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Obviousness Clinical Trials FDA Approval

Fish & Richardson

Can Clinical Trials Negate Patentability for Pharma Inventions?

Fish & Richardson on

The answer to this inquiry is “yes” — but maybe “no.” Will confidentiality agreements shield any prior art concerns? Once again, maybe “yes” — but maybe “no.” Indeed, do clinical trials constitute an experimental use that...more

Knobbe Martens

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

Knobbe Martens on

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

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