News & Analysis as of

Generic Drugs Pharmaceutical Industry

District of Delaware “Clips”- Off Venue-Discovery for Medical Device Company but Allows It for Pharmaceutical Company

by Orrick - IP Landscape on

Boston Sci. Corp. v. Cook Grp., Inc., No. 15-980-LPS-CJB, 2017 U.S. Dist. LEXIS 146126, at *2 (D. Del. Sep. 11, 2017); Bristol-Myers Squibb Co. v. Mylan Pharm., Inc., No. 17-379-LPS, 2017 U.S. Dist. LEXIS 146372, at *3 (D....more

Pharma and Biologic Disputes in Canada – New Regulations Take Effect September 21, 2017

by Bennett Jones LLP on

Pharma and biologics manufacturers will soon have big decisions to make regarding their pharmaceutical and biological product strategy in Canada. On September 6, 2017, the Governor General in Council, on recommendation of the...more

FDA Implements a New “Concept of Operations” for Drug Inspections

The Food and Drug Administration (FDA) has announced implementation of a new “concept of operations” that seeks to improve FDA’s oversight over pharmaceutical manufacturers. The concept of operations complements FDA’s program...more

Pharma advertising in Italy – Online publication of OTC medicinal products list, prices and reimbursability

by Hogan Lovells on

The Court of Milan held in a Judgment recently handed down in the proceedings brought by Bayer S.p.a. against the generic manufacturer DOC Generici S.r.l. that online publication of over-the-counter (OTC) medicinal products...more

Third Circuit Holds No Sham Litigation or Unlawful Reverse Payment in Wellbutrin XL Litigation

The Third Circuit recently affirmed the grant of summary judgment to GlaxoSmithKline (“GSK”) in the nearly 10-year-old Wellbutrin XL Antitrust Litigation, which challenged the lawfulness of settlement agreements resolving...more

Excessive Pricing in Generic Drug Markets

by Ropes & Gray LLP on

EU and UK antitrust laws make it illegal for dominant firms to charge unfair or excessive prices. These laws have most often been applied in markets that feature high barriers to entry or expansion, which enable a dominant...more

Alza Corp. v. Amneal Pharmaceuticals of New York, LLC

by Robins Kaplan LLP on

Case Name: Alza Corp. v. Amneal Pharmaceuticals of New York, LLC, Civ. No. 16-cv-914-RGA, 2017 U.S. Dist. LEXIS 53551 (D. Del. Apr. 7, 2017) (Andrews, J.)....more

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

by Robins Kaplan LLP on

Case Name: Par Pharm., Inc. v. Luitpold Pharms., Inc., 2017 U.S. Dist. LEXIS 62020 (D.N.J. Apr. 24 2017) (Walls, J.)....more

Horizon Pharma Ireland Ltd. v. Actavis Laboratories, UT, Inc.

by Robins Kaplan LLP on

Case Name: Horizon Pharma Ireland Ltd. v. Actavis Laboratories, UT, Inc., No. 14-7992 (NLH/AMD) (D.N.J. May 12, 2017) (Hillman, J.)....more

Teva Pharms. USA, Inc. v. Sandoz Inc.

by Robins Kaplan LLP on

Case Name: Teva Pharms. USA, Inc. v. Sandoz Inc., Civ. No. 17-275(FLW), 2017 U.S. Dist. LEXIS 78002 (D.N.J. May 23, 2017) (Wolfson, J.)....more

GlaxoSmithKline LLC v. Glenmark Pharms. Inc., USA

by Robins Kaplan LLP on

Case Name: GlaxoSmithKline LLC v. Glenmark Pharms. Inc., USA, 2017 U.S. Dist. LEXIS 82534 (D. Del. May 23, 2017) (Burke, M.J.)....more

Sebela Int’l Ltd. v. Actavis Labs. Florida Inc.

by Robins Kaplan LLP on

Case Name: Sebela Int’l Ltd. v. Actavis Labs. Florida Inc., No. 14:6414 (CCC) (MF), 2017 U.S. Dist. LEXIS (D.N.J. June 16, 2017) (Cecchi, J.)....more

The Medicines Co. v. Mylan, Inc.

by Robins Kaplan LLP on

Case Name: The Medicines Co. v. Mylan Inc., Civ. No. 11-cv-1285, 2017 U.S. Dist. LEXIS 99898 (N.D. Ill. June 28, 2017) (St. Eve, J.)....more

Forest Labs., LLC v. Sigmapharm Labs., LLC

by Robins Kaplan LLP on

Case Name: Forest Labs., LLC v. Sigmapharm Labs., LLC, Civ. No. 16-cv-914-RGA, 2017 U.S. Dist. LEXIS 101653 (D. Del. June 30, 2017) (Robinson, J.)....more

The Medicines Co. v. Mylan Inc.

by Robins Kaplan LLP on

Case Name: The Medicines Co. v. Mylan, Inc., No. 2015-1113, -1151, -1181 (Fed. Cir. Apr. 6, 2017) (Circuit Judges Dyk, Wallach, and Hughes presiding; Opinion by Dyk, J.) (appeal from N.D. Ill., St. Eve, J.)....more

Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 855 F.3d 1356, 2017 U.S. App. LEXIS 7650 (Fed. Cir. May 1, 2017) (Circuit Judges Dyk, Mayer, and O’Malley presiding; Opinion by Dyk, J.) (appeal from D.N.J.,...more

Braintree Labs., Inc. v. Breckenridge Pharm., Inc.

by Robins Kaplan LLP on

Case Name: Braintree Labs., Inc. v. Breckenridge Pharm., Inc., No. 2016-1731 (Fed. Cir. May 5, 2017) (Circuit Judges Newman, Moore, and Wallach presiding; Opinion by Moore, J.) (appeal from S.D.N.Y., Nathan, J.)....more

Mylan Institutional LLC v. Aurobindo Pharma Ltd.

by Robins Kaplan LLP on

Case Name: Mylan Institutional LLC v. Aurobindo Pharma Ltd., 2017-1645, 2017 U.S. App. LEXIS 8792 (Fed. Cir. May 19, 2017) (Circuit Judges Lourie, Moore, and Reyna presiding; Opinion by Lourie, J.) (appeal from E.D. Tex.,...more

Capitol Hill Healthcare Update

by BakerHostetler on

Senate Republicans face a key procedural vote this week that would allow for debate of their healthcare legislation, but significant uncertainty remains about whether GOP senators can meet that procedural hurdle, what the...more

Italian time-machine : Limitation of the duration of an SPC may be decided by the Italian Patent Office

by Hogan Lovells on

The Board of Appeal of the Italian Patent Office (Commissione dei Ricorsi), by decision published on June 26, 2017, acknowledged the right of the patent holder to ask the Italian Patent Office for the limitation of the...more

EU excessive pricing laws

by Ropes & Gray LLP on

Ruchit Patel, Ropes & Gray antitrust partner, examines excessive pricing laws in the EU and the increase of cases involving generic pharmaceuticals. ________ EU and UK antitrust laws make it illegal for dominant firms to...more

A Meeting, a MaPP, and Two Lists: Initial Elements of the Commissioner’s Drug Competition Action Plan Rolled Out

FDA has been busy recently in areas tied to drug pricing. In the last half of June, FDA issued a public meeting notice, a revised Manual of Policy and Procedures (MaPP), and two lists of approved drugs for which a generic has...more

FDA Stays in the Spotlight with Drug Pricing Moves, but Could Be Facing Risk as UFA Bill Loses Attention

It appears that – at least for now – the U.S. Food and Drug Administration (FDA) is serving as the public face of the executive branch’s efforts to tackle the increasingly contentious debate about prescription drug prices. As...more

Maryland Is First to Ban “Price Gouging” on Generic Drugs, but Other State and Federal Initiatives May Soon Follow

by Epstein Becker & Green on

Executive Summary - Going back a number of years, federal and state policymakers have discussed various mechanisms to address the increasing costs of certain prescription drugs in the United States. This issue gained...more

FDA Works to Increase Competition Under Commissioner’s Drug Competition Action Plan

by Latham & Watkins LLP on

Agency works to speed approvals and improve access to generic prescription drugs. In recent weeks, the US Food and Drug Administration (FDA or the Agency) has taken a series of steps — under FDA Commissioner Scott...more

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