Novartis Pharmaceuticals Canada Inc. v. Teva Canada Ltd. et al., (2013) 429 F.T.R. 158 (FC)

• Jurisdiction: Federal Jurisdiction (Canada)
• Court: Federal Court (Canada)
• Judge: Hughes, J.
• Citation: (2013), 429 F.T.R. 158 (FC),2013 FC 283
• Date: 19 March 2013

Novartis Pharmaceuticals v. Teva Can. (2013), 429 F.T.R. 158 (FC)

MLB headnote and full text

[French language version follows English language version]

[La version française vient à la suite de la version anglaise]

.........................

Temp. Cite: [2013] F.T.R. TBEd. MR.057

Novartis Pharmaceuticals Canada Inc. (applicant) v. Teva Canada Limited and The Minister of Health (respondents) and Novartis AG and Boehringer Mannheim GmbH (respondent/patentees)

(T-1420-11)

Novartis Pharmaceuticals Canada Inc. (applicant) v. Teva Canada Limited and The Minister of Health (respondents) and Novartis AG and Roche Diagnostics GmbH (respondent/patentees)

(T-288-12; 2013 FC 283; 2013 CF 283)

Indexed As: Novartis Pharmaceuticals Canada Inc. v. Teva Canada Ltd. et al.

Federal Court

Hughes, J.

March 19, 2013.

Summary:

Novartis Pharmaceuticals Canada Inc. (first person) held Notices of Compliance to sell a bone mechanism regulator product containing zoledronate as an active agreement. Teva Canada Ltd. (second person) sought a Notice of Compliance for two zoledronic acid IV infusion products until the expiry of each of Canadian Letters Patent No. 1,338,895 and 1,338,937. Novartis filed two applications seeking to restrain the Minister of Health from issuing a Notice of Compliance to Teva until the expiry of each of the patents. Teva claimed that the patents were invalid.

The Federal Court held that Teva's allegations with respect to invalidity, on the basis of inutility and lack of sufficiency of the '895 patent (claim 14) were justified thus the prohibition application was dismissed with respect to that patent. The court found that Teva's allegations with respect to invalidity of the '937 patent were not justified thus the application was allowed in respect of that patent.

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - Date for determining sufficiency - The Federal Court discussed what was the appropriate date for determining sufficiency - The court concluded that the most appropriate date for consideration of sufficiency of a Canadian patent was the date of publication (i.e., the date the public was seized with the application) - In the case of an "old" Patent Act patent it would be the day that the patent was issued and granted - In the case of a "new" Act patent, it would be the date of publication - See paragraphs 179 to 188.

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - The Federal Court held that for a disclosure to be sufficient, it had to enable a person skilled in the art, having only the disclosure, to put the invention into practice - However, the specification did not have to set out all the advantages, nor all the reasons why the invention worked - See paragraphs 174 and 175.

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - Novartis (first person) held Notices of Compliance to sell a bone mechanism regulator product containing zoledronate as an active agreement (Canadian Patent No. 1,338,937 (claims 1 and 2) and Canadian Patent No. 1,338,895 (claim 14), both "old" Patent Act patents) - Claim 14 of the '895 patent was an independent claim respecting a broad family of compounds while the '937 patent related only to one compound (zoledronate) - Teva (second person) sought a Notice of Compliance - Novartis applied for a prohibition order - Teva challenged the patents' validity, alleging insufficiency - The Federal Court held that the appropriate date for determining sufficiency was the date of publication, which in the case of "old" Patent Act patents was the date the patent was issued and granted - The '895 patent, claim 14, was insufficient even on the date it was issued and granted - However, as of the date the '937 patent was issued and granted, the allegations as to insufficiency were not justified - See paragraphs 173 to 189.

Patents of Invention - Topic 1133

The specification and claims - The description - Particular patents - [See third Patents of Invention - Topic 1128 ].

Patents of Invention - Topic 1136

The specification and claims - The description - Chemicals - [See third Patents of Invention - Topic 1128 ].

Patents of Invention - Topic 1502

Grounds of invalidity - Onus and standard of proof - The Federal Court quoted the following statement as to burden of proof in Notice of Compliance (NOC) proceedings: "There have been many decisions addressing the question of burden when the issue in NOC proceedings is that of patent validity ... To put the matter briefly, the Patent Act, subsection 43(2) affords a patent a presumption of validity. In NOC proceedings the 'second person' must lead some evidence to rebut that presumption. Once such evidence has been led the Court must determine the issue of validity on the usual civil burden of proof having regard to all the relevant evidence." (Pfizer v. Pharmascience, FC 2013) - See paragraph 28.

Patents of Invention - Topic 1581

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - General - The Federal Court agreed that "... one cannot raise the bar too high in respect of obviousness. Research ought to be rewarded, not discouraged ..." - See paragraph 161.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The Federal Court referred to a review of the law respecting obviousness - See paragraph 114.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - Novartis (first person) held Notices of Compliance to sell a bone mechanism regulator product containing zoledronate as an active agreement (Canadian Patent No. 1,338,937 (claims 1 and 2) and Canadian Patent No. 1,338,895 (claim 14)) - Claim 14 of the '895 patent was an independent claim respecting a broad family of compounds while the '937 patent related only one compound (zoledronate) - Teva (second person) sought a Notice of Compliance to sell generic products containing zoledronic acid - Novartis applied for a prohibition order - Teva challenged the validity of the patents, alleging obviousness - The Federal Court found that neither claim 14 of the '895 patent, nor claims 1 and 2 of the '937 patent, were invalid for obviousness - Teva's allegations in that respect were not justified - See paragraphs 114 to 162.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - Novartis (first person) held Notices of Compliance to sell a bone mechanism regulator product containing zoledronate as an active agreement (Canadian Patent No. 1,338,937 (claims 1 and 2) and Canadian Patent No. 1,338,895 (claim 14)) - Claim 14 of the '895 patent was an independent claim respecting a class of 1.2 million compounds - The '937 patent related only to one compound (zoledronate) - Teva (second person) sought a Notice of Compliance to sell generic products containing zoledronic acid - Novartis applied for a prohibition order - Teva challenged the patents' validity, alleging lack of utility - The Federal Court held that because only two of the compounds covered by the '895 patent were tested, it was not established that, as of the Canadian filing date, the class of 1.2 million compounds embraced by claim 14 had utility - Thus Teva's allegations as to lack of utility of claim 14 were justified; however, the allegations of lack of utility respecting claims 1 and 2 of the '937 patent were not justified - See paragraphs 163 to 172.

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - [See Patents of Invention - Topic 1723 ].

Cases Noticed:

Pfizer Canada Inc. et al. v. Pharmascience Inc. et al. (2013), 427 F.T.R. 6; 2013 FC 120, refd to. [para. 28].

AstraZeneca Canada Inc. et al. v. Teva Canada Ltd. et al. (2013), 428 F.T.R. 269; 2013 FC 245, refd to. [para. 116].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2012), 436 N.R. 299; 2012 SCC 60, dist. [para. 127].

Teva Canada Ltd. v. Pfizer Canada Inc. - see Pfizer Canada Inc. et al. v. Novopharm Ltd. et al.

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 122 D.L.R.(3d) 203; 56 C.P.R.(2d) 145, refd to. [para. 129].

Pioneer Hi-Bred Ltd. v. Commissioner of Patents, [1989] 1 S.C.R. 1623; 97 N.R. 185, refd to. [para. 129].

MedImmune Ltd. v. Novartis Pharmaceuticals UK, [2012] EWCA Civ 1234, refd to. [para. 161].

May & Baker Ltd. v. Boots Pure Drug Co. (1950), 67 R.P.C. 23 (H.L.), refd to. [para. 169].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [para. 182].

Biogen Inc. v. Medeva plc, [1997] R.P.C. 1; 205 N.R. 257 (H.L.), refd to. [para. 185].

Authors and Works Noticed:

Terrell on the Law of Patents (16th Ed. 2006), para. 7-93 [para. 184].

Counsel:

Anthony Creber and Livia Aumand, for the applicant, Novartis Pharmaceuticals Canada Inc. (T-1420-11 and T-288-12);

Jeffrey Leon, Dominique T. Hussey and Chandimal Nicholas, for the respondent, Teva Canada Limited (T-1420-11 and T-288-12);

No appearance, for the respondent/patentees, Novartis AG and Boehringer Mannheim GmbH (T-1420-11);

No appearance, for the respondent, The Minister of Health (T-1420-11 and T-288-12);

No appearance, for the respondent/patentees, Novartis AG and Roche Diagnostics GmbH (T-288-12).

Solicitors of Record:

Gowling Lafleur Henderson LLP, Ottawa, Ontario, for the applicant, Novartis Pharmaceuticals Canada Inc. (T-1420-11 and T-288-12);

Bennett Jones LLP, Ottawa, Ontario, for the respondent, Teva Canada Limited (T-1420-11 and T-288-12);

Not represented, for the respondent/patentees, Novartis AG and Boehringer Mannheim GmbH (T-1420-11);

William F. Pentney, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, The Minister of Health (T-1420-11 and T-288-12);

Not represented, for the respondent/patentees, Novartis AG and Roche Diagnostics GmbH (T-288-12).

This application was heard in Ottawa, Ontario, on March 4-7, 2013, by Hughes, J., of the Federal Court, who delivered the following decision on March 19, 2013.