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…
We discussed Braintree Labs v. Novel Labs in a previous post. In the panel decision, Judge Prost, with Judge Dyk joining, found the term “a patient” in Braintree’s Suprep colon cleanser patent to mean a general class of persons, i.e., a patient population. Accordingly, the panel vacated and remanded the infringement ruling relying on erroneous…
A recent Federal Circuit case shows that broad, functionally-defined genus claims are susceptible to written-description invalidity challenges. In AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. et al., the Federal Circuit affirmed a jury verdict invalidating a patent, finding that there was substantial evidence to conclude that the claims failed to meet the Patent…
On June 18, 2014, the Patent Office issued changes to how it calculates patent term adjustments under 35 U.S.C. § 154. The new rules—drafted in response to the Federal Circuit’s decision in Novartis AG v. Lee, 740 F.3d 593 (Fed. Cir. 2014)—are now subject to public comment for the next sixty days. As we discussed…
We discussed the Bristol-Myers Squibb Co. v. Teva Pharmaceuticals, Inc. in a previous post, in which a Judge Burke of the District of Delaware found the patent for the hepatitis B drug entecavir (the active ingredient in Baraclude) obvious. Last week, the Federal Circuit affirmed. There were two main issues on appeal, the selection of…