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: Orange Book Blog: At the Intersection of Patent Law and FDA Law

Pharma News Briefs

By Aaron Barkoff

• 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.

Full post as published by Orange Book Blog: At the Intersection of Patent Law and FDA Law on December 01, 2007 (boomark / email).