By Kurt R. Karst – [FDA’s] ultimate conclusion that Vascepa, a drug “no active ingredient of which . . . has been approved” in a previous NDA, was not entitled to exclusivity, is contrary to the statute’s plain meaning. Rather than explaining this discrepancy, the administrative …
By Kurt R. Karst – Like rapid gunfire (judicial style), two courts – the U.S. District Court for the District of Maryland and the U.S. District Court for the District of Columbia – issued decisions on May 27, 2015 within hours of one another denying challenges …
By Kurt R. Karst – Each month we pore over the latest Orange Book Cumulative Supplement in an effort to keep our popular 180-Day Exclusivity Tracker as current as possible, and to look for interesting precedents. Last month, one entry in particular caught our attention. It …
By James E. Valentine* & Alexander J. Varond – After giving us a few months to shake our sticks at the nearly 400-page 21st Century Cures Act (the Cures Act) discussion draft, the House Energy and Commerce Committee (the Committee) dropped a 200-page version that was …
By Kurt R. Karst – There’s no rest for the weary! There certainly hasn’t been much rest for FDA’s litigation team this past week . . . . and it’s not getting any better. The week started off quiet (though clearly anxiety was in the air), …
By Kurt R. Karst – Some days we feel like the “Dickie V” (Dick Vitale) of the Hatch-Waxman and Biosimilars worlds – enthusiastically calling play-by-play on litigation and other FDA happenings, just like the Basketball Hall of Fame broadcaster does for college basketball games. (And while …
By Kurt R. Karst – It’s not all that often that we see the Patent and Trademark Office (“PTO”) dismiss or deny a request to extend the term of a patent covering a medical device, though such actions on a Patent Term Extension (“PTE”) request do …
By Kurt R. Karst – Last week, the U.S. Court of Appeals for the Federal Circuit ruled in Apotex Inc. v. Daiichi Sankyo, Inc., saying that there is subject matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed Orange Book-listed patent. The …
By Kurt R. Karst – Over the past few months we’ve seen various pieces of the 21st Century Cures Initiative discussion draft released as stand-alone bills in both the U.S. House of Representatives and the U.S. Senate (see our FDA Legislation Tracker). One section of the …
By Kurt R. Karst – Last week marked the 5th anniversary of the March 23, 2010 enactment of the Affordable Care Act (“ACA”). Title VII of the ACA, the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), amended the Public Health Service Act (“PHS Act”) …
By Kurt R. Karst – Does FDA has the authority to approve a new indication for an approved drug when that new indication has not been shown to be safe and effective by adequate and well-controlled studies submitted by the sponsor of the application? And under …
By John A. Gilbert – On March 16th, the U.S. House of Representatives passed by voice vote H.R. 639, the Improving Regulatory Transparency for New Medical Therapies Act, which would amend the Federal Food, Drug & Cosmetic Act (FD&C Act) and the Controlled Substances Act (CSA) …
By Kurt R. Karst – Nothing lasts forever in our mortal world, though some things try to come close: Wonka’s Everlasting Gobstoppers, The NeverEnding Story, Doctor Who, the Energizer Bunny . . . . and perhaps one day in the not too distant future, the Everlasting …
By Kurt R. Karst – Every once in a while FDA gets asked a question along the lines of: “Can my company submit two ANDAs to FDA – from two different subsidiaries – each containing the same bioequivalence data?” . . . or “Can my company …
By Kurt R. Karst – It’s been a long time since we last posted on a Patent Term Extension (“PTE”) controversy – a little more than a year it seems (see here) – but that doesn’t mean we’re not keeping an eye on decisions coming out …
