The U.S. Supreme Court on Tuesday vacated a lower court's ruling that had ended patent protection for Teva Pharmaceuticals' multiple sclerosis drug Copaxone. The decision could have broader implications for how courts decide future pharmaceutical patent disputes.
The justices decided 7-2 to vacate a lower court's ruling that the Jerusalem-based pharmaceutical company's key patent on the drug was invalid. They ruled that the U.S. Court of Appeals for the Federal Circuit was wrong to evaluate the facts of the case independently rather than rely on the district court's previous finding of the facts.
The justices decided to send the case back to the U.S. Court of Appeals for the Federal Circuit, which handles patent issues, for further review in light of their ruling.
The federal circuit court had ruled against Teva on a technical question having to do with whether Teva had adequately described the molecular weight of an active ingredient in Copaxone known as Copolymer 1 in its drug patents.
More broadly, the justices' decision Tuesday will likely make it more difficult for the U.S. Court of Appeals for the Federal Circuit to overturn district court decisions in certain pharmaceutical patent cases moving forward, said Daryl Wiesen, an attorney for Teva with Goodwin Proctor.
Arti Rai, a professor at Duke University School of Law, also said that the ruling Tuesday might make appeals in certain patent cases less frequent. It might also make trial courts more willing to “engage in time-consuming” analysis when it comes to looking into claim construction, or what specific patents cover and prevent others from doing.
“In the past, because trial courts knew they would be reviewed de novo in any event, they didn't want to do inquiries that were time consuming,” Rai said. Rai co-authored a brief filed in the Teva case arguing for a result similar to the one reached by the Supreme Court. The brief was not in support of either side, however.
“We are encouraged by the U.S. Supreme Court's decision and look forward to the Federal Circuit's review,” Erez Vigodman, Teva president and CEO, said in a statement. “We will continue to explore all available avenues to protect our intellectual property for COPAXONE 20mg/mL.”
In 2013, Teva sold $4.3 billion worth of the drug, according to a company financial statement.
Mylan Inc. CEO Heather Bresch said in a statement Tuesday that, “We continue to believe that the '808 patent is invalid as indefinite and we will address that issue with the Federal Circuit Court of Appeals.” The pharmaceutical company, along with Sandoz, Momenta Pharmaceuticals and Natco Pharma were respondents in the Supreme Court case. The other three either didn't return requests for comment or declined to comment Tuesday.
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