Apotex Wins Australia Dispute With Sanofi Over Arava

Apotex Pty defeated Sanofi, France’s biggest drugmaker, in an Australian patent dispute over the rheumatoid arthritis drugs Arava and Arabloc, with the country’s highest court ruling for the first time on the patentability of medical treatments for humans.

The High Court of Australia said in a majority decision today that Apotex, a Canadian maker of generic drugs, didn’t infringe Sanofi’s patents. It overturned two lower court rulings that sided with the French drugmaker and blocked Apotex sales of generic copies in the country.

Sanofi’s patent, due to expire in March in Australia, on the compound leflunomide in the drugs is limited to treating or curing psoriasis, Justices Susan Crennan and Susan Kiefel wrote on behalf of the majority. Because Apotex proposed to use leflunomide in its generic copies of the drugs for the treatment of active rheumatoid arthritis and active psoriatic arthritis, it didn’t infringe the patent, the judges said.

“It was not shown, nor could it be inferred, that Apotex had reason to believe that the unpatented pharmaceutical substance, which it proposes to supply, would be used by recipients in accordance with the patented method,” the judges said.

Apotex, based in Toronto, argued unsuccessfully that methods of medical treatment couldn’t be patented. Earlier laws and rulings had excluded such methods from patenting.

“This court has not had to decide the question until now,” Chief Justice Robert French wrote in his decision. “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.’”

Sanofi has competed with copycat versions of Arava in the U.S. since 2005, when Apotex and other generic drug manufacturers won U.S. Food and Drug Administration approval to sell their copies of the medicine.

The case is Apotex Pty v Sanofi-Aventis Australia Pty. S219/2012 and S1/2013. High Court of Australia (Canberra).

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