FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Supreme Court Sides With Teva in Dispute Over Aloxi Patent

Jan. 29, 2019

The Supreme Court unanimously sided with Teva Pharmaceuticals in a patent infringement lawsuit filed by Helsinn Healthcare.

In 2011, Teva filed an ANDA for a generic version of Helsinn’s anti-nausea drug Aloxi (palonosetron hydrochloride). Helsinn subsequently filed a patent infringement suit in the U.S. District Court for the District of New Jersey. The court found in Helsinn’s favor the same year.

But the U.S. Court of Appeals for the Federal Circuit overturned the decision in 2017, citing the America Invents Act’s (AIA) “on-sale bar” to patentability. Under the act, when an inventor of a product privately sells an invention to a third party, it qualifies as “prior art,” making the patent invalid. The appeals court noted that in 2001 — two years before its patent application — Helsinn had entered into an agreement to license the product to MGI Pharma.

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