Posts Tagged: "Actavis"

Four Judges Dissent from CAFC Denial of Rehearing in Generic Osteoarthritis Drug Case

The U.S. Court of Appeals for the Federal Circuit (CAFC) today denied HZNP Medicines LLC’s (Horizon’s) request for rehearing in HZNP Medicines LLC v. Actavis Laboratories UT, Inc., with Judges Newman, O’Malley, Stoll and Lourie dissenting. Judge Lourie, writing for the dissent, said that the Court “has erroneously misconstrued the ‘consisting essentially of’ language in evaluating the definiteness requirement of 35 U.S.C. § 112” and that rehearing en banc should have been granted. In October, the CAFC affirmed the U.S. District Court for the District of New Jersey’s findings of invalidity and noninfringement of certain claims of some of the asserted Horizon patents, as well as the district court’s finding of nonobviousness of one claim of another Horizon patent. Judge Newman dissented in that decision, saying that “The majority’s new ruling sows conflict and confusion” and that it could “cast countless patents into uncertainty.”

Federal Circuit Decision Delays Generic Osteoarthritis Drug

On October 9, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a decision in HZNP Medicines LLC v. Actavis Laboratories UT, Inc. affirming the U.S. District Court for the District of New Jersey’s findings of invalidity and noninfringement of certain claims of some of the asserted HZNP (Horizon) patents, as well as the district court’s finding of nonobviousness of one claim of another Horizon patent. The finding of nonobviousness means that Actavis, owned by generic drug maker Teva Pharmaceuticals, is enjoined from engaging in the commercial use, offer for sale, or sale of its product covered in its Abbreviated New Drug Application (ANDA) until the expiration of U.S. Patent No. 9,066,913 (the ‘913 patent) in 2027.

Federal Circuit Affirms Validity of Endo Pharmaceuticals Patent for Morphinan Pain Relief Compounds

The Federal Circuit recently affirmed a district court ruling finding patent infringement after holding that Actavis LLC, Actavis South Atlantic LLC, and Teva Pharmaceuticals USA, Inc. (collectively, “Actavis”) failed to prove by clear and convincing evidence that the claims asserted by Endo Pharmaceuticals and Mallinckrodt LLC (collectively, “Endo”) were invalid. See Endo Pharms., Inc. v. Actavis LLC, No. 2018-1054, 2019 U.S. App. LEXIS 13348 (Fed. Cir. May 3, 2019) (Before Wallach, Clevenger, and Stoll J.) (Opinion for the Court, Wallach, J.) (Dissenting opinion, Stoll, J.). However, the decision was not a unanimous one, with Judge Stoll authoring a dissent that would have reversed the district court. The patent at issue, U.S. Patent No 8,871,779 (the “‘779 patent”), is directed generally to compounds known as “morphinan alkaloids,” which are used for pain relief. More specifically, the ‘779 patent concerned processes for making “highly pure” morphinan products in the form of hydrochloride salts. Actavis claimed that the ‘779 patent was invalid, citing three key references as prior art. The first reference was a scientific article from 1957 by Ulrich Weiss (the “Weiss reference”) discussing a method for producing oxymorphone, a compound within the scope of the asserted claims. The second reference was U.S. Patent Application No. 2005/0222188 (the “Chapman reference”), which disclosed a purification process related to the asserted claims. Finally, the third reference was another article from 1967 by Henry Rapoport et al. (the “Rapoport reference”), which disclosed another purification process for oxycodone. The district court found that none of these references rendered the asserted claims obvious, and Actavis appealed.

District Court Upholds Orexo Patent for Opioid Dependency Treatment Over Actavis’ Generic

On January 10, the U.S. District of Delaware held that Actavis’ generic version of Orexo’s opioid dependency treatment infringed an Orexo patent. The patent-at-issue in this order was U.S. Patent No. 8940330, titled Abuse-Resistant Pharmaceutical Composition for the Treatment of Opioid Dependence. This non-appealable infringement judgment prevents Actavis from commercializing its generic opioid dependency treatment until Orexo’s patent rights expire in September 2032. The judgment covers all dosage levels of the Actavis generic product.

FTC v. Actavis: Where We Stand After 5 Years

It has been five years since FTC v. Actavis. In that landmark ruling, the Supreme Court held that settlements by which brand-name drug companies pay generics to settle patent litigation and delay entering the market could have “significant anticompetitive effects” and violate the antitrust laws. What has happened in these five years? For starters, the number of “pay for delay” settlements (involving payment and delayed entry) has declined.