The Federal Court of Appeal recently reversed a decision impeaching a selection patent and remitted to the Trial Division for consideration issues of utility and sufficiency as the Court found that the trial judge had failed to provide sufficient facts and analysis to allow for a meaningful review.
At the same time, the Court of Appeal criticized the Court below for not having applied the correct legal tests for anticipation, obviousness and double patenting in assessing the validity of the '113 Patent. In doing so, the Court of Appeal affirmed, yet again, that selection patents are to be treated no differently than any other patent in terms of the validity analysis being conducted for each of the grounds of invalidity raised, denying a separate ground of invalidity called "improper selection".
In setting aside the trial decision, the Court of Appeal held as follows:
- "improper selection" is a not an independent basis for attacking the invalidity of a patent;
- anticipation, obviousness, double patenting, lack of utility and insufficiency are distinct and separate legal tests that should not be tainted by a finding of invalid selection;
- evidence beyond the patent specification can and normally will be necessary to determine the utility of a patent whether demonstrated or soundly predicted; and
- sufficiency under s. 27 of the Patent Act requires only that the patent disclose the compound, its advantages and how it works.
Selection Patent - Not an Independent Validity Attack
The Court of Appeal began its analysis by considering what is a selection patent, reiterating the often quoted passage of Maugham J. in I.G. Farbenindustrie. After a thorough review of the law, the Court of Appeal concluded that a selection patent is the same as any other patent; its validity is vulnerable to attack on any of the grounds set out in the Patent Act.
The Court of Appeal found that the trial judge erred in that he began his validity analysis by asking, is the '113 Patent a valid selection patent, answered the question negatively and then permeated this negative answer throughout his analyses of all the grounds of invalidity raised by the defendant.
The Court found that there is no single prior art reference that provides prior disclosure of olanzapine. At best, the prior art only identifies a genus that encompasses olanzapine as one of many trillions of compounds.
The Court of Appeal stated that the trial judge did not follow the Supreme Court decision in Sanofi. The trial judge's view of anticipation was tainted by his determination that olanzapine was not the subject of a valid selection patent. While the anticipation analysis was argued in terms of the advantages disclosed, the Court of Appeal ruled that it is the compound that must be disclosed and enabled for there to be anticipation.As neither olanzapine nor its advantages were disclosed or enabled, no anticipation was found.
Following the Windsurfer approach prescribed in the Sanofi decision, the Court considered all of the criteria for obviousness and indicated that the patentee is not required to prove the advantages in order to have a selection patent, but that the analysis of the inventive step is to be conducted in light of the obvious "to try" and "ought to work" criteria. Following the Sanofi analysis, the Court of Appeal concluded that had the trial judge followed this analysis, it would have been clear that olanzapine was not obvious to try and therefore, was not an obvious compound.
The trial judge's determination that olanzapine was both non-inventive and non-obvious was inconsistent and constituted a palpable and an overriding error. The trial judge found no inventive step because of his inappropriate consideration of selection patent criteria in his obviousness analysis. The Court found that the inventive step in the '113 Patent is olanzapine, coupled with its advantages over the compounds of the earlier '687 Patent.
The double patenting analysis begins with comparing the claims of the two separate patents to determine if they are identical or coterminous. Comparing the genus and species claims, the claims were clearly not coterminous.
The Court then turned its analysis to obviousness double patenting to determine whether the claims of the '113 Patent were patentably distinct over the genus patent. Again, the trial judge failed in this regard because of his mistaken view that the '113 Patent was not a valid selection. The Court of Appeal found that the '113 Patent was patentably distinct by virtue of having found that olanzapine had beneficial properties over flumezapine and other compounds within the '687 genus patent. Thus, the challenge based on obviousness double patenting also failed.
Utility and Sound Prediction
On the issue of utility, the Court of Appeal found that there were insufficient facts in the trial judge's decision to make a full assessment on appeal as to whether the claimed invention was useful. The Court of Appeal highlighted that the party attacking the patent must demonstrate that the invention will not work, either in the sense that it will not operate at all or will not do what the specification promises it will do. If an actual promise is made the utility will be measured against that promise. The Court of Appeal indicated that a selection patent must provide an advantage or avoid a disadvantage over the genus and that advantage possessed by the selection must be stated in the specification in clear terms. However, no specific number of advantages is required, one advantage may be enough, or several less significant advantages may suffice when taken cumulatively, so long as the advantage is ultimately substantial.
The Court also drew a distinction between the promised advantage and the data upon which it is based.
The question to be determined is whether, at the date of filing, the patentee had sufficient information upon which to base the promise in the patent and it is the party challenging the validity of the patent who bears the onus of demonstrating that the patentee did not have that information. If it is shown that there was insufficient information upon which to base the promise in the patent, the patentee may nevertheless have had sufficient information upon which to make a sound prediction for the promise. The promise nonetheless must ultimately be borne out and the requirements for a sound prediction must be met as of the filing date, namely a factual basis for the prediction and articulable line of reasoning from which the desired result can be inferred from the factual basis, with proper disclosure.
The evidence described by the trial judge with respect to utility will generally go well beyond the patent's contents and will typically include a summary of the pertinent evidence required to understand the patent. Credibility findings and other factual determinations are often made, however, in this case the trial judge failed to do so. Because there is a lack of information and factual findings, the Court of Appeal found it particularly troublesome to conduct a meaningful appellate review on the questions of law as to utility when there is no construction of the patent based upon the expert testimony provided.
Consequently, the Court of Appeal raises several concerns with the trial judge's analysis. For example, the trial judge appeared to have required that every advantage mentioned in the patent was elevated to the level of a promise. The Court emphasizes that the overarching analysis is to look at the overall promise that the patent has made for the claimed compounds. There is also the question of whether the trial judge had an appreciation of the distinction between the promised advantage and the data upon which it was based. The judge also failed to consider cumulatively the individual advantages that may have been recited. The Court of Appeal also criticized the trial judge for stating that Lilly had "no proof of anything" with respect to the utility of the compounds, when the presumption of validity applies and the onus is on the attacking party to establish that the patent lacks utility.
The Court also reviewed the law of sufficiency. The Court of Appeal summarized the requirements for disclosure to indicate that the patent must contain a disclosure of the compound, its advantages and a teaching of how it works. The Court found insufficient facts to enable the Court of Appeal to conduct a meaningful review of the issue.
The Court of Appeal allowed the appeal and set aside the judgment of the Federal Court and remitted the issues of utility and sufficiency of disclosure to the trial judge for determination in accordance with the Court of Appeal's reasons.
The full text of the decision can be found at: Federal Court of Appeal
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