By Kurt R. Karst – One of the more memorable lines from the original Star Wars Trilogy is uttered in Return of the Jedi when Luke Skywalker surrenders himself to Darth Vader on the Forest Moon of Endor. Luke tries to convince Vader to return to …
The American Conference Institute (“ACI”) will hold its 26th FDA Boot Camp conference in Boston, Massachusetts from September 30 to October 1, 2015. A copy of the conference program can be obtained here. Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will co-chair the event with …
By Kurt R. Karst – We try our best to stay on top of the latest lawsuits against FDA, but every once in a while one gets past us without us quickly noticing. That recently happened when Prometheus Laboratories Inc. (“Prometheus”) filed a Complaint and a …
By Kurt R. Karst – For months now we’ve been waiting patiently for anything out of the U.S. District Court for the District of Columbia with respect to the case that Veloxis Pharmaceuticals, Inc. (“Veloxis”) initially lodged against FDA in December 2014 (and then re-upped in …
By Kurt R. Karst – The folks over at Inside Health Policy brought to our attention a recent article authored by Len M. Nichols, Ph.D., Director and Professor of Health Policy at the George Mason University Center for Health Policy Research & Ethics that we thought …
By Kurt R. Karst – Sometimes curiosity gets the better of us . . . . We take some bait and go down a rabbit hole. That’s what happened last week after FDA published a notice in the Federal Register announcing the Agency’s determination that Ondansetron …
By Kurt R. Karst – We thought FDA would be hauled into court after the Agency denied, on October 10, 2014, two Petitions for Reconsideration (here and here) asking the Agency to rethink a February 21, 2014 Consolidated Response Denial to three Citizen Petitions requesting that …
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 …
