Apotex and Novopharm started actions to impeach Novartis’ patent covering the compound imatinib, sold under the brand name GLEEVEC®. They then sent Notices of Allegation to Novartis in respect of the same patent. As a result, 4 proceedings were started and later consolidated. The Court heard the cases and although several of the claims in the patent were found to be invalid, the validity of a number of other claims was upheld. Thus, Apotex’ and Novopharm’s actions were dismissed. In addition, the Notices of Allegation were found to be not justified.
The patent at issue claimed a novel genus of compounds, as well as pharmaceutical compositions, uses and processes to make the compounds. Sound prediction of utility and sufficiency of disclosure were the only two validity issues raised at the hearing.
When assessing utility, the Court held that utility is determined based on the state of the art and information available at the filing date. The Court confirmed that utility can be either demonstrated or met through sound prediction. With respect to sound prediction, the Court stated that “[i]ts introduction into Canadian law was not ... to give a crushing hammer to those who challenge patents.” (para 164)
The Court held that determining the promise of the patent, in a purposive manner, is the first step in a utility analysis. It is hoped that this guidance, provided by the Court, will serve to reduce the unpredictability of decisions on this issue in the future. The Court held that different types of claims have different promises. The compound claims were held to promise selective inhibition of certain enzymes. The use claims were held to promise in vivo utility.
The generic companies conceded during the trial that the in vitro activity of imatinib was demonstrated or soundly predicted. Despite this concession, the Court considered the utility of the compound claims. Selective inhibition of certain enzymes was agreed to be a valuable pharmacological property. The Court also held that demonstrated utility does not mean that all in vitro tests need to be carried out on all of the compounds. The Court then considered the evidence and held that utility of the compounds for some of the claims had been demonstrated, and for some of the claims had been soundly predicted. However, for several of the genus claims, the Court held that utility had neither been demonstrated nor soundly predicted. In considering the use claims, the Court also found them to be soundly predicted.
Regarding the allegations that the patent’s disclosure is insufficient, the Court held interpreted the Supreme Court’s recent decision regarding sufficiency and held that three questions must be answered: 1) what is your invention; 2) how does it work; and 3) having only the specification, can the person of ordinary skill in the art produce the invention using only the instructions contained in the disclosure? (para 344) The Court then held that the patent was not invalid for insufficiency.
Finally, the Court considered allegations of infringement against Apotex. Apotex acknowledged that it had in its possession bulk imatinib. However, the Court held that most of it had been used for regulatory purposes and the remainder had expired. Furthermore, Apotex’ chairman undertook that the imatinib it had would not be used for commercial purposes. Thus, an order to deliver it up was not made.