In this case, the FCA considered an appeal and cross-appeal of a decision relating to omeprazole. The trial decision can be found here (2015 FC 322) and our summary is found here. It was modified here (2015 FC 671) and our summary is found here. The Court dismissed the validity challenges and the cross-appeal. The appeal relating to limitation periods was allowed. The FCA considered validity allegations on appeal relating to sufficiency of disclosure, ambiguity, overbreadth and inutility.
The FCA reviewed construction on a correctness standard, holding that the objective intention of the inventor is to be found within the four corners of the patent. The FCA also held that it is trite law that a court will consider the disclosure when construing the claims, as it may help to determine if a particular meaning was provided for an expression in the claim. However, the disclosure cannot be used to enlarge or contract the scope of the claim.
With respect to ambiguity, the FCA held that simply because Apotex argued one construction issue over another, the language of the claim is not ambiguous. With respect to sufficiency, the FCA dismissed Apotex's argument that the patent was insufficient because it did not describe the particular process that Apotex was using (the in situ process), which only became known several years after the patent issued. The FCA held that in the Teva case at the SCC, the problem was that the inventor had not disclosed his invention because only one compound worked, and which compound that was was not disclosed. However, in this case, the experts agreed that if they followed the teachings of the patent, they would expect the formulation of Claim 1 to have the advantages set out for the patent. Furthermore, the FCA held that routine testing is acceptable as part of enablement. The inventor does not need to provide all methods to make a product and does not need to provide for detailed technical support in respect of new methods that are not discussed in the disclosure.
With respect to inutility, Apotex was making the same argument that the patent was invalid for inutility based on a lack of sound prediction to make the formulation through the in situ process. The FCA held that requiring an inventor to demonstrate the utility of the preparation made by a process that was not known when the claim was drafted makes no sense.
The FCA held that the Federal Court erred in holding that the 6-year limitation period in the Patent Act applied to all acts of infringement by Apotex when considering the old Patent Act. The FCA held that, under the old Patent Act, if a cause of action arises in a province, that cause of action may be subject to the applicable provincial limitation period. This issue was remanded to the Federal Court. The FCA also dismissed AstraZeneca's cross-appeal seeking punitive damages or solicitor/client costs.