Limitations in Claim Language Frame Reasonable Expectation of Success Analysis

TEVA PHARMACEUTICALS USA, INC., v. CORCEPT THERAPEUTICS, INC.

Before Moore, Newman, and Reyna. Appeal from the Patent Trial and Appeal Board.

Summary: Limitations, such as specific drug doses, in claim language can impact the application of the reasonable expectation of success analysis for obviousness.

Teva sought a post-grant review of the claims of Corcept’s patent. The claims were generally directed to a method of treating Cushing’s syndrome that involved a co-administration of drugs. Teva argued that the claims were obvious. The prior art materials disclosed information related to drug-drug interaction. The PTAB found that Teva failed to show that the claims would have been obvious because Teva failed to show that a skilled artisan would have had a reasonable expectation of success for safe co-administration of the drugs. Teva appealed and argued that the PTAB misapplied the law relating to obviousness. Teva argued that the PTAB required precise predictability, rather than a reasonable expectation of success.

The Federal Circuit affirmed the PTAB’s decision. The Federal Circuit stated that “[t]he reasonable expectation of success analysis must be tied to the scope of the claimed invention.” In the present case, the claim was construed to require safe administration of a specific amount of mifepristone, and thus, the PTAB was required to frame its reasonable-expectation-of-success analysis around that specific dosage. The Federal Circuit found that Teva had failed to prove that a skilled artisan would have expected co-administration of the claimed dosage of mifepristone with a strong inhibitor to be safe and that the PTAB did not require precise predictability.

Editor: Paul Stewart