As reported previously here, the Federal Court found that Kennedy’s new use patent for infliximab (Janssen’s REMICADE) was valid and infringed by Hospira’s biosimilar INFLECTRA. On January 30, 2020, the Federal Court of Appeal released a decision remitting for reconsideration to the trial judge certain issues relating to the validity of Canadian Patent No. 2,261,630 (the 630 patent): Hospira Healthcare Corporation v Kennedy Trust for Rheumatology Research, 2020 FCA 30. The trial of the remedies phase of the proceeding started on January 27, 2020 but was adjourned pending the trial judge’s reconsideration.
The claims of the 630 patent relate to a combination of an anti-TNF-α antibody and methotrexate (MTX) for the treatment of rheumatoid arthritis in patients who do not completely respond to MTX alone (MTX Incomplete Responders or MTX IRs).
A summary of the key issues follows:
- Infringement (Saccharin doctrine not applicable to Celltrion): The Court of Appeal found that there was ample evidence to support the trial judge’s conclusion that INFLECTRA would be used in MTX IRs. In contrast, the Court of Appeal overturned the finding of infringement of certain dependent claims, finding that there was no evidence in support. Further, since there was no evidence that one defendant, Celltrion, had conducted any activities in Canada, the trial judge erred in finding Celltrion infringed; the Saccharin doctrine did not apply as it was limited to those who conduct activities in the territory of the patent.
- Anticipation (remanded as reasons unclear): The Court of Appeal remanded the issue of anticipation to the trial judge to consider whether two prior art references anticipated the 630 patent. The Court of Appeal stated that “[t]he disclosure requirement is satisfied if performing what is described in the prior art reference would necessarily result in infringement” and held that it was not clear how this requirement was not satisfied with respect to two prior art references.
The Court of Appeal found that “in order for any particular results from the claimed combination treatment to be a basis for distinguishing over the prior art, it would be necessary to conclude that such results constituted an essential element of the claim in question.” Based on the lower Court’s construction, the essential elements of the claims did not have a requirement for any particular results, including the kind of results described by the judge as the “special advantage”. The Court further held that the judge did not appear to have considered enablement in relation to these two prior art references.
- Obviousness (rejected reasonably diligent search requirement for scope of prior art; questioned trial judge’s application of obvious to try test):
- The Court of Appeal remanded the issue of obviousness to the trial judge for reconsideration: (i) to take into account two further pieces of prior art and (ii) to properly assess all the factors required by the obvious to try test.
- Skilled person: Although this issue did not affect the trial judge’s decision, the Court of Appeal specifically commented that “inventiveness is not tied to class rank”, and that “[a]n inventive person may be at the bottom of the class, and a person at the top of the class may not be inventive”.
- Scope of prior art: The Court of Appeal determined “it is an error to exclude from consideration prior art that was available to the public at the relevant date simply because it would not have been located in a reasonably diligent search”. However, the likelihood that a prior art reference would not have been located by a skilled person may be relevant “in that the uninventive [person of skill in the art] might not have thought to combine that prior art reference with other prior art to make the claimed invention”.
- Obvious to try: The Court of Appeal stated that it was not clear that the trial judge properly considered this issue. In particular, the trial judge appeared to have been swayed by his conclusion that “it was not self-evident that this combination [anti-TNF-α and MTX] would work to solve the problem identified in the prior art”. However, this is merely a factor – the only “determinative test … is whether it was more or less self-evident to try to obtain the invention.” The Court of Appeal held that the trial judge’s consideration of another factor (concerning the extent, nature and amount of effort required to achieve the invention) was inadequate. Given that the essential elements (which were agreed upon by the parties) “did not contemplate particular experiments or results,” the skilled person did not have to conduct a clinical trial. Rather, “it would be enough to co-administer an anti-TNF-α antibody and MTX as claimed and observe the results.”
- Other issues (method of medical treatment deserves deep analysis in a future case): The Court of Appeal dealt with several other issues, including claims construction, methods of medical treatment, double patenting, and insufficiency, but was not convinced that the trial judge made any reviewable errors in considering these issues. On the issue of patentability of methods of medical treatment, the Court of Appeal stated that the issue “deserves deep analysis” but this case was not the one for such analysis as “[m]ost of the claims in issue here are limited to fixed dosages and intervals of administration, or do not specify any dosage or interval of administration.”
The trial judge has scheduled the reconsideration hearing in June 2020. Any appeal by Janssen would require the grant of leave by the Supreme Court of Canada.