Abbott Laboratories et al. v. Canada (Minister of Health) et al., 2006 FCA 187
Judge | Décary, Sharlow and Malone, JJ.A. |
Court | Federal Court of Appeal (Canada) |
Case Date | May 18, 2006 |
Jurisdiction | Canada (Federal) |
Citations | 2006 FCA 187;(2006), 350 N.R. 242 (FCA) |
Abbott Lab. v. Can. (2006), 350 N.R. 242 (FCA)
MLB headnote and full text
Temp. Cite: [2006] N.R. TBEd. JN.011
Abbott Laboratories and Abbott Laboratories Limited (appellants) v. The Minister of Health and Ratiopharm, a Division of Ratiopharm Inc. (respondents)
(A-384-05; 2006 FCA 187)
Indexed As: Abbott Laboratories et al. v. Canada (Minister of Health) et al.
Federal Court of Appeal
Décary, Sharlow and Malone, JJ.A.
May 18, 2006.
Summary:
Abbott sought an order prohibiting the Minister of Health from issuing a Notice of Compliance to Ratiopharm for Clarithromycin 250 mg and 500 mg tablets because it infringed Abbott patents.
The Federal Court, in a decision reported at 277 F.T.R. 262, dismissed the application. Ratiopharm appealed.
The Federal Court of Appeal dismissed the appeal.
Food and Drug Control - Topic 1105
Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - Abbott sought an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Ratiopharm for Clarithromycin 250 mg and 500 mg tablets on the basis that Ratiopharm infringed Abbott patents - Ratiopharm alleged in its Notice of Allegation that an Abbott patent ('274 patent) was invalid - It alleged that, if Clarithromycin Form 0 was eligible for listing under the NOC Regulations, it could only be asserted against the final product produced by a Ratiopharm, not against an intermediate product used by Ratiopharm - The trial judge held that the intermediate was not made, constructed, used or sold as a medicine within s. 5(1)(b)(iv) of the NOC Regulations but was merely a way station on the road to the final product - The Federal Court of Appeal held that "making, constructing, using or selling" in s. 5(1)(b)(iv) described a range of activities that was broader than merely including a patented substance in the proposed new drug - The phrase was broad enough to include the use of the patented substance at an intermediate stage in the production of the proposed new drug - See paragraphs 7 to 17.
Patents of Invention - Topic 1033
The specification and claims - Construction of a patent - By reference to disclosure - Ratiopharm alleged in its Notice of Allegation that an Abbott patent ('606 patent) was invalid due to anticipation - The trial judge agreed - Abbott appealed, arguing that the trial judge erred in his construction of Claim 1 of the '606 patent which read "6-0-methylerythromycin A Form II characterized by peaks in the powder x-ray diffraction pattern having ..." - Abbott argued that the words "Form II", as a coined word with no intrinsic meaning, had to be given the meaning ascribed to them in the disclosure - The disclosure of the '606 patent explained that Form II could be identified in three ways: by the line produced by the powder x-ray diffraction and by two other chemical tests - Abbott argued that the subject of Claim 1 was a substance that was identified by all three of those methods, not only powder x-ray diffraction - The Federal Court of Appeal rejected the argument - Abbott could not answer why the result of the powder x-ray diffraction was described specifically in Claim 1, while the results of the other two tests were not mentioned - See paragraphs 31 to 37.
Patents of Invention - Topic 1603
Grounds of invalidity - Anticipation - By previous published article or patent - Ratiopharm alleged that the discovery by Abbott of Clarithromycin Form 0, over which Abbott claimed a patent, was inherent in the discovery of Clarithromycin by others (i.e., inherent in previous crystallizations of Clarithromycin) - The trial judge rejected the argument - The Federal Court of Appeal held that the allegation of invalidity due to anticipation was justified - A skilled practitioner who made Form I or II Clarithromycin following the teaching of the prior art inevitably would make Form 0, even if no steps were taken to stabilize it -The Form 0 might not be recognized, but that did not matter - See paragraphs 18 to 27.
Cases Noticed:
Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 20].
Synthon BV v. Smithkline Beecham plc, [2005] N.R. Uned. 180; [2005] UKHL 59, refd to. [para. 24].
Smithkline Beecham plc's (Paroxetine Methanesulfonate) Patent, Re - see Synthon BV v. Smithkline Beecham plc.
Lightning Fastener Co. v. Colonial Fastener Co., [1933] S.C.R. 377, refd to. [para. 25].
Technic France S.A.'s Patent, Re, [2004] R.P.C. 919, refd to. [para. 25].
Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88, refd to. [para. 35].
Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2005), 278 F.T.R. 187; 2005 FC 1095, refd to. [para. 38].
Statutes Noticed:
Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance Regulations), SOR/93-133, sect. 5(1)(b)(iv) [para. 13].
Patented Medicines (Notice of Compliance Regulations) - see Patent Act Regulations (Can.).
Authors and Works Noticed:
Hughes, Roger T., and Woodley, John H., Patents (2nd Ed. 2005), p. 134 [para. 25].
Counsel:
Andrew Reddon, Stephen Mason and Marcus Klee, for the appellants;
David Aitken and Geoffrey North, for the respondents.
Solicitors of Record:
McCarthy Tetrault, Toronto, Ontario, for the appellants;
Osler, Hoskin & Harcourt, Ottawa, Ontario, for the respondents.
This appeal was heard at Toronto, Ontario, on April 5 and 6, 2006, by Décary, Sharlow and Malone, JJ.A., of the Federal Court of Appeal. Sharlow, J.A., delivered the following judgment for the court at Ottawa, Ontario, on May 18, 2006.
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