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Federal Court of Appeal upholds decision finding Seedlings’ LifeCard patent invalid and not infringed by Pfizer’s EpiPen

On July 28, 2021, the Federal Court of Appeal (FCA) dismissed Seedlings’ appeal from the Federal Court decision of Justice Grammond (2020 FC 1, previously reported), which concluded that certain claims of Seedlings’ LifeCard patent, Patent No. 2,486,935 (935 Patent), were invalid and not infringed by Pfizer’s next generation EpiPen: Seedlings Life Science Ventures, LLC v Pfizer Canada ULC, 2021 FCA 154.

The 935 patent relates to an auto-injection device, primarily used for the administration of epinephrine in treating symptoms of anaphylaxis.

Claim Construction

Seedlings took issue with the Federal Court’s construction of several terms in the relevant claims. The FCA found no reviewable error. The FCA commented that it is not an error to apply the principle of claim differentiation to compare similar clauses in two claims (such as “coupled to” and “operatively associated with”), even if those two claims have other differences. 

Overbreadth

The Federal Court held that all relevant claims of the 935 patent were invalid for overbreadth because they omitted essential elements of the invention that were described in the patent disclosure. On appeal, Seedlings argued that (1) overbreadth lacks statutory basis and is not a proper ground of invalidity, and (2) even if overbreadth is a proper ground of invalidity, the trial judge erred in its application to the case. The FCA rejected both arguments.

The FCA affirmed that overbreadth is supported by the combination of subsections 27(3) and 27(4) of the Patent Act and therefore, remains a proper ground of invalidity. While overbreadth can overlap with other grounds of invalidity, it is a distinct ground that must be considered separately.

Seedlings contended that an element described in the patent disclosure but not claimed cannot be considered an essential element that goes to the core of the invention and therefore, should not be considered when assessing overbreadth. The FCA disagreed, stating that “determining whether a feature is essential is a distinct exercise for the purpose of overbreadth than for the purpose of claim construction.” The FCA clarified that the test for assessing essentiality for the purpose of overbreadth is whether the element is “so key to the invention described in the disclosure that a claim that omits it encompasses embodiments that were not contemplated in the disclosure.” 

Finally, the FCA found that the trial judge, despite having erred in some aspects of the law on overbreadth, had applied the correct legal principles and made no palpable or overriding error.

Anticipation, Obviousness and Insufficiency

The Federal Court also held that some claims were anticipated and obvious in view of earlier auto-injector patents. Seedlings argued that the trial judge (1) misunderstood the doctrine of approbation and reprobation (i.e., accepting Pfizer’s position that a prior patent did not anticipate its next generation EpiPen patent but anticipated Seedlings’ patent), and (2) engaged in a tortured reading of the prior art (i.e., finding that a prior patent taught a needle shield with three positions rather than only two positions). The FCA agreed with the trial judge that the doctrine of approbation and reprobation does not apply to this case and found no reviewable error in the trial judge’s analysis.  

While Pfizer’s allegation of insufficiency was dismissed at trial, the FCA found that all relevant claims of the 935 patent were also insufficient based on the trial judge’s finding that a skilled person would not know how to make a device without certain elements described in the disclosure but which do not appear in the claims.

Remedies

Although the issues on remedies were moot, the FCA disagreed with the Federal Court’s ruling that a patentee who makes profits by licensing its patent should not be entitled to elect an accounting of profits. The FCA was concerned that such a broad principle can have the potential effect of forcing specialist inventors to choose between business efficiency by selling licences to their patents and retaining their right to elect infringement remedies. It further noted that the purpose of an accounting of profits is to deter wrongful conduct rather than to compensate the patentee for its losses.

Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.

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