News & Analysis as of

ANDA Pharmaceutical Industry Generic Drugs

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

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

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

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

Roxane Labs., Inc. v. Vanda Pharms., Inc.

by Robins Kaplan LLP on

Case Name: Roxane Labs., Inc. v. Vanda Pharms., Inc., No. 16-0179, 2016 U.S. Dist. LEXIS 175785 (S.D. Ohio Dec. 20, 2016) (Marbley, J.). Drug Product and Patent(s)-in-Suit: Fanapt® (iloperidone); U.S. Patents Nos....more

Bayer Pharma AG v. Watson Labs., Inc.

by Robins Kaplan LLP on

Case Name: Bayer Pharma AG v. Watson Labs., Inc., 12-1726-LPS, 2016 U.S. Dist. LEXIS 179103 (D. Del. Dec. 28, 2016) (Stark, J.). Drug Product and Patent(s)-in-Suit: Natazia® (estradiol valerate/estradiol...more

Endo Pharms. Inc. v. Actavis Labs. UT, Inc.

by Robins Kaplan LLP on

Case Name: Endo Pharms. Inc. v. Actavis Labs. UT, Inc., 2016-1146, 2016 U.S. App. LEXIS 18490 (Fed. Cir. Oct. 14, 2016) (Circuit Judges Moore, Taranto, and Hughes presiding; Opinion by Taranto, J.) (Appeal from E.D. Tex.,...more

How Will Trump Change The FDA?

by Foley & Lardner LLP on

President-elect Trump’s plans for his first 100 days in office include “cutting the red tape at the FDA” and “speed[ing] the approval of life-saving medications.” Here, we consider specific steps Trump could take–without or...more

Copying as Objective Evidence of Non-Obviousness in ANDA Cases Is Alive and Well

Originally published in BNA’s Pharmaceutical Law & Industry Report Journal, 15 PLIR 73 - January 13th, 2017. In recent years, certain court decisions have suggested that copying is not a significant secondary...more

Speculation of ANDA Product Launch Before FDA Approval Does Not Warrant Permanent Injunction

by Locke Lord LLP on

On December 28, 2016, Judge Stark of the District of Delaware, despite having previously found infringement, held that plaintiffs Bayer Pharma AG, Bayer Intellectual Property GmbH, and Bayer HealthCare Pharmaceuticals Inc....more

Federal District Court finds brand-name manufacturer’s alleged regulatory delay tactics a valid theory of attempted monopolization

In a recent decision denying the defendant’s motion to dismiss, Judge Mitchell Goldberg of the Eastern District of Pennsylvania allowed the manufacturer of a generic version of Suboxone to proceed upon an interesting theory...more

Protecting Against Big Pharma's Tactics for Delaying Market Entry of Generics

by Tarter Krinsky & Drogin LLP on

Branded companies make millions of dollars each day that a generic version of a drug is held from the market. Therefore, the branded companies are highly motivated to obstruct the path of generic pharma companies. For some...more

Judgment For Plaintiffs After Cyclobenzaprine ANDA Trial

by Morris James LLP on

Robinson, J. The court enters judgment against defendants following 2-day bench trial. Trial took place on November 16 and 17, 2015. The disputed product relates to cyclobenzaprine formulations with extend release...more

FDA Is Evolving on Qualifications for 'New Chemical Entity'

by Pepper Hamilton LLP on

The prior approval of a drug containing an active ingredient of the innovator drug is not necessarily a death knell for NCE exclusivity. Originally published in the Intellectual Property and Life Sciences sections of...more

Forest Labs. Holdings Ltd. v. Mylan Inc.

by Robins Kaplan LLP on

Case Name: Forest Labs. Holdings Ltd. v. Mylan Inc., No. 13–1602–SLR (Consolidated), 2016 U.S. Dist. LEXIS 89268 (D. Del. July 11, 2016) (Robinson, J.) - Drug Product and Patent(s)-in-Suit: Savella® (milnacipran...more

GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Civ. No. 14-878-LPS-CJB, 2016 U.S. Dist. LEXIS 94438 (D. Del. July 20, 2016) (Burke, M.J.) - Drug Product and Patent(s)-in-Suit: Coreg® (carvedilol); U.S....more

Tyco Healthcare Group LP v. Mutual Pharm. Co., Inc.

by Robins Kaplan LLP on

Case Name: Tyco Healthcare Group LP v. Mutual Pharm. Co., Inc., Civ. No. 07-cv-1299 (SRC)(CLW), 2016 U.S. Dist. LEXIS 95789 (D.N.J. July 22, 2016) (Chesler, J.) - Drug Product and Patent(s)-in-Suit: Restoril®...more

Torrent Pharmaceuticals Ltd. et al v. Daiichi Sankyo Co., Ltd., et al

by Robins Kaplan LLP on

Case Name: Torrent Pharmaceuticals Ltd. et al v. Daiichi Sankyo Co., Ltd., et al, Civ. No. 16-C-2988, 2016 U.S. Dist. LEXIS 96448 (N.D. Ill. July 25, 2016) (Pallmeyer, J.) - Drug Product and Patent(s)-in-Suit: Benicar®...more

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