Date: 20050513
Docket: A-80-04
Citation: 2005 FCA 183
CORAM: LINDEN J. A.
SEXTON J. A
EVANS J. A.
BETWEEN:
ASTRAZENECA AB and
ASTRAZENECA CANADA INC.
Appellants
(Applicants)
and
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
(Respondents)
Heard at Toronto, Ontario, on May 3, 2005.
Judgment delivered at Ottawa, Ontario, on May 13, 2005.
REASONS FOR JUDGMENT BY: EVANS J.A.
CONCURRED IN BY: LINDEN J.A.
SEXTON J.A.
Date: 20050513
Docket: A-80-04
Citation: 2005 FCA 183
CORAM: LINDEN J. A.
SEXTON J. A
EVANS J. A.
BETWEEN:
ASTRAZENECA AB and
ASTRAZENECA CANADA INC.
Appellants
(Applicants)
and
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
(Respondents)
REASONS FOR JUDGMENT
A. INTRODUCTION
[1] This is an appeal by the appellants, AstraZeneca AB and AstraZeneca Canada Inc. ("AstraZeneca"), from a decision by Justice Russell of the Federal Court, reported as AstraZeneca AB and AstraZeneca Canada Inc. v. Apotex Inc. and the Minister of Health (2004), 245 F.T.R. 196, 2004 FC 44.
[2] The Judge dismissed AstraZeneca's application for an order pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, to prohibit the Minister of Health from issuing a notice of compliance ("NOC") to Apotex Inc. in respect of its Apo-Omeprazole tablets, until the expiry of AstraZeneca's Canadian Patent 2,166,794 ("'794 Patent").
[3] In my opinion, Russell J. made no reversible error in dismissing the application and, despite the broad jurisprudential terrain over which Mr. Gaikis, counsel for the appellants, led us, this appeal can be decided on quite narrow grounds.
B. ISSUES AND ANALYSIS
Issue 1: sufficiency of the detailed statement
[4] AstraZeneca says that Apotex' notice of allegation ("NOA") does not "provide a detailed statement of the legal and factual basis for the allegation" pursuant to subparagraph 5(1)(b)(iv) of the Regulations that, "by the making, constructing, using or selling" its omeprazole tablets, Apotex will infringe no claims in the '794 Patent, either for the medicine itself or the use of it. As a result, the NOA does not comply with paragraph 5(3)(a) of the Regulations and is defective.
[5] In particular, AstraZeneca submits that, while Apotex' detailed statement addressed claim 22 in the '794 Patent for tablets containing magnesium omeprazole having a degree of crystallinity higher than 70%, it did not address the independent claim for the raw material itself, which is asserted in claim 1. Thus, AstraZeneca argues that, although Apotex' allegation of non-infringement was broad enough to cover claims 1 and 22 of the '794 Patent, the detailed statement supported only claim 22.
[6] Finally, AstraZeneca contrasts the present NOA with one served by Apotex in 1997 in connection with the same patent, which responded to both claims by stating that Apotex would only use magnesium omeprazole with a degree of crystallinity lower than 70%.
[7] Apotex' detailed statement is contained in its letter to AstraZeneca, dated December 12, 2001.
The claims of [the '794] patent relate only to magnesium omeprazole having a degree of crystallinity higher than 70% as determined by x-ray powder diffraction, processes for making same, compositions containing same, and use of same.
Our tablets will not infringe by reason of the fact that the tablets will contain only amorphous magnesium omeprazole [emphasis added].
[8] In the circumstances of this case, Russell J. found (at para. 66) Apotex' detailed statement to be sufficient, on the ground that,
when read together, the two paragraphs are clear enough to me that there will be no infringement of process, composition or use claims because only amorphous magnezium [sic] omeprazole will be involved.
In other words, he interpreted the statement as addressing claims 1 and 22 of the '794 Patent.
[9] Whether the detailed statement in the NOA sufficiently addressed both claims is a question of mixed fact and law: Pfizer Canada Inc. v. Apotex Inc. (2004), 329 N.R. 152, 2004 FCA 398. Since no general legal principle can readily be extricated from the Judge's conclusion that it did, this Court can only interfere if satisfied that the decision is vitiated by some palpable and overriding error: Housen v. Nikolaisen, [2002] 2 S.C.R. 235, 2002 SCC 33. In my opinion, it is not.
[10] First, the first paragraph of Apotex' detailed statement, quoted at [7] above, explicitly recognizes that the '794 Patent claims for both the "composition containing" magnesium omeprazole having a degree of crystallinity higher than 70% and the "use of same". Hence, it was not unreasonable for the Judge to conclude that a mind willing to understand would construe the second paragraph as covering both of the claims described in the first. Unlike the situation in Genpharm Inc. v. AB Hassle (2004), 329 N.R. 374, 2004 FCA 413, this is not a case of an obviously missed claim.
[11] Second, AstraZeneca's argument that the NOA was not sufficient because the detailed statement did not address claim 1 depends on its theory that infringing omeprazole could convert into its amorphous form in the course of the manufacture of the tablets. However, Russell J. was not satisfied on the evidence before him that Apotex could start with magnesium omeprazole having a degree of crystallinity higher than 70% and, in the course of the tableting process, convert it into non-infringing amorphous omeprazole in the tablets. A second person should not be required to anticipate every theory of possible infringement, however speculative, in the detailed statement supporting its allegations.
[12] Third, a detailed statement of the bases of an allegation must be sufficiently complete to enable a patentee to make an informed decision as to whether to respond to the allegation by instituting proceedings for an order of prohibition: AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (F.C.A ) at para. 21. InSmithKline Beecham Inc. v. Apotex Inc. (2001), 10 C.P.R. (4th) 338 (F.C.A.) at para. 27, Noël J.A. held that the detailed statement in that case was not insufficient "in the sense that it left SmithKline having to guess at the real grounds for the respondents' allegation that the patent would not be infringed."
[13] In the present case, it is clear from AstraZeneca's notice of application that it understood that it would be open to it to attempt to establish that the allegation of non-infringement in the NOA was not justified, on the ground that Apotex could use infringing omeprazole in the process of manufacturing the tablets, even if, in their finished form, the tablets contained only amorphous magnesium omeprazole. No affidavit was filed on behalf of AstraZeneca stating that it was not in a position to decide whether to challenge Apotex' NOA because of the detailed statement's lack of specificity.
[14] I am not persuaded, therefore, that Russell J. made a palpable and overriding error in concluding that the NOA was sufficient.
Issue 2: the evidential issue
[15] AstraZeneca says that Russell J. committed a reversible error when he found that its expert witness, Dr. Ymén, did not support AstraZeneca's theory that magnesium omeprazole having a degree of crystallinity higher than 70% could be converted into amorphous magnesium omeprazole in the process of manufacturing Apo-Omeprazole tablets.
[16] In the relevant paragraph of his affidavit, on which he was not cross-examined, Dr. Ymén stated:
The assertion that Apotex' tablets will contain only amorphous magnesium omeprazole only addresses the state of magnesium omeprazole in the Apotex tablet. Apotex makes no assertion regarding the crystallinity of the magnesium omeprazole used during the processing steps leading to such tablets, which could have a degree of crystallinity higher than 70%.
[17] Having described (at para. 80) Dr. Ymén's evidence as "surprisingly brief and unhelpful", Russell J. regretted (at para. 82) that, "on such a crucial issue, Dr. Ymén was not a little more forthcoming about the basis for such a claim". Further, he added (at para. 85), "Dr. Ymén could quite easily have explained matters further, but he chose not to do so". In the result, the Judge concluded that the possibility that Apotex could use magnesium omeprazole having a degree of crystallinity higher than 70% in the process of manufacture, and then convert it into the amorphous form contained in the Apo-Omeprazole tablets remained no more than "a vague theoretical doubt".
[18] Housen v. Nikolaisen has provided (at para. 25) a forceful reminder that, in making assessments of the evidence, even if, as here, it was not viva voce, the Judge at first instance is entitled to considerable deference from an appellate court. And, in AB Hassle v. Canada (Minister of National Health and Welfare) (2002), 22 C.P.R. (4th) 1 (F.C.A.) at para. 30, appellate court deference was said also to extend to documentary expert evidence.
[19] I have not been persuaded that Russell J.'s assessment of the evidence of Dr. Ymén was based on some error of law or contained a palpable and overriding error. Nor do I find that AstraZeneca's case is materially advanced by Dr. Sherman's answers, in response to cross-examination on his affidavit, when he referred to Dr. Ymén's "speculation" that Apotex could start the tableting process with infringing material. Dr. Sherman flatly denied that this occurred in the manufacturing process of Apo-Omeprazole. To the extent that Dr. Sherman addressed the possibility of a conversion at all, he described the development of crystals from an amorphous form, not vice versa as AstraZeneca alleges could occur. It is not the role of this Court to make its own assessment of Dr. Sherman's evidence.
[20] Finally, I would note that, unlike the patent considered in Glaxo Group Ltd. v. Canada (Minister of National Health and Welfare) (1998), 80 C.P.R. (3d) 424 (F.C.T.D.), the '794 Patent does not teach conversion.
Issue 3: abuse of process
[21] In an attempt to curb the proliferation of litigation in this notoriously highly litigious area, the Court has held that it is an abuse of process for a second person to repeat an allegation in a second NOA, unless the legal and factual bases are separate and distinct from those supporting its earlier allegation: see, for example, Bayer AG v. Apotex Inc. (1998), 84 C.P.R. (3d) 23 ((F.C.T.D.) at paras. 27-28, aff'd. (2001), 14 C.P.R. (4th) 263 (F.C.A.).
[22] In this case, AstraZeneca says that Apotex' allegation giving rise to this proceeding is not "separate and distinct" from an allegation it served in 1997. When Apotex withdrew its 1997 NOA, AstraZeneca discontinued the prohibition proceeding following an agreement between the parties. Hence, it is argued, Apotex is precluded by the doctrine of abuse of process from alleging that its tablets will not infringe claim 22 in the '794 Patent for the content of AstraZeneca's tablets.
[23] In the 1997 NOA, Apotex had stated that its tablets would not infringe the '794 Patent because it would only use magnesium omeprazole having a degree of crystallinity lower than 70%. Dr. Sherman stated that Apotex withdrew this NOA because it was experiencing difficulties in complying with regulatory standards of safety and effectiveness.
[24] AstraZeneca argues that, since the amorphous form of omeprazole, which Apotex now says its tablets contain, has 0% crystallinity, it has a degree of crystallinity lower than 70%, which is what the 1997 NOA alleged.
[25] In my opinion, while 0% is literally less than 70%, it was not unreasonable for the Judge to conclude that the 1997 NOA contemplated some crystallinity, as opposed to the present NOA, which clearly does not, and that the allegations were therefore separate and distinct.
C. CONCLUSIONS
[26] For these reasons, I would dismiss the appeal with costs. Since counsel for Apotex requested a subsequent opportunity to address the scale of costs, this question will be decided on the basis of a motion in writing brought pursuant to rule 369 of the Federal Courts Rules.
"John M. Evans"
J.A.
"I agree
A.M. Linden J.A."
"I agree
J. Edgar Sexton J.A."
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-80-04
STYLE OF CAUSE: ASTRAZENECA AB and ASTRAZENECA CANADA INC. v. APOTEX INC. and THE MINISTER OF HEALTH
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: MAY 3, 2005
REASONS FOR JUDGMENT BY: EVANS J.A.
CONCURRED IN BY: LINDEN AND SEXTON JJ.A.
DATED: MAY 13, 2005
APPEARANCES:
Mr. Gunars Gaikus
Ms. Yoon Kang FOR THE APPELLANT
Mr. Andrew Brodkin FOR THE RESPONDENT
SOLICITORS OF RECORD:
Smart & Biggar
Toronto, Ontario FOR THE APPELLANT
Goodmans LLP
Toronto, Ontario FOR THE RESPONDENT
John H. Sims, Q.C.
Deputy Attorney General of Canada FOR THE RESPONDENT