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26 June 2018Americas

SCOTUS agrees to hear on-sale bar battle

The US Supreme Court has agreed to hear a dispute over whether confidential sales of an invention can trigger the on-sale bar and invalidate a patent under the America Invents Act (AIA).

Yesterday, June 25, the Supreme Court granted a petition of certiorari from Switzerland-based pharmaceutical company Helsinn Healthcare in a patent case against Teva Pharmaceuticals.

Helsinn had filed the petition in February this year after the US Court of Appeals for the Federal Circuit ruled that certain patents covering Helsinn’s Aloxi (palonosetron hydrochloride) injection are invalid.

The Federal Circuit also held that Teva didn’t infringe the four patents—US numbers 7,947,724; 7,947,725; 7,960,424 and 8,598,219, which are all directed to reducing the likelihood of chemotherapy-induced nausea and vomiting.

According to the Federal Circuit, the asserted claims of the patents “were subject to an invalidating contract for sale prior to the critical date of January 30, 2002, and the AIA did not change the statutory meaning of ‘on-sale’ in the circumstances involved here”.

The “on-sale bar” refers to when a patent can be rendered invalid if the invention was on sale more than one year before the date of the patent application.

In its petition, Helsinn argued that the AIA has narrowed the on-sale bar to sales that are “publicly available” and that it should cover Helsinn’s confidential agreement with a licensee for the treatment.

Joseph O’Malley, partner at law firm Paul Hastings, which represents Helsinn, said: “We are pleased that the Supreme Court will consider the validity of the patent covering our client’s Aloxi drug franchise and clarify the AIA’s on-sale bar provision.”

Christopher Loh, partner at Fitzpatrick, Cella, Harper & Scinto, added that this grant gives the Supreme Court the opportunity to clarify an issue that has become an increasing source of confusion for patentees and lower 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. 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,” said Loh.

A spokesperson for Teva said: “We acknowledge that the Supreme Court granted further review, but we remain confident in our position on the merits.”

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More on this story

Americas
5 March 2018   Swiss-based pharmaceutical company Helsinn Healthcare has filed a petition for writ of certiorari with the US Supreme Court.
Americas
2 May 2017   The US Court of Appeals for the Federal Circuit ruled yesterday that a patent is invalid if the invention was sold before being patented, even if the invention was not publicly disclosed.

More on this story

Americas
5 March 2018   Swiss-based pharmaceutical company Helsinn Healthcare has filed a petition for writ of certiorari with the US Supreme Court.
Americas
2 May 2017   The US Court of Appeals for the Federal Circuit ruled yesterday that a patent is invalid if the invention was sold before being patented, even if the invention was not publicly disclosed.