Stanley Chesler
Stanley Chesler (Carmen Natale)

A New Jersey federal judge on Tuesday blocked Emcure Pharmaceuticals and Teva Pharmaceuticals from proceeding with generic versions of Sunovion Pharmaceuticals’ bipolar disorder drug Latuda after the parties agreed to enter a final judgment that allows the defendants to appeal a key claims construction ruling.

The permanent injunction bars Emcure and Teva from bringing their generics to market until Jan. 2, 2019, when Sunovion’s patent is set to expire. However, the parties are free to appeal to the U.S. Court of Appeals for the Federal Circuit a Nov. 15 ruling on how a claim in the patent was constructed.

In the Markman ruling, U.S. District Judge Stanley R. Chesler of the District of New Jersey sided with Sunovion’s interpretation of the disputed claim, leading the parties to agree—under the holding—that generic drug applications Emcure and Teva had filed with the U.S. Food and Drug Administration infringed a Sunovion patent for Latuda.

Should the appeals court reverse the claims construction ruling, the case would be sent back to the district court, where Chesler could reconsider the injunction.

Emcure and Teva have agreed not to challenge the validity of Sunovion’s patent.

According to Sunovion’s January 2015 complaint, Emcure and Teva filed abbreviated new drug applications with the FDA, seeking to make and sell generic lurasidone hydrochloride in dosages of 20, 40, 60, 80 and 120 miligrams to treat schizophrenia and depressive episodes associated with Bipolar I Disorder, or bipolar depression.

Sunovion’s parent company, Sumitomo Dainippon Pharma Co., obtained its patent for Latuda in 1996. A top-selling antipsychotic drug, it can be used alone, or combined with lithium or valproate.

Both sides had tussled over a chemical formula disclosed in Claim 14 of the so-called ’372 patent. But Chesler sided with Sunovion, rejecting the defendants’ argument that tried to distinguish between what the formula “depicts and what it represents.”

The position, Chesler said, was not rooted in Federal Circuit case law and had no basis in the Federal Circuit’s law-of-claim construction.

“Defendants propose a construction which lacks a foundation in the intrinsic evidence as well as in patent law, and conflicts with the intrinsic evidence, while Plaintiffs propose a construction grounded in the intrinsic evidence and supported by patent law,” he wrote.

Teva said it was looking forward to appealing the rulings.

Attorneys for Sunovion declined to comment on the case. The company is represented by Charles M. Lizza and William C. Baton of Saul Ewing, and Joseph M. O’Malley Jr. and Preston K. Ratliff II of Paul Hastings.

Emcure is represented by David C. Kistler, Gary J. Ruckelshaus and Stephen L. Orlofsky of Blank Rome. Teva is represented by Michael E. Patunas of Patunas Law.

The attorneys were not available Thursday to comment.

The case is captioned Sumitomo Dainippon Pharma v. Teva Pharmaceuticals.

A New Jersey federal judge on Tuesday blocked Emcure Pharmaceuticals and Teva Pharmaceuticals from proceeding with generic versions of Sunovion Pharmaceuticals’ bipolar disorder drug Latuda after the parties agreed to enter a final judgment that allows the defendants to appeal a key claims construction ruling.

The permanent injunction bars Emcure and Teva from bringing their generics to market until Jan. 2, 2019, when Sunovion’s patent is set to expire. However, the parties are free to appeal to the U.S. Court of Appeals for the Federal Circuit a Nov. 15 ruling on how a claim in the patent was constructed.

In the Markman ruling, U.S. District Judge Stanley R. Chesler of the District of New Jersey sided with Sunovion’s interpretation of the disputed claim, leading the parties to agree—under the holding—that generic drug applications Emcure and Teva had filed with the U.S. Food and Drug Administration infringed a Sunovion patent for Latuda.

Should the appeals court reverse the claims construction ruling, the case would be sent back to the district court, where Chesler could reconsider the injunction.

Emcure and Teva have agreed not to challenge the validity of Sunovion’s patent.

According to Sunovion’s January 2015 complaint, Emcure and Teva filed abbreviated new drug applications with the FDA, seeking to make and sell generic lurasidone hydrochloride in dosages of 20, 40, 60, 80 and 120 miligrams to treat schizophrenia and depressive episodes associated with Bipolar I Disorder, or bipolar depression.

Sunovion’s parent company, Sumitomo Dainippon Pharma Co., obtained its patent for Latuda in 1996. A top-selling antipsychotic drug, it can be used alone, or combined with lithium or valproate.

Both sides had tussled over a chemical formula disclosed in Claim 14 of the so-called ’372 patent. But Chesler sided with Sunovion, rejecting the defendants’ argument that tried to distinguish between what the formula “depicts and what it represents.”

The position, Chesler said, was not rooted in Federal Circuit case law and had no basis in the Federal Circuit’s law-of-claim construction.

“Defendants propose a construction which lacks a foundation in the intrinsic evidence as well as in patent law, and conflicts with the intrinsic evidence, while Plaintiffs propose a construction grounded in the intrinsic evidence and supported by patent law,” he wrote.

Teva said it was looking forward to appealing the rulings.

Attorneys for Sunovion declined to comment on the case. The company is represented by Charles M. Lizza and William C. Baton of Saul Ewing , and Joseph M. O’Malley Jr. and Preston K. Ratliff II of Paul Hastings .

Emcure is represented by David C. Kistler, Gary J. Ruckelshaus and Stephen L. Orlofsky of Blank Rome . Teva is represented by Michael E. Patunas of Patunas Law.

The attorneys were not available Thursday to comment.

The case is captioned Sumitomo Dainippon Pharma v. Teva Pharmaceuticals.