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Federal Court of Appeal upholds Federal Court’s summary trial finding of patent invalidity

Background

The Federal Court of Appeal has rarely upheld or granted a finding of invalidity in the context of a summary trial; for example, based on the Supreme Court of Canada’s finding that the disclosure of the patent at issue was insufficient (in Pfizer Ireland Pharmaceuticals v. Apotex Inc.) and based on evidence that the prior sale of the products more than a year before the filing date of the patent constituted an enabling disclosure (in Sterling Lumber Company v. Harrison).

In Eli Lilly Canada Inc. v. Apotex Inc., the Federal Court of Appeal upheld the Federal Court’s summary trial decision that various claims of Canadian Patent No. 2,226,784 are invalid for overbreadth and insufficiency (see our previous post, here).

The present appeal turned on the Federal Court’s interpretation of the term “physiologically acceptable” as used in the 784 Patent. The Federal Court concluded that a “physiologically acceptable” salt was non-toxic, as well as “stable and pure, not degraded.” Applying this interpretation, the Federal Court found that the claims in issue were invalid for overbreadth and insufficiency.

Claims construction

The Appellants argued that the Federal Court erred in relying on the evidence of the Respondents’ expert, Dr. Beauchemin, in construing the term “physiologically acceptable” for three reasons:

  1. Dr. Beauchemin’s interpretation of the term “physiologically acceptable” was made before seeing the 784 Patent and therefore did not follow the principle that claim construction comes before the assessment of validity;
  2. The 784 Patent refers to the salts in question as “non-toxic” and doesn’t use the term “stable and pure, not degraded”; and
  3. Dr. Beauchemin opined on the skilled person’s understanding of “physiologically acceptable” without taking into account the relevant common general knowledge.

The Federal Court of Appeal found that it was open to the Federal Court to consider Dr. Beauchemin’s evidence of how a skilled person would understand the term “physiologically acceptable”. Although Dr. Beauchemin initially formed this opinion before reviewing the 784 Patent, his opinion did not change once he had read the patent. The Federal Court of Appeal found that the Federal Court did not err by considering Dr. Beauchemin’s evidence.

The Federal Court of Appeal found that “[t]he fact that the 784 Patent does not use the term ‘stable and pure, not degraded’ is insufficient to conclude that, as a matter of law, the Federal Court could not accept Dr. Beauchemin’s definition of ‘physiologically acceptable’.” It was open to the Federal Court to conclude that “physiologically acceptable” meant something more than non-toxic and to construe the term “physiologically acceptable” to mean that the salt must also stable and pure, not degraded.

The Federal Court of Appeal saw no problem in the fact that Dr. Beauchemin did not indicate he considered the common general knowledge when determining how a skilled person would interpret the term “physiologically acceptable”. By definition, skilled persons are aware of the common general knowledge so, by referring to the skilled person, Dr. Beauchemin implicitly considered the common general knowledge.

Insufficiency

Because the Federal Court of Appeal rejected the Appellants’ arguments concerning claim construction, it was not necessary to review the questions of insufficiency, overbreadth, and inutility. However, the Federal Court of Appeal clarified that “a patent may be sufficient even if it requires a minor research project, provided no inventiveness or undue experimentation is involved.”

Conclusion

The Federal Court of Appeal dismissed the appeal, with costs. A copy of the decision is available here.

In this appeal, Scott Beeser successfully represented Teva Canada Limited and Marcus Klee successfully represented Pharmascience Inc. and Laboratoire Riva Inc.

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