By Kurt R. Karst – The Electronic Age has changed nearly every aspect of our daily lives, and the day-to-day operations of the U.S. Federal Government are no different. The government is no longer open for business from 9-5, but rather 24 hours a day by …
By Kurt R. Karst – The Wachowski Brothers’ Matrix Trilogy of movies depict a post-apocalyptic world in which reality is not what it seems. The reality most people perceive is actually a simulated reality created by sentient machines – a dream world created by virtue of …
By Kurt R. Karst – In a new paper published by The Petrie-Flom Center for Health Law Policy, BioTechnology, and BioEthics at Harvard Law School, and presented at a February 3, 2014 Health Law Workshop, Kevin Outterson, a Professor of Law at Boston University and member …
By Kurt R. Karst – The U.S. Patent and Trademark Office (“PTO”) has finally issued a final decision in the long-running dispute over eligibility for a Patent Term Extension (“PTE”) for U.S. Patent No. 5,674,860 (“the ‘860 patent”) covering AstraZeneca LP’s SYMBICORT (budesonide and formoterol fumarate …
By Kurt R. Karst – FDA’s implementation of the Generic Drug User Fee Amendments of 2012 (“GDUFA”) and adherence to the triad of key aims laid out in the accompanying Performance Goals and Procedures – Safety, Access, and Transparency – have been a bit of a …
By Kurt R. Karst – In a Januarry 22, 2014 letter to FDA Commissioner Margaret Hamburg, M.D. signed by 28 members of Congress, lawmakers express “grave concerns” about FDA’s November 2013 proposed rule to allow generic drug manufacturers to independently update product labeling (with respect to …
By Kurt R. Karst – In a notice that will appear in the Federal Register later this week, FDA is announcing the establishment of a public docket (Docket No. FDA-2014-N-0032) to receive input and suggestions on ways to improve the quality of ANDAs (original, amendments, and …
By Kurt R. Karst – It’s been quite some time since FDA established a public docket soliciting comment on an ANDA approval/Hatch-Waxman issue. But FDA revived the process earlier this week when the Agency issued a “Dear NDA/ANDA Applicant” letter (Docket No. FDA-2014-N-0087) concerning approval of …
By Kurt R. Karst – So much of what we do and think about each day inevitably leads us back to one topic: Hatch-Waxman. Take, for example, Polar Vortex 2014. That recent event got us thinking about two things: Snowmageddon 2011, and how warm we hope …
By Kurt R. Karst – Sandoz Inc. (“Sandoz”) is appealing to the U.S. Court of Appeals for the Federal Circuit (Docket No. 14-1693) a November 2013 decision from the U.S. District Court for the Northern District of California granting Amgen Inc.’s (“Amgen’s”) and Hoffmann-La Roche Inc.’s …
By Kurt R. Karst – In a recent memorandum to Center for Drug Evaluation and Research (“CDER”) staff (reprinted below, and a condensed version of which was posted on FDA’s website, here), CDER Director Janet Woodcock, M.D. announced that the Department of Health and Human Services …
By Kurt R. Karst – Congress has been silent on new legislation addressing drug patent settlement agreements (aka “reverse payment agreements” or “pay-for-delay agreements”) since the U.S. Supreme Court issued its June 2013 opinion in Federal Trade Commission v. Actavis, Inc., 570 U.S. ___ (2013). As …
By Kurt R. Karst – Our hopes that FDA might publish a proposed rule to implement at least some of the changes made to the Hatch-Waxman Amendments to the FDC Act by the Medicare Modernization Act (“MMA”), enacted on December 8, 2003, before the 10-year anniversary …
By Kurt R. Karst – A Complaint recently filed in the U.S. District Court for the District of Delaware by Otsuka Pharmaceutical Co., Ltd. (“Otsuka”) against Par Pharmaceutical, Inc. (“Par”) concerning notice of a Paragraph IV certification contained in an ANDA Par submitted to FDA for …
By Kurt R. Karst – Earlier this week, Representative Robert Hurt (R-VA) introduced new legislation – H.R. 3631, the Small Manufacturer Protection Act of 2013 – that, if enacted, would bring relief to some companies that are required to pay user fees under the Generic Drug …
