News & Analysis as of

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

FTC Workshop to Revisit Competition Issues Regarding Follow-On Biologics

Five years ago, the Federal Trade Commission (FTC) waded into the debate regarding the benefits and potential competition issues posed by the introduction of "follow-on biologics." Now, some three years after Congress...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

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

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

Reverse Payment Settlements Now Subject to Antitrust Scrutiny, But Lower Courts Left to Fill in the Blanks

Earlier this week in FTC v. Actavis, No. 12-416 (U.S. Jun. 17, 2013), the Supreme Court handed down its long-anticipated ruling on “reverse payment” or “pay-for-delay” agreements, holding that these agreements—while not...more

Reverse-Payment Patent Settlements Subject to Antitrust Analysis

The Supreme Court today decided FTC v. Actavis, Inc. and held, in a 5-3 decision authored by Justice Breyer, that so-called reverse-payment patent settlements are subject to full antitrust Rule of Reason analysis....more

Litigation Alert: Supreme Court Rules on “Reverse Payment” Settlements in Federal Trade Commission v. Actavis, Inc.

Today, the U.S. Supreme Court held in Federal Trade Commission v. Actavis, Inc. that so-called “reverse payment” settlement agreements should be analyzed under a rule-of-reason analysis under which the court assesses any...more

Supreme Court Chooses Middle Ground in Assessing Reverse Payment Settlements

The U.S. Supreme Court issued its much-anticipated opinion today in FTC v. Actavis, Inc., ruling that so-called “reverse payment” patent settlements between innovator and generic pharmaceutical manufacturers that are...more

MBHB Snippets: Review of Developments in Intellectual Property Law - Winter 2013 - Volume 11, Issue 1

In This Issue: Federal Courts Debate Safe Harbor Exemption for Patent Infringement Under 35 U.S.C. § 271(e) Following Merck v. Integra; If I Prioritize Examination of My Application, Should the Patent Office?;...more

Cephalon, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)

Whether ANDA litigation has had a positive or negative impact on generic drug availability is an open question, in view of several recent reports looking at the effects such litigation has had on both branded and generic...more

The Continuing Saga of Reverse Payment Patent Litigation

In FTC v. Watson Pharmaceuticals, Inc. (Supreme Court No. 12-416), the FTC unsurprisingly filed a merits brief this month again arguing that pay-for-delay (or “reverse payment”) patent settlements are presumptively...more

Supreme Court Declines Opportunity to Clarify Scope of Hatch-Waxman Safe Harbor

The U.S. Supreme Court on Jan. 14, 2013, denied GlaxoSmithKline’s petition for certiorari seeking review of the Federal Circuit’s interpretation of the Hatch-Waxman safe-harbor provision at 35 USC 271(e)(1) in Classen...more

In re Rosuvastatin Calcium Patent Litigation (Fed. Cir. 2012)

Late last year, in AstraZeneca v. Aurobindo (In re Rosuvastatin Calcium Patent Litigation), the Federal Circuit affirmed that a reissue patent covering the active ingredient of Crestor® was valid, enforceable, and infringed...more

Supreme Court Grants Cert in Watson Pay-For-Delay Case

On December 7, 2012, the Supreme Court granted certiorari in FTC v. Watson Pharmaceuticals. The Supreme Court is now poised to resolve the circuit split on the treatment of so-called “pay for delay” Hatch-Waxman Act patent...more

Supreme Court to Review Reverse Payment Settlement Agreements

The Supreme Court granted certiorari Friday in Federal Trade Commission v. Watson Pharmaceuticals, Inc., one of two cases with certiorari petitions before the Court relating to reverse payment settlement agreements in ANDA...more

Jumping the Line: Generic drug makers aren’t waiting until patents expire

Since passage of the Hatch-Waxman Act in 1984, generic drug companies have used its Abbreviated New Drug Application (ANDA) process to bring cheaper versions of brand-name drugs to market after their patents expire. In the...more

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