Date: 20000627
Docket: A-39-99
CORAM: LÉTOURNEAU J.A.
ROBERTSON J.A.
SEXTON J.A.
BETWEEN:
APOTEX INC.
Appellant
(Respondent)
AND:
MERCK FROSST CANADA INC. and
MERCK & CO. INC.
Respondents
(Applicants)
- and -
THE MINISTER OF NATIONAL HEALTH AND WELFARE
and KYORIN PHARMACEUTICAL CO., LTD.
Respondents
(Respondents)
Heard at Ottawa, Ontario, Thursday, June 8, 2000
Judgment delivered at Ottawa, Ontario, Tuesday, June 27, 2000
REASONS FOR JUDGMENT BY: LÉTOURNEAU J.A.
CONCURRED IN BY: ROBERTSON J.A.
SEXTON J.A.
Date: 20000627
Docket: A-39-99
CORAM: LÉTOURNEAU J.A.
ROBERTSON J.A.
SEXTON J.A.
BETWEEN:
APOTEX INC.
Appellant
(Respondent)
AND:
MERCK FROSST CANADA INC. and
MERCK & CO. INC.
Respondents
(Applicants)
- and -
THE MINISTER OF NATIONAL HEALTH AND WELFARE
and KYORIN PHARMACEUTICAL CO., LTD.
Respondents
(Respondents)
REASONS FOR JUDGMENT
LÉTOURNEAU J.A.
This is an appeal from a decision of Campbell J. who issued an order against the Minister of National Health and Welfare (Minister) prohibiting the latter from issuing a Notice of Compliance to Apotex, the appellant, for the production of the antibiotic norfloxacin until the expiry of Canadian Patent 1,178,961 (patent "961).
The appellant raised numerous grounds of appeal. After an analysis of these grounds and a careful review of the evidence that was before the Motions judge, I am satisfied, for the following reasons, that the Motions judge came to the right conclusion.
Patent "961 was issued for a process which involved reacting piperazine with quinoline carboxylic acid derivatives, the hydrates and the acid addition salts thereof.
Subsection 41(1) of the Patent Act, R.S.C. 1985, c. P-4, as it then read, protected not only the methods or processes of manufacture as claimed, but also the obvious chemical equivalents of such processes or methods:
41. (1) In the case of inventions relating to substances prepared or produced by chemical processes and intended for food or medicine, the specification shall not include claims for the substance itself, except when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents.
41. (1) Lorsqu"il s"agit d"inventions couvrant des substances préparées ou produites par des procédés chimiques et destinées à l"alimentation ou à la médication, le mémoire descriptif ne doit pas comprendre les revendications pour la substance même, excepté lorsque la substance est préparée ou produite par les modes ou procédés de fabrication décrits en détail et revendiqués, ou par leurs équivalents chimiques manifestes.
(emphasis added)
With respect to the use of carboxylic acid derivatives, claim 11 of patent "961 repeats the statutory protection given by subsection 41(1) against infringement by use of obvious chemical equivalents.
The doctrine of equivalents applies to compositions where there is equivalence between chemical ingredients1:
| ... In its early development, the doctrine was usually applied in cases involving devices where there was equivalence in mechanical components. Subsequently, however, the same principles were also applied to compositions, where there was equivalence between chemical ingredients. Today the doctrine is applied to mechanical or chemical equivalents in compositions or devices. See discussions and cases collected in 3 Walker on Patents (Deller"s ed. 1937) "" 489-492 Ellis; Patent Claims (1949) "" 59-60. |
| What constitutes equivalency must be determined against the context of the patent, the prior art, and the particular circumstances of the case. Equivalence, in the patent law, is not the prisoner of a formula and is not an absolute to be considered in a vacuum. It does not require complete identity for every purpose and in every respect. In determining equivalents, things equal to the same thing may not be equal to each other and, by the same token, things for most purposes different may sometimes be equivalents. Consideration must be given to the purpose for which an ingredient is used in a patent, the qualities it has when combined with the other ingredients, and the function which it is intended to perform. An important factor is whether persons reasonably skilled in the art would have known of the interchangeability of an ingredient not contained in the patent with one that was. |
Basically, there is equivalence when the substituting ingredient or device "performs substantially the same function in substantially the same way to obtain the same result"2.
The expert evidence adduced in the proceedings established that the quinoline carboxylic acid described and used in patent "961 is an electron withdrawing group which contributes to the nucleophilic substitution that occurs when the chloroquinoline compound reacts with the piperazine. The expert evidence also established that bromine used by Apotex at position 3 of its process is an electron withdrawing group like the quinoline carboxylic acid whose function is also to contribute to the same nucleophilic substitution previously mentioned. The expert evidence of Dr. Just supports the proposition that substituting bromine as the appellant did in its process amounts to using obvious chemical equivalents of the methods or processes of manufacture described or claimed by the respondent in patent "961 and "that a person reasonably skilled in the art would have known of the interchangeability of that ingredient not contained in the patent with the one that was"3.
I find no merit in the appellant"s complaint that the Motions judge made "extreme findings of credibility" with respect to the expert opinion of Dr. McClelland who was a key witness for the appellant. A review of the evidence relating to the appellant"s process of manufacturing norfloxacin shows that Dr. McClelland was less than forthright when he testified on the hybrid nature and function of the carbonyl group at C4 as an activating group in the quinoline ring: see his cross-examination at pages 690-693 and 702-706, Appeal Book, vol. III. I cannot say that the Motions judge"s decision to prefer the evidence of Dr. Just over that of Dr. McClelland and to give little weight to the opinion of the latter is arbitrary and unsupported by the record.
In concluding, I do not want to be taken as endorsing the Motions judge"s conclusion that the decision of our Court in Nu-pharm Inc. v. Abbott Laboratories et al.4 stands for the proposition that a subsequent patent can only be relevant to prove the state of the art respecting a patent under consideration when both patents are invented by the same person. Nor do I want to be taken as approving or disproving his finding that patent "466 is an improvement patent. It is unnecessary to rule on this last issue as the affidavit evidence justified the conclusion that the process to be used by Apotex was an obvious chemical equivalent of patent "9615.
For these reasons, I would dismiss the appeal with costs payable to respondents Merck Frosst Canada Inc. and Merck & Co., Inc..
"Gilles Létourneau"
J.A.
"I agree:
J.P. Robertson J.A."
"I agree
J. Edgar Sexton J.A."
__________________1 Graver Tank & Mfg. Co., Inc., et al. v. Linde Air Products Co. (1950), 85 U.S.P.Q. 328 (U.S. Sup. Ct.), at pp. 330-31, quoted in Pfizer Canada Inc. v. Apotex Inc. (1998), 78 C.P.R. (3d) 3, at p. 29 (F.C.T.D.).
2 Id. at p. 330.
3 In this affidavit (Appeal Book, vol. II, p. 260, para. 52), Dr. Just, Merck"s expert, stated that it would be obvious for a person skilled in the art to substitute bromine (an electron withdrawing group) for carboxylic acid (another electron withdrawing group): In light of the general knowledge of nucleophilic aromatic substitution reactions, as summarised in Morrison and Boyd on page 831 (Exhibit "GJ-9"), every chemist skilled in the art would have known that a bromoquinolone such as 6 found in the Apotex synthesis (Scheme 1) had an excellent chance to react with piperazine or a piperazine derivative to provide a compound such as 7.
4 Published as Abbot Laboratories, Ltd. v. Nu-Pharm Inc., [1998] F.C.J. No. 1393 (F.C.A.).
5 Apotex Inc. v. Merck Frosst Canada Inc. et al. (1999) 86 C.P.R. (3d) 489, at p. 491.