Helsinn seeks SCOTUS review of patent case

Swiss-based pharmaceutical company Helsinn Healthcare has filed a petition for writ of certiorari with the US Supreme Court.

The petition, filed on Wednesday, February 28, relates to a patent infringement case against Teva Pharmaceuticals.

It comes in response to the US Court of Appeals for the Federal Circuit ruling that certain patents covering the Aloxi (palonosetron hydrochloride) injection are invalid. The court ruled in May 2017 that Teva did not infringe the patents.

Aloxi is an injection used in adults to prevent nausea and vomiting when they undergo chemotherapy. The drug is co-promoted by Helsinn and Eisai.

Helsinn specifically requested that the Supreme Court consider whether, under the America Invents Act (AIA), the sale of an invention to a third party that is obliged to keep the invention confidential is an act that can invalidate a patent.

The US District Court for the District of New Jersey ruled that the four patents were not invalid. Regarding three of the patents, governed by the pre-AIA law, the court ruled that there was a commercial offer for sale before the critical date, but that the invention was not ready for patenting before the critical date.

Regarding the fourth patent, the court said there was no commercial offer for sale because the AIA changed the relevant standard.

The Federal Circuit reversed the decision. It said 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”.

“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 particular, Helsinn questions whether under the AIA, “an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential is an act that can invalidate a patent, which is a question that the courts are addressing for the first time”.

Helsinn and Eisai believe the Federal Circuit made an error in its decision when ruling that the patents are invalid.

“Helsinn and Eisai maintain their position that the patents protecting Aloxi are valid and will continue to pursue all available options to protect and enforce these patents,” said the press release.

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