Jazz plays on as Xyrem challenges quashed

The US Patent and Trademark Office (USPTO) has rejected several petitions that challenged a patent covering Jazz Pharmaceuticals’ narcolepsy drug Xyrem (sodium oxybate).

Par Pharmaceutical, along with Roxane Laboratories and Amneal Pharmaceuticals, filed petitions requesting a covered business method (CBM) review of Jazz’s US patent 7,668,730 (’730).  CBM reviews were created by the America Invents Act (AIA).

Jazz had sued Par, Roxane and Amneal for allegedly infringing the disputed patent.

Under a CBM review, companies may challenge a patent’s validity only if the USPTO’s Patent Trial and Appeal Board (PTAB)finds that they meet CBM criteria.

A CBM patent is defined by the AIA as: “A patent that claims a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service.”

Patent ‘730, called “sensitive drug distribution system and method”, describes a computerised method for monitoring prescription patterns of Xyrem to prevent abuse of the drug.

The method uses a database that contains information about all physicians authorised to prescribe the drug and about all the patients who receive it. According to the Orange Book, the patent is due to expire in 2024.

Par, Roxane and Amneal argued that the ‘730 patent was a CBM patent, and that 11 of its claims are not patentable.

In its January 13 decision, the PTAB said that the petitioners failed to show that the ‘730 patent claims a method used in the practice, administration, or management of a financial product or service, so it denied the petitions.

“A patent needs only one claim directed to a covered business method to be eligible for review,” the decision said.

“We conclude [that the] petitioners has not demonstrated that the ‘730 patent is a ‘covered business method’,” it added.

Signed into law in 2011, the AIA provides more options for challenging the validity of issued US patents.