Teva Wins Patent Case Related to Orexo Opioid-Treatment Drug

A U.S. jury on Friday rejected a claim by Sweden’s Orexo AB that two generic opioid-addiction treatments created by Teva Pharmaceutical Industries Ltd. infringed a patent for Orexo’s biggest drug, Zubsolv.

A Teva unit had created copies of the drugs Suboxone and Subutex, which are made by a third company, Indivior Plc, which wasn’t party to the lawsuit. Orexo had argued that the Teva products used the same essential formula as that covered by the patent for Zubsolv. After a trial in Wilmington, Delaware, federal court jurors disagreed.

Orexo shares fell as much as 20 percent in Stockholm, before ending the day down 9.3 percent. In its lawsuit, the company had sought $41 million in royalties from sales of the competing generic drugs. A spokesman said the verdict will have no impact on Zubsolv, and that its patent remains in effect.

The market for drugs that treat opioid abuse totaled almost $2.8 billion in the 12 months ended June 2018, based on Symphony Health data reported by Bloomberg Intelligence. Overall sales for the class have flattened but are expected to accelerate due to an increase in opioid-related deaths.

The epidemic shows few signs of abating. Annual opioid overdose deaths in the U.S. are expected to climb to 81,700 in 2025, a 147 percent increase from 2015, according to a study last month by the Massachusetts General Hospital Institute of Technology Assessment. States, counties and cities are suing drugmakers and distributors to recover billions in human and financial costs.

“I’m very disappointed and surprised by the court’s decision,” Orexo Chief Executive Officer Nikolaj Sørensen said in an interview. “I found we had a strong case.” Orexo, a small company in a sector dominated by giants, is considering an appeal, Sørensen said.

Earlier Ruling

The jury never got to hear that in November 2016, Judge Sue Robinson, now retired, had found the Orexo patent was valid and that it had been infringed by Teva’s generic version of Zubsolv. At trial, Judge Colm Connolly excluded that case from the evidence, which was “a major obstacle” that made Orexo’s case “much more difficult,” Sørensen said.

Kelley Dougherty, a Teva spokeswoman, said the company “is pleased by today’s ruling,” and “we look forward to continuing to provide these important medicines to patients suffering from opioid addiction.”

During the trial, Sørensen testified that sales of Zubsolv would have been “much better” when it was first marketed in September 2013 if there wasn’t already a generic version of Suboxone. Zubsolv “is no doubt a better product” than generic Suboxone because the tablets dissolve faster and have fewer ingredients, Sorensen said. But the therapeutic effects are similar, so “in the eyes of the pharmacist,” the two drugs are “interchangeable,” he said.

Zubsolv “is the future” of Orexo, Sorensen said. “For a lot of people, this is Orexo.”

‘Overreaching’ Claims

Teva’s lawyer, George Lombardi, said during closing arguments that Orexo was “overreaching” with its lawsuit claims against the Teva unit, Actavis Elizabeth LLC. “It’s not Actavis’s fault that Mr. Sørensen doesn’t like generic competition,” Lombardi said.

During his rebuttal, Errol Taylor, a lawyer for Orexo, said, “They’ve been infringing the patent since 2013, when it was issued, to today. They’ve made hundreds of millions of dollars infringing that patent.”

The patent expires Sept. 24, according to the U.S. Food and Drug Administration’s official registry of patents for approved drugs, known as the Orange Book.

Zubsolv also competes with Alkermes Plc’s Vivitrol. Dr. Reddy’s Laboratories Ltd., after a two-year legal battle, recently won the right to sell a cheaper version of Suboxone Film, the best-selling opioid-addiction drug in the U.S.

The case is Orexo AB v. Actavis Elizabeth LLC, 17-cv-205, U.S. District Court, Delaware (Wilmington).