On January 5, 2016, Chief Judge Leonard P. Stark of the District of Delaware found the claim language of several patents covering Namenda XR®—Forest Laboratories, Inc.’s extended-release drug for treating Alzheimer’s-type dementia—indefinite. Forest Labs., Inc. et. al v. Teva Pharm. USA, Inc. et al., Civ. No. 14-cv-00121-LPS (D. Del. Jan. 5, 2016). Notably, the court…
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…
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. …
Yesterday’s precedential decision in Apotex v. Daiichi Sankyo, Inc. et al. v. Mylan Pharmaceuticals, Inc., 2014-1282, 2014-1291, dealt with the questions of whether declaratory judgment jurisdiction permits a second-filer to challenge a disclaimed Orange Book patent for purposes of triggering the first-filer’s exclusivity. Daiichi markets Benicar®, a drug to treat hypertension. It listed two patents…
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…
The U.S. Food and Drug Administration (“FDA”) recently issued Draft Guidance to the Industry, titled “New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products,” that proposes a change in its longstanding policy concerning 5-year new chemical entity (“NCE”) exclusivity for fixed-combination drug products. For many years, FDA’s interpretation of the word “drug” in certain provisions…
The day has finally arrived where the full Federal Circuit will reconsider the precedent established in Cybor Corp. v. FAS Technologies Inc. In the 1998 case, the Federal Circuit established that claims construction rulings must be reviewed de novo on appeal and no deference is given to the district court. This might result in a new standard…
This week, the Federal Circuit confirmed that a strong affirmative case of obviousness can overcome unexpected results in Allergan, Inc. v. Sandoz, Inc. The case involved a number of patents covering Combigan®, a combination eye-drop solution for indicated for glaucoma containing 0.2% brimonidine, an α2-agonist, and 0.5% timolol, a beta-blocker, along with benzalkonium chloride preservative, including a formulation…