By Kurt R. Karst – Ever since FDA came up with the idea of a so-called “180-day exclusivity punt,” the Agency has taken a shine to using it with impunity, as a quick perusal of our 180-Day Exclusivity Tracker shows. FDA’s recent approval of ANDAs for …
By Kurt R. Karst – Last week, as Congress, FDA, and industry continue to ramp up debate on what changes or modifications should be made to the FDC Act and PHS Act as part of a user fee package of bills expected to be enacted later …
By Kurt R. Karst – Following the Federal Circuit’s recent precedential decision in AstraZeneca Pharms. v. Apotex et al. (Case No. 2011-1182) (in which the Court held that an ANDA sponsor who submits a “section viii” statement with respect to an Orange Book-listed method-of-use patent and does …
By Kurt R. Karst – Last week, Representative Bobby Rush (D-IL) announced the introduction of H.R. 3995, the Protecting Consumer Access to Generic Drugs Act of 2012. The bill is the latest piece of legislation that attempts to stymie so-called pay-for-delay patent settlement agreements. In January …
By Kurt R. Karst – In music, “coda” is a term used primarily to designate a passage that brings a piece (or a movement, which may be part of a symphony – an extended musical composition) to an end – the “fine.” A coda can be …
By Kurt R. Karst – On February 7, 2012, Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia issued her decision in the long-running dispute concerning FDA’s July 23, 2010 approval of Sandoz Inc.’s (“Sandoz’s”) ANDA No. 077857 for a generic version …
By Kurt R. Karst – The U.S. Patent and Trademark Office (“PTO”) has been sued once again after denying a Patent Term Extension (“PTE”) request. The latest case in a long line of lawsuits concerns U.S. Patent No. 5,206,248 (“the ‘248 patent”), which is listed in …
By Kurt R. Karst – In a recent Hatch-Waxman decision from the U.S. District Court for the Northern District of Illinois (Eastern Division), the court denied Plaintiffs’ Seattle Children’s Hospital, Novartis Vaccines and Diagnostics, Inc., and Novartis Pharmaceuticals Corporation (collectively “Novartis”) Motion to Dismiss the lawsuit …
By Kurt R. Karst – It’s absolutely amazing how, after nearly 28 years, the 1984 Hatch-Waxman Amendments continue to provide surprises. Consider the latest example we came upon recently (with a little help) involving PRISTIQ (desvenlafaxine) Extended-Release Tablets. FDA approved PRISTIQ under NDA No. 021992 in a …
The American Conference Institute will be holding its FDA Boot Camp conference in New York City from Tuesday, March 20 to Wednesday, March 21, 2012. A copy of the conference program can be obtained here. Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be …
By Kurt R. Karst – Last week, FDA Commissioner Margaret A. Hamburg, M.D. announced that the Agency sent to Congress packages for three user fee programs, including proposed statutory language for the fifth iteration of the Prescription Drug User Fee Act (“PDUFA V”), and two new …
By Kurt R. Karst – FDA recently denied a 2008 citizen petition (Docket No. FDA-2008-P-0291) requesting that the Agency amend its drug label regulations to require that product labels include the Orange Book-listed NDA number under which the product is approved. According to the petition, “[i]ncreasingly, …
By Kurt R. Karst – In what appears to be the first federal court decision on the so-called Reference Listed Drug (“RLD”) theory of liability, Judge Marvin H. Shoob of the U.S. District Court for the Northern District of Georgia (Atlanta Division) recently ruled in Moore …
By Kurt R. Karst – In what appears to be a further sign of FDA’s efforts to clamp down on differences between brand-name Reference Listed Drugs (“RLDs”) and their proposed generic counterparts, FDA’s Office of Generic Drugs (“OGD”) is now looking more closely at tablet size …
By Kurt R. Karst – Just one day after FDA announced a December 16th public meeting and comment period to discuss the Agency’s proposed recommendations for a user fee program for biosimilar biological products for Fiscal Years (“FYs”) 2013 through 2017 (see our post here), the …
