By Kurt R. Karst – On November 16th, Senators Jeff Bingaman (D-NM), David Vitter (R-LA), Sherrod Brown (D-OH), and Jeff Merkley (D-OR) announced the introduction of the Fair And Immediate Release of Generic Drugs Act, or the “FAIR GENERxICS Act,” a draft version of which is …
By Kurt R. Karst – In a lawsuit filed in the U.S. District Court for the District of Columbia, Florida-based Hill Dermaceuticals, Inc. (“Hill”) is seeking declaratory and injunctive relief after FDA approved, on October 17, 2011, three ANDAs submitted by Identi Pharmaceuticals Inc. (“Identi”) – …
By Kurt R. Karst – Politico recently published an opinion piece authored by Federal Trade Commission (“FTC”) Chairman Jon Leibowitz, who is up for reappointment for a second term on the Commission, in which he stated he wanted to throw in his “two cents” on how …
By Kurt R. Karst – On November 15th, the U.S. Court of Appeals for the Federal Circuit will hear oral argument in Medicines Co. V. Kappos et al., Case No. 2010-1534, perhaps starting (or ending) another chapter in the saga over a Patent Term Extension (“PTE”) …
By Kurt R. Karst – The U.S. District Court for the District of New Jersey recently granted a Motion to Dismiss filed by Pfizer, Inc. (“Pfizer”) in an action brought by Impax Laboratories, Inc. (“Impax”) in an apparent attempt to trigger a forfeiture of 180-day exclusivity …
By Kurt R. Karst – For a few weeks now we’ve been hearing rumors that once the ball gets rolling in Congress with legislation to reauthorize the various user fee statutes (e.g., the Prescription Drug User Fee Act and the Medical Device User Fee and Modernization …
By Kurt R. Karst – In a 53-page decision handed down earlier this week by the California Court of Appeal, Fourth Appellate District (Division I), the Court ruled that patent settlement agreements between Bayer AG and several generic drug manufacturers did not violate the Cartwright Act …
By Kurt R. Karst – The U.S. Patent and Trademark Office (“PTO”) recently indicated in a letter to FDA that U.S. Patent No. RE 41,571 (“the ‘571 patent”), a method-of-use patent listed in the Orange Book covering BUTRANS (buprenorphine) Transdermal System is not eligible for a …
By Kurt R. Karst – Like the character Michael Keaton plays in the 1988 film “Beetlejuice,” in which spirit (a “bio-exorcist”) comes back from the afterlife (after having his name said three times) to wreak havoc and to try and scare away the new inhabitants of …
By Kurt R. Karst – On October 25, 2011, the Federal Trade Commission (“FTC”) announced the release of its annual summary of agreements filed with the Commission during the last fiscal year (Fiscal Year 2011) – “Agreements Filed with the Federal Trade Commission under the Medicare …
By Kurt R. Karst – A recent decision out of the U.S. District Court for the Eastern District of Virginia that Teva Pharmaceuticals USA, Inc.’s (“Teva’s”) generic version of Pfizer Inc.’s (“Pfizer’s”) VIAGRA (sildenafil citrate) Tablets would infringe Orange Book-listed U.S. Patent No. 6,469,012 (“the ‘012” …
By Kurt R. Karst – Like any good thriller movie that coaxes you into a feeling of finality – right before the surprise twist makes you jump out of your seat – the saga over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 …
By Kurt R. Karst – Since we last updated our popular Generic Drug Labeling Carve-Out Citizen Petition Scorecard in February 2011, there have been several new citizen petitions submitted to FDA raising questions about FDA approval of ANDAs with labeling that omits information protected by periods …
By Kurt R. Karst – A recent decision from the U.S. District Court for the Eastern District of North Carolina in patent infringement litigation concerning Sandoz, Inc.’s (“Sandoz’s”) pending ANDA for a generic version of XYZAL (levocetirizine dihydrochloride) is one of the rare instances in which …
By Kurt R. Karst – With each stroke of the pens President Obama used to sign into law the Leahy-Smith America Invents Act, it seemed as though another nail was hammered into the coffin of any attempts to deny The Medicines Company (“MDCO”) a win in …
