News & Analysis as of

Marketing Exclusivity Periods Patent Infringement

McDonnell Boehnen Hulbert & Berghoff LLP

Why Method of Treatment Patents for Repurposed Drugs Are Worth the Investment

Scientists, clinicians, and other investigators are discovering new uses for drugs previously known for different medical indications. Such “drug repurposing” (also called drug repositioning, profiling, or re-tasking) has...more

Smart & Biggar

Health Canada reasonable in finding Natco’s indirect comparison to GENVOYA triggered data protection

Smart & Biggar on

On July 24, 2020, Justice McHaffie of the Federal Court dismissed Natco’s application for judicial review, finding that Health Canada’s refusal to accept Natco’s Abbreviated New Drug Submission (ANDS) for its tenofovir...more

Wilson Sonsini Goodrich & Rosati

Federal Circuit Holds That Claims of a Patent Asserted During a Patent Term Extension Are Not Infringed by the Carboxylic Acid...

Recently, the Federal Circuit issued its holding in a case dealing with asserting claims of an extended patent covering administration of dimethyl fumarate formulations to treat multiple sclerosis (MS). Dimethyl fumarate...more

McDonnell Boehnen Hulbert & Berghoff LLP

Takeda Pharmaceuticals U.S.A., Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)

ANDA litigation, pursuant to the Hatch-Waxman Act, has become more complicated over the years since enactment of the statute in 1984, with more patents being asserted and more parties participating over the opportunity to...more

Foley & Lardner LLP

Biosimilars Can Sit Out Patent Dance, But May Have To Wait Out Second Exclusivity Period

Foley & Lardner LLP on

In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that...more

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