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Sufficiency Only Requires A Description Of One Way Of Making The Inventive Product

On January 12, the Federal Court of Appeal dismissed Apotex’s appeal of Justice Barnes decision (see our previous post here) holding Canadian Patent No 1,292,693 valid and infringed. The 693 Patent is generally related to an oral pharmaceutical formulation comprising (a) a core region containing omeprazole and an alkaline reacting compound; (b) an inert subcoat disposed on the core; and (c) and outer enteric coating.

Justice Barnes nevertheless found that Apotex’s proposed tablets did contain a substantially continuous in situ formed subcoat resulting from a chemical reaction between ingredients in the core and enteric coat. On appeal, one main issue on the appeal was whether the construction of claim 1 includes an in situ formed subcoat.

Construction

The Court of Appeal reaffirmed that patent construction is a question of a law, reviewable on the standard of correctness. The Court of Appeal, consistent with its recent jurisprudence, however held the trial judge’s appreciation of the expert evidence of how a skilled person would understand the patent was entitled to deference.

Before the Court of Appeal, Apotex did not dispute that the Trial Judge properly summarized the principles of constructions but rather argued that the Trial judge fettered his consideration of the wording of claim 1 by asking whether claim 1 covered an in situ formed subcoating. According to Apotex, the Trial Judge improperly applied a results oriented approach which failed to properly consider the disclosure of the 693 Patent. Apotex further argued that since the 693 Patent did not disclose the possibility of an in situ subcoat, claim 1 could not include this subject matter.

After exhaustively considering the disclosure to determine the inventors’ objective intention, the Court of Appeal confirmed that the Trial Judge was correct in construing claim 1 as a product claim that was not limited by any process by which the subcoating was made, with Justice Gauthier holding:

[62] With respect to the word “subcoating”, it is defined in the claim itself as one or more layers made of one of the selected materials described in the product claims. As the word itself indicates, this or these layers are under the enteric coating (thus subcoating). The evidentiary record and the disclosure support the Federal Court’s finding that it would be understood by the skilled person that these layers are substantially continuous, with a thickness appropriate to their purpose. It is not the role of this Court to reweigh the evidence in that respect. It was also open to the Federal Court to conclude as it did with respect to the meaning of the word “inert”. Contrary to what Apotex suggested, that expression in section (b) of Claim 1 refers to the state of the layer or layers in the finished oral pharmaceutical preparation.

[63] I am satisfied that the expression “disposed on”, which expression is not a term of art, meant to describe the position or spatial arrangement in the final structure of the claimed preparations. I agree with the Federal Court that the disclosure does not attribute a particular meaning such as “coated” or “applied” to this expression. In my view, it is telling that this nontechnical expression is used instead of words like “coated” or “applied” when describing this aspect of the invention at page 5. The drafter chose to use a different expression than when describing how one can make these preferred embodiments and the process claimed throughout the disclosure. This construction is perfectly in harmony with the purpose of the invention as noted by Justice Rothstein at paragraph 23 of AB Hassle referred to in the Reasons at paragraph 173. It is also in line with the inventive concept agreed upon by the parties and used by the Federal Court in its unchallenged findings that the invention was new and not obvious.

Validity – Sufficiency

Apotex argued that if Claim 1 covers a formulation having an in situ subcoat, the 693 Patent was invalid for failing to teach the skilled person how to make such a formulation. In rejecting Apotex’s argument, the Court of Appeal distinguished the case law relied upon by Apotex and held that that it is sufficient if the specification discloses one way of making the inventive product:

[79] It is well established in patent law that when one claims a new and inventive product, an inventor is only required to enable the person skilled in the art to work the invention. He or she need only describe one method or process for making it (see for example Cobalt Pharmaceuticals Company v. Bayer Inc., 2015 FCA 116 at para. 68, 474 N.R. 311). Thus, in my view on the law as it stands, the Federal Court made no palpable and overriding error in finding that the information contained in the 693 Patent is sufficient

A copy of the Court of Appeal’s Reasons for Judgment may be found here.