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Generic Drugs › Food and Drug Administration (FDA) › Corporate Counsel

Wilson Sonsini Goodrich & Rosati

Federal Court Challenges FTC’s Litigation Authority in FTC v Shire ViroPharma

Wilson Sonsini Goodrich & Rosati on

In a novel interpretation of the Federal Trade Commission (FTC) Act, the U.S. District Court for the District of Delaware recently held in FTC v. Shire ViroPharma that the FTC had failed to plead the facts necessary to invoke...more

Patterson Belknap Webb & Tyler LLP

Second Circuit Declares That, to Survive Motions to Dismiss, Antitrust Allegations Require Factual Support for All “Necessary...

Patterson Belknap Webb & Tyler LLP on

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

Patterson Belknap Webb & Tyler LLP

Federal District Court finds brand-name manufacturer’s alleged regulatory delay tactics a valid theory of attempted monopolization

Patterson Belknap Webb & Tyler LLP on

In a recent decision denying the defendant’s motion to dismiss, Judge Mitchell Goldberg of the Eastern District of Pennsylvania allowed the manufacturer of a generic version of Suboxone to proceed upon an interesting theory...more

Pierce Atwood LLP

In a Groundbreaking Decision, Third Circuit Provides Framework for Evaluating Numerosity

Pierce Atwood LLP on

One of the least disputed elements of class certification is Rule 23(a)(1) numerosity, and so there is relatively little analysis from the courts about it. Last month, however, a divided panel of the Third Circuit provided a...more

BakerHostetler

Court Decides that ANDA Approved Before Patent Issued Cannot Infringe 35 U.S.C. § 271(e)(2)(A)

BakerHostetler on

Although the Hatch-Waxman Act was passed by Congress decades ago, it still produces new questions. Despite vigorous argument by the patent owner, a district court dismissed a count alleging that the ANDA-filer infringed under...more

Saul Ewing LLP

New Jersey Rulings Allay Personal Jurisdiction Concerns Raised by Daimler and Goodyear

Saul Ewing LLP on

Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more

Robins Kaplan LLP

Patent Litigation and Generic Drug Companies: How to Avoid Becoming an “Exceptional Case”

Robins Kaplan LLP on

2013 brought generic drug companies increased financial and legal hurdles when it came to marketing their products in the U.S. First, substantial new GDUFA “user fees” got levied on generics for access to the FDA. Then, the...more

McDermott Will & Emery

Contractual Duty to Deal Does Not Equal Antitrust Duty to Deal

McDermott Will & Emery on

Addressing for the first time whether a patent holder under a contractual duty to deal is also subject to an antitrust duty to deal, the U. S. Court of Appeals for the Second Circuit upheld dismissal of a putative antitrust...more

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