The Disposition: On remand from the Supreme Court, the Federal Circuit affirmed its earlier decision finding the claims of Teva’s Orange Book patent for Copaxone invalid as indefinite. See Teva Pharmaceuticals USA, Inc. et al. v. Sandoz, Inc. et al., No. 12-1567 (June 18, 2015). Case History. In its initial review, the Federal Circuit reversed […]
Last week, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a district court finding that the asserted claims of a prenatal diagnostic testing method patent are not directed to patent eligible subject matter and are therefore invalid under § 101. The Patent. The patent at issue (the ‘540 patent) involves a technology […]
Last week, in Virginia Innovation Sciences (“VIS”) v. Samsung, the Federal Circuit provided some indication of the circumstances under which it would defer to a district court’s evaluation of extrinsic evidence in the post-Teva world. We have previously written about the Supreme Court’s 2015 Teva v. Sandoz opinion, which overturned long-standing precedent, holding that while […]
The Ruling. In a 6-2 decision issued Tuesday, the Supreme Court once again disagreed with the Federal Circuit and held that a defendant’s good-faith (but incorrect) belief that a patent is invalid is not a defense to an induced infringement claim. Commil USA, LLC v. Cisco Sys., Inc., No. 13-896. The Court also affirmed that induced […]
Last week the Second Circuit upheld an injunction blocking Forest Laboratories (“Forest”) from removing immediate-release Namenda (“Namenda IR”) from the market. The decision prevents Forest from effectuating a so-called “product-hopping” strategy under which it planned to stop selling Namenda IR and switch patients to its newer extended-release product, Namenda XR, prior to entry of a […]
In Classen Immunotherapies, Inc. v. Elan Pharms., Inc., the Federal Circuit determined that an NDA-holder’s post-approval activities fall within the scope of the § 271(e) safe harbor. 2015 U.S. App. LEXIS 7854 (Fed. Circ. May 13, 2015). Specifically, 35 U.S.C. § 271(e)(1) exempts activities reasonably relating to developing clinical data on an approved drug and submitting that […]
Last Thursday, in its decision in AstraZeneca LP v Breath Ltd., the Federal Circuit affirmed Breath Ltd.’s Paragraph IV ANDA challenge of AstraZeneca’s Orange Book patent covering sterile budesonide compositions. It was undisputed that those of ordinary skill in the art would have been motivated to pursue a sterile budesonide composition, limiting the obviousness dispute […]
A United States District Court has decided generic versions of aripiprazole (Abilify®) may proceed to market despite the brand name drug’s orphan drug status. On April 28, 2015, the FDA approved four generic versions of aripiprazole (Abilify®), which is marketed and sold by Otsuka America Pharmaceutical, Inc. Otsuka sought a temporary restraining order that would […]
PIV certifications do not preclude ANDA filers from seeking inter partes review of Orange Book patents, according to the court in Senju Pharmaceutical Co. v. Metrics, Inc., 14-CV-3962 (D. N.J. Mar. 31, 2015). Plaintiffs Senju and Bausch & Lomb own three patents covering formulations of bromfenac, the active ingredient in Prolensa®. They sued Metrics for […]
In its recent decision in Insite Vision, Inc. v. Sandoz, Inc., the Federal Circuit reminds us of the importance of properly selecting and preparing experts for trial. Insite markets Azasite®, a topical azithromycin solution approved for the treatment of bacterial conjunctivitis. Sandoz stipulated to infringement so the only issue at trial was Sandoz’s its obviousness defense. […]