Prejay Holdings Ltd v Commissioner of Patents

The case of Prejay Holdings Ltd v Commissioner of Patents was heard in the Federal Court of Australia. The dispute centred on the interpretation and application of the Patents Act 1990, particularly section 70(2)(a), which allows for the extension of the term of a patent for certain pharmaceutical substances. The applicant, Prejay Holdings Ltd, sought to extend the term of a patent for a pharmaceutical substance known as Premia, a combination of medroxyprogesterone acetate and oestrogen-conjugate. The Commissioner of Patents, as the respondent, opposed the application, arguing that the term of the patent could not be extended under the Act.

The primary legal issue the court had to decide was whether the term of the patent could be extended for a pharmaceutical substance that was disclosed in the patent specification but not claimed as a standalone substance. The court had to interpret the meaning of "pharmaceutical substance" and "therapeutic use" as defined in the Act, and determine whether the substance in question met the criteria for an extension of patent term under section 70(2)(a). This required the court to consider the legislative intent behind the provision, particularly the distinction between claims for a pharmaceutical substance "per se" and those that are part of a method or process claim.

The court examined the decision of the delegate, who had previously ruled against the applicant, and the precedent set by the Boehringer case. In Boehringer Ingelheim International GmbH v Commissioner of Patents, the court had held that section 70(2)(a) only applied to claims for a pharmaceutical substance by itself, without process or method components. The court in the current case agreed with the delegate's interpretation of Boehringer, finding that the intent of the legislation was to provide an extension of term for patents in certain circumstances, specifically for claims to a pharmaceutical substance "per se". The court held that since the claim in question related to a method of use rather than the substance itself, the term of the patent could not be extended.

As a result, the court dismissed the application for an extension of the patent term. The applicant was ordered to pay the respondent's costs, including reserved costs, as per the orders of the court.