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New FDA Draft Guidance on REMS and Bioequivalence Studies: Does New Procedure Secure ANDA Applicants The Right to Obtain Samples?

Applicants seeking approval of Abbreviated New Drug Applications (ANDAs) in most cases must perform bioequivalence studies comparing their proposed generic product to the innovator drug listed in the Orange Book, called the...more

FTC Targets Reporting of Licensing of Pharmaceutical Patents With Special Rules for Premerger Notification: What You Need to Know

On November 15, 2013, the Federal Trade Commission (“FTC”) adopted special rules for determining whether “exclusive” licenses of pharmaceutical patents are required to be reported to the FTC and the Antitrust Division of the...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

No Avoiding BPCIA For Biosimilars: No Patent Declaratory Judgment Action Before Biosimilars Application Is Filed

The United States District Court for the Northern District of California ruled November 12, 2013, that a party seeking to obtain approval of a biosimilar could not avoid the process set forth in the Biologics Price...more

A Short-Lived Victory for Generic Drug Manufacturers?

On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where...more

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