ANDA Patents

News & Analysis as of

Patents-In Suit In ANDA Trial Are Non-Obvious

A 6-day bench trial was held from April 6-14, 2015. After trial, the court entered stipulations and orders regarding infringement of certain claims of the ‘178 and ‘206 patents. The court rejected defendant’s claim that the...more

Judge Griesa Grants Endo an Injunction Against Generic Manufacturers of Opioid Opana ER

On April 29, 2016, S.D.N.Y. District Judge Thomas P. Griesa granted Defendants Actavis, Inc., Actavis South Atlantic LLC (together “Actavis”) and Roxane Laboratories, Inc.’s motion to correct the court’s August 14, 2015...more

Apotex, Inc. v. Daiichi Sankyo, Inc.

Case Name: Apotex, Inc. v. Daiichi Sankyo, Inc., C.A. Nos. 12-cv-9295, 15-cv-3695, 2016 U.S. Dist. LEXIS 2126 (N.D. Ill. Jan. 8, 2016) (Coleman, J.)... Drug Product and Patent(s)-in-Suit: Benicar® and Benicar® HCT...more

Supernus Pharms., Inc. v. Actavis Inc.

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

Helsinn Healthcare, S.A. v. Dr. Reddy’s Labs. Ltd.

Case Name: Helsinn Healthcare, S.A. v. Dr. Reddy’s Labs. Ltd., Civ. No. 11-3962 (MLC), 2016 U.S. Dist. LEXIS 27477 (D.N.J. Mar. 3, 2016) (Cooper, J.)... Drug Product and Patent(s)-in-Suit: Aloxi® (palonosetron); U.S....more

Braintree Labs. Inc. v. Breckenridge Pharm., Inc.

Case Name: Braintree Labs. Inc. v. Breckenridge Pharm., Inc., C.A. No 12-cv-6851 (AJN), 2016 U.S. Dist. LEXIS 33336 (S.D.N.Y. Mar. 15, 2016) (Nathan, J.)... Drug Product and Patent(s)-in-Suit: Suprep® (sodium sulfate /...more

Shire Development, LLC v. Watson Pharms., Inc.

Case Name: Shire Development, LLC v. Watson Pharms., Inc., Civ. No. 12-60862-CIV-MIDDLEBROOKS/BRANNON, 2016 U.S. Dist. LEXIS 40360 (S.D. Fla. Mar. 25, 2016) (Middlebrooks, J.)... Drug Product and Patent(s)-in-Suit:...more

Acorda Therapeutics Inc. v. Mylan Pharms. Inc.

Case Name: Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 2015-1456, 2015-1460, 2016 U.S. App. LEXIS 4942 (Fed. Cir. Mar. 18, 2016) (Circuit Judges Newman, O’Malley, and Taranto presiding; Opinion by Taranto, J.; Concurring...more

March 2016 Life Sciences Litigation Update

Federal Circuit Affirms Broad Personal Jurisdiction Over ANDA Filers. On March 18, 2016, in the first decision of its kind since the U.S. Supreme Court decided Daimler AG v. Bauman, 134 S. Ct. 746 (2014), the Federal...more

Court Report - March 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Vanda Pharmaceuticals Inc. v. Roxane Laboratories Inc. 1:15-cv-00919; filed October 13, 2015 in the District Court of...more

Claims Are Construed In ANDA Case

Sleet, J. Claim construction opinion issues regarding three terms from four patents. A Markman hearing took place on February 5, 2016 The disputed technology relates to the drug Copaxone. Thirty-one terms were found...more

Court Report - January 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Merck Sharp & Dohme B.V. v. Teva Pharmaceuticals USA Inc. 1:15-cv-00806; filed September 11, 2015 in the District Court...more

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

Claim Is Construed In ANDA Case

Tris Pharma, Inc. v. Actavis Laboratories FL, Inc., et al., C.A. No. 14-1309 – GMS, January 8, 2016. Sleet, J. Claim construction opinion issues regarding one term from four patents....more

Directing a Known Treatment to a Sub-Population of Patients Is Obvious - Prometheus Labs, Inc. v. Roxane Labs., Inc.

Addressing obviousness issues, the U. S. Court of Appeals for the Federal Circuit affirmed the district court’s invalidity conclusion, agreeing that the elements present in the prior art—including earlier disclosed genus...more

Post-Approval Quality Control Testing of Pharmaceutical Products: What Constitutes 35 U.S.C. § 271(g) Infringement or Falls Under...

The Federal Circuit recently affirmed that a generic pharmaceutical company’s use of post-approval quality control testing was not “making” under 35 U.S.C. § 271(g). See Momenta Pharmaceuticals, Inc. et al. v. Teva...more

Obviousness Versus Obviousness-Type Double Patenting

In Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc., the Federal Circuit affirmed the district court’s finding that Prometheus’ claims were invalid as obvious, but in so doing it cited its own precedent regarding...more

Claims Are Construed In ANDA Case

Sleet, J. Claim construction opinion issues regarding two terms from one patent. The disputed technology relates to dexmedetomidine and its pharmaceutically acceptable salts. The following term was considered...more

Court Report - November 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Amgen Inc. et al. v. Apotex Inc. et al. 0:15-cv-61631; filed August 6, 2015 in the Southern District of Florida. •...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

Supplier to ANDA Filer Is Not Liable for Induced Infringement Until After ANDA Approval - Shire LLC v. Amneal Pharms., LLC

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

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

Court Report - November 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Biotech Inc. et al. v. Par Pharmaceutical Inc. et al. 1:15-cv-00679; filed August 3, 2015 in the District Court of...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

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