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Abbreviated New Drug Submission (ANDS) Today's Popular Updates

Foley & Lardner LLP

Skinny Label Doesn’t Prevent Infringement Liability

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The Federal Circuit decision in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., is getting attention for potentially “endangering” the practice of skinny labelling. Indeed, the Federal Circuit held that Teva’s skinny...more

Harris Beach PLLC

IBSA v. Teva: Indefinite Scope of Key Term in Patent Description Rendered a Thyroid Medication Patent Invalid Under Section 112

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In a recent decision, the Federal Circuit affirmed Delaware District Court’s finding of invalidity based on failure to define the scope of the invention and to meet the written description requirements of 35 USC § 112. IBSA...more

Smart & Biggar

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

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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

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