WASHINGTON (Legal Newsline) - The U.S. Supreme Court must decide whether a district court’s factual finding in support of its patent claim construction may be reviewed de novo or only for clear error.


The nation’s high court heard arguments in the case, Teva Pharmaceuticals USA Inc. v. Sandoz Inc., Wednesday.


According to some reports, the justices appeared divided over the case, which pits Teva against generic drug makers. Teva sued over patent protections for its multiple sclerosis drug Copaxone.


In March, the Supreme Court granted a writ of certiorari to hear Teva’s appeal of the U.S. Court of Appeals for the Federal Circuit’s decision invalidating several patents on the company’s multi-billion dollar drug.


Now, the court is tasked with addressing the Federal Circuit’s standard of review of district court claim construction -- a critical issue in almost every patent case. The Federal Circuit, which hears all U.S. patent appeals, requires de novo review, while Federal Rule of Civil Procedure 52(a) requires review only for clear error.


In its July 2013 ruling, the Federal Circuit invalidated several patents asserted against Sandoz, Momenta Pharmaceuticals Inc., Mylan Pharmaceuticals Inc. and Natco Pharma Ltd. by Teva.


The case involved a total of nine patents asserted by Teva for patent infringement associated with submission to the Food and Drug Administration of an Abbreviated New Drug Application, or ANDA, for generic Copaxone.


The asserted patents included seven FDA Orange Book patents and one non-Orange Book patent expiring in May 2014, and one non-Orange Book patent expiring in September 2015.


The publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book, identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food Drug and Cosmetic Act.


In 2012, the U.S. District Court for the Southern District of New York found all nine patents valid and infringed, and issued injunctions enjoining the FDA from approving any ANDA for generic Copaxone and enjoining the defendants in the case from making, using, offering for sale or selling a generic version of the drug until September 2015, the date of the latest expiring asserted patent.


The Federal Circuit’s opinion vacated the district court’s finding and injunctions, clearing the way for the FDA to grant final approval of a Copaxone ANDA and for potential commercialization of an approved generic of the drug.


Teva appealed the appellate court’s decision in January, arguing that the court’s standard of review -- incorrectly -- determined the outcome.


“This case therefore gives the Court an ideal opportunity to correct an important and fundamental error,” Teva wrote in its petition to the Supreme Court. “The divisions within the Federal Circuit on this issue are deep and basic, stemming from disagreement over how to read this Court’s decisions.


“While the Federal Circuit has tried to resolve it several times, and has another case before it presenting the question, a definitive answer -- which the patent system urgently needs -- can come only from this Court.”


From Legal Newsline: Reach Jessica Karmasek by email at patents@legalnewsline.com.

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