News & Analysis as of

Pharmaceutical Industry Hatch-Waxman

Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC, Civ. No. 15-250-SLR, 2017 U.S. Dist. LEXIS 12165 (D. Del. Jan. 30, 2017) (Robinson, J.). Drug Product and U.S. Patent: Nasonex® (mometasone furoate nasal...more

In re copaxone consolidated cases

by Robins Kaplan LLP on

Case Name: In re copaxone consolidated cases, No. 14-1171-GMS (consolidated) 2017 U.S. Dist. LEXIS 12168 (D. Del. Jan. 30, 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Copaxone® (prefilled syringes of...more

Par Pharm., Inc. v. Luitpold Pharms., Inc.

by Robins Kaplan LLP on

Case Name: Par Pharm., Inc. v. Luitpold Pharms., Inc., No. 16-2290 (WHW)(CLW), 2017 U.S. Dist. LEXIS 15050 (D.N.J. Feb. 1, 2017) (Walls, J.). Drug Product and Patent(s)-in-Suit: Adrenalin® (epinephrine); U.S. Patents...more

AstraZeneca AB v. Aurobindo Pharma Ltd.

by Robins Kaplan LLP on

Case Name: AstraZeneca AB v. Aurobindo Pharma Ltd., 14-664-GMS, 2017 U.S. Dist. LEXIS 14647 (D. Del. Feb. 2, 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Onglyza® (saxagliptin) and Kombiglyze™ XR (saxaglibtin...more

Endo Pharma. Solutions Inc. v. Custopharm, Inc.

by Robins Kaplan LLP on

Case Name: Endo Pharma. Solutions Inc. v. Custopharm, Inc., 14-1422-SLR, 2017 U.S. Dist. LEXIS 19035 (D. Del. Feb. 10, 2017) (Robinson, J.). Drug Product and Patent(s)-in-Suit: Aveed® (testosterone undecanoate); U.S....more

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

by Robins Kaplan LLP on

Case Name: Helsinn Healthcare S.A. v. Dr. Reddy's Labs., Ltd., No. 12-2867 (MLC) (DEA), 2017 U.S. Dist. LEXIS 21477 (D.N.J. Feb. 14, 2017) (Cooper, J.). Drug Product and Patent(s)-in-Suit: Aloxi® (palonosetron); U.S....more

Recro Gainesville LLC v. Actavis Labs. FL, Inc.

by Robins Kaplan LLP on

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

Apotex Inc. v. Alcon Research, Ltd.

by Robins Kaplan LLP on

Case Name: Apotex Inc. v. Alcon Research, Ltd., No. 16-3145-WTL-MJD, 2017 U.S. Dist. LEXIS 27016 (S.D. Ind. Feb. 27, 2017) (Lawrence, J.). Drug Product and Patent(s)-in-Suit: Pataday® (olopatadine); U.S. Patents Nos....more

Purdue Pharma L.P., v. Mylan Pharms. Inc.

by Robins Kaplan LLP on

Case Name: Purdue Pharma L.P., v. Mylan Pharms. Inc., 15-1155-RGA-SRF, 2017 U.S. Dist. LEXIS 28460 (D. Del. Mar. 1, 2017) (Fallon, M.J.). Drug Product and Patent(s)-in-Suit: OxyContin® (oxycodone hydrochloride); U.S....more

Reckitt Benckiser LLC v. Aurobindo Pharma Ltd.

by Robins Kaplan LLP on

Case Name: Reckitt Benckiser LLC v. Aurobindo Pharma Ltd., Civ. No. 14-1203-LPS, 2017 U.S. Dist. LEXIS 31985 (D. Del. Mar. 6, 2017) (Stark, J.). Drug Product and Patent(s)-in-Suit: Mucinex® DM (dextromethorphan...more

Novartis Pharms. Corp. v. Breckenridge Pharm., Inc.

by Robins Kaplan LLP on

Case Name: Novartis Pharms. Corp. v. Breckenridge Pharm., Inc., Civ. Nos. 14-1043-RGA, 14-1196-RGA, 14-1289-RGA, 2017 U.S. Dist. LEXIS 46595 (D. Del. Mar. 28, 2017) (Andrews, J.)....more

Impax Labs., Inc. v. Lannett Holdings Inc.

by Robins Kaplan LLP on

Case Name: Impax Labs., Inc. v. Lannett Holdings Inc., Nos. 14-0984, -999 (RGA), 2017 U.S. Dist. LEXIS 47244 (D. Del. Mar. 29, 2017) (Andrews, J.)....more

Acorda Therapeutics Inc. v. Roxane Labs., Inc.

by Robins Kaplan LLP on

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

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

by Robins Kaplan LLP on

Case Name: Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., No. 2015-2067, 2017 U.S. App. LEXIS 555 (Fed. Cir. Jan. 12, 2017) (Circuit Judges Prost, Newman, and Dyk presiding; Opinion by Prost, C.J.) (Appeal from S.D....more

Federal Circuit Clarifies AIA On-Sale Bar Provision Applies Where Existence of Sale Is Public

by Polsinelli on

Yesterday, the Federal Circuit provided much-anticipated guidance on the scope of the America Invents Act’s “on-sale” bar provision. Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., et al., Nos. 2016-1284, 2016-1787...more

Cumberland Pharms. Inc. v. Mylan Institutional LLC

by Robins Kaplan LLP on

Case Name: Cumberland Pharms. Inc. v. Mylan Institutional LLC, Nos. 2016-1155, -1259, 846 F.3d 1213 (Fed. Cir. Jan. 26, 2017) (Circuit Judges Moore, Taranto, and Reyna presiding; Opinion by Taranto, J.) (appeal from N.D....more

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

by Robins Kaplan LLP on

Case Name: Shire Development, LLC v. Watson Pharms., Inc., No. 2016-1785, 848 F.3d 981 (Fed. Cir. Feb. 10, 2017) (Circuit Judges Prost, Taranto, and Hughes presiding; Opinion by Hughes, J.) (appeal from S.D. Fla.,...more

Allergan, Inc. v. Sandoz, Inc.

by Robins Kaplan LLP on

Case Name: Allergan, Inc. v. Sandoz, Inc., Nos. 2016-1085, -1160, 2017 U.S. App. LEXIS 4733 (Fed. Cir. Mar. 17, 2017) (Circuit Judges Reyna, Wallach, and Chen presiding; Opinion by Wallach, J.) (Appeal from M.D.N.C., Eagles,...more

Second Circuit Declares That, to Survive Motions to Dismiss, Antitrust Allegations Require Factual Support for All “Necessary...

Last Wednesday, the Second Circuit Court of Appeals partially vacated the judgment of the district court in In re Actos End-Payor Antitrust Litigation. In doing so, the Second Circuit allowed only plaintiffs’ claims that...more

Endo Pharms. Inc. v. Amneal Pharms. LLC

by Robins Kaplan LLP on

Case Name: Endo Pharms. Inc. v. Amneal Pharms. LLC, Civ Nos. 14-1382-RGA, 14-1389-RGA, 2016 U.S. Dist. LEXIS 140112 (D. Del. Oct. 7, 2016) (Andrews, J.). Drug Product and Patent(s)-in-Suit: Opana® ER (oxymorphone...more

Merck Sharp & Dohme Corp. v. Hospira Inc.

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme Corp. v. Hospira Inc., 14-cv-915-RGA, 2016 U.S. Dist. LEXIS 139721 (D. Del. Oct. 7, 2016) (Andrews, J.). Drug Product and Patent(s)-in-Suit: Invanz® (ertapenem); U.S. Patents Nos. 5,952,323...more

Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc., No. 14-874-SLR, 2016 U.S. Dist. LEXIS 158514 (D. Del. Nov. 16, 2016) (Robinson, J.). Drug Product and Patent(s)-in-Suit: Nasonex® (mometasone furoate...more

Orexo AB v. Actavis Elizabeth LLC

by Robins Kaplan LLP on

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

Mylan Institutional LLC v. Aurobindo Phama Ltd

by Robins Kaplan LLP on

Case Name: Mylan Institutional LLC v. Aurobindo Phama Ltd, 2:16-cv-00491-RWS-RSP, 2016 U.S. Dist. LEXIS 180551 (E.D. Tex. Nov. 21, 2016) (Payne, MJ). Drug Product and Patents-in-Suit: isosulfan blue; U.S. Patents Nos....more

Aptalis Pharamtech, Inc. v. Apotex Inc.

by Robins Kaplan LLP on

Case Name: Aptalis Pharamtech, Inc. v. Apotex Inc., Civ. No. 14-1038-SLR, 2016 U.S. Dist. LEXIS 169520 (D. Del. Dec. 8, 2016) (Robinson, J.). Drug Product and U.S. Patent: Amrix® (cyclobenzaprine); U.S. Patents Nos....more

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