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

Written: Paige L. Cappelli & Nicole R. Townes