Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. et al.


Docket No. 13-854

U.S. Supreme Court (opinion delivered by J. Breyer)
January 20, 2015

Brief Summary: The FC was found to have erred in not accepting the DC’s factual findings regarding the meaning of the term “molecular weight” without finding clear error. However, the opinion also explains that the “ultimate question of construction will remain a legal question” that may still be reviewed de novo.

Summary: This case was previously appealed to the FC (Teva, FC 2013) and the SC granted certiorari on the question of whether the appeals court must find clear error in the factual findings of a DC in order to review de novo. The DC concluded the meaning of the term “molecular weight” in Teva’s claim encompassing a method for producing the multiple sclerosis drug Capaxone (a mizture of copolymers) was not indefinite under § 112, second paragraph. The patent provided three ways to calculate molecular weight and “[i]n Sandoz’s view, since Teva’s patent claim does not say which method of calculation should be used, the claim’s phrase ‘molecular weight’ is indefinite”. The DC “found that in context a skilled artisan would understand that the term…referred to molecular weight as calculated by the first method.” On appeal, the FC disagreed with the DC and found the term indefinite and the patent invalid. Teva’s petition for certiorari was granted. The SC determined that the FC erred in failing to “accept Teva’s expert explanation” (a factual finding) without finding the DC’s determination “clearly erroneous”. It explained “when we held in Markman that the ultimate question of claim construction is for the judge and not the jury, we did not create an exception from the ordinary rule governing appellate review of factual matters” (that all factual determinations, “subsidiary” and “ultimate” facts, “must be reviewed for clear error”). Sandoz argued “that separating ‘factual’ from ‘legal’ questions is often difficult [and] that it is simpler for that appellate court to review the entirety of the district court’s claim construction de novo rather than to apply two separate standards” but the SC was not convinced, noting “[c]ourts of appeals have long found it possible” to do so. However, the opinion emphasized that the “ultimate question of construction will remain a legal question” which may still be reviewed de novo. In failing to accept the DC factual findings regarding the meaning of molecular weight in Teva’s patent, “the Federal Circuit was wrong” and the case was therefore remanded to the FC.

This entry was posted in Claim Construction, Indefiniteness, U.S. Supreme Court. Bookmark the permalink.

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