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Reasonable Expectations Test › Patent Litigation › Food and Drug Administration (FDA)

Knobbe Martens

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

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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

Knobbe Martens

Prior Art Regulatory Guidelines That Recite a Goal Without Teaching How That Goal Can Be Achieved Are of Limited Value as an...

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ENDO PHARM, INC., v. ACTAVIS LLC - Before Wallach, Clevenger, and Stoll. Appeal from the United States District Court for the District of Delaware....more

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