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Patent Directed to System for Controlling Access to Drugs Is Not Listable in the Orange Book

JAZZ PHARMACEUTICALS, INC. v. AVADEL CNS PHARMACEUTICALS, LLC - Before Lourie, Reyna, and Taranto. Appeal from the United States District Court for the District of Delaware. Summary: A patent directed to a system to reduce...more

Evidence of Actual Physician Practice is Relevant in Determination of Direct Infringement

GENENTECH, INC. V. SANDOZ INC. Before Newman, Lourie, and Prost. Appeal from the United States District Court for the District of Delaware. Summary: The district court did not clearly err in considering evidence of...more

Is Evidence of Generic Industry Skepticism Enough to Preclude a Finding of a Motivation to Combine?

AURIS HEALTH, INC., v. INTUITIVE SURGICAL OPERATIONS, INC., Before Dyk, Prost, and Reyna. Appeal from the Patent Trial and Appeal Board (PTAB). Summary: Evidence of generic industry skepticism cannot, by itself, form...more

Venue in Hatch-Waxman Cases Tied to Acts of ANDA Submission

VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS - Before Newman, O’Malley, and Taranto. Appeal from the District Court of New Jersey - Summary: Venue in Hatch-Waxman cases is proper only in districts where actions...more

Sharing Active Moiety With an FDA-Approved Product Is Not Enough to Be Considered an Approved Product for the Purposes of Patent...

BIOGEN INTERNATIONAL GMBH v. BANNER LIFE SCIENCES LLC - Before Lourie, Moore, and Chen. Appeal from the U.S. District Court for the District of Delaware - Summary: If a claimed product is not the active ingredient of...more

Completion of Phase I Safety Trials for FDA Approval May Not Be Sufficient to Show Reasonable Expectation of Success

OSI PHARMACEUTICALS, LLC v. APOTEX INC - Before Stoll, Newman, and Taranto. Appeal from the Patent Trial and Appeal Board. Summary: A pharmaceutical company’s statement touting the completion of Phase I safety trials...more

Secondary Consideration of Skepticism Supports Non-Obviousness at PTAB

Before Moore, Wallach, and Hughes. Appeal from the Patent Trial and Appeal Board - Summary: Industry skepticism is a question of fact that weighs in favor of non-obviousness and can range on a scale, with the most weight...more

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