A three judge panel of the Federal Circuit on November 18, 2014 affirmed the District of Delaware’s summary judgment decision that Warner Chilcott’s patents covering the osteoporosis drug Actonel were invalid for obviousness. Despite some uncertainty in the prior art regarding effective dosing of the drug, the Federal Circuit affirmed, stating that obviousness does not […]
Mylan recently filed two ANDAs seeking approval to sell generic versions of AstraZeneca’s ONGLYZA® and KOMBIGLYZE™ drug products. In response, AstraZeneca LP (“AZP”) filed a complaint in the District of Delaware for patent infringement, and Mylan moved to dismiss for lack of personal jurisdiction. Judge Gregory M. Sleet denied the motion, finding specific jurisdiction because […]
The Eastern District of Virginia recently allowed a subsequent ANDA filer to proceed with a declaratory judgment action seeking a declaration of unenforceability of a patent that remained listed in the Orange Book after the patentee disclaimed it and requested its delisting from the Orange Book. Glenmark Generics Ltd. v. Ferring B.V., Civ. No. 3:14-CV-422-HEH […]
Last week, the Supreme Court held arguments in the closely watched case of Teva v. Sandoz. Teva won at the district court level based on claim construction arguments. The Federal Circuit reversed, affording no deference to the district courts factual findings underlying claim construction. In March, the Supreme Court granted certiorari to answer one lone […]
In a pair of opinions, both issued as Ferring B.V. v. Watson Laboratories, Inc., the Federal Circuit held that Watson’s and Apotex’s ANDA products will not infringe Ferring’s patents covering Lysteda, a tranexamic acid treatment for menorrhagia, or heavy menstrual bleeding in women. The cases had been consolidated at the district court level, where the […]
In United Therapeutics Corp. v. Sandoz, Inc., Judge Peter G. Sheridan of the District of New Jersey ruled that Sandoz’s proposed label for a generic version of UTC’s anti-hypertensive Remodulin (treprostinil sodium) injection did not induce infringement of various UTC method patent claims. (Civil Action No. 3:13-cv-1617-PGS-LHG, Dkt. No. 364). As a way to reduce […]
In Depomed Inc. v. Actavis Elizabeth LLC, et al., the District of New Jersey blocked Actavis from producing and selling generic gabapentin once-daily tablets. Actavis filed an ANDA for approval to market a generic version of Depomed’s timed release Gralise®, a once-a-day gabapentin treatment for post-herpetic neuralgia (PHN), or nerve pain due to shingles. Following […]
In Apotex, Inc. v. UCB, Inc. the Federal Circuit affirmed the Southern District of Florida’s holding that Apotex’s patent (U.S. Patent No. 6,767,556) is unenforceable for inequitable conduct. This marks a rare instance of success for the defense after the Federal Circuit’s Therasense decision raised the bar on the materiality and intent requirements necessary to […]
Plaintiffs in ANDA actions frequently include declaratory judgment infringement allegations under § 271(a) – (c) (the section of the statute governing traditional patent infringement cases) in addition to § 271(e)(2) (the section of the statute governing Hatch Waxman actions). Although the case law is unsettled, defendants have successfully obtained dismissals of duplicative declaratory judgment infringement […]
On July 24, 2014, the Federal Circuit ordered that Endo Pharmaceuticals Inc. and Mylan Pharmaceuticals Inc. were required to continue their attempts to memorialize a previously-agreed-to settlement in a patent-litigation suit relating to Endo’s Frova tablets, a frovatriptan succinate EQ medication that treats migraine headaches. Specifically, the Federal Circuit denied Endo’s bid for an emergency […]