Merck & Co Inc v Arrow Pharmaceuticals Ltd

Merck & Co Inc brought a case against Arrow Pharmaceuticals Ltd regarding the extension of the term of a patent under section 70 of the relevant Act. The central dispute was over whether the patent term for a pharmaceutical substance, Lovastatin, could be extended. The matter was heard in the Federal Court of Australia.

The legal issues at hand primarily revolved around the interpretation of section 70 of the Act, particularly focusing on the requirements for extending the patent term of a pharmaceutical substance. Specifically, the court had to determine whether the pharmaceutical substance in question, Lovastatin, and its ß-hydroxy metabolite, met the criteria for a patent term extension. Merck argued on two fronts: that Lovastatin itself was eligible for extension, and alternatively, that the ß-hydroxy metabolite of Lovastatin was eligible. The court needed to assess whether these substances fell within the scope of the patent claims and whether they satisfied the specific conditions laid out in the Act.

The court, in its reasoning, noted that while Lovastatin is a pro-drug that converts into its ß-hydroxy metabolite upon administration, this transformation does not inherently make Lovastatin itself fall within the scope of the patent claims for the metabolite. The court highlighted that the actual infringement occurs due to the use of Lovastatin, leading to the formation of the metabolite, rather than Lovastatin itself being the infringed entity. The court concluded that Merck's argument, relying on Beecham Group Ltd v Bristol Laboratories Ltd, did not sufficiently establish that Lovastatin in substance fell within the claims to the metabolite. Consequently, the court found that the application for extension could not be upheld based on the arguments presented.

The court allowed the appeal, set aside the delegate's decision to refuse the patent term extension, and ordered that the opposition to the extension be dismissed. Additionally, the application for the patent term extension was granted.