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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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