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7 February 2018Americas

Federal Circuit remands Hospira’s on-sale bar question

The US Court of Appeals for the Federal Circuit yesterday affirmed a district court’s findings that Hospira doesn’t infringe two patents owned by biopharma firm The Medicines Company, while remanding an on-sale bar question.

In a precedential ruling, the Federal Circuit remanded the case to determine whether a distribution agreement entered into by The Medicines Company and Integrated Commercialization Solutions (ICS) would render the patents invalid under the on-sale bar.

“A patent is invalid under the on-sale bar if, before the critical date, the product is the subject of a commercial offer for sale, and the invention is ready for patenting,” explained the Federal Circuit.

The Medicines Company had appealed against findings of non-infringement of US patent numbers 7,582,727 and 7,598,343 made by the US District Court of the District of Delaware.

The patents cover a process for manufacturing bivalirudin, a synthetic peptide used as an anti-coagulant. The Medicines Company’s bivalirudin product is marketed under the brand name Angiomax.

Circuit Judge Todd Hughes, on behalf of the court, found that Hospira “clearly does not infringe the patented method”.

Hospira had also cross-appealed against the Delaware court’s finding that a distribution agreement did not constitute an invalidating “offer for sale”.

The Medicines Company had entered into a distribution agreement with ICS in February 2007.

Under the agreement, The Medicines Company passed title to the product to ICS and The Medicines Company was stopped from selling Angiomax to any other party in the US for the three-year duration of the contract.

The Delaware court found that the invention was ready for patenting but was not sold or offered for sale before the critical date of July 27, 2008 (when both patent applications were filed).

It also held that the agreement only allowed ICS to be the US distributor and was not an offer to sell Angiomax.

Hughes said that under the standards established by Medicines Co v Hospira, the terms of the distribution agreement made it clear that the parties were agreeing to sell and purchase Angiomax.

He added that the parties had “entered into an exclusive distribution agreement that provided all of the necessary terms and conditions to constitute a commercial offer for sale”.

According to the Federal Circuit, because the district court had incorrectly concluded that the agreement was not a commercial offer for sale, the court did not reach the question of whether the agreement covered Angiomax which had been created by the new, patented process.

The issue was remanded for the district court to consider this question.

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