U.S. top court rejects Helsinn over anti-nausea drug patent in win for Teva

[January 23, 2019]  By Andrew Chung

WASHINGTON (Reuters) - The U.S. Supreme Court on Tuesday refused to revive Swiss drug company Helsinn Healthcare S.A.'s patent on the lucrative anti-nausea drug Aloxi in a victory for Teva Pharmaceutical Industries, which launched a generic version of it last year.

The nine justices unanimously upheld a lower court ruling that had canceled Helsinn's patent on Aloxi for violating a provision in U.S. patent law that forbids sales of an invention before applying for a patent. Teva began selling its generic version of the drug in March 2018 after convincing the lower court to invalidate the patent.

Aloxi is used to prevent nausea and vomiting in patients receiving chemotherapy. The high court's decision comes after it previously refused Helsinn's request to block the lower court ruling while it considered the company's case, which allowed Israel-based Teva to bring its Aloxi generic to market.

The ruling could make it easier to cancel key patents, especially among smaller drugmakers, widening the patent law provision prohibiting the patenting of an invention if it has been on sale or offered to the public more than a year before the patent application was filed.

The dispute centered on a licensing and purchase agreement that Helsinn, a small, family-owned pharmaceutical company, struck with another pharmaceutical firm in 2001 to distribute the drug in the United States and defray its own costs. The deal had been announced in regulatory filings and a press release.

Teva said the patent was invalid because the deal was reached nearly two years before Helsinn first applied for a patent and constituted a public sale. Helsinn, backed by President Donald Trump's administration, said that the distribution deal did not constitute a sale to the public because its drug formulation was kept secret.

Helsinn sued in 2011 over Teva's plans for a generic version of Aloxi. In 2017, the U.S. Court of Appeals for the Federal Circuit, a Washington-based specialized patent court, agreed with Teva and invalidated the patent, finding that a commercial offer or contract to sell a product makes it available to the public.

Helsinn said the appeals court's decision hindered small companies that often need partners to develop and bring drugs to the market, and would dissuade them developing new medicines.

Before Teva's generic was launched, Aloxi accounted for hundreds of millions of dollars in annual sales for Helsinn, the "overwhelming majority" of its worldwide revenue, according to court filings.

(Reporting by Andrew Chung; Editing by Will Dunham)

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