The Federal Court of Appeal (FCA) has affirmed a decision of the Federal Court (FC) finding that a patent concerning glatiramer acetate (GA) is valid and would be infringed under the Patented Medicines (Notice of Compliance) Regulations.
As we previously reported, the FC decision concerned allegations by Teva Canada Innovation and Teva Canada Limited (together, Teva) that Pharmascience Inc. (Pharmascience) would infringe Canadian Patents No. 2,702,437 (the 437 Patent) and 2,760,802 (the 802 Patent) if it were to market its generic GA product, Glatect® 40 mg, in Canada for the treatment of multiple sclerosis (MS). Pharmascience challenged the validity of the asserted claims.
The 802 Patent’s asserted claims were found to be valid and would be infringed by Glatect® 40 mg. These claims address the use of 40 mg of GA, injected three times weekly with at least one day between each injection, for the treatment of patients with relapsing-remitting MS. Pharmascience appealed the FC judgment on validity.
The action with respect to the 437 Patent was unsuccessful and was not addressed on appeal.
No reviewable error on utility
Pharmascience challenged the Trial Judge’s identification and application of the “heightened disclosure requirement” applicable for a sound prediction of utility. The parties did not challenge the existence of such a requirement, and the FCA expressly chose not to comment in that regard. Rather, Pharmascience claimed that the FC had failed to require a description of the factual basis and line of reasoning supporting the prediction of utility in the patent.
The FCA disagreed, holding that the Trial Judge explicitly recognized and understood the applicable test. The FCA also found that, although the Trial Judge was mistaken about whether certain information was disclosed in the patent, she had nonetheless identified facts sufficient to support a scintilla of soundly predicted utility. In reaching this conclusion, the FCA was critical of Pharmascience’s failure to adduce evidence from its own experts on the issue of utility and its reliance on cross-examinations, despite holding the burden of proof.
No reviewable error on obviousness
In the alternative, Pharmascience argued: If the 802 Patent does not fail for inutility, then it must fail for obviousness. Pharmascience noted that the 802 Patent does not provide any experiment results that could form the factual basis for a sound prediction of utility. Therefore, the required factual basis and line of reasoning must come from the common general knowledge (CGK). Pharmascience reasoned: if the CGK was sufficient to support a sound prediction of utility, then that same knowledge would make that invention “obvious to try”.
The FCA disagreed, noting that the legal tests for sound prediction and obviousness have distinct requirements:
There is no necessary inconsistency between the finding, on the one hand, that an idea is sufficiently described in the patent disclosure and the common general knowledge to support a sound prediction that it will be useful (a prima facie reasonable inference of utility […]) and, on the other, that the idea is not sufficiently known in the prior art (including but not limited to the common general knowledge) to lead the [skilled person] directly and without difficulty to the solution taught in the patent.
Accordingly, it was open to the FC to find enough in the CGK to support a sound prediction of utility, supported by the logic in the description of the 802 Patent, while still concluding that the prior art did not render the invention obvious.
In this regard, the FCA highlighted that the relevant date for assessing sound prediction is the patent’s filing date, whereas the relevant date for assessing obviousness is the claim date – which could be a year earlier. The CGK could change as between those two dates, supporting a sound prediction that was not available as of the relevant date for obviousness.
The FCA also noted that a party alleging obviousness bears the burden of showing that the skilled person would have thought to combine prior art references that are not part of the CGK. In this regard, the difficulty of locating the references may be relevant.
Links to decisions: