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. …
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…
In Eli Lilly & Co. et al. v. Mylan et al., No. 14-cv-0389, 2015 U.S. Dist. LEXIS 30175 (S.D. Indiana March 12, 2015), the District Court denied a motion to dismiss for lack of personal jurisdiction. The Issue. Eli Lilly and friends filed a lawsuit against Mylan based on Mylan’s ANDA for Effient®, an anti-thrombotic drug…
Judge Hochberg of the District of New Jersey just issued an opinion finding two patents covering Warner Chilcott’s osteoporosis drug Altevia® (risedronate) invalid for obviousness. Warner Chilcott, LLC v. Teva Pharmaceuticals USA, Inc., 2015 U.S. Dist. LEXIS 26207 (D.N.J. March 4, 2015). This case demonstrates the importance of challenging whether alleged unexpected properties and skepticism…
A recent decision by the PTAB highlights two unsuccessful arguments by a patent owner attempting to prevent institution of an IPR. Petitioner, Johnson Matthey Inc. and two others, filed an IPR petition against U.S. Pat. No. 8,129,431 (“the ‘431 patent”). The patent relates to an aqueous liquid preparation named Prolensa, consisting of essentially two components:…
A recent District of New Jersey case highlights the importance of presenting evidence in federal district court in addition to presenting it in proceedings before the PTAB. New Jersey District Court Judge Hochberg recently held that the PTAB’s institution of an IPR was not a basis to reconsider the court’s order granting plaintiff a preliminary…