Brandon Bourdages / Shutterstock.com
19 March 2019Big Pharma

SCOTUS to hear pharmaceutical patent dispute

The US Supreme Court will seek the advice of the country’s solicitor general after it agreed to hear an appeal in a dispute over whether a medical treatment is directed towards a natural law.

Hikma Pharmaceuticals v Vanda Pharmaceuticals was added to the Supreme Court’s schedule yesterday, March 18.

The dispute arose when American company Vanda Pharmaceuticals sued Roxane Labs, since acquired by UK-based Hikma Pharmaceuticals, for patent infringement in 2014.

Vanda claimed that a Roxane Labs abbreviated new drug application (ANDA) had infringed a patent of which Vanda is the exclusive assignee (US number 8,586,610).

The patent covers methods of using iloperidone, a schizophrenia drug. Roxane had argued that the patent was directed towards ineligible subject matter.

The US District Court for the District of Delaware ruled in 2016 that the patent was valid. Even though the patent claims “depend on laws of nature”, they contained a sufficient inventive step which made them eligible, the court said.

Roxane appealed against the decision to the US Court of Appeals for the Federal Circuit, which upheld the district court’s ruling.

According to the Federal Circuit, the patent claims recite “steps of carrying out a dosage regimen based on the results of genetic testing”.

The company argued that the district court had deviated from the Supreme Court’s Alice/Mayo test, which determines whether a patent is directed towards eligible subject matter.

The Federal Circuit, however, said that Vanda’s patent claimed “an application” of a natural relationship in the form of a “novel method of treating a disease”, rather than a natural process itself.

The Supreme Court will now hear the case after Hikma Pharmaceuticals, Roxane’s parent company, successfully petitioned for certoriari.

In Hikma’s petition to the Supreme Court, the company said that the treatment steps claimed in the patent were nothing more “than an instruction to apply the natural law in routine fashion”.

The Supreme Court said the solicitor general would be invited to express the views of the US government in the case.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk