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 Janssen Pharmaceuticals, Inc. v. Mylan Laboratories., the United States Court of Appeals for the Federal Circuit affirmed a district court ruling that a pharmaceutical dosing claim limitation was nonobvious despite prior...more
On March 28, 2025, the United States Court of Appeals for the Federal Circuit issued an opinion affirming the United States District Court for the District of New Jersey decision that Mylan Laboratories Ltd. (“Mylan”) induced...more
Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., Appeal No. 2023-1977 (Fed. Cir. Apr. 8, 2025) In our Case of the Week, the Federal Circuit affirmed that defendant Alkem’s proposed generic antibiotic did not...more
Case Name: Auxilium Pharms., Inc. v. FCB I LLC, Civ. No. 20-16456, 2021 WL 2802537 (D.N.J. July 6, 2021) (Vazquez, J.) - Drug Product and Patent(s)-in-Suit: Testim® (testosterone gel); U.S. Patents Nos. 7,320,968 (“the ’968...more
BECAUSE THE PRIOR ART TAUGHT OVERLAPPING PH RANGES AND STRUCTURALLY SIMILAR COMPOUNDS AS THOSE CLAIMED IN THE PATENT-IN-SUIT, THE FEDERAL CIRCUIT REVERSED SUMMARY JUDGMENT OF NON-OBVIOUSNESS. Case Name: Valeant Pharms...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: Bayer Intellectual Prop. GmbH v. Aurobindo Pharma Ltd., No. 15-902, 2018 U.S. Dist. LEXIS 116931 (D. Del. July 13, 2018) (Stengel, C.J.)....more
Case Name: Galderma Labs., L.P. v. Amneal Pharmaceuticals LLC, No. 16-207-LPS, 2018 U.S. Dist. LEXIS 151037 (D. Del. Aug. 27, 2018) (Stark, C.J.)....more
Case Name: Endo Pharms. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 2018 U.S. App. LEXIS 19265 (Fed. Cir. July 13, 2018) (Circuit Judges Moore, Linn, and Chen presiding; Opinion by Chen, J.) (Appeal from D. Del., Robinson,...more
In Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 (Jul. 11, 2018), the PTAB held that the claims of U.S. Patent No. 9,187,405 were not unpatentable on three separate grounds. Shortly thereafter, Novartis filed suit...more
Case Name: Endo Pharms. Inc. v. Teva Pharms. USA, Inc., Fed. Cir. Nos. 2015-2021, -2022, -2023, -2024, -2025, -2026, -2028, -2031, -2033, -2034, -2035, -2041, -2042, -2046, -2047, -2049, -2059, -2060, 2016-1025, -1060, -1117,...more
MILLENNIUM PHARMACEUTICALS, INC. v. SANDOZ INC - (Fed. Cir. July 17, 2017) (NEWMAN, Mayer, O’Malley) - This case arose out of an ANDA litigation between Millennium and a number of generic-drug companies who sought FDA...more
On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court...more
Case Name: Acorda Therapeutics Inc. v. Roxane Labs., Inc., 14-882-LPS, 2016 U.S. Dist. LEXIS 48479 (D. Del. Mar. 31, 2017) (Stark, J.)....more
Case Name: Genzyme Corp. v. Dr. Reddy’s Labs., Ltd., C.A. No. 13-1506-(GMS), 2016 U.S. Dist. LEXIS 62056 (D. Del. May 11, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Mozobil® (plerixafor solution); U.S. Pat....more
Case Name: Intendis GMBH et al. v. Glenmark Pharms. Inc., USA, 822 F.3d 1355 (Fed. Cir. May 16, 2016) (Circuit Judges Prost, Moore, and Taranto presiding; Opinion by Moore, J.) (Appeal from D. Del., Robinson, J.) - Drug...more
Addressing infringement under the doctrine of equivalents and obviousness issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s ruling barring approval of a generic version of Finacea® gel...more
In Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA, the Federal Circuit affirmed the district court decision that found infringement under the doctrine of equivalents. This case shows that the doctrine of equivalents...more
Addressing the scope of the safe harbor provision of § 271(e)(1), the U.S. Court of Appeals for the Federal Circuit reversed the district court, holding that supplying an active pharmaceutical ingredient (API) to the filer of...more
Last week the Federal Circuit affirmed a District Court's finding of invalidity and non-infringement in ANDA litigation between Spectrum Pharmaceuticals and Sandoz. In so doing, the Court deferred to the factual...more
Case Name: Novartis Pharms. Corp. v. Watson Labs., Inc., Fed. Cir. Nos. 2014-1799, -1800, 2015-1061, -1062, -1120, -1121, -1141, 2015 U.S. App. LEXIS 8374 (Fed. Cir. May 21, 2015) (Circuit Judges Lourie, Taranto, and Hughes...more
In The Medicines Company v. Hospira, Inc., the Federal Circuit held that a transaction with a contract manufacturer gave rise to an on sale bar that invalidated The Medicines Company’s Angiomax® patents. Are the facts of this...more
Hoffmann La-Roche Inc. v. Apotex Inc. - Addressing the validity of a dosing regimen patent in Abbreviated New Drug Application (ANDA) litigation, the U.S. Court of Appeals for the Federal Circuit affirmed a lower...more