Bayer Inc. et al. v. Cobalt Pharmaceuticals Co. et al., (2015) 474 N.R. 311 (FCA)

• Judge: Pelletier, Stratas and Webb, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: September 11, 2014
• Jurisdiction: Canada (Federal)
• Citations: (2015), 474 N.R. 311 (FCA);2015 FCA 116

Bayer Inc. v. Cobalt Pharmaceuticals (2015), 474 N.R. 311 (FCA)

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[French language version follows English language version]

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

Temp. Cite: [2015] N.R. TBEd. MY.016

Cobalt Pharmaceuticals Company (appellant) v. Bayer Inc. and Bayer Pharma Aktiengesellschaft and The Minister of Health (respondents)

(A-376-13)

Bayer Inc. and Bayer Pharma Aktiengesellschaft (appellants) v. Cobalt Pharmaceuticals Company and The Minister of Health (respondents)

(A-385-13)

(2015 FCA 116; 2015 CAF 116)

Indexed As: Bayer Inc. et al. v. Cobalt Pharmaceuticals Co. et al.

Federal Court of Appeal

Pelletier, Stratas and Webb, JJ.A.

May 4, 2015.

Summary:

The applicant drug companies applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a notice of compliance to the respondent generic drug company in respect of its proposed drospirenone and ethinylestradiol combination product until the expiry of the applicants' two patents.

The Federal Court, in a decision reported at 441 F.T.R. 72, allowed the application with respect to one patent and dismissed it with respect to the second patent. The applicants and the respondent appealed.

The Federal Court of Appeal dismissed the appeals.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of allegation (NOA) - The applicant drug companies applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a notice of compliance to the respondent generic drug company (Cobalt) in respect of its proposed drospirenone and ethinylestradiol combination birth control product until the expiry of the applicants' '426 and '728 patents - With respect to Claim 31 of the '426 patent, Cobalt made allegations of inutility and lack of sound prediction - The applications judge held that Cobalt's allegations were not justified - Cobalt appealed, asserting that the utility of Claim 31 across its scope was not demonstrated because only micronized drospirenone was tested - Consequently, it asserted that Claim 31 was invalid because it depended on an unsound prediction that pharmaceutical compositions containing rapidly dissolving drospirenone particles, however created, would work - The Federal Court of Appeal stated that Cobalt's submissions strayed from its notice of allegations which only alleged that Claim 31 lacked utility because micronized drospirenone had not been demonstrated or soundly predicted to work - It was not open to Cobalt in prohibition proceedings under the Regulations or appeals therefrom to stray from its notice of allegations - Accordingly, the court rejected Cobalt's assertions - See paragraphs 55 to 61.

Patents of Invention - Topic 1006

The specification and claim - General - Interpretation of - The applicant drug companies applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a notice of compliance to the respondent generic drug company (Cobalt) in respect of its proposed drospirenone and ethinylestradiol combination product until the expiry of the applicants' '426 and '728 patents - With respect to the '426 patent, Cobalt asserted non-infringement as Claim 31 was limited to micronized drospirenone particles and Cobalt's products would not be "micronized" - The applications judge construed the '426 patent as not being restricted to a micronized tablet, but restricted only in respect of dissolution parameters - Cobalt appealed, asserting that properly construed, "micronized" should be read into Claim 31 so that it claimed only drospirenone particles in micronized form - The Federal Court of Appeal dismissed the appeal - Cobalt relied on stray phrases in the patent description - Cobalt was "cherry-picking" particular portions of the patent to support the result it wished to reach - Patents were not to be construed in a tendentious way - Rather, the court had to examine the patent as a whole construing the language of the claims with due regard to the inventor's purpose through the eyes of the skilled reader - Examining the patent as a whole, the court had to conclude that Claim 31 embraced all rapidly dissolving drospirenone particles - See paragraphs 26 to 38.

Patents of Invention - Topic 1006

The specification and claim - General - Interpretation of - The applicant drug companies applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a notice of compliance to the respondent generic drug company (Cobalt) in respect of its proposed drospirenone and ethinylestradiol combination birth control product until the expiry of the applicants' '426 and '728 patents - The applications judge dismissed the application with respect to the '728 patent - In construing claim 8 of the '728 patent, the judge stated that there was no certainty as to what precise dosage would be the drospirenone equivalent of 75 ug of gestodene but the most "likely" answer was 2 mg - The applicants appealed, asserting that the judge did not find that the drospirenone dose equivalent of 75 ug of gestodene was 2 mg because the claim was found to be ambiguous, and that the finding of ambiguity was a clear legal error - They further asserted that if the judge did find that the dose equivalent was 2 mg, that finding was also a reversible error - The Federal Court of Appeal stated that too much significance should not be attached to the applications judge's use of "likely" - Where a claim could be construed in a meaningful way, that construction was to be preferred over finding ambiguity - The judge found that the claim posed a challenging question of construction, but was able to construe it and did - The judge found that the dose equivalent was 2 mg - There was no basis for setting aside that construction - The applicants urged the court to essentially re-weigh the expert testimony to find that three mg was the dosage equivalent - Absent palpable and overriding error, the court could not interfere with the judge's assessment of the expert evidence and the judge's preference for one expert over another - The applicants also urged the court to consider a paper published on an unascertained date in 1995 - A patent was read by the skilled reader as of its publication date - For the court to consider the paper, the applicant had to establish that it was published prior to June 29, 1995 (the patent's publication date) - The applicants failed to do so and the judge was correct not to consider the paper - See paragraphs 82 to 98.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - [See both Patents of Invention - Topic 1006 ].

Patents of Invention - Topic 1034

The specification and claims - Construction of a patent - Evidence (incl. extrinsic evidence) - [See second Patents of Invention - Topic 1006 ].

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - The applicant drug companies applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a notice of compliance to the respondent generic drug company (Cobalt) in respect of its proposed drospirenone and ethinylestradiol combination birth control product until the expiry of the applicants' '426 and '728 patents - Cobalt asserted that the '426 patent was invalid based on insufficient disclosure - The applications judge did not consider the argument - Cobalt appealed - The Federal Court of Appeal held that the applications judge erred in not considering the argument - However the disclosure had been sufficient - The invention was that "an oral contraceptive comprised of a combination of drospirenone and ethinylestradiol, the drospirenone may be provided in ... rapidly dissolving form without an enteric coat" - The inventor taught the skilled reader that the invention could be practised by preparing a pharmaceutical composition using micronized drospirenone particles - The inventor had both described the invention and taught the skilled reader how to practice it - See paragraphs 62 to 70.

Patents of Invention - Topic 1128.2

The specification and claims - The description - Ambiguity - [See second Patents of Invention - Topic 1006 ].

Patents of Invention - Topic 1130

The specification and claims - The description - Claims for more than what was invented - The applicant drug companies applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a notice of compliance to the respondent generic drug company (Cobalt) in respect of its proposed drospirenone and ethinylestradiol combination birth control product until the expiry of the applicants' '426 and '728 patents - Cobalt asserted that Claim 31 of the '426 patent was invalid based on overbreadth - The applications judge did not consider the argument - Cobalt appealed - The Federal Court of Appeal held that the applications judge erred in not considering the argument - However, Claim 31 was not overbroad - Claim 31 embraced all drospirenone particles which, when formulated into a tablet, had the required dissolution properties - The disclosure of the '426 Patent extended to drospirenone in forms other than micronized particles - Therefore Claim 31 was not broader than the invention disclosed - Rather, Claim 31 claimed exactly what was invented: the particular solution to a particular problem - See paragraphs 71 to 77.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. common general knowledge and mosaicing) - The applicant drug companies applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a notice of compliance to the respondent generic drug company (Cobalt) in respect of its proposed drospirenone and ethinylestradiol combination birth control product until the expiry of the applicants' '426 and '728 patents - With respect to the '426 patent, Cobalt made allegations respecting obviousness and the common general knowledge in the prior art as of August 1999 - The applications judge concluded that as of August 1999, it was known that a combination of drospirenone and ethinylestradiol in amounts falling within the range stipulated in the claims of the '426 patent could be used as an oral contraceptive - However, the inventive concept was that, in an oral contraceptive comprised of a combination of drospirenone and ethinylestradiol, the drospirenone could be provided in micronized or other rapidly dissolving form without an enteric coat - The difference between the prior art and the inventive concept was not more or less self-evident - The prior art pointed away from providing an acid-labile drug, such as drospirenone, in a rapidly dissolving form - Previous unsuccessful attempts were tested in vitro - The breakthrough was to ignore the in vitro results and test in vivo which gave an unexpected result - The invention was contrary to the thinking at the time and was not obvious - The Federal Court of Appeal dismissed Cobalt's appeal - See paragraphs 44 to 54.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - [See Food and Drug Control - Topic 1105 ].

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - [See Food and Drug Control - Topic 1105 ].

Patents of Invention - Topic 8163

Practice - Appeals - Questions of law, fact or mixed fact and law (incl. applicable standard of review) - The Federal Court of Appeal stated that "The Federal Court's construction of the patent is to be reviewed on the basis of correctness ... As the Supreme Court has said, 'claims construction is a matter of law for the judge' ... This view has been said to stem from the fact that issued letters patent are a 'regulation' under subsection 2(1) of the Interpretation Act ... and, thus, are laws whose interpretation should be reviewed on the basis of correctness ... However, in the process of interpretation, patents are to be read through the eyes of the skilled reader ... The skilled reader approaches the patent with an appreciation of the common general knowledge in the art to which the patent relates. This is not within the purview of a judge, so almost always the parties adduce expert evidence to explain how the skilled reader would read and understand the patent ... The Federal Court's assessment of the expert evidence - for example, evidence concerning the state of scientific knowledge at the relevant time or how a reasonable person skilled in the art would understand the patent - is reviewable for palpable and overriding error ..." - The court added that it had to, and would apply the law as it now stood - However, in the interests of the sound development of the law, the court offered observations for the Supreme Court of Canada to consider in a future case - See paragraphs 12 to 25.

Cases Noticed:

AstraZeneca Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2012), 432 N.R. 292; 2012 FCA 109, refd to. [para. 12].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 SCC 67, refd to. [para. 12].

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. 14].

Wenzel Downhole Tools Ltd. et al. v. National-Oilwell Canada Ltd. et al., [2014] 2 F.C. 459; 443 N.R. 173; 2012 FCA 333, refd to. [para. 15].

Eurocopter v. Bell Helicopter Textron Canada Ltd. et al. (2013), 449 N.R. 111; 2013 FCA 219, refd to. [para. 15].

Weatherford Canada Ltd. et al. v. Corlac Inc. et al. (2011), 422 N.R. 49; 95 C.P.R.(4th) 101; 2011 FCA 228, refd to. [para. 15].

Unilever plc v. Procter & Gamble Inc. (1995), 184 N.R. 378; 61 C.P.R.(3d) 499 (F.C.A.), refd to. [para. 17].

Novartis AG v. Dexcel-Pharma Ltd., [2008] E.W.H.C. 1266 (Pat.); [2008] All E.R. (D) 97, refd to. [para. 18].

Housen v. Nikolaisen et al., [2002] 2 S.C.R. 235; 286 N.R. 1; 219 Sask.R. 1; 272 W.A.C. 1; 2002 SCC 33, refd to. [para. 20].

Allergan Inc. et al. v. Canada (Minister of Health) et al. (2012), 440 N.R. 269; 105 C.P.R.(4th) 371; 2012 FCA 308, refd to. [para. 21].

Creston Moly Corp. v. Sattva Capital Corp., [2014] 2 S.C.R. 633; 461 N.R. 335; 2014 SCC 53, refd to. [para. 24].

Monsanto Canada Inc. et al. v. Schmeiser et al., [2004] 1 S.C.R. 902; 320 N.R. 201; 2004 SCC 34, refd to. [para. 39].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 2008 SCC 61, refd to. [para. 46].

South Yukon Forest Corp. et al. v. Canada (2012), 431 N.R. 286; 2012 FCA 165, refd to. [para. 53].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, refd to. [para. 55].

Sanofi-Aventis Canada Inc. et al. v. Apotex Inc. (2011), 426 N.R. 196; 97 C.P.R(4th) 415; 2011 FCA 300, refd to. [para. 55].

Teva Canada Ltd. v. Novartis AG (2013), 428 F.T.R. 1; 109 C.P.R.(4th) 1; 2013 FC 141, refd to. [para. 56].

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. 61].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 122 D.L.R.(3d) 203, refd to. [para. 64].

Minerals Separation North American Corp. v. Noranda Mines Ltd., [1947] Ex. C.R. 306; 12 C.P.R. 99, refd to. [para. 65].

Pioneer Hi-Bred Ltd. v. Commissioner of Patents, [1989] 1 S.C.R. 1623; 97 N.R. 185; 25 C.P.R.(3d) 257, refd to. [para. 66].

Lundbeck Canada Inc. v. Canada (Minister of Health) et al. (2010), 409 N.R. 322; 88 C.P.R.(4th) 325; 2010 FCA 320, refd to. [para. 67].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al., [2012] 3 S.C.R. 625; 436 N.R. 299; 2012 SCC 60, refd to. [para. 67].

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

AbbVie Corp. et al. v. Janssen Inc., [2014] F.T.R. Uned. 23; 116 C.P.R.(4th) 399; 2014 FC 55, revd. [2014] N.R. Uned. 142; 2014 FCA 242, refd to. [para. 68].

Leithiser and Timberland Ellicott Ltd. v. Pengo Hydra-Pull of Canada Ltd., [1974] 2 F.C. 954; 6 N.R. 301 (F.C.A.), refd to. [para. 74].

Farbwerke Hoechst Akiengesellschaft Vormals Meister Lucius & Bruning v. Commissioner of Patents, [1966] Ex. C.R. 91; 50 C.P.R. 200, affd. [1966] S.C.R. 604, refd to. [para. 74].

Mobil Oil Corp. et al. v. Hercules Canada Inc. (1995), 188 N.R. 382; 63 C.P.R.(3d) 473 (F.C.A.), refd to. [para. 87].

Lubrizol Corp. et al. v. Imperial Oil Ltd. et al. (1990), 39 F.T.R. 161; 33 C.P.R.(3d) 1 (T.D.), affd. (1992), 150 N.R. 207; 45 C.P.R.(3d) 449 (F.C.A.), refd to. [para. 87].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd. (1998), 145 F.T.R. 161; 79 C.P.R.(3d) 193 (T.D.), affd. [2001] 1 F.C. 495; 262 N.R. 137; 10 C.P.R.(4th) 65 (F.C.A.), affd. [2002] 4 S.C.R. 153; 296 N.R. 130, refd to. [para. 87].

Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Co. et al. (2013), 440 F.T.R. 1; 2013 FC 985, affd. (2014), 459 N.R 17; 2014 FCA 17, refd to. [para. 101].

Tennessee Eastman Co. et al. v. Commissioner of Patents, [1974] S.C.R. 111; 33 D.L.R.(3d) 459, refd to. [para. 101].

Authors and Works Noticed:

Fox, Harold G., The Canadian Law and Practice Relating to Letters Patent for Inventions (4th Ed. 1969), p. 349 [para. 39].

Hayhurst, William L., The Distinction Between 'Letters Patent' and 'Patent Specifications': How Did We Get Where We Are? (2006), 57 C.P.R.(4th) 161, generally [para. 23].

Counsel:

Douglas Deeth and Heather Watts, for the appellant, Cobalt Pharmaceuticals Company (A-376-13);

Peter Wilcox, Lindsay Neidrauer and Ariel Nauer, for the respondent, Bayer Inc. and Bayer Pharma Aktiengesellschaft (A-376-13);

Peter Wilcox, Lindsay Neidrauer and Ariel Nauer, for the appellants, Bayer Inc. and Bayer Pharma Aktiengesellschaft (A-385-13);

Douglas Deeth and Heather Watts, for the respondent, Cobalt Pharmaceuticals Company (A-385-13).

Solicitors of Record:

Deeth Williams Wall LLP, Toronto, Ontario, for the appellant, Cobalt Pharmaceuticals Company (A-376-13);

Belmore Neidrauer LLP, Toronto, Ontario, for the respondent, Bayer Inc. and Bayer Pharma Aktiengesellschaft (A-376-13);

William F. Pentney, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, The Minister of Health (A-376-13);

Belmore Neidrauer LLP, Toronto, Ontario, for the appellants, Bayer Inc. and Bayer Pharma Aktiengesellschaft (A-385-13);

Deeth Williams Wall LLP, Toronto, Ontario, for the respondent, Cobalt Pharmaceuticals Company (A-385-13);

William F. Pentney, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, The Minister of Health (A-385-13).

These appeals were heard at Toronto, Ontario, on September 11, 2014, by Pelletier, Stratas and Webb, JJ.A., of the Federal Court of Appeal. The judgment of the court was delivered on May 4, 2015, with the following opinions:

Stratas, J.A. (Webb, J.A., concurring) - see paragraphs 1 to 104;

Pelletier, J.A. - see paragraph 105.