CASE: Apotex Inc. et. al. v. Adir and Servier Canada Inc. (Federal Court of Appeal)

DRUG: Perindopril (COVERSYL®)

NATURE OF CASE: Patent Infringement Action and Invalidity and Competition Counterclaim

SUCCESSFUL PARTY: Adir and Servier Canada Inc.

DATE OF DECISION: June 30, 2009

SUMMARY:

On June 30, 2009, the Federal Court of Appeal ("FCA") upheld the decision of Snider J. who had found Canadian Patent No. 1,341,196 ("'196 patent") valid and infringed by Apotex Inc.’s use, sale and export of its Apo-perindopril product1. The FCA found that Apotex’s allegations of error largely related to factual determinations made by the trial judge for which no palpable and overriding error had been shown. Furthermore, Justice Snider did not err in respect of any allegations that related to questions of law. Ogilvy Renault LLP represented Adir and Servier Canada Inc. at both the trial and appeal level.

Apotex’s alleged errors were classified as follows: 1) nature of the invention, 2) obviousness 3) first inventorship, 4) utility, 5) sound prediction, 6) claim 5 corrections and 7) Competition Act .

Nature of the invention – Apotex argued that Snider J. erred in concluding that claims 1, 2, 3 and 5 of the '196 patent disclose one or more inventions distinct from the larger class of compounds described in the specification. Apotex maintained that the general formula found in the disclosure constitutes the invention and nothing else. The FCA rejected this argument, finding that Snider J. followed the jurisprudence which requires claims construction antecedent to issues of infringement and validity. The FCA held that Snider J. did not conclude that each claim discloses a separate invention. Rather, she concluded that "this case is one where reading the claims in light of the specification results in more than one invention". The FCA held that the Patent Act specifically contemplates the possibility of a patent containing more than one invention.

Obviousness – The FCA noted that the question of obviousness is largely a factual inquiry. Snider J.’s decision preceded the recent decision of the Supreme Court of Canada which re-framed the test for obviousness, however the FCA held that her reasoning was consistent therewith. The FCA endorsed and adopted the reasoning of a UK decision (Angiotech) in which the House of Lords held that “the invention is the product specified in a claim and the patentee is entitled to have the question of obviousness determined by reference to his claim and not to some vague paraphrase based upon the extent of his disclosure in the specification.” In dismissing Apotex’s various allegations of error, the FCA found that Apotex’s argument was partly a “rehashing” of its thesis regarding the nature of the invention.

First Inventorship – At trial, Justice Snider dismissed Apotex’s argument that the Adir scientists were not the first inventors of the '196 patent for two reasons: a) Apotex had failed to establish the existence of a "missed conflict" required by s. 61(1)(b); and, b) Apotex had failed to demonstrate that the invention had previously been known or used by another. The FCA found that there was no palpable and overriding error in Snider J.’s "painstaking" review of the evidence which led her to conclude that there was no evidence to show that another (Dr. Smith) was the first to know or use the invention of the '196 patent. The FCA confirmed that to have done so, Dr. Smith must have "planted [her] flag at the precise destination before the patentee" which included either demonstrating or soundly predicting utility of the claimed invention. In view of this finding, the FCA did not need to address section 61(1)(b).

Utility – The FCA held that the promise of a patent is an aspect of claims construction and therefore a question of law generally requiring the assistance of expert evidence, as in this case. The FCA upheld Justice Snider’s finding that the '196 patent promised enzyme inhibition and that therapeutic use was possible but not guaranteed. The FCA also upheld her finding that the abstract cannot be used to construe the promise of the patent (section 175 of the Patent Act). The FCA agreed that the trial judge ought not to have limited the promise to in vitro enzyme inhibition and struck "when measured in vitro" from her conclusion. However, that error did not affect the outcome.

Sound Prediction – The FCA upheld Snider J.’s determination that a patent does not need to soundly predict how to make the invention. Rather, “the sufficiency of disclosure is the appropriate line of inquiry to sustain an allegation that the subject-matter of a patent could not be made.”

Claim 5 Corrections – The FCA found there to be no reason to interfere with Snider J.’s factual findings and that a review of the evidence leads "inescapably" to the conclusion she reached.

Competition Act – The FCA noted that it has repeatedly held that undue impairment of competition cannot be inferred from evidence of the exercise of rights under the Patent Act alone. Apotex’s arguments were based on "speculation" and it failed to demonstrate a palpable and overriding error. The FCA held that there must be “something more” than the mere assertion of patent rights to sustain a violation under s. 45 of the Competition Act. The FCA had "some difficulty conceptualizing that an agreement effecting a remedy that was open to the court to grant and was placed before the court for its approval could constitute an offence under the Competition Act."

LINK TO DECISION:

The decision has not yet been posted, the citation will be 2009 FCA 222.