News & Analysis as of

Federal Circuit Looks for a Different Kind of Unexpected Results in BMS v. Teva

In Bristol-Myers Squibb Co. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed the district court’s finding that BMS’s Baraclude® patent is invalid as obvious. In so doing, the court gave little weight to...more

Court Report - June 2014 #5

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Pharmaceuticals Corp. et al. v. Mylan Inc. et al. 1:14-cv-00777; filed June 19, 2014 in the District Court of...more

Braintree Laboratories, Inc. v. Novel Laboratories, Inc. (Fed. Cir. 2014) - Whither the Meaning of "a" as a Claim Term

Every once in a while a Federal Circuit panel construes a common claim term contrary to how it has been construed in prior precedent, usually based on the particular situation or circumstance the Court is addressing and...more

Purgation Case Still Held Up

Braintree Laboratories, Inc. v. Breckenridge Pharmaceuticals, Inc. Case Number: 1:12-cv-06851-AJN (Dkt. 69) - Judge Nathan approved the parties’ proposal to maintain the case on administrative hold pending...more

Establishing Personal Jurisdiction Over Foreign Corporations in ANDA Cases

In this BNA Insight, attorney Paul Ragusa examines the impact of a recent U.S. Supreme Court decision on litigation involving foreign corporations and abbreviated new drug applications. He says it may become more challenging...more

What Is “a Patient?”

Braintree Labs, Inc. v. Novel Labs, Inc. - On appeal from summary judgment, the U.S. Court of Appeals for the Federal Circuit construed “a patient” to mean “a population of patients,” overturning the district court’s...more

Jumping Into The Actavis Briar Patch — Insight Into How Courts May Structure Reverse Payment Antitrust Proceedings And The...

In This Issue: - INTRODUCTION - WHAT ARE REVERSE PAYMENT SETTLEMENT AGREEMENTS? ..The Basic Framework of Hatch-Waxman Litigation ..The Federal Trade Commission’s View of Reverse Payment Settlements and Its...more

A Combination of References Need Only Provide a “Reasonable Expectation of Success”

Hoffmann La-Roche Inc. v. Apotex Inc. - Addressing the validity of a dosing regimen patent in Abbreviated New Drug Application (ANDA) litigation, the U.S. Court of Appeals for the Federal Circuit affirmed a lower...more

Federal Circuit Vacates Infringement of Braintree SUPREP Patent

In a divided opinion issued in Braintree Labs., Inc. v. Novel Labs., Inc., the Federal Circuit reversed the district court on one of two challenged claim construction issues and vacated the district court’s finding of...more

FTC v. Actavis on Remand: A New Chapter

District Court refuses to grant renewed motion to dismiss based on Noerr-Pennington doctrine. In re AndroGel Antitrust Litigation (No. II), MDL No. 2084 (re Federal Trade Commission v. Actavis, Inc., No. 1:09-CV-955-TWT)...more

Court Report - May 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Otsuka Pharmaceutical Co. v. Aurobindo Pharma Ltd. et al. 1:14-cv-03306; filed May 23, 2014 in the District Court of New...more

When Is a Claimed Drug Formulation Enabled and Adequately Described?

Alcon Research Ltd. v. Barr Labs., Inc. - Addressing the requirements for enablement and written description, the U.S. Court of Appeals for the Federal Circuit reversed a district court’s ruling of patent invalidity,...more

Court Report

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cephalon Inc. v. Uman Pharma Inc. 1:14-cv-00568; filed April 30, 2014 in the District Court of...more

Endo Pharmaceuticals Inc. v. Actavis, Inc. & Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. (Fed. Cir. 2014)

The Federal Circuit's decision in the consolidated appeals of Endo Pharmaceuticals Inc. v. Actavis, Inc. and Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. amply demonstrates the concept that you should be careful...more

GENERICally Speaking - Vol. 4, No. 1

The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the...more

Court Report - Part II: February 03, 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Pharmaceuticals Corp. et al. v. Noven Pharmaceuticals Inc. et al. 1:14-cv-00111; filed January 30, 2014 in the...more

Court Report - February 02, 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Eli Lilly and Company v. Glenmark Generics Inc., USA. 1:14-cv-00104; filed January 23, 2013 in the Southern District of...more

Court Report - December 29, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Pharmaceuticals Inc. et al. v. Alkem Laboratories Limited 1:13-cv-09227; filed December 26, 2013 in the Northern...more

Federal Circuit Invalidates Galderma Differin Patents

In Galderma Laboratories v. Tolmar, Inc., the Federal Circuit reversed the district court’s findings that the Orange Book-listed patents for Galderma’s Differin® 0.3% gel product were not invalid as obvious. In so doing, the...more

Court Report -- November 24, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Shire LLC et al. v. Apotex Corp. et al. 1:13-cv-24236; filed November 21, 2013 in the Southern District of...more

Federal Circuit Finds LUNESTA Patent Infringement Based on ANDA Product Description Not Avoided by Other Certifications

In Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reversed the district’s holding of no Lunesta® patent infringement that was based on a certification submitted to the court, and found...more

Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2013)

Saying "But I won't do it" is not sufficient to avoid infringement in a Hatch-Waxman litigation, according to the Federal Circuit in the recently decided Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. The...more

Pronova Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc. (Fed Cir. 2013)

Last week, the Federal Circuit in a non-precedential opinion, invalidated claims to Orange Book-listed patents on omega-three fatty acid formulations in Pronova Biopharma Norge v. Teva Pharmaceuticals USA. The grounds for...more

Court Report - September 9, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Senju Pharmaceutical Co., Ltd. et al. v. Akorn, Inc. 1:13-cv-06080; filed August 28, 2013 in the Southern District of...more

Court Report -- August 11, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Exela Pharma Sciences, LLC v. EKR Therapeutics, LLC et al. - 5:13-cv-00111; filed August 8, 2013 in the Western...more

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