Hatch-Waxman Patents

News & Analysis as of

A Stay of Litigation Pending IPR Does Not Provide a Basis For Extending 30-Stay of FDA ANDA Approval

On December 11, 2015, the United States District Court for the Southern District of Indiana granted a motion to stay a Hatch-Waxman litigation pending the outcome of inter partes reviews (IPRs) on two of the patents-in-suit...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

Business Litigation Report - September 2015

Alleging Fraud in a Financial Crisis: The Second Circuit Articulates a Less Stringent Pleading Standard for Loss Causation: Loss causation has emerged as a central obstacle to post-financial-crisis fraud cases. The loss...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

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

Contract Manufacturing Is a Commercial Transaction for Purpose of “On-Sale” Bar - The Medicines Company v. Hospira, Inc.

Addressing the application of the on-sale bar under § 102(b), the U.S. Court of Appeals for the Federal Circuit found that the claims of an asserted patent were invalid based on an agreement, dated more than one year prior to...more

Purdue Pharma L.P. v. Amneal Pharms., LLC

Case Name: Purdue Pharma L.P. v. Amneal Pharms., LLC, Civ. Nos. 04-Md-1603 (SHS); 13-cv-3372 (SHS), 2015 U.S. Dist. LEXIS 45967 (S.D.N.Y. Apr. 8, 2015) (Stein, J.) - Drug Product and Patent(s)-in-Suit: OxyContin®...more

Otsuka Pharm. Co., Ltd. v. Torrent Pharms. Ltd., Inc.

Case Name: Otsuka Pharm. Co., Ltd. v. Torrent Pharms. Ltd., Inc., Civ. No. 14-1078 (JBS/KMW), 2015 U.S. Dist. LEXIS 50082 (D.N.J. Apr. 16, 2015) (Simandle, C.J.) - Drug Product and Patent(s)-in-Suit: Abilify®...more

Riddle Me This: The Federal Circuit Provides a Measure of Clarity to the Enigmatic Biosimilar Approval Pathway

In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more

115 Results
|
View per page
Page: of 5

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×