Abbott Laboratories v. Canada (Health)

Abbott Laboratories v. Canada (Health) Court (s) Database Federal Court of Appeal Decisions Date 2007-04-19 Neutral citation 2007 FCA 153 File numbers A-510-05 Notes Digest Decision Content Date: 20070419 Docket: A-510-05 Citation: 2007 FCA 153 CORAM: SHARLOW J.A. MALONE J.A. RYER J.A. BETWEEN: ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED Appellants and THE MINISTER OF HEALTH and APOTEX INC. Respondents Heard at Ottawa, Ontario, on March 7, 2007. Judgment delivered at Ottawa, Ontario, on April 19, 2007. REASONS FOR JUDGMENT BY: SHARLOW J.A. CONCURRED IN BY: MALONE J.A. RYER J.A. Date: 20070419 Docket: A-510-05 Citation: 2007 FCA 153 CORAM: SHARLOW J.A. MALONE J.A. RYER J.A. BETWEEN: ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED Appellants and THE MINISTER OF HEALTH and APOTEX INC. Respondents REASONS FOR JUDGMENT SHARLOW J.A. [1] This is an appeal of a judgment of the Federal Court (2005 FC 1332) dismissing the application of Abbott Laboratories and Abbott Laboratories Limited (collectively, “Abbott”) under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the NOC Regulations), for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. for Apo-Clarithromycin 250 and 500 mg tablets until the expiry of Canadian Patent 2,261,732 (the 732 patent) in 2017. [2] Apotex is seeking a notice of compliance for Apo-Clarithromycin on the basis of an abbreviated new drug submission naming as the comparator drug a product called Biaxin, produced and sold by Abbott since 1993. The medicine in both products is called “clarithromycin Form II”. The patent list maintained by the Minister in relation to Biaxin includes the 732 patent. [3] Apotex argued as a preliminary point that this appeal is moot because of another Federal Court decision, Abbott Laboratories v. Canada (Minister of Health), 2006 FC 1558. In that case, a judge dismissed an application by Abbott for an order prohibiting the Minister from issuing a notice of compliance to Apotex for Apo-Clarithromycin 250 and 500 mg tablets until after the expiry of a number of patents, one of which is the 732 patent. Abbott has appealed that decision (Court File A-59-07) but without challenging the correctness of that decision in relation to the 732 patent. On that basis, Abbott has conceded that its appeal in this case is now moot. [4] However, Abbott argued that this appeal should be heard despite being moot because of the part of the decision under appeal that was based on Hoffmann-La Roche & Co. Ltd. v. Commissioner of Patents, [1955] S.C.R. 414. Abbott argued that the principle in Hoffmann was incorrectly applied by the Federal Court in this case, and is being relied upon in a number of other matters soon to be heard in the Federal Court. Given the striking similarities between this case and the other cases to which we were referred, the Court permitted the appeal to continue on that one point only. [5] The notice of appeal in this case also challenges the correctness of the judgment under appeal in relation to utility and sound prediction. Those issues were not heard. As Abbott would have had to succeed on those issues as well as the Hoffman issue to achieve a reversal of the judgment under appeal, the judgment under appeal will be affirmed. Facts [6] There are 21 claims in the 732 patent. The first fifteen (claims 1 through 15) claim methods for preparing clarithromycin Form II. Previously, the process for making clarithromycin Form II involved heating clarithromycin Form I to a certain temperature. The process disclosed in the 732 patent is an entirely different process in which clarithromycin Form I is treated with one of a number of solvents and clarithromycin Form II is isolated from the resulting substance. [7] Claims 16 through 21 of the 732 patent claim clarithromycin Form II when made by one of the processes in claims 1 through 15. It is undisputed that those claims are within the scope of the NOC Regulations, while claims 1 through 15 are not. Patent claims that are not within the scope of the NOC Regulations need not be addressed in proceedings under the NOC Regulations. [8] When Apotex filed its abbreviated new drug submission using Biaxin as its comparator, it was obliged by section 5 of the NOC Regulations to address claims 16 through 21 of the 732 in a notice of allegation, failing which it would not be entitled to a notice of compliance for its product until after the expiry of the 732 patent. Apotex served a notice of allegation asserting on a number of grounds that claims 16 through 21 are invalid. Abbott considered the allegations of invalidity not to be justified, and responded with an application for an order prohibiting the Minister from issuing a notice of compliance to Apotex. That application failed, resulting in this appeal. The presumption of validity [9] It is now beyond debate that an applicant for a prohibition order under the NOC Regulations bears the burden of establishing its entitlement to the order. Abbott argues that the Judge in this case failed to recognize and apply that principle correctly, in light of the presumption of validity in subsection 43(2) of the Patent Act, R.S.C. 1985, c. P-4, which reads as follows: 43. (2) After the patent is issued, it shall, in the absence of any evidence to the contrary, be valid and avail the patentee and the legal representatives of the patentee for the term mentioned in section 44 or 45, whichever is applicable. 43. (2) Une fois délivré, le brevet est, sauf preuve contraire, valide et acquis au breveté ou à ses représentants légaux pour la période mentionnée aux articles 44 ou 45. [10] In my view, the Judge made no such error. The presumption in subsection 43(2) is weakly worded (Apotex Inc. v. Wellcome Foundation Limited, [2002] 4 S.C.R. 153, per Justice Binnie at paragraph 43). It cannot determine the outcome of prohibition proceedings under the NOC Regulations if, as in this case, the record contains any evidence that, if accepted, is capable of rebutting the presumption (see Rubbermaid (Canada) Ltd. v. Tucker Plastic Products Ltd. (1972), 8 C.P.R. (2d) 6 (F.C.T.D.) at page 14, and Bayer Inc. v. Canada (Minister of National Health and Welfare) (2000), 6 C.P.R. (4th) 285, at paragraph 9). Invalidity allegation based on Hoffmann [11] The only ground of invalidity to be considered in this appeal is the allegation that claims 16 through 21 are invalid because they are claims for a known substance. That allegation is based on the Hoffmann case, cited above. [12] Hoffmann involved an application for a patent that claimed a new process for making a known substance called aldehyde, as well as aldehyde when made by that process. The Commissioner of Patents granted the claim for the new process for making aldehyde, but not the claim for aldehyde made by that process. The inventor appealed to the Exchequer Court, without success: Hoffmann-La Roche Ltd. v. Canada (Commissioner of Patents), [1954] Ex. C.R. 52, and then to the Supreme Court of Canada, again without success. [13] Then, as now, a patent could be issued only for an “invention”, defined as follows: . . . “invention” means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter. . . . « invention » Toute réalisation, tout procédé, toute machine, fabrication ou composition de matières, ainsi que tout perfectionnement de l’un d’eux, présentant le caractère de la nouveauté et de l’utilité. [14] The inventor’s appeal was rejected because there was nothing new about aldehyde, regardless of how it was made, and the degree of novelty required for a patent cannot be achieved by associating a known substance with a new process for making it. The inventor was entitled to patent protection for what had actually been invented, which was the new process, but no more. That protection was assured because anyone making aldehyde in Canada by the new process, or importing into Canada any aldehyde made by the new process, would necessarily be infringing the claim for the process. [15] There is no jurisprudence that casts any doubt on the correctness of the principle stated in Hoffmann. I did not understand Abbott to argue that Hoffmann is no longer good law. [16] Rather, Abbott argues that the Hoffmann principle should not have been applied in this case because the facts are not analogous. Abbott argues that clarithromycin Form II, unlike aldehyde, was not “known” at the relevant date. The parties seem to have accepted without debate that the relevant date was July 29, 1996. [17] It is not clear from Hoffmann or the later jurisprudence how one is to discern whether, for the purposes of applying the Hoffmann principle, a substance is “known” at a particular point in time. In this case, it was assumed in argument that a substance is “known” if a hypothetical claim for its invention would fail on the ground of anticipation of lack of novelty. I have proceeded on the basis of that same assumption, although I would leave open the possibility that a substance might be “known” if a hypothetical claim for its invention would fail for other reasons. [18] In this case, the Judge found that clarithromycin Form II was known at the relevant time. That conclusion is supported by a body of evidence to the effect that the creation of a crystal form of clarithromycin by the use of solvents was known prior to July 29, 1996. I need not list all the prior art references. It is sufficient to say that the Judge understood the evidence of Dr. Myerson, a witness for Abbott, to confirm that an article by Yoshiaki Watanabe and others, published in 1993 in The Journal of Antibiotics, describes substantially the same process as described in example 10 of the disclosure in the 732 patent, which is said to result in clarithromycin Form II. [19] Abbott points out that that the Watanabe article does not state that the result of the process in the article is clarithromycin Form II. Nor is there evidence that any of the witnesses for Apotex attempted to follow the Watanabe article to see if it produced clarithromycin Form II. Because of that, it would have been open to the Judge to draw an inference adverse to Apotex on that point. [20] However, the Judge also had before him the patent disclosure representing that the method described in example 10 results in clarithromycin Form II. There was no evidence that the representation in example 10 is false. Therefore, it was open to the Judge to infer that following substantially the same process as described in the Watanabe article would also have produced clarithromycin Form II. Given the body of evidence presented to the Judge, I cannot conclude that he made a palpable and overriding error in accepting the truth of the representation in example 10 of the patent disclosure and following its logic. [21] The conclusion of the Judge is also supported by evidence relating to the creation of clarithromycin Form II by a heating technique that was known before 1996. Clarithromycin Form II can be obtained by heating clarithromycin Form I by that known technique until its temperature exceeds 135˚C. It is undisputed that clarithromycin Form I, when so heated, is transformed into clarithromycin Form II at some point after the heated substance reaches 135˚C, although it ceases to be clarithromycin Form II by the time the substance reaches the melting point at 225˚C. [22] Abbott argues that a person skilled in the art who heated clarithromycin Form I by the known technique would not and could not know that clarithromycin Form II had been created, unless they also knew that the heating process had to be stopped before the substance reached its melting point at 225˚C. In my view, the absence of that knowledge is legally irrelevant. The undisputed evidence is that clarithromycin Form II would have been present if the heating technique had been followed. There were well established analytical techniques that would have disclosed its presence if anyone had cared to look at the appropriate moment. [23] It was argued by Abbott that the sale of clarithromycin Form II in Canada prior to 1993 in the form of Biaxin could not establish that clarithromycin Form II was a known substance on July 29, 1996. As the Judge did not rely on prior sales as a factor in concluding that clarithromycin Form II was a known substance, it is not necessary to deal with that point. Conclusion [24] As explained above, this appeal must be dismissed. As Abbott did not succeed on the only point that was permitted to be argued, the costs of this appeal should be borne by Abbott. “K. Sharlow” J.A. “I agree B. Malone J.A.” “I agree C. Michael Ryer J.A.” FEDERAL COURT OF APPEAL NAMES OF COUNSEL AND SOLICITORS OF RECORD DOCKET: A-510-05 APPEAL FROM AN ORDER OF THE FEDERAL COURT DATED SEPTEMBER 28, 2005, NO. T-1133-02 STYLE OF CAUSE: ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED v. THE MINISTER OF HEALTH and APOTEX INC. PLACE OF HEARING: Ottawa, Ontario DATE OF HEARING: March 7, 2007 REASONS FOR JUDGMENT BY: SHARLOW J.A. CONCURRED IN BY: MALONE J.A. RYER J.A. DATED: April 19, 2007 APPEARANCES: Andrew J. Reddon Steven G. Mason FOR THE APPELLANTS Andrew Brodkin FOR THE RESPONDENT, APOTEX INC. SOLICITORS OF RECORD: McCarthy Tétrault LLP Toronto, Ontario FOR THE APPELLANTS John H. Sims, Q.C. Deputy Attorney General of Canada Ottawa, Ontario Goodmans LLP Toronto, Ontario FOR THE RESPONDENT, THE MINISTER OF HEALTH FOR THE RESPONDENT, APOTEX INC.