Patent for Anti-Nausea Drug Faces High Court Reckoning

WASHINGTON (CN) – A drugmaker that markets anti-nausea medication for chemotherapy patients persuaded the Supreme Court to take up its case Monday.

Helsinn Healthcare brought the underlying suit in New Jersey after Teva Pharmaceuticals brought an abbreviated new drug application for generic palonosetron.

Though Helsinn had four patents for an intravenous formulation of the medication, which is used to reduce chemotherapy-induced nausea and vomiting, Teva told the Food and Drug Administration that the patents were invalid.

A federal judge sided with Helsinn initially, but the Federal Circuit reversed last year, setting the stage for Helsinn to petition the Supreme Court for certiorari.

Per its custom, the U.S. Supreme Court did not issue any comment Monday in taking up the case.

Helsinn is represented by Kannon Shanmugam of Williams & Connolly.

Teva is represented by Steffen Johnson with Winston & Strawn.

Christopher Loh, an attorney with Fitzpatrick, Cella, Harper & Scinto, emphasized that Helsinn’s case underscores “an issue that has increasingly been a source of confusion to both patentees and the courts.”

“The Federal Circuit to date has been reluctant to draw bright lines in applying the AIA on-sale bar, instead preferring to focus on the specific facts of each base,” Loh said in a statement. “As statutory interpretation is the focus of certiorari here, I think it will be difficult for the Supreme Court to avoid crafting a bright-line ruling as to how the bar should apply.”

President Barack Obama signed the AIA, short for the Leahy-Smith America Invents Act, into law in 2011.

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