ANDA

News & Analysis as of

ANDA Update - March 2017 Volume 3, Number 1

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

Speculation That FDA May Require a Formulation Change ≠ Infringement

Last month, we reported on the District of Delaware’s decision in Bayer Pharma AG et al. v. Watson Laboratories, Inc., C.A. No. 12-1726-LPS, 2016 WL 7468172 (D. Del. Dec. 28, 2016) which held that speculation of a...more

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

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 Circuit Finds "Consisting Of" Requires Reversing Infringement Of Shire Lialda Patent

The Federal Circuit focused on the “consisting of” language in the claims at issue when it reversed the district court’s finding that Watson’s ANDA product would infringe the only Orange Book-listed Shire Lialda patent. In so...more

Federal Trade Commission Deploys Antitrust Weaponry Against Pharmaceutical Company

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

Moving From Everyday Dosing to Less Frequent Dosing is Obvious

In a consolidated Hatch-Waxman patent infringement action, a district court judge in Delaware recently found claims directed to a treatment for multiple sclerosis invalid as obvious....more

Patent Claims Directed to Treatment for Multiple Sclerosis Invalid as Obvious

In a consolidated Hatch-Waxman patent infringement action, a district court judge in Delaware recently found claims directed to a treatment for multiple sclerosis invalid as obvious....more

Endo Pharms. Inc. v. Amneal Pharms. LLC

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.

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.

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

Federal Circuit Finds Infringement Under Akamai Of Two-Step Method Of Treatment

In Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., the Federal Circuit affirmed the district court decision finding infringement under Akamai of a two-step method of treatment when the prescribing information for the...more

Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC (Fed. Cir. 2017)

The Federal Circuit had the opportunity to provide guidance on a question now in its twilight: what is the standard for determining who is the true inventor under pre-AIA 35 U.S.C. § 102(f), in Cumberland Pharmaceuticals...more

Orexo AB v. Actavis Elizabeth LLC

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

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.

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.

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.

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...

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.

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?

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

398 Results
|
View per page
Page: of 16
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 to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*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.
×