News & Analysis as of

Hatch-Waxman

Changes to pharmaceutical/biopharmaceutical patent litigation in Canada

by DLA Piper on

As a result of the Comprehensive Economic Trade Agreement with the European Union, significant changes to the patent linkage provisions and patent litigation framework relating to generic and biosimilar drug approval in...more

Sanofi v. Lupin Atlantis Holdings SA

by Robins Kaplan LLP on

Case Name: Sanofi v. Lupin Atlantis Holdings SA, Civ. No. 15-415-RGA, 2017 U.S. Dist. LEXIS 10653 (D. Del. Jan. 26, 2017) (Andrews, J.). Drug Product and U.S. Patent: Multaq® (dronedarone tablets); U.S. Patent No....more

Practical Issues for the Pharmaceutical and Biopharmaceutical Industry in the Wake of TC Heartland

The US Supreme Court this week held that the broad venue provision of 28 U.S.C. § 1391(c) does not apply to patent law—at least, when the defendant is a domestic entity. This decision arises after years of judicial...more

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

by Robins Kaplan LLP on

Case Name: Shire Development, LLC v. Mylan Pharms., Inc., No: 12-1190-T-36AEP, 2017 U.S. Dist. LEXIS 11441 (M.D. Fla. Jan. 27, 2017) (Honeywell, J.). Drug Product and Patent(s)-in-Suit: Lialda® (mesalamine); U.S. Patent...more

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

Federal Circuit Patent Updates - May 2017

by WilmerHale on

Chen, J. The estoppel provision of pre-AIA section 317(b) did not serve as a bar to maintain an inter partes reexamination where district court invalidity claims had been dismissed without prejudice. On the merits, affirming...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

Par’s Hatch-Waxman Claims Too Speculative and Discovery Requests Too Broad

by Foley & Lardner LLP on

The recent decision from the New Jersey District Court in Par Pharmaceutical, Inc. v. Luitpold Pharmaceuticals, Inc., Civ. No. 16-02290 (WHW)(CLW) (D.N.J. April 24, 2017) provides an interesting look at the boundaries of...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

Supreme Court Oral Argument in Sandoz v. Amgen

by Goodwin on

The Supreme Court held a 70-minute oral argument in Sandoz v. Amgen this morning. Before beginning the argument, the Chief Justice announced that the Court would give each side five extra minutes–a highly unusual step...more

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