Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc.

 
DOCKET NO.
OP. BELOW
SUBJECT
Patent

Question(s) Presented

1. “In light of a patent’s presumption of validity under 35 U.S.C. § 282 and the concomitant clear and convincing standard for proving invalidity, may patent claims that cover a class be invalidated as non-enabled under 35 U.S.C. § 112 based on a finding of high unpredictability in the art despite an absence of any evidence of inoperability within the class?”

2. “In concluding that the patent claims that cover a class are invalid as non-enabled under 35 U.S.C. §112 despite an absence of any evidence of inoperability within the class, did the United States Court of Appeals for the Federal Circuit (‘Federal Circuit’) erroneously shift the burden to the patent owner to prove the claims were enabled, and therefore valid, in violation of the presumption of validity under 35 U.S.C. § 282?”

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