News & Analysis as of

ANDA Generic Drugs

Allergan, Inc. v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Allergan, Inc. v. Teva Pharms. USA, Inc., 15-1455-WCB, 2017 U.S. Dist. LEXIS 4545 (E.D. Tex. Jan. 12, 2017) (Bryson, J.). Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine ophthalmic solution); U.S....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

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

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

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

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

Novartis v. Noven: The PTAB is not Bound by Prior Decisions of District Courts

Novartis, together with LTS Lohmann Therapie-Systeme, owns a pair of patents covering rivastigmine transdermal patches. These patches are useful for treating Alzheimer’s disease. Noven Pharmaceuticals filed an abbreviated new...more

Markush Madness: Watson Avoids Infringement by Adding an Element to a Formulation

by K&L Gates LLP on

On February 1, 2017, in Shire Development, LLC v. Watson Pharmaceuticals, Inc., the U.S. Court of Appeals for the Federal Circuit held that Watson’s proposed generic version of Shire’s LIALDA® did not infringe claims 1 and 3...more

Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule. The proposed rule would give...more

February 2017: Life Sciences Litigation Update

Recently Amended FDA Rules Can Affect Settlements in Pharmaceutical Litigations. After more than thirteen years of bureaucratic analysis and rulemaking, the U.S. Food and Drug Administration recently implemented its new rules...more

The Federal Circuit Found Direct Infringement Attributable to Physicians Where “No Single Actor Performs All Steps of a Claim"

by Miles & Stockbridge P.C. on

Can a patient’s action in taking a generic drug be attributable to a physician such that it can support a finding of the physician’s direct patent infringement? According to a recent precedential opinion of the Court of...more

Federal Trade Commission Deploys Antitrust Weaponry Against Pharmaceutical Company

by Shipman & Goodwin LLP on

In Federal Trade Commission v. Shire ViroPharma Inc. (D. Del. Feb. 7, 2017), the FTC has, for the first time, deployed its antitrust weaponry against a pharmaceutical company’s alleged practice of using the FDA’s...more

TrumpCare: The Pharmaceutical Industry and FDA

Hope in the Midst of Uncertainty - The New Year ushered a period of uncertainty for the pharmaceutical industry. We face the beginning of the Trump Administration and a Congress with both houses controlled by Republicans...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

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