By Kurt R. Karst – In a widely anticipated move, Momenta Pharmaceuticals, Inc. and Sandoz Inc. have petitioned the U.S. Supreme Court to review the August 3, 2012 judgment of the U.S. Court of Appeals for the Federal Circuit, in which a divided (2-1) Federal …
By Kurt R. Karst – A rather interesting and unexpected (to most) ANDA approval popped up on FDA’s website late last week. On February 6, 2013, FDA approved Macleods Pharmaceuticals Limited’s (“Macleods’”) ANDA No. 202467 for a generic version of ACTOS (pioglitazone HCl) Tablets, 15 …
By Kurt R. Karst – Two recent citizen petitions submitted to FDA – one from Gilead Sciences, Inc. (“Gilead”) under Docket No. FDA-2013-P-0058, and another from Ferring Pharmaceuticals, Inc. (“Ferring”) under Docket No. FDA-2013-P-0119 – take issue with FDA’s long-standing position that in order for a …
By Kurt R. Karst – As if on cue after our post yesterday concerning briefing in FTC v. Watson Pharmaceuticals, Inc. (Docket No. 12-416), where the U.S. Supreme Court will consider whether drug patent settlement agreements (aka “reverse payment agreements” or “pay-for-delay agreements”) are generally …
By Kurt R. Karst – Excitement is building (and will soon reach fever pitch) over the U.S. Supreme Court’s March 25, 2012 Oral Argument in Federal Trade Commission v. Watson Pharmaceuticals, Inc. (Docket No. 12-416) concerning whether drug patent settlement agreements (aka “reverse payment agreements” or …
By Kurt R. Karst – We don’t like loose ends – especially loose ends in the Hatch-Waxman world! Last June, we posted on FDA’s decisions to require sponsors of ANDAs for generic versions of ADDERALL XR (dextroamphetamine mixed salts of a single-entity amphetamine product) Extended-release …
By Kurt R. Karst – Last week, Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) filed what might be the company’s last motion in its preemptive lawsuit filed last September in the U.S. District Court for the District of New Jersey seeking declaratory …
By Kurt R. Karst – Late last year, FDA submitted to Congress the Agency’s latest report on FDC Act § 505(q) citizen petitions. The report, titled “Fourth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions For Stay of Agency …
By Kurt R. Karst – Although FDA has yet to accept an application for a biosimilar version of a biological product licensed under the Public Health Service Act (“PHS Act”) pursuant to the provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) …
By Kurt R. Karst – The Federal Trade Commission (“FTC”) has announced the release of its annual summary of agreements (a.k.a. “drug patent settlement agreements,” “reverse payment agreements” or “pay-for-delay agreements”) filed with the Commission during the last fiscal year (Fiscal Year 2012): “Agreements Filed …
By Kurt R. Karst – In a notice that will be published in the January 17th Federal Register, FDA announces the establishment of Fiscal Year 2013 (“FY2013”) user fee rates established pursuant to the Generic Drug User Fee Amendments of 2012 (“GDUFA”) for both Active Pharmaceutical …
By Kurt R. Karst – In a decision handed down last week by Judge Ellen Segal Huvelle of the U.S. District Court for the District of Columbia, the court may have finally put an end to ViroPharma Inc.’s (“ViroPharma’s”) litigation over FDA’s approval of generic …
By Kurt R. Karst – Every once in a while we receive a series of similar questions from various quarters such that a critical mass has been reached justifying a blog post on the topic. This is one of those posts. And it has to do …
By Kurt R. Karst – Although the number of cases involving 180-day exclusivity under the version of the FDC Act in effect before the December 8, 2003 enactment of the Medicare Modernization Act (“MMA”) is nearing an end, the pre-MMA statute, and the handling of it …
By Kurt R. Karst – Last week in a post-Christmas decision, Judge John D. Bates of the U.S. District Court for the District of Columbia granted both FDA’s and Intervenor-Defendant Ranbaxy Laboratories Limited’s (“Ranbaxy’s”) Motions for Summary Judgment and denied Mylan Laboratories Limited’s and Mylan …
