Bayer Inc. et al. v. Apotex Inc. et al., (2014) 454 F.T.R. 48 (FC)

• Judge: Hughes, J.
• Court: Federal Court (Canada)
• Case Date: May 07, 2014
• Jurisdiction: Canada (Federal)
• Citations: (2014), 454 F.T.R. 48 (FC);2014 FC 436

Bayer Inc. v. Apotex Inc. (2014), 454 F.T.R. 48 (FC)

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[French language version follows English language version]

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Temp. Cite: [2014] F.T.R. TBEd. JN.006

Bayer Inc. and Bayer Pharma Aktiengesellschaft (applicants) v. Apotex Inc. and The Minister of Health (respondents)

(T-1579-12; 2014 FC 436; 2014 CF 436)

Indexed As: Bayer Inc. et al. v. Apotex Inc. et al.

Federal Court

Hughes, J.

May 7, 2014.

Summary:

Bayer Inc. and Bayer Pharma Aktiengesellschaft (collectively Bayer) distributed birth control tablets in Canada under the brand name YAZ. Apotex Inc. served on Bayer a Notice of Allegation stating that it had applied for a Notice of Compliance (NOC) in order to distribute in Canada a generic version of Bayer's YAZ tablets. Bayer applied under the provisions of the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a NOC to Apotex Inc. in respect of its proposed drospirenone and ethinylestradiol combination until the expiry of Canadian Letters Patent No. 2,382,426.

The Federal Court found that Apotex's allegations as to non-infringement were justified and dismissed the application. The court found that Apotex's allegations as to invalidity were not justified but that was irrelevant as to the dismissal of the proceedings. While Apotex had been successful in the result that the application was dismissed, it was successful only in the respect of the non-infringement issue. Therefore, Apotex was permitted to recover only one-half of its taxable costs and disbursements to be assessed at the middle of Column IV.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The applicants (collectively Bayer) applied under the provisions of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations) to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in respect of its proposed drospirenone and ethinylestradiol combination until the expiry of Canadian Letters Patent No. 2,382,426 (the '426 Patent) - Apotex alleged that the '426 patent was ineligible for listing by Bayer under the provisions of the NOC Regulations as amended October 5, 2006 - Those allegations were raised in Apotex's Notice of Allegation, but no motion was brought in that respect under s. 6(5)(a) of the NOC Regulations - The Federal Court held that Apotex, having raised the allegations as to eligibility for listing in its Notice of Allegation, could argue the matter at the hearing notwithstanding that no motion was brought under s. 6(5) of the NOC Regulations - See paragraphs 70 to 81.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The applicants (collectively Bayer) distributed birth control tablets in Canada under the brand name YAZ - Apotex Inc. served on Bayer a Notice of Allegation stating that it had applied for a Notice of Compliance (NOC) in order to distribute in Canada a generic version of Bayer's YAZ tablets - Bayer applied under the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations) to prohibit the Minister of Health from issuing a NOC to Apotex in respect of its proposed drospirenone and ethinylestradiol combination until the expiry of Canadian Letters Patent No. 2,382,426 (the '426 Patent) - Apotex alleged that the '426 patent was ineligible for listing by Bayer under the provisions of the NOC Regulations as amended October 5, 2006 - The gist of Apotex's allegation was that Bayer listed the '426 patent under the NOC Regulations in December 2008 as against its YAZ tablets - Those tablets contained, as the active ingredients, drospirenone and a molecular inclusion complex formed between ethinylestradiol (EE) and B-cyclodextrin (i.e., EE-B-cyclodextrin complex) - This was defined by Apotex's expert as a clathrate - Apotex argued that this clathrate was not the ethinylestradiol as claimed in the '426 patent thus the patent was improperly listed in respect of the YAZ product - The Federal Court concluded that given the evidence which it found demonstrated that ethinylestradiol in the particulars of this case included a clathrate of that compound, listing of the '426 patent was not improper - See paragraphs 68 to 69 and 82 to 97.

Food and Drug Control - Topic 1111.2

Drugs - New drugs - Notice of compliance - Costs - The applicants (collectively Bayer) applied to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in respect of its proposed drospirenone and ethinylestradiol combination until the expiry of Canadian Letters Patent No. 2,382,426 (the '426 Patent) - The Federal Court found that Apotex's allegations as to non-infringement were justified and dismissed the application - The court found that Apotex's allegations as to invalidity were not justified but that was irrelevant as to the dismissal of the proceedings - While Apotex had been successful in the result that the application was dismissed, it was successful only in the respect of the non-infringement issue - Therefore, Apotex was permitted to recover only one-half of its taxable costs and disbursements to be assessed at the middle of Column IV - See paragraphs 128 to 129.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - The applicants (collectively Bayer) applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in respect of its proposed drospirenone and ethinylestradiol combination until the expiry of Canadian Letters Patent No. 2,382,426 (the '426 Patent) - With respect to the construction of the claims of the '426 Patent at issue, the contentious issues raised by the parties were whether the claims included drospirenone found as a molecular dispersion and whether the claims included ethinylestradiol in the form of a clathrate - The Federal Court construed the term "drospirenone particles" as appearing in all of the claims at issue not to include a drospirenone solution nor particles of a matrix into which drospirenone had previously been dissolved - The court also concluded that the claims at issue included a clathrate of ethinylestradiol within the term ethinylestradiol - See paragraphs 46 to 61.

Patents of Invention - Topic 1128.2

The specification and claims - The description - Ambiguity - [See Patents of Invention - Topic 1779 ].

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - [See Patents of Invention - Topic 1608 ].

Patents of Invention - Topic 1608

Grounds of invalidity - Anticipation - By clinical studies - The applicants (collectively Bayer) applied to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in respect of its proposed drospirenone and ethinylestradiol combination until the expiry of Canadian Letters Patent No. 2,382,426 (the '426 Patent) - Apotex alleged that the claims at issue of the '426 patent were invalid because, more than one year before the filing date of the application for that patent, Bayer conducted certain clinical studies in Europe and the United States whereby what was claimed was both disclosed and enabled - The Federal Court found that Apotex's allegations that the clinical studies conducted an anticipation of the claims at issue were not justified - There were two considerations that had to be taken into account with respect to the law - The first was whether there was a disclosure of the invention such as would constitute an anticipation under s. 28.2(1)(a) of the Patent Act - The second was whether, nonetheless, the disclosure was exempted from those provisions because it was experimental - There had been established a "theoretical" possibility that a tablet could have been kept and analyzed, therefore the requirements of s. 28.2(1)(a) of the Act had been met - However the theoretical possibility that some tablets were retained and analyzed did not preclude the fact that the studies were experimental, and of necessity, conducted by the provision of tablets to members of the public - Thus these clinical studies were exempted from public use - See paragraphs 98 to 122.

Patents of Invention - Topic 1779

Grounds of invalidity - Insufficiency - Particular cases - The applicants (collectively Bayer) applied to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in respect of its proposed drospirenone and ethinylestradiol combination until the expiry of Canadian Letters Patent No. 2,382,426 (the '426 Patent) - Apotex alleged that claim 31 of the '426 patent was ambiguous/insufficient because a skilled person could not ascertain whether a composition other than a tablet comprising 3 mg of drospirenone possessed by the dissolution profile was required by that claim - In particular, it alleged that claim 31 embraced compositions comprising from about 2 mg to about 4 mg of drospirenone yet the dissolution test described in the patent related only to 3 mg tablets - Further it alleged that claim 31 embraced compositions including tablet, capsule and liquid dosage forms, yet the dissolution test described in the patent related only to a tablet - The Federal Court stated that "Apotex does not argue on the basis on any evidence that it presented rather, it picks at the evidence presented by Bayer through Dr. Davies. I am entirely satisfied on the basis of Dr. Davies' evidence, particularly at paragraphs 385 to 387 of his affidavit that Apotex's allegations in this respect are not justified" - See paragraphs 123 to 126.

Patents of Invention - Topic 2945

Infringement of patent - Chemical products and substances intended for food and medicine - Particular patents - The applicants (collectively Bayer) distributed birth control tablets in Canada under the brand name YAZ - Apotex Inc. served on Bayer a Notice of Allegation stating that it had applied for a Notice of Compliance (NOC) in order to distribute in Canada a generic version of Bayer's YAZ tablets - Bayer applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a NOC to Apotex Inc. in respect of its proposed drospirenone and ethinylestradiol combination until the expiry of Canadian Letters Patent No. 2,382,426 - The Federal Court found that Apotex's allegations as to non-infringement were justified and dismissed the application - The court stated that "Given that the drospirenone is provided in a form which I have found is not within any claim at issue, and given that this is the basis upon which Apotex has alleged non-infringement, I find that Bayer has not established that Apotex's allegation in this regard is not justified" - See paragraphs 62 to 67.

Practice - Topic 7030

Costs - Party and party costs - Entitlement to party and party costs - Where success or fault divided - [See Food and Drug Control - Topic 1111.2 ].

Cases Noticed:

Bayer Inc. et al. v. Cobalt Pharmaceuticals Co. et al. (2013), 441 F.T.R. 72; 2013 FC 1061, refd to. [para. 4].

Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Co. et al. (2013), 440 F.T.R. 1; 2013 FC 985, refd to. [para. 30].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2011), 420 N.R. 337; 2011 FCA 215, refd to. [para. 31].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2000), 256 N.R. 172; 7 C.P.R.(4th) 272 (F.C.A.), refd to. [para. 33].

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al., [2003] 1 F.C. 402; 291 N.R. 339; 2002 FCA 290, refd to. [para. 33].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2005), 282 F.T.R. 8; 2005 FC 1421, refd to. [para. 72].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 370 N.R. 109; 2007 FCA 187, refd to. [para. 73].

Solvay Pharma Inc. et al. v. Apotex Inc. et al. (2008), 323 F.T.R. 1; 64 C.P.R.(4th) 256; 2008 FC 308, refd to. [para. 75].

Baker Petrolite Corp. et al. v. Canwell Enviro-Industries Ltd. et al. (2002), 288 N.R. 201; 17 C.P.R.(4th) 478; 2002 FCA 158, refd to. [para. 117].

Gibney v. Ford Motor Co. of Canada, [1967] 2 Ex. C.R. 279, refd to. [para. 119].

Elias v. Grovesend Tinplate Co. (1890), 7 R.P.C. 455, refd to. [para. 119].

Hi-Qual Manufacturing Ltd. et al. v. Rea's Welding & Steel Supplies Ltd. (1994), 74 F.T.R. 99; 55 C.P.R.(3d) 224 (T.D.), affd. (1995), 184 N.R. 258; 61 C.P.R.(3d) 270 (F.C.A.), refd to. [para. 120].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 28.2(1)(a) [para. 116].

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 2 [para. 82]; sect. 4(2)(a), sect. 4(2)(b) [para. 83]; sect. 5(1), sect. 5(2) [para. 77]; sect. 5(3) [para. 79]; sect. 6(5)(a) [para. 68].

Patented Medicines (Notice of Compliance) Regulations - see Patent Act Regulations (Can.).

Counsel:

Peter Wilcox, Lindsay Neidrauer and Ariel Neuer, for the applicants;

Andrew Brodk and Jenene Roberts, for the respondent, Apotex Inc;

No appearance, for the respondent, Minister of Health.

Solicitors of Record:

Bellmore Neidrauer LLP, Toronto, Ontario, for the applicants;

Goodmans LLP, Toronto, Ontario, for the respondent, Apotex;

William F. Pentney, Deputy Attorney General of Canada, for the respondent, Minister of Health.

This application was heard on April 28 and 29, 2014, at Toronto, Ontario, before Hughes, J., of the Federal Court. Hughes, J., released confidential reasons and judgment on May 7, 2014, and public reasons for judgment on June 4, 2014.