Teva Pharmaceuticals v. Sandoz: Supreme Court Sides with Teva in Patent Case, Holds That Appeals Court Must Review Factual Findings Underlying Claim Construction for "Clear Error"

The Supreme Court on Tuesday handed down an important decision regarding how patent claims are handled on appeal. The U.S. Court of Appeals for the Federal Circuit hears every patent appeal in the country. Until yesterday, the Federal Circuit gave no weight to a trial judge’s interpretation regardless of whether the district court had heard factual evidence outside of the patent documents themselves.  In legal terms, the Federal Circuit reviewed every issue of claim construction de novo. Since the appeal gave no deference to the lower court, the Federal Circuit had an extraordinary amount of control over one of the fundamental issues affecting patent case outcomes. 
In Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the Court held 7-2 that the Federal Circuit was incorrect in applying this de novo standard in its review of factual findings underlying a claim construction--meaning the specific claims in a patent. The majority opinion, penned by Justice Stephen Breyer, stated that appellate review of factual matters relating to claim construction must not be set aside unless they are “clearly erroneous.”  The construction of the claim itself, after taking into consideration all the facts, remains subject to de novo review at the Federal Circuit.
The facts of the case help to illuminate the issue. 
The basic dispute in Teva v. Sandoz concerns the meaning of the words “average molecular weight” in T...

Source: Policy and Medicine - January 22, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs