Pharmaceutical business method patent refused certification

The Australian Patent Office has refused to certify an innovation patent directed to a pharmaceutical business method.

Celgene Corporation has been pursuing certification of a ‘business method’ innovation patent directed to a system for prescribing and dispensing drugs, such as thalidomide, which have particularly severe risks associated with their use. The method involves registration of doctors, pharmacists and patients in a centralised database, so that the drug can be dispensed only when these registrations are in place and a unique ‘prescription approval code’ is obtained.

The TGA has approved the sale of thalidomide for the treatment of erythema nodosum leprosum (ENL), an inflammatory complication of leprosy that results in painful skin lesions, and multiple myeloma in specified circumstances.

In refusing certification, the hearing officer found that the method was merely a scheme for dispensing a drug and was therefore not patentable subject matter. The claims were also found to lack novelty over an earlier US patent application.

Celgene has been given until 29 February to file amendments that overcome these objections.

Contact: If you have any specific enquiries about this matter, or pharmaceutical patents generally, please contact Paul Jones.