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 …
By Kurt R. Karst – Generic Pharmaceutical Association (“GPhA”) Board of Directors Chairman Paul Bisaro recently sent a letter to members announcing both the completion of the negotiating phase (see here and here) of what is intended to become the Generic Drug User Fee Act (“GDUFA”) …
By Kurt R. Karst – September 12th marked the beginning of the eighth round of Trans-Pacific Partnership (“TPP”) negotiations, which are taking place in Chicago, Illinois. The TPP is an Asia-Pacific regional trade agreement being hammered out among the United States and eight other partners. The …
By Kurt R. Karst – On September 8th, the U.S. Senate passed, by an 89-9 vote, H.R. 1249, the Leahy-Smith America Invents Act. Final passage of the bill, which will make significant changes to the U.S. patent system, was preceded by a contentious vote on, you …
By Kurt R. Karst – A recent Citizen Petition submitted on behalf of Abbott Laboratories (“Abbott”) calls into question FDA’s authority for granting Therapeutic Equivalence (“TE”) ratings (i.e., “A” ratings) for drug products approved pursuant to FDC Act § 505(b)(2). Specifically, Abbott’s petition requests that FDA …
By Kurt R. Karst – In what appears to be the first instance in which a court has considered the U.S. Supreme Court’s decision in PLIVA, Inc. v. Mensing in the context of a preemption defense in a state tort-law failure-to-warn case, Nevada State Court Judge Jerry …
