Webinar: Orange Book listing sheets under the microscope
Key Considerations for Reshoring U.S. Drug Manufacturing
Drug Pricing Initiatives During the Trump Presidency
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Patent law in Europe: What pharmaceutical companies need to know
EU excessive pricing laws
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
In Actavis v. U.S., a case at the intersection of tax law and patent law, the Federal Circuit held that generic drug companies’ Hatch-Waxman litigation expenses are “ordinary and necessary business expenses” and can be...more
Quillivant XR® (methylphenidate (“MPH”)) - Case Name: Tris Pharma, Inc. v. Actavis Labs. FL, Inc., No. 14-1309-CFC, 2020 WL 7028456 (D. Del. Nov. 30, 2020) (Connolly, J.)...more
RELYING ON PLAINTIFFS’ TESTING OF DEFENDANT’S ANDA PRODUCT, AND FINDING THAT THE PRIOR ART TAUGHT AWAY FROM THE CLAIMED INVENTION, THE COURT HELD THE ASSERTED CLAIMS VALID AND INFRINGED. Case Name: Bausch Health Cos. v....more
THE FEDERAL CIRCUIT AFFIRMED THE DISTRICT COURT’S FINDING THAT ONE OF THE PATENTS WAS ADEQUATELY DESCRIBED, BUT REVERSED THE DISTRICT COURT’S FINDING OF NON-OBVIOUSNESS. Case Name: Nalpropion Pharms., Inc. v. Actavis Labs....more
Case Name: Tris Pharma Inc. v. Actavis Labs. Fl, Inc., Fed. Cir. Nos. 2017-2557, -2559, -2560, 2018 U.S. App. LEXIS 32774 (Fed. Cir. Nov. 20, 2018) (Circuit Judges Newman, O’Malley, and Chen presiding; Opinion by Chen, J.)...more
Case Name: Impax Labs., Inc. v. Actavis Labs. FL, Inc., Civ. No. 15-6934, 2018 U.S. Dist. LEXIS 38623 (D.N.J. Mar. 8, 2018) (Chesler, J.)....more
The issue of venue—where geographically a case can be brought—and jurisdiction are a pair of principles to determine in which forum a case can properly be brought. Jurisdiction in personam concerns whether a particular party...more
Case Name: Tris Pharma, Inc. v. Actavis Labs. FL, Inc., No. 14-1309-GMS, 2017 U.S. Dist. LEXIS 143299 (D. Del. Sept. 5, 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Quillivant XR® (methylphenidate...more
Case Name: Merck Sharp & Dohme Corp. v. Actavis Labs. Fl, Inc., No. 15-cv-6075 (PGS) (DEA), 2017 U.S. Dist. LEXIS 164131 (D.N.J. Sept. 29, 2017) (Sheridan, J.)... Drug Product and Patent(s)-in-Suit: Noxafil®...more
Case Name: Sebela Int’l Ltd. v. Actavis Labs. Florida Inc., No. 14:6414 (CCC) (MF), 2017 U.S. Dist. LEXIS (D.N.J. June 16, 2017) (Cecchi, J.)....more
Case Name: Recro Gainesville LLC v. Actavis Labs. FL, Inc., Civ. No. 14-1118-GMS, 2017 U.S. Dist. LEXIS 24428 (D. Del. Feb. 22, 2017) (Sleet, J.). Drug Product and U.S. Patent: Zohydro® ER (hydrocodone bitartrate...more
Case Name: Orexo AB v. Actavis Elizabeth LLC, 14-cv-829-SLR, 2016 U.S. Dist. LEXIS 157683 (D. Del. Nov. 15, 2016) (Robinson, J.). Drug Product and Patents-in-Suit: Zubsolv® (buprenorphine / naloxone sublingual tablet);...more
Case Name: Endo Pharms. Inc. v. Actavis Labs. UT, Inc., 2016-1146, 2016 U.S. App. LEXIS 18490 (Fed. Cir. Oct. 14, 2016) (Circuit Judges Moore, Taranto, and Hughes presiding; Opinion by Taranto, J.) (Appeal from E.D. Tex.,...more
It has been over three years since the Supreme Court’s Actavis decision. Since then, numerous putative class actions alleging harm to competition as a result of “reverse-payment” settlements have flooded the courts. The...more
Case Name: Ferring B.V. v. Actavis, Inc., Civil No. 15-4222 (SRC)(CLW), 2016 U.S. Dist. LEXIS 69328 (D.N.J. May 26, 2016) (Chesler, J.) - Drug Product and Patents-in-Suit: Lysteda® (tranexamic acid); U.S. Patent No....more
Patent settlement agreements were traditionally deemed outside the purview of antitrust scrutiny unless the patent holder’s conduct fell outside the legitimate scope of the patent’s exclusionary power. This all changed when...more
Case Name: Supernus Pharms., Inc. v. Actavis Inc., Civil Nos. 13-4740 (RMB/JS), 14-1981 (RMB/JS), 2016 U.S. Dist. LEXIS 14111 (D.N.J. Feb 5, 2016) (Bumb, J.)... Drug Product and Patent(s)-in-Suit: Oxtellar XR®...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC 1:15-cv-00831; filed September 17, 2015 in the District Court of...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Spectrum Pharmaceuticals, Inc. et al. v. Amneal Pharmaceuticals LLC - 2:15-cv-01697; filed September 3, 2015 in the...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Warner Chilcott (US), LLC et al. v. Teva Pharmaceuticals USA, Inc. et al. - 1:15-cv-00761; filed August 31, 2015 in...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Vivus, Inc. v. Actavis Laboratories FL, Inc. 2:15-cv-06256; filed August 17, 2015 in the District Court of New Jersey. ...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Purdue Pharma L.P. et al. v. Actavis Laboratories FL, Inc. 1:15-cv-00686; filed August 5, 2015 in the District Court of...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. United Therapeutics Corp. v. Watson Laboratories, Inc. 3:15-cv-05723; filed July 22, 2015 in the District Court of New...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Senju Pharmaceutical Co. et al. v. Watson Laboratories, Inc. et al. 1:15-cv-05591; filed July 16, 2015 in the District...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Bristol-Myers Squibb Co. et al. v. Merck & Co., Inc. et al. 1:15-cv-00572; filed July 7, 2015 in the District Court of...more