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: Thursday 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.