News & Analysis as of

ANDA Pharmaceutical Industry

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

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

FDA Reauthorization Act Aims to Speed Product Reviews Through User Fee Funding

by Latham & Watkins LLP on

Congress passes sweeping user fee reauthorization bill to fund increased FDA staffing and support commitments to product review timelines. Key Points: ..Congress authorized FDA to collect increased total annual user...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., 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

Federal Circuit Finds Velcade Patent Not Obvious Under Lead Compound Analysis

by Foley & Lardner LLP on

In Millennium Pharmaceuticals, Inc. v. Sandoz, the Federal Circuit reversed the district court decision that invalidated one of the Orange Book-listed patents covering the anti-cancer drug Velcade. In so doing, the court...more

Millennium Pharmaceuticals, Inc. v. Sandoz Inc. (Fed. Cir. 2017)

In multiple ANDA litigations against multiple defendants, Millennium Pharmaceuticals, Inc. had several of its asserted claims held invalid for obviousness at the district court. The Federal Circuit reversed these decisions...more

New Jersey Court Rules That a Parent Company Is Still on the Hook for Divested Subsidiary’s ANDA Filing

by McDermott Will & Emery on

Addressing a motion to dismiss for lack of subject matter jurisdiction, a New Jersey district court held that Merck could maintain a Hatch-Waxman lawsuit against Actavis, Inc. n/k/a Allergan Finance LLC (Actavis), despite...more

Supply and Purchase Agreement Triggers On-Sale Bar Provision of 35 USC § 102(b)

by McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit reversed the district court and found that a Supply and Purchase Agreement between Helsinn and third-party MGI Pharma, Inc. (MGI) before the critical date of the asserted...more

Second Circuit Allows Class Action Suit Involving Diabetes Drug to Proceed

by McDermott Will & Emery on

Purchasers of Takeda Pharmaceuticals Company’s branded diabetes drug, ACTOS, filed an antitrust suit alleging that Takeda falsely described two patents to the US Food and Drug Association (FDA) and, as a result, delayed...more

The Effects of the Actavis Decision on Reverse Payment Settlement Agreements in ANDA cases -- Four Years After

In 2013, the U.S. Supreme Court rendered its decision in FTC v. Actavis, finding that although so-called reverse payment settlement agreements were not per se antitrust violations in cases brought against generic drug makers...more

Deuterated Drugs Are New Chemical Entities

by Pepper Hamilton LLP on

FDA recently awarded new chemical entity (NCE) exclusivity to Austedo™ (deutetrabenazine). The Austedo approval is notable for two reasons: One, it is the first deuterated drug (i.e., a drug containing the stable isotope —...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

FDA Report: Agency Announces Expedited Review of Certain ANDAs

On June 27, 2017, the U.S. Food and Drug Administration issued a press release stating how it would begin implementing its plan to increase competition for prescription drugs. This comes on the heels of FDA Commissioner...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

Chief Judge Stark Denies Defendants’ Motion For Reargument Of Court’s Order Holding Defendants Liable For Costs Of ANDA Litigation...

by Fox Rothschild LLP on

By Memorandum Order entered by The Honorable Leonard P. Stark in UCB, Inc., et al. v. Watson Laboratories, Inc. et al., Civil Action No. 14-1083-LPS-SRF (D.Del., May 19, 2017), the Court denied Defendants’ motion for...more

To certify or not to certify? FDA has answered the question

by Hogan Lovells on

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674...more

AIA On-Sale Bar Applies to Publicized Sales, Even When Knowledge of Sale Did Not Disclose the Underlying Invention

by Pepper Hamilton LLP on

The Court of Appeals for the Federal Circuit (CAFC) recently construed the on-sale bar provision of 35 U.S.C. 102(a) in a way that will make it easier for petitioners to challenge third party patents. While in an inter-partes...more

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

314 Results
|
View per page
Page: of 13
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.