Sanofi-Aventis

The decision in the matter of Sanofi-Aventis involved the patent holder seeking an extension of the term of a patent for the pharmaceutical substance STILNOX CRTM. The dispute centred on whether STILNOX CRTM qualified as a pharmaceutical substance per se, which is crucial for determining the eligibility for a patent term extension. The case was heard by Gillian Jenkins, the Deputy Commissioner of Patents. The primary issue before the court was whether STILNOX CRTM, a bi-layered Zolpidem tartrate tablet, constituted a compound of pharmaceutical substances as defined in the legislation, specifically under section 70(2) of the relevant Act. The court also had to consider whether the unique pharmacokinetic profile of STILNOX CRTM was attributable to the bi-layered spatial arrangement of the tablet and if this arrangement met the criteria for a pharmaceutical substance.

The court examined the composition of STILNOX CRTM and found that both layers of the tablet consisted of mixtures of therapeutically active substances and pharmaceutical excipients, which fit within the common understanding of pharmaceutical substances. The union of these layers into a form suitable for administration resulted in a compound that was considered a pharmaceutical substance per se, as it did not include any purely physical integers. Instead, it comprised of components that are widely recognised as pharmaceutical substances. The court concluded that granting an extension to the term of the patent for STILNOX CRTM was in line with the legislative intent to protect new and inventive pharmaceutical substances.

In light of the findings, Gillian Jenkins allowed the request for an extension of the patent term for STILNOX CRTM, confirming that it fulfilled the requirements under section 70(2) of the Act. The decision underscored the importance of the unique bi-layered structure of STILNOX CRTM and its contribution to the pharmaceutical substance's efficacy. The court's reasoning was grounded in the statutory definition and legislative intent, ensuring that the patent term extension was granted in accordance with the legal framework governing pharmaceutical patents.