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Thursday, September 19, 2019

U.S. SC sides with Teva in case over multiple sclerosis drug patent

By Jessica M. Karmasek | Feb 12, 2015

WASHINGTON (Legal Newsline) - The U.S. Supreme Court, in a decision last month, ruled that a federal appeals court must apply a “clear error,” not a de novo, standard of review when reviewing a district court’s factual finding in support of its patent claim construction.

The nation’s high court, in its 17-page ruling, vacated the U.S. Court of Appeals for the Federal Circuit’s judgment in the case, Teva Pharmaceuticals USA Inc. v. Sandoz Inc.


Justice Stephen Breyer authored the court’s Jan. 20 opinion. Chief Justice John Roberts and justices Antonin Scalia, Anthony Kennedy, Ruth Bader Ginsburg, Sonia Sotomayor and Elena Kagan joined. Justice Clarence Thomas filed a dissenting opinion, in which Justice Samuel Alito joined.


Breyer said “practical considerations” favor clear error review.

“We have previously pointed out that clear error review is ‘particularly’ important where patent law is at issue because patent law is ‘a field where so much depends upon familiarity with specific scientific problems and principles not usually contained in the general storehouse of knowledge and experience,’” he wrote.


“A district court judge who has presided over, and listened to, the entirety of a proceeding has a comparatively greater opportunity to gain that familiarity than an appeals court judge who must read a written transcript or perhaps just those portions to which the parties have referred.”


The case 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 Federal Circuit’s decision invalidating several patents on the company’s multi-billion dollar drug.


The Supreme Court heard arguments in the case in October.


The Federal Circuit’s standard of review of district court claim construction is 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 2014, arguing that the court’s standard of review -- incorrectly -- determined the outcome.


The Supreme Court’s ruling now sends the case back to the Federal Circuit for proper review.


“We are encouraged by the U.S. Supreme Court’s decision and look forward to the Federal Circuit’s review,” said Erez Vigodman, president and CEO of Teva.


Mylan CEO Heather Bresch said she still believes Teva’s patent -- U.S. Patent No. 5,800,808 -- is invalid as indefinite. She said Mylan plans to address the issue with the Federal Circuit.


“Nevertheless, Mylan’s global platform has consistently demonstrated that our success is not about any one product,” Bresch said in a statement. “With that said, we look forward to bringing our generic version of Copaxone to market.”


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

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