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US Seeks Comments on Text for WIPO Genetic Resources Treaty

Summary - Last year the World Intellectual Property Organization (WIPO), under a threat of a vote, accelerated negotiations on an international legal instrument related to intellectual property (IP) and genetic resources...more

Federal Circuit Decision Provides Opening for Preparation Methods in Diagnostic Space, But Not for Diagnostic Claims

The Federal Circuit held that two patents directed to methods of preparing samples for use in diagnostic methods are patent eligible under Section 101, reversing a decision from the District Court for the Northern District of...more

Bases, and Esters, and Salts, Oh My! Limits on PTE Benefits Provide a Drug Applicant with a Winning Non-Infringement Position

Chief Judge Stark granted a defendant’s Rule 12(c) motion for judgment on the pleadings based on non-infringement, holding that plaintiff’s patent term extension (PTE) did not extend to the accused product because the PTE was...more

Federal Circuit Partially Clarifies Obviousness-Type Double Patenting Law in Two Opinions Released the Same Day

The Court of Appeals for the Federal Circuit issued two opinions on December 7 that address two unsettled questions relating to obviousness-type double patenting (OTDP). These issues are of particular interest to...more

FDA Accepts First Biosimilar Application under New Approval Pathway

July 24, 2014 was a landmark day in the biotechnology industry: Sandoz (the generic arm of Novartis) announced that the U.S. Food and Drug Administration (FDA or “the Agency”) had accepted the first application for a U.S....more

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