News & Analysis as of

FDA Requests Comments and Issues Notice of Public Hearing Related to Implementation of GDUFA

On August 19, 2014, the U.S. Food and Drug Administration (FDA) issued in the Federal Register a request for comment and notice of public hearing on a variety of topics relating to its implementation of the Generic Drug User...more

Court Report -- Part III

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cubist Pharmaceuticals Inc. v. Fresenius Kabi USA LLC 1:14-cv-00914; filed July 11, 2014 in the District Court of...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

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

A Short-Lived Victory for Generic Manufacturers? – Part 2

In our prior blog post of the same title on July 5, 2013, we predicted that the protection from product liability/failure to warn litigation for generic manufacturers as a result of the Supreme Court decision in Mutual...more

New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers

Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...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

Federal Circuit Finds “Molecular Weight” to Be Insolubly Ambiguous

In Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the Federal Circuit invalidated a number of claims directed to a polymer defined by its “molecular weight” because the term was ambiguous, and Applicants’ conflicting...more

IMS Study Shows Pro-Competitive Effects of Reverse Payment Settlement Agreements in ANDA Litigation

Earlier this month, the Generic Pharmaceutical Association (GPhA) held a press conference to announce the release of a study of the effects of reverse settlement payment agreements in ANDA litigation. ...more

Court Report - Part I

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. UCB Inc. et al. v. Teva Pharmaceuticals USA Inc. et al. 1:13-cv-01148; filed June 28, 2013 in the District Court of...more

Supreme Court: Reverse Payment Settlements Subject to Antitrust Scrutiny

On June 17, 2013, the U.S. Supreme Court handed down a decision that addressed a “reverse payment” settlement agreement between a brand-name pharmaceutical company (plaintiff patent holder) and multiple generic drug companies...more

Court Report -- June 23, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Alza Corp. et al. v. Par Pharmaceutical Inc. et al. 1:13-cv-01104; filed June 19, 2013 in the District Court of...more

Supreme Court Holds Reverse Payment Settlements Are Subject to Rule-of-Reason Scrutiny in Landmark Ruling

In Federal Trade Commission v. Actavis, Inc., the Supreme Court, in a 5-3 decision written by Justice Breyer, reversed the Eleventh Circuit's dismissal of an FTC complaint under Section 5 of the Federal Trade Commission Act...more

Federal Trade Commission v. Actavis, Inc. et al. – Supreme Court Holds Reverse Payment Settlement Agreements to be Analyzed under...

On June 17, 2013, the Supreme Court of the United States ruled 5-3 in favor of the Federal Trade Commission and issued its long-awaited decision in Federal Trade Commission v. Actavis, Inc. et al. 570 U.S. __ (2013), Slip Op....more

“Reverse Payment” Settlements Subject to Greater Antitrust Scrutiny: Implications of Supreme Court FTC v. Actavis Ruling

By rejecting the “scope of the patent” test and holding that reverse payment patent settlements “can sometimes violate the antitrust laws,” the Supreme Court of the United States subjects such settlements to greater antitrust...more

Supreme Court Applies Antitrust Scrutiny to ANDA Reverse Payment Settlement Agreements

In Federal Trade Commission v. Actavis, Inc., the Supreme Court held that reverse payment (“pay-for-delay”) settlement agreements made in the context of settling Hatch-Waxman ANDA litigation should be evaluated for antitrust...more

Drug Company Patent Settlements Subject To Rule Of Reason Antitrust Scrutiny

This week, the Supreme Court announced that “reverse payment” settlements of patent litigation between branded and generic pharmaceutical companies are, when challenged in a subsequent antitrust case, to be judged under the...more

U.S. Supreme Court Rules That “Reverse Payment” Settlements in ANDA Litigation Are Not Presumptively Unlawful But Must Be Assessed...

The Supreme Court ruled 5-3 on June 17, 2013 in favor of the Federal Trade Commission in FTC v. Actavis. Writing for the majority that included Justices Kennedy, Ginsburg, Sotomayor and Kagan, Justice Breyer’s opinion...more

Supreme Court Game-Changer: Rule of Reason Applies to ANDA Reverse Payment Settlements

In Federal Trade Commission v. Actavis, Inc., No. 12-416, 2013 U.S. LEXIS 4545 (U.S. June 17, 2013), the U.S. Supreme Court reversed the Eleventh Circuit decision in FTC v. Watson Pharmaceuticals, Inc., 677 F.3d 1298 (2012),...more

Federal Trade Commission v. Actavis, Inc. (2013)

The Supreme Court ruled 5-3 today in favor of the Federal Trade Commission in FTC v. Actavis, Inc. Writing for the majority that included Justices Kennedy, Ginsburg, Sotomayor and Kagan, Justice Breyer's opinion reversed the...more

Court Report -- May 27, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Fresenius Kabi USA LLC v. Dr. Reddy's Laboratories Ltd. et al. 1:13-cv-00925; filed May 23, 2013 in the District...more

April 2013: Life Sciences Litigation Update: Will the Supreme Court Resolve Circuit Split on Settlement of ANDA Disputes?

On March 25, 2013, the U.S. Supreme Court heard oral argument in Federal Trade Commission v. Actavis, Inc. (Docket No. 12-416). The Actavis case centers around the debate over the type of antitrust analysis that should apply...more

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