Abbott Laboratories et al. v. Canada (Minister of Health) et al., (2008) 354 F.T.R. 1 (FC)

• Judge: Barnes, J.
• Court: Federal Court (Canada)
• Case Date: March 18, 2008
• Jurisdiction: Canada (Federal)
• Citations: (2008), 354 F.T.R. 1 (FC);2008 FC 352

Abbott Lab. v. Can. (2008), 354 F.T.R. 1 (FC)

MLB headnote and full text

Temp. Cite: [2008] F.T.R. TBEd. MR.030

Abbott Laboratories and Abbott Laboratories Limited (applicants) v. The Minister of Health and Sandoz Canada Inc. (respondents)

(T-1672-06; 2008 FC 352)

Indexed As: Abbott Laboratories et al. v. Canada (Minister of Health) et al.

Federal Court

Barnes, J.

March 18, 2008.

Summary:

Sandoz moved under ss. 6(5)(a) and 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations, SOR/1993-133, for the dismissal in part of Abbott Laboratories' prohibition application in respect of clarithromycin patents which included patent 2,387,361.

A Prothonotary of the Federal Court, in a decision unreported in this series, dismissed Sandoz's motion. Sandoz appealed.

The Federal Court allowed the appeal in part.

Editor's Note: For related decisions, see 307 F.T.R. 271 (F.C.), affd. 370 N.R. 109 (F.C.A.).

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order (incl. compensation by first person) - [See first Food and Drug Control 1109.1 ].

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - Sandoz moved under ss. 6(5)(a) and 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations, SOR/1993-133, for the dismissal in part of Abbott Laboratories' prohibition application in respect of Abbott's clarithromycin patents which included patent 2,387,361 (the '361 patent) - Heneghan, J., had earlier declared the '361 patent to be ineligible for listing on the Patent Register - Sandoz argued that it would be an abuse of process to re-litigate this issue in this proceeding either because the issue of eligibility was resolved for all purposes by Heneghan, J., or, alternatively, because Abbott failed to put all of the claims of the '361 patent into play in that proceeding and thereby failed to "put its best foot forward" - The Federal Court rejected this argument and dismissed Sandoz's motion respecting this issue - Heneghan, J., dealt with process claims while this proceeding dealt with claims for the use of a medicine - See paragraphs 1 to 8.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The Federal Court discussed the proper test for the listing of patents on the Patent Register under the Notice of Compliance Regulations in force prior to October 5, 2006, and the process by which a listing could be challenged by a "second person" - See paragraphs 9 to 14.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - Sandoz moved under ss. 6(5)(a) and 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations, SOR/1993-133, for the dismissal in part of Abbott Laboratories' prohibition application in respect of Abbott's clarithromycin patents - Sandoz questioned the eligibility of the Abbott patents for listing on the Patent Register against Abbott's 1998 Notice of Compliance which allowed for a monograph revision for Biaxin pertaining to a new indication for the medicine clarithromycin in a triple therapy regimen to treat H. pylori - Abbott's experts testified that, notwithstanding the fact that the Abbott patents did not refer to combination therapies, the medicinal use claims in those patents did not exclude, and therefore included, such uses - They believed that what was important was the claimed use of clarithromycin in Forms I, II and 0 as antibiotics to treat bacterial infections such as H. pylori and not precisely how those medicines could be therapeutically administered - The Federal Court dismissed Sandoz's motion on this issue where the weight of judicial authority favoured Abbott's construction of the subject claims in Abbott patents - See paragraphs 15 to 26.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - Sandoz moved under ss. 6(5)(a) and 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations, SOR/1993-133, for the dismissal in part of Abbott Laboratories' prohibition application in respect of Abbott's clarithromycin patents - Sandoz questioned the eligibility of the Abbott patents for listing on the Patent Register against Abbott's 2003 Notice of Compliance (NOC) for a new formulation for its 500 mg tablet of Biaxin - This NOC authorized substantive changes to Abbott's clarithromycin product - The Federal Court allowed Sandoz's motion on this issue - The court accepted Sandoz's position that Abbott's 2003 NOC would not support the listing of the Abbott patents because there was no apparent linkage between the asserted claims and the product changes that were authorized by that NOC - See paragraphs 27 to 30.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - Sandoz moved under ss. 6(5)(a) and 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations, SOR/1993-133, for the dismissal in part of Abbott Laboratories' prohibition application in respect of Abbott's clarithromycin patents - Sandoz questioned the eligibility of the Abbott patents for listing on the Patent Register - Sandoz argued that the clarithromycin products claimed in the Abbott patents had, in proceedings involving other generics, been declared to be old products or their uses well-known - In the result, Sandoz said that the Abbott application was an abuse of process by re-litigation and should be struck - The Federal Court rejected the argument and dismissed the motion on this issue - The earlier decisions relied upon by Sandoz did not examine the patent claims that were in issue in this proceeding - In addition, Abbott "correctly" said that it did not intend to re-litigate any patent claims that were previously resolved against it - See paragraphs 31 to 40.

Cases Noticed:

Wyeth Canada et al. v. ratiopharm Inc. et al. (2007), 370 N.R. 89; 60 C.P.R.(4th) 375; 2007 FCA 264, reving. in part (2007), 370 N.R. 89; 2007 FC 340, refd to. [para. 9].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2004), 320 N.R. 37; 31 C.P.R.(4th) 321; 2004 FCA 154, refd to. [para. 15].

Abbott Laboratories Ltd. et al. v. Canada (Minister of Health) et al. (2006), 304 F.T.R. 104; 55 C.P.R.(4th) 48; 2006 FC 1411, affd. (2007), 367 N.R. 120; 2007 FCA 251, consd. [paras. 22, 23].

AstraZeneca AB et al. v. Apotex Inc. et al. (2007), 314 F.T.R. 177; 60 C.P.R.(4th) 199; 2007 FC 688, refd to. [para. 23].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2006), 350 N.R. 242; 2006 FCA 187, consd. [para. 35].

Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al., [2008] 1 F.C.R. 174; 364 N.R. 325; 2007 FCA 163, refd to. [para. 36].

Counsel:

Steven Mason and David Tait, for the applicants;

Ed Hore, Kevin Zive and Geoff Langen, for the respondent;

William Platt, for the respondent.

Solicitors of Record:

McCarthy Tétrault LLP, Toronto, Ontario, for the applicants;

Hazzard & Hore LLP, Toronto, Ontario, for the respondent;

John H. Sims, Q.C., Deputy Attorney General of Canada, Toronto, Ontario, for the respondent.

This appeal was heard at Toronto, Ontario, on January 22 and 23, 2008, by Barnes, J., of the Federal Court, who delivered the following decision on March 18, 2008.