News & Analysis as of

ANDA Pharmaceutical Industry

The Medicines Company v. Mylan, Inc. (Fed. Cir. 2017)

The Federal Circuit returned to its consideration of the outcome in the District Court of The Medicines Company's ANDA litigation against Mylan and Bioniche Pharma over a proposed generic version of Medicines' bivalirudin...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

ANDA Update - March 2017 Volume 3, Number 1

by McDermott Will & Emery on

Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...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

Shire Development LLC v. Watson Pharmaceuticals Inc. (Fed. Cir. 2017)

The Federal Circuit, in its third opinion involving ANDA litigation between these parties over Shire's LIALDA® (mesalamine) product, has apparently brought this case to a close in generic drug maker Watson's favor, in a...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

Direct Infringement Prong of 35 U.S.C. § 271(b) in a Hatch-Waxman Case May Be Satisfied When the Prescribing Physician Directs or...

by Locke Lord LLP on

On January 12, 2017, the Federal Circuit affirmed the district court’s holding that, under Akamai Technologies, Inc. v. Limelight Networks, Inc., 797 F.3d 1020, 1022 (Fed. Cir. 2015) (en banc), the acts of patients may be...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

Health Update - January 2017

Top Five Healthcare Antitrust Trends to Watch in 2017 - Antitrust enforcement and litigation had a big year in 2016. In this article, we look back at the most significant cases for the healthcare industry over the last...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

Supreme Court Declines to Revisit Broad Personal Jurisdiction Over ANDA Filers

On Monday, January 9, 2017, the U.S. Supreme Court denied, without comment, Mylan Pharmaceuticals’ petition for certiorari to reverse an opinion by the Court of Appeals for the Federal Circuit, which affirmed a broad scope of...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

Closed Case Is Reopened To Amend Induced Infringement Claims In ANDA Litigation Relating To Mitigare

by Morris James LLP on

Robinson, J. Plaintiff’s motion to reopen judgment and amend the complaint is granted. Plaintiff’s request for a preliminary injunction was denied and the denial was affirmed on appeal. On September 10, 2015, Takeda...more

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