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Federal Circuit

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Biogen v. Mylan — Federal Circuit Affirms Invalidity for Lack of Written Description Where Single Dosage Mention Was Insufficient

In a divided decision, the Federal Circuit affirmed that Biogen’s multiple sclerosis drug patent lacked adequate written description because the specification’s single passing reference to a 480 mg/day dose of dimethyl fumarate did not demonstrate the inventors actually possessed that specific thera

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Celgene Corp. v. Mylan Pharmaceuticals — Federal Circuit Clarifies Hatch-Waxman Venue: It’s Where the ANDA Was Submitted, Not Where Drugs Will Be Sold

The Federal Circuit affirmed dismissal of Celgene’s Hatch-Waxman patent suit for improper venue, holding that for ANDA litigation venue purposes, the act of infringement is the submission of the ANDA itself — not the receipt of a notice letter or the state where future generic sales are antici

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University of Strathclyde v. Clear-Vu Lighting LLC — Federal Circuit Reverses IPR Obviousness Finding for Lack of Reasonable Expectation of Success

The Federal Circuit reversed a PTAB obviousness determination, holding that the Board lacked substantial evidence for a reasonable expectation of success because the cited prior art references did not actually achieve the claimed result of inactivating antibiotic-resistant bacteria without photosens

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