Federal Court reaffirms disclosure requirement for sound prediction
In Eli Lilly Canada Inc v. The Minister of Health et al, 2016 FC 47, Justice Barnes dismissed Eli Lilly’s prohibition application in respect of Hospira’s generic version of pemetrexed.
Canadian Patent No. 1,340,794 is directed to novel pyrrolopyrimidine derivatives which are useful as antitumor agents, the production and utilization thereof. The inventive concept of the 794 Patent was agreed to be the unexpected discovery that classical antifolates bearing a 6/5 bicyclic pyrrolopyrimidine ring system have antifolate activity.
Justice Barnes’ decision, for reasons of judicial economy and having regard to the summary and non-binding nature of the NOC proceedings, focussed only on the issue of sound prediction, specifically whether there was sufficient test data to support a sound prediction for the thousands of untested compounds within the relevant claim.
Justice Barnes addressed the controversy over the disclosure requirement in the test for sound prediction, holding that there remains a requirement to disclose the factual basis and sound line of reasoning in the specification, holding:
[46] Notwithstanding Justice Binnie’s remarks in Apotex Inc v Wellcome Foundation Ltd, quoted above, the issue of what the patentee must disclose to the public where utility is predicted remains somewhat controversial. In AstraZeneca v Apotex, 2014 FC 638, [2014] FCJ No 671, Justice Donald Rennie (as he then was), distinguished Apotex Inc v Wellcome Foundation Ltd, above, by limiting Justice Binnie’s remarks concerning disclosure to new use patents.
[47] Justice Rennie also drew support from Justice Johanne Gauthier’s concurring, separate reasons in Sanofi-Aventis v Apotex, 2013 FCA 186, [2013] FCJ No 856, where she questioned the general requirement for a heightened level of disclosure in sound prediction cases. Justice Rennie dealt with Eurocopter, 2013 FCA 261, 116 C.P.R. (4th) 161, by describing the contrary view there expressed as both obiter and a less than robust endorsement of the need for heightened disclosure in sound prediction cases: see para 157.
[48] While I have some sympathy for Justice Rennie’s and Justice Gauthier’s views, I am not persuaded that the state of the law on this issue has changed. In particular, it would take something more than Justice LeBel’s apparent reservations expressed in Pfizer v Novopharm, 2012 SCC 60 at paras 38-40, [2012] SCJ No 60, to displace the requirement for disclosure described by Justice Binnie in Apotex Inc v Wellcome Foundation Ltd, above, and, later, as clearly endorsed by the Federal Court of Appeal in Eli Lilly v Apotex, 2009 FCA 97 at paras 14-15, 78 CPR (4th) 388, in Eli Lilly v Novopharm, 2010 FCA 197 at para 83, [2012] 1 FCR 349 and in many decisions of this Court.
[49] In my view where utility is based on a sound prediction, there remains an obligation to disclose in the patent specification the factual basis and a sound line of reasoning supporting the prediction. That said, there is no requirement to disclose that which forms a part of the common general knowledge of the person of skill. Such knowledge may be relied upon by a patentee to strengthen its assertion of predicted utility: see Bell Helicopter v Eurocopter, above, at para 154.
After reviewing the relevant expert evidence, Justice Barnes preferred the evidence of Hospira’s experts that small structural changes can result in dramatic differences in biological activity including inactivity, such that the skilled person would not be able to extrapolate the activity of a small number of antifolate compounds to the large number of untested compounds within the claims:
[114] The evidence of Drs. Kalman, Phillips and Chong was clear and decisive and for the most part it was left unchallenged. I accept their evidence about the significant barriers to predicting antifolate activity for an untested compound based on data for another.
[115] In contrast, the evidence from the Lilly experts was equivocal and vague. This was particularly the case for Dr. Jones’ evidence concerning a theory of sound prediction of activity “in the round”. This seems to me to be largely meaningless generalization intended to avoid the evidence offered by Dr. Phillips and Dr. Kalman about the inherent difficulties of predicting antifolate activity from one compound to another and across cell lines.
A copy of Justice Barnes decision may be found here.