Hatch-Waxman Pharmaceutical Industry

News & Analysis as of

Cumberland Pharms., Inc., v. Mylan Institutional LLC

Case Name: Cumberland Pharms., Inc., v. Mylan Institutional LLC, Civ. No. 12-C-3846, 2015 U.S. Dist. LEXIS 134495 (N.D. Ill. Oct. 2, 2015) (Pallmeyer, J.)... Drug Product and Patent(s)-in-Suit: Acetadote®...more

Otsuka Pharm. Co., Ltd. v. Zydus Pharms. USA,

Case Name: Otsuka Pharm. Co., Ltd. v. Zydus Pharms. USA, C.A. Nos. 14-3168 (JBS/KMW),14-4671 (JBS/KMW),14-5878 (JBS/KMW),14-6398 (JBS/KMW),14-7252 (JBS/KMW), 2015 U.S. Dist. LEXIS 138853 (D.N.J. Oct. 13, 2015) (Simandle,...more

Cubist Pharms., Inc. v. Hospira, Inc.

Case Name: Cubist Pharms., Inc. v. Hospira, Inc., 2015-1197, 2015-1204, 2015-1259, 2015 U.S. App. LEXIS 19662 (Fed. Cir. Nov. 12, 2015) (Circuit Judges Wallach, Bryson, and Hughes presiding; Opinion by Bryson, J.) (Appeal...more

Federal Circuit Hears Argument on Personal Jurisdiction in Two Hatch-Waxman Appeals

On Monday, January 4, the Court of Appeals for the Federal Circuit heard oral argument in two appeals that may determine what effect the Supreme Court’s Daimler AG v. Bauman decision will have on the exercise of personal...more

Patent Infringement Safe Harbor and Importation Redefined: Ruling Incentivizes Generic Pharmaceutical Offshore Product Testing

A recent ruling by the U.S. Court of Appeals for the Federal Circuit has provided an apparent loophole for manufacturers to avoid infringement liability for conducting patented manufacturing quality control steps offshore. On...more

Novartis Pharm. Corp. v. Zydus Noveltech Inc.

Case Name: Novartis Pharm. Corp. v. Zydus Noveltech Inc., Civ. No. 14-cv-1104-RGA, 2015 U.S. Dist. LEXIS 103708 (D. Del. Aug. 7, 2015) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Exelon® (rivastigmine); U.S....more

Endo Pharms. Inc. v. Amneal Pharms. LLC

Case Name: Endo Pharms. Inc. v. Amneal Pharms. LLC, Civ. Nos. 12 Civ. 8115 (TPG), 12 Civ. 8060 (TPG), 12 Civ. 8317 (TPG), 12 Civ. 8985 (TPG), 13 Civ. 435 (TPG), 13 Civ. 436 (TPG), 13 Civ. 3288 (TPG), 13 Civ. 4343 (TPG), 13...more

Millennium Pharms., Inc. v. Sandoz Inc.

Case Name: Millennium Pharms., Inc. v. Sandoz Inc., Civ. No. 12-1011-GMS (consolidated), 2015 U.S. Dist. LEXIS 110099 (D. Del. Aug. 20, 2015) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Velcade® (bortezomib); U.S....more

Eli Lilly & Co. v. Nang Kuang Pharm.Co., Ltd.

Case Name: Eli Lilly & Co. v. Nang Kuang Pharm.Co., Ltd., 1:14-cv-1647-TWP-DKL, 2015 U.S. Dist. LEXIS 11510 (S.D. Ind. Aug. 24, 2015) - Drug Product and Patent-in-Suit: Alimta® (pemetrexed disodium); U.S. Patents Nos....more

ANDA Update - October 2015

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Eli Lilly & Co. v. Teva Parenteral Medicines, Inc.

Case Name: Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., Civ. No. 10-cv-1376-TWP, 2015 U.S. Dist. LEXIS 112221 (S.D. Ind. Aug. 25, 2015) (Pratt, J.) - Drug Product and Patents-in-Suit: Alimta® (pemetrexed...more

Merck Sharp & Dohme Corp. v. Sandoz Inc.

Case Name: Merck Sharp & Dohme Corp. v. Sandoz Inc., Civ. No. 3:12-cv-03289-PGS-LHG, 2015 U.S. Dist. LEXIS 113710 (D.N.J. Aug. 27, 2015) (Sheridan, J.) - Drug Product and Patent(s)-in-Suit: Emend® (fosaprepitant...more

Merck & CIE v. Watson Labs., Inc.

Case Name: Merck & CIE v. Watson Labs., Inc., Civ. Nos. 13-978-RGA, 13-1272-RGA, 2015 U.S. Dist. LEXIS 115245 (D. Del. Aug. 31, 2015) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Safyral® and Beyaz®...more

Novartis Pharm. Corp. v. Noven Pharm., Inc.

Case Name: Novartis Pharm. Corp. v. Noven Pharm., Inc., Civ. No. 13-527-RGA, 2015 U.S. Dist. LEXIS 115246 (D. Del. Aug. 31, 2015) (Andrews, J.) - Drug Product and Patents-in-Suit: Exelon® (rivastigmine); U.S. Patent No....more

Endo Pharms. Inc. v. Actavis Inc.

Case Name: Endo Pharms. Inc. v. Actavis Inc., Civ. No. 14-1381-RGA, 2015 U.S. Dist. LEXIS 127104 (D. Del. Sept. 23, 2015) (Thynge, M.J.) - Drug Product and Patent(s)-in-Suit: Opana ER® (oxymorphone); U.S. Patent No...more

Baxter Healthcare Corp. v. HQ Specialty Pharma Corp.

Case Name: Baxter Healthcare Corp. v. HQ Specialty Pharma Corp., Civ. No. 13-6228 (JBS/KMW), 2015 U.S. Dist. LEXIS 128002 (D.N.J. Sept. 23, 2015) (Simandle, C.J.)...more

The Medicines Co. v. Hospira, Inc.

Case Name: The Medicines Co. v. Hospira, Inc., Fed. Cir. Nos. 2014-1469, -1504, 2015 U.S. App. LEXIS 11410 (Fed. Cir. July 2, 2015) (Circuit Judges Dyk, Wallach, and Hughes presiding; Opinion by Hughes, J.) (Appeal from D....more

Allergan, Inc., v. Sandoz Inc.

Case Name: Allergan, Inc., v. Sandoz Inc., Civ. No. 2014-1275, 2015 U.S. App. LEXIS 13616 (Fed. Cir. Aug. 4, 2015) (Circuit Judges Lourie, Linn, and Hughes presiding; Opinion by Lourie, J.) (Appeal from E.D. Tex., Schneider,...more

Shire LLC v. Amneal Pharms. LLC

Case Name: Shire LLC v. Amneal Pharms. LLC, 2014-1736, -1737, -1738, -1739, -1740, -1741, 2015 U.S. App. LEXIS 16908 (Fed. Cir. Sept. 24, 2015) (Circuit Judges Moore, Mayer, and Linn presiding; Opinion by Linn, J.) (Appeal...more

101 Patient Organizations Ask Congress to Curb IPR Abuse

Last month, in a letter to the Senate and House Committees on the Judiciary, 101 patient organizations expressed "concern[] that, as currently written, H.R. 9 [the Innovation Act] falls short of preserving important patent...more

Post-Grant Challenges in Life Sciences: A Midyear Assessment

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

Shire v. Amneal Pharma – Adjusting the Rearview Mirror

While the IP law world is being rocked by new developments in biosimilars, patent-eligible subject matter and IPR’s, it is almost refreshing to see a decision upholding the validity of claims to a “small molecule” drug based...more

Guest Post -- The Biggest Side-effect of Making Medicine: How to Manage Intellectual Property and Patent Law

International intellectual property regulations are doing serious damage to the pharmaceutical industry and, by extension, to the health of people around the world. The core of the problem: growing global concern about how...more

Fireworks for Animal Compounding and More at ACI’s Inaugural Animal Health and Veterinary Drugs and Therapeutics Conference-Part...

On September 10-11, the American Conference Institute (ACI) held its inaugural Animal Health and Veterinary Drugs and Therapeutics Conference in New York City. The Conference featured two workshops: a pre-conference overview...more

First Biosimilar Drug Now Available; Ongoing Legal Dispute Remains

The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch...more

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