H Lundbeck A/S v Sandoz Pty Ltd

In the case of H Lundbeck A/S v Sandoz Pty Ltd, the applicant, H Lundbeck A/S, opposed Sandoz' application for a licence to use a patent for generic escitalopram products. The opposition centred around whether Sandoz exploited the invention before the Commissioner granted an extension of time for the filing of an application for an extension of term, and if so, whether this exploitation was due to the patent's cessation. The opposition was heard in the Australian Patent Office by the Commissioner, with the legal issues focusing on the interpretation and application of section 223(9) of the Patents Act 1990 (Cth) and regulation 22.21 of the Patents Regulations 1991 (Cth).

The primary legal issues the court had to decide were whether Sandoz could claim protection or compensation under section 223(9), if there was exploitation of the invention, and whether any exploitation was due to the patent's cessation or the failure to file an application for an extension of term in time. The court also needed to consider whether the Commissioner had discretion to grant a licence, and if so, what factors should be balanced in exercising that discretion.

The court examined the statutory provisions and found that section 223(9) provides for the protection or compensation of persons who exploited the invention because of the failure to do the relevant act within time, the lapsing of the patent application, or the ceasing of the patent. The court concluded that Sandoz' awareness of the risk of patent restoration did not preclude it from claiming protection under section 223(9). The court also determined that there was exploitation and that it was because of the failure to file the application for an extension of term in time. The court further held that the Commissioner had discretion to grant a licence and that the balance of considerations favoured granting a licence to Sandoz.

The court's final orders included granting a licence to Sandoz on the terms set out in the decision, allowing Sandoz to use the patented invention for its generic escitalopram products. The court also ordered that Sandoz pay Lundbeck reasonable compensation for the use of the patented invention.