12 December 2013Asia-Pacific

Australian High Court says medical treatment methods are patentable

The High Court in Australia has said for the first time that a method of medical treatment for the human body can be a patentable invention.

The ruling stems from the Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd case covering a method for the treatment of a skin disease, psoriasis.

Pharmaceutical company Sanofi and generics company Apotex had been in a dispute since 2008 over the claims of a patent that describes a method for treating the disease.

Sanofi is the registered owner of Australian Patent 670,491, called “pharmaceutical for the treatment of skin disorders”. Its claims centre on a method for treating the disease using a compound called leflunomide.

However, in 2008 Apotex registered a version of the compound with the intention of selling it to treat rheumatoid arthritis and psoriatic arthritis.

Sanofi said the generic product would infringe its patent, before Apotex responded with a challenge to the patent’s validity, arguing that it is not patentable as a method of manufacture.

The case was the first time Australia had considered whether claims of a medical treatment could be deemed a manner of new manufacture within the scope of the Patents Act 1990.

On December 4, the High Court was split 4-1, but the majority ruling stated that assuming all other requirements for patentability are met, a method for medical treatment of the human body is deemed a manner of manufacturing and is therefore patentable.

“While this question had been considered by various tribunals and courts in a number of major jurisdictions, it was the first time that the High Court of Australia had the opportunity to decide the question in the context of the law in Australia,” said Virginia Beniac-Brooks, partner at Marks & Clerk LLP in Melbourne, Australia.

“While this decision … merely confirms the judicially-sanctioned orthodoxy that an invention directed to a method of medical treatment is proper subject matter for letters patent, it is nevertheless significant as it now provides patentees in the life sciences industry with greater certainty as to what is patentable subject matter.”

The court wrote: "The exclusion from patentability of methods of medical treatment represents an anomaly for which no clear and consistent foundation has been enunciated.”

It added: “Whatever views may have held in the past, methods of medical treatment, particularly the use of pharmaceutical drugs, cannot today be conceived as ‘essentially non-economic.’”

According to a blog post by Simone Mitchell and Nicholas Tyacke, partners at DLA Piper LLP, the Australian Patent Office has been granting patents for methods of medical treatment, particularly in relation to pharmaceutical products, for many years.

However, they added: “This decision now provides the Australian life sciences sector with certainty that patents are available for inventions that are methods of medical treatment, provided that the invention is otherwise patentable (that is, it meets the requirements of novelty, utility, inventive step and no prior use).”

The court also concluded that Apotex’s generic product had not infringed Sanofi-Aventis's because the product information expressly excluded using the generic product for the patented purpose. The court found that because the product was indicated for the treatment of Active Rheumatoid Arthritis and Active Psoriatic Arthritis, and not for the treatment of psoriasis, it did not infringe the patent.