Posts Tagged: "district of delaware"

CAFC Affirms Dismissal of Arendi’s Second Complaint Against LG After Failure to Follow Delaware’s Initial Disclosure Rules

On September 7, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in Arendi S.A.R.L. v. LG Electronics Inc., authored by Circuit Judge Sharon Prost, affirming the District of Delaware’s dismissal of a patent infringement complaint filed by Arendi under the duplicative-litigation doctrine. The ruling highlights the importance of adhering to local rules on initial disclosures in Delaware, one of the most popular U.S. district courts for patent infringement litigation.

District of Delaware Makes it Harder to Corner the Market on Antibody Patents in MorphoSys v. Janssen

Patents covering an antibody are often claimed by the antibody’s function (the residues where it binds to the antigen) rather than its structure (amino-acid sequence). This tactic can successfully cast a very wide net of patent protection over potentially millions of different antibodies. In doing so, even if the patent holder’s own antibodies never make it out of the laboratory, the patents can nevertheless corner the market on intellectual property covering a new class of inhibitors. The risk of this strategy, however, is that extremely broad patent scope can simultaneously doom a patent’s validity for not being sufficiently enabled or lacking written description. As an example, a recent decision from the District of Delaware, MorphoSys AG v. Janssen Biotech, Inc., No. 16-221 (LPS) (Dkt. 471) (Jan. 25, 2019), invalidated broad antibody patents for not being sufficiently enabled, as well as coming near to invalidating the same patents for lacking written description. The case is important to the growing body of patents covering biologic drugs because it delineates more precisely when functionally-claimed antibody patents can survive enablement and written description challenges.

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.

Hospira Patent Claims that Previously Survived IPR Held Invalid

While the claims-in-suit had previously survived validity challenges in an inter partes review (IPR) proceeding at the Patent Trial and Appeal Board (PTAB) and in a District of Delaware case, Aly credited additional testimony and evidence in this case with leading Judge Pallmeyer towards finding that the claimed advance was inherent to the invention in the prior art. “In IPR, there’s a limited record so there’s not a lot of testing to examine, and two tests were submitted in the Delaware case,” Aly said. While that could have been enough, he noted that, in the Fresenius Kabi case, multiple companies had done more than 20 tests, all of which showed that the claimed advances were inherent to the stable product.

CAFC Overturns Preliminary Injunction on Generic Suboxone Film Over Newman Dissent

The Federal Circuit issued a nonprecedential decision in Indivior Inc. v. Dr. Reddy’s Laboratories, S.A., which vacated a preliminary injunction handed out by the District of New Jersey in a Hatch-Waxman patent infringement case brought by British pharmaceutical firm Indivior. The Federal Circuit panel majority concluded that the district court had abused its discretion in granting the injunction. The majority found that the ‘305 patent’s specification disparaged, and therefore disclaimed, the method of drying the films with the use of conventional methods which only dry the top of the film. Judge Pauline Newman authored a dissenting opinion in which she explained she would have found the district court’s preliminary injunction grant sustained on appeal. According to Judge Newman, the majority’s decision imported the drying limitation from the ‘514 patent claims into the ‘305 patent claims despite the fact that the ‘305 patent was amended specifically to remove this limitation.