Australian bid for OxyContin generic dismissed

The Federal Court of Australia has dismissed Spirit Pharmaceuticals Pty Ltd's bid to introduce a generic version of painkiller OxyContin.

Pharmaceutical company Mundipharma Pty Ltd holds the Australian patent for OxyContin, which has been on the Australian Register of Therapeutic Goods (ARTG) since 1999. The patent covers the controlled release of active ingredient oxycodone.

Mundipharma’s patent holding agent Euro-Celtique SA received a patent term extension (PTE) on its OxyContin patent from the Commissioner of Patents in 2000.

In the case that concluded on July 5, Spirit argued the PTE is not valid as the formulation of OxyContin is not a “pharmaceutical substance per se.”

It said that as Mundipharma’s patent refers only to active ingredient oxycodone, the PTE violates section 70(2) (a) of the Australian Patent Act, which states: “One or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification.”

Spirit also claimed that Euro-Celtique, the registered holder of the patent at the time of the PTE application, had no beneficial interest in the patent and “therefore no legal entitlement” to apply for an extension.

Federal Court Justice Steven Rares dismissed all of Spirit’s claims, finding OxyContin is a pharmaceutical substance because it is a new and inventive formulation that makes use of a mixture of dosages of oxycodone and other inactive ingredients.

Rares said in the judgment: “Since I have found that OxyContin is a pharmaceutical substance per se and a different pharmaceutical substance to oxycodone, [Spirit’s] arguments cannot succeed.”

Mundipharma’s patent expires on July 23, 2014.

Jason Rutt, head of patents at law firm Rouse in London, said there are two grounds for revocation of PTEs in Australia – one is that the active ingredient is already included on the Australian Register of Therapeutic Goods, and the other is that the patent is not based on a pharmaceutical substance.

“The judge (reasonably in my view) has ruled that the patent does cover the product and so the extension is reasonably granted,” he said.

He added: “People tend to extend compound patents when deciding which patent covering a product to extend as it has strongest protection against infringers. But I don’t think that precludes extending [formulation patents] provided it's clear the patent covers the product.”

In April 2013 Actavis secured licensing rights to market an OxyContin generic in the US.