Supreme Court Grants Cert. in Teva v. Sandoz Patent Case

By Gabriella Khorasanee, JD on April 02, 2014 | Last updated on March 21, 2019

The third time is the charm. After being distributed for three judicial conferences, the Supreme Court granted Teva Pharmaceutical's petition for writ of certiorari on Monday.

The Stakes Are High

The Teva case is a patent dispute surrounding the multiple-sclerosis drug Copaxone. Teva Pharmaceuticals holds the patents for Copaxone, and a decision in its favor would keep the patents alive until September 2015. Generic manufacturers want to release their generic drug in May -- which technically they could, under the Federal Circuit's decision. Annual U.S. sales of Copaxone make up more than half of Teva's profit, and reach over $3 billion annually, so there is much at stake for both Teva, and generic manufacturers, reports Blooomberg.

The Correct Standard of Review

The district court found that all of the claimed patents were infringed, but the Federal Circuit disagreed. It affirmed in part, and reversed in part with the end effect being the upholding of four patents due to expire this May, and the invalidation of a patent "that would have blocked generic competition until September 2015," reports Bloomberg .

Teva petitioned for writ of certiorari to clarify the correct standard of review. While most federal appeals courts must review a trial court's conclusions to see if they are "clearly erroneous," the Federal Circuit has had a practice of reviewing an inventor's claims using de novo review , reports SCOTUSblog.

The Effect of Delay

The Supreme Court is no longer adding cases to the docket for this term, so this case will be decided in the October 2014 term. Under the Federal Circuit's ruling generic manufacturers could start selling generics this May -- but if the Court finds in favor of Teva, they will be liable for lost revenues -- something they will probably not want to risk. Though Teva in some ways wins by default because of the delay that Supreme Court review will bring, this case will be closely watched as it will affect many patent cases to come.

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