By Kurt R. Karst – Last month FDA responded to an August 25, 2010 request from New Jersey State Senator Joseph F. Vitale (D) concerning pending legislation – Assembly Bill 1995 (the State Senate version of which is Senate Bill 961) – that, if enacted, would …
By Kurt R. Karst – Following up on a June 11, 2010 invitation from the U.S. Court of Appeals for the Sixth Circuit to file an amicus brief in the consolidated appeals of Smith v. Wyeth, Inc. (Case No. 09-5460), Wilson v. Pliva, Inc. (Case No. …
By Kurt R. Karst– The generic drug industry is headed for its own version of a “patent cliff” – a “180-day exclusivity cliff” – according to a report from MorganStanley on large cap and specialty pharmaceuticals issued earlier this month. “Patent cliff” is a colloquial term …
By Kurt R. Karst – In our post last week on letters issued by the U.S. Patent and Trademark Office (“PTO”) clarifying when patents covering certain drug products are eligible for a Patent Term Extension (“PTE”) in light of the U.S. Court of Appeals for the Federal …
By Kurt R. Karst – In a series of letters, the U.S. Patent and Trademark Office (“PTO”) has clarified when patents covering certain drug products are eligible for a Patent Term Extension (“PTE”). The PTO issued the letters as a result of recent decisions from the …
By Kurt R. Karst – Just as FDA was getting started with its two-day public meeting earlier this week on the Approval Pathway for Biosimilar and Interchangeable Biological Products, which occurred a little more than seven months after the enactment of the Biologics Price Competition and …
By Kurt R. Karst – Company submissions to the Securities and Exchange Commission (“SEC”) can be a valuable source of information. Consider, for example, a recent quarterly report from Celgene Corporation, which states with respect to Risk Evaluation and Mitigation Strategies (“REMS”) that: In the fourth quarter …
By Kurt R. Karst – Some Senate Democrats have joined their Republican colleagues in voicing opposition to the inclusion of the “Preserve Access to Affordable Generics Act” (S. 369) in the Fiscal Year 2011 Financial Services and General Government Appropriations Bill (S. 3677). As we previously …
By Kurt R. Karst – FDA’s recent decision to grant an April 27, 2010 citizen petition submitted on behalf of Genzyme Corporation (“Genzyme”) concerning the Agency’s ability to approve Cobrek Pharmaceuticals, Inc.’s (“Cobrek’s”) pending ANDA for a generic version of HECTOROL (doxercalciferol) Injection sheds some light on …
By Kurt R. Karst – 2011 is shaping up to be an interesting year in the Hatch-Waxman world, and all eyes seem to be focusing on what will happen with Ranbaxy’s purported (sole) 180-day exclusivity for a generic version of the mega-blockbuster drug LIPITOR (atorvastatin calcium) …
By Kurt R. Karst – Earlier this year we posted on the effects of the U.S. Court of Appeals for the Federal Circuit’s December 2009 “false marking” decision in Forest Group, Inc. v. Bon Tool Co. False marking is the act of placing an item in …
By Kurt R. Karst – The U.S. Court of Appeals for the Federal Circuit answered “Yes” to this question in an October 6th decision in Teva v. Eisai (2009-1593) that could pave the way for generic versions of Eisai, Inc.s’ ARICEPT (donepezil HCl) Tablets sooner than …
By Kurt R. Karst – The voice of Michael Corleone – “Just when I thought I was out . . . they pull me back in” – played over and over again in our heads today when we learned that Apotex, Inc. filed a Petition for …
By Kurt R. Karst – In a short, but scathing opinion piece published in the October 5th Wall Street Journal (“WSJ”), the editors take on the Federal Trade Commission (“FTC”) and those Members of Congress who want to ban patent settlements between brand-name and generic drug …
Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be speaking at the Center for Business Intelligence’s (“CBI’s”) 3rd Annual Life Sciences Congress on Paragraph IV Disputes, which is scheduled for October 18-19, 20109 at the Hilton Alexandria Old Town in Alexandria, Virginia. This popular …
