validity of Pfizer's Accupril Patent, Rejecting Teva's Nonenablement Argument »

November 30, 2007

Pharma News Briefs

  • Apotex and an anonymous ANDA filer recently submitted new comments to FDA on ramipril 180-day exclusivity issues.  Earlier this month, we summarized previous comments on the ramipril docket.
  • Roxane Labs recently submitted new comments to FDA on acarbose 180-day exclusivity, and Impax indicated that it intends to do the same.  Their submissions are available on FDA's acarbose docket.
  • The FTC announced Thursday that it has settled its antitrust complaint against Barr Labs concerning Warner Chilcott's Ovcon birth control pill.  According to FTC's press release, the settlement provides that "Barr must refrain from entering into anticompetitive supply agreements with branded companies similar to Barr's agreement with Warner Chilcott regarding Ovcon."
  • Via SpicyIP and Pharmalot, Sun Pharma has filed a paragraph IV challenge of Novartis's polymorph patent on Gleevec (imatinib mesylate), which expires in 2019.  The compound patent on imatinib expires in 2015.
  • FDA Law Blog had an interesting post last week about a lawsuit by two pharmacy associations against the Center for Medicaid Services, charging that the new "AMP rule," which CMS uses to calculate how much it reimburses states for generic drugs, is unlawful.  Some believe that the new Medicaid reimbursement rules make it cost-prohibitive for brand name drug companies to sell authorized generics in many cases.
  • Pharmalot reported recently that legislation that would have banned "reverse payment" settlements of Hatch-Waxman litigation has stalled in the Senate.  For background, see this OBB post from last February.

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