Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.


Question(s) Presented

“Section 103 of title 35 of the U.S. Code provides that an invention is not patentable if it ‘would have been obvious’ to a person of ordinary skill in the relevant art. In KSR International Co. v. Teleflex, Inc., this Court explained that a ‘combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.’ 550 U.S. 398, 416 (2007).”

“The Federal Circuit, based on its own longstanding rule, holds that a combination of known elements is obvious where an ordinarily skilled artisan would have a ‘reasonable expectation of success’ in reaching the resulting invention. Applying that rule here, the Federal Circuit concluded that the mere existence of a clinical trial and long-existing general FDA guidance would contribute to a skilled artisan’s reasonable expectation of success, rendering the results of the ensuing experimentation unpatentable, no matter how innovative or unpredictable the results.”

“The question presented is:”

“Whether obviousness requires a showing of ‘predictable’ results, as this Court held in KSR, or a mere ‘reasonable expectation of success,’ as the Federal Circuit has held both before and after KSR?”

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