High Court Allows Generic Anti-Nausea Drug for Cancer

(CN) – The Supreme Court refused Tuesday to reinstate a Swiss pharmaceutical company’s patent for anti-nausea medication for chemotherapy patients, ruling patents can’t be issued for inventions that have already been offered for sale.

The unanimous decision from the nine justices upheld a Federal Circuit ruling that stripped Helsinn Healthcare of the patent and allowed rival Teva Pharmaceuticals Industries to begin selling a generic version of the drug Aloxi.

Helsinn successfully appealed to the U.S. Supreme Court last year after a three-judge panel sided with Teva.

The Swiss company acquired the right to develop palonosetron, the active ingredient in Aloxi, in 1998, according to Tuesday’s opinion written by Justice Clarence Thomas.

Helsinn held four patents for the medication, which is administered by drip to chemotherapy patients to mitigate nausea and vomiting.

The company sold its formulation to third-party clients before filing for the patents, which the Supreme Court ruled makes them invalid under the Leahy-Smith America Invents Act, abbreviated as AIA.  

The AIA was signed into law by former President Barack Obama in 2011 and prohibits a person from getting a patent for an invention that was “in public use, on sale, or otherwise available to the public” before the patent filing date.

Helsinn sold Aloxi under confidentiality agreements with the third parties and argued that the sales do not qualify as public, but the high court disagreed.

The Supreme Court found that, under the AIA, patents cannot be issued for any product that is made available to the public or put “on sale” over a year before the date of filing.

“More than 20 years ago, this Court determined that an invention was ‘on sale’ within the meaning of an earlier version of [patent law] when it was ‘the subject of a commercial offer for sale’ and ‘ready for patenting,’” Justice Thomas wrote.

He continued, “We did not fur­ther require that the sale make the details of the inven­tion available to the public. In light of this earlier con­struction, we determine that the reenactment of the phrase ‘on sale’ in the AIA did not alter this meaning. Accordingly, a commercial sale to a third party who is required to keep the invention confidential may place the invention ‘on sale’ under the AIA.”

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