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…
Last week, an unconventional new player launched its first drug patent attack. The hedge fund Hayman Credes Master Fund, L.P., under the name Coalition For Affordable Drugs (ADROCA) LLC, filed an IPR petition against U.S. Pat. No. 8,663,685. (IPR2015-00720.) The patent, which covers the drug AMPYRA (dalfampridine), is owned by Acorda Therapeutics, Inc. This is…
In the first Federal Circuit ruling of an appeal from an inter partes review (“IPR”) decision, the Court held that the Patent Trial and Appeal Board (“the PTAB”) correctly applied the broadest reasonable interpretation standard to construct patent claims, held that it lacked jurisdiction to review the PTAB’s decision to institute an IPR, affirmed the…
In In re Modafinil Litigation, the Eastern District of Pennsylvania recently held that a plaintiff challenging a reverse payment as anti-competitive need not prove as a threshold matter that the reverse payment was both large and unjustified. Rather, this analysis should be part of the traditional “rule of reason” test. The Court also held that…
The Patent Trial and Appeal Board recently denied petitions from generic drug companies Amneal, Par, and Roxane Laboratories challenging the validity of Jazz Pharmaceuticals’ four Orange-Book-listed patents covering the narcolepsy drug Xyrem® under the America Invents Act’s (AIA) covered business method (CBM) review program. Par Pharm., Inc. et al. v. Jazz Pharm., Inc., CBM2014-00149, CBM2014-00150,…