News & Analysis as of

Generic’s Counterclaims for Non-Infringement are Proper Despite Covenant Not to Sue From Brand

On April 9, 2014, in Purdue Pharmaceutical Products, L.P. v. TWi Pharmaceuticals, Inc., Civ. No. 12-5311 (D.N.J.), Judge Jose L. Linares of the United States District Court for the District of New Jersey ruled that a generic...more

Federal Circuit Find Fractures in Roche Boniva Patents

In Hoffman-LaRoche, Inc. v. Apotex, Inc., the Federal Circuit affirmed the district court’s summary judgment that two Roche Boniva patents are invalid as obvious. The conclusion of obviousness is not particularly remarkable...more

Shire Development, LLC v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2014)

Claim construction in patent cases, and the propensity for the Federal Circuit to disagree with a district court's conclusions regarding the scope and meaning of claim terms, remains one of the most vexing aspects of patent...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

The District of Delaware Stops Exela’s Bid To Market Generic Orimev

In the District of Delaware, Judge Leonard Stark recently issued a final judgment and permanent injunction in Cadence Pharms., Inc. v. Exela Pharma. Scis., LLC, No 11-733, 2013 U.S. Dist. LEXIS 166097 (D. Del. Nov. 14, 2013),...more

AstraZeneca AB v. Hanmi USA, Inc. (Fed. Cir. 2013)

A classic example of product "evergreening" is how AstraZeneca used its experience with its omeprazole franchise (sold for over a decade as Prilosec®) to promote an alternative form of the drug, Nexium® (particularly, the...more

Galderma Laboratories, L.P. v. Tolmar, Inc. (Fed. Cir. 2013)

When does a prior art disclosure of a concentration range of a medicament render obvious the use of a species that falls within that range, when that same use was also known in the prior art? After all, common sense should...more

Recent Federal Circuit decision leaves certain composition claims vulnerable

Last week, in a ruling that could be a boon to generic drug makers, the Federal Circuit invalidated claims covering the 0.3% concentration of Differin® (adapalene) acne gel as obvious. Galderma Labs. v. Tolmar, Inc. (Fed....more

Prove that You Are DIFFERIN Enough!

In the recent case of Galderma Labs v. Tolmar Inc., the Federal Circuit announced an important new rule for evaluating obviousness of selection inventions. The court also gave important guidance as to what constitutes...more

FDA Publishes Draft Guidance on Refuse-to-Receive Standards for ANDA’s in Federal Register for Public Comment

The FDA recently issued draft guidance in the Federal Register setting forth the circumstances in which the FDA will refuse to receive an ANDA. [Guidance for Industry ANDA Submissions] The draft guidance is subject to a...more

Pay-for-delay to Stay FTC’s Top Priority

In a recent interview, Federal Trade Commission (FTC) Bureau of Competition chairwoman Deborah Feinstein announced that targeting pay-for-delay arrangements by pharmaceutical companies would continue as a top priority for the...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

Supreme Court, in FTC v. Actavis, rejects the “scope of the patent” test, holding that antitrust law’s “rule of reason” analysis...

Patent rights and antitrust law contain inherently antagonistic policies: While antitrust law is aimed at preventing monopolies and promoting competition, patent law explicitly rewards inventors with a time-limited right to...more

Court Report -- June 30, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Alpex Pharma S A et al. v. Zydus Pharmaceuticals USA Inc. et al. 1:13-cv-01143; filed June 26, 2013 in the District...more

Mutual Pharmaceutical Co. v. Bartlett (2013)

The old adage "Bad cases make bad law" is invoked when the facts of a case lead a court to rule in favor of the particular entities before it rather than applying the law consistently. (Although anyone familiar with recent...more

News from Abroad: UK Court of Appeal Rules on Interim Injunctions

The Court of Appeal recently issued a decision concerning the issues that should be considered when granting an interim injunction. The proceedings related to Novartis' product zoledronic acid, which was used to treat...more

Supreme Court Subjects Reverse Payment Settlements to Antitrust Review

In a recent opinion with powerful implications for drug manufacturers, the U.S. Supreme Court decided in FTC v. Actavis that reverse payment settlement agreements can violate the antitrust laws despite the antitrust immunity...more

Supreme Court Rules That Pay-For-Delay Settlements Subject To Antitrust Challenges

Antitrust challenges to so-called “pay-for-delay” settlements in drug patent suits are allowed under the U.S. Supreme Court’s recent decision in Federal Trade Commission v. Actavis, Inc....more

Supreme Court Applies Rule of Reason in Antitrust Challenges to Reverse-Payment Patent Settlements

One of the most controversial antitrust issues for the pharmaceutical industry during the last decade has been the treatment of patent settlements in which a patent-holding branded manufacturer made payments to its generic...more

High Court Finds Antitrust Scrutiny Applies to Pay-for-Delay Settlements

On June 17, 2013, the U.S. Supreme Court determined that the Federal Trade Commission’s (FTC) antitrust challenge to a reverse payment settlement agreement between drug manufacturers, otherwise known as a “pay-for-delay”...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

Heenan Blaikie Brings Olanzapine Litigation to Final and Successful Conclusion

On May 16, 2013, the Supreme Court of Canada dismissed the application for leave to appeal in Eli Lilly v. Teva Canada, otherwise known as the “olanzapine” case. This dismissal followed a rare oral hearing of the leave...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

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