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30 March 2020
In March 2018 the Federal Court found that Kennedy's new use patent for infliximab (Janssen's Remicade) was valid and had been infringed by Hospira's biosimilar Inflectra (for further details please see "New use patent valid and infringed by biosimilar"). However, on 30 January 2020 the Federal Court of Appeal released a decision remitting for reconsideration by the trial judge certain issues relating to the validity of Canadian Patent 2,261,630 (the 630 patent).(1) The trial of the remedies phase of the proceeding started on 27 January 2020 but was adjourned pending the trial judge's reconsideration.
The 630 patent's claims 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).
The key issues are summarised below.
The appeal court found that there was ample evidence to support the trial judge's conclusion that Inflectra would be used by MTX IRs. In contrast, the appeal court overturned the finding of infringement of certain dependent claims, concluding that there was no supporting evidence. Further, since there was no evidence that one defendant, Celltrion, had conducted any activities in Canada, the trial judge had erred in finding that Celltrion had infringed. The Saccharin doctrine did not apply as it was limited to those which conduct activities in the territory of the patent.
The appeal court remanded the issue of anticipation to the trial judge to consider whether two prior art references anticipated the 630 patent. The court stated that the "disclosure requirement is satisfied if performing what is described in the prior art reference would necessarily result in infringement" and held that it was unclear how this requirement was not satisfied with respect to two prior art references.
The appeal court 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.
The appeal court remanded the issue of obviousness to the trial judge for reconsideration, citing the need to consider two further pieces of prior art and properly assess all of the factors required by the obvious-to-try test.
Although this issue did not affect the trial judge's decision, the appeal court specifically commented that "inventiveness is not tied to class rank" and that an "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 appeal court determined that "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 appeal court held that it was unclear whether the trial judge had 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 concluded 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 by the parties) did not contemplate specific 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.
The appeal court dealt with several other issues, including:
However, the court was unconvinced that the trial judge had made any reviewable errors in considering these issues. On the issue of patentability of methods of medical treatment, the court stated that the issue "deserves deep analysis" but that this case was not the one for such analysis as most "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 for June 2020. Any appeal by Janssen would require a grant of leave by the Supreme Court of Canada.
For further information on this topic please contact Katie Lee or Urszula Wojtyra at Smart & Biggar by telephone (+1 416 593 5514) or email (email@example.com or firstname.lastname@example.org). The Smart & Biggar website can be accessed at www.smart-biggar.ca.
(1) Hospira Healthcare Corporation v Kennedy Trust for Rheumatology Research, 2020 FCA 30.
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