Bayer Inc. et al. v. Cobalt Pharmaceuticals Co. et al., (2013) 441 F.T.R. 72 (FC)

• Judge: Hughes, J.
• Court: Federal Court (Canada)
• Case Date: October 22, 2013
• Jurisdiction: Canada (Federal)
• Citations: (2013), 441 F.T.R. 72 (FC);2013 FC 1061

Bayer Inc. v. Cobalt Pharmaceuticals (2013), 441 F.T.R. 72 (FC)

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[French language version follows English language version]

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

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Temp. Cite: [2013] F.T.R. TBEd. OC.035

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

(T-215-12; 2013 FC 1061; 2013 CF 1061)

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

Federal Court

Hughes, J.

October 22, 2013.

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 allowed the application with respect to one patent and dismissed it with respect to the second patent.

Courts - Topic 101

Stare decisis - Authority of judicial decisions - English, American and foreign authorities - General - 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 - Each party sought to rely on foreign court decisions - The Federal Court stated that "None of these decisions is precedential in a Canadian Court. There may be many differences in the patents considered there, and here, that are critical. The evidence may have been different. There are differences in the law. I therefore note that different Courts and different judges can and do come to different results. These cases illustrate that. This is particularly so where the cases are vigorously contested and the decisions to be made could, in many cases, go either way; depending on the specifics of the patent, the evidence and the law with which each Court had to deal." - See paragraph 21.

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 product until the expiry of the applicants' patents - The Federal Court stated that "It has been firmly established by the Court of Appeal that the second person, a generic such as Cobalt, has an obligation in its Notice of Allegation to raise all the facts and legal arguments upon which it relies in support of its allegations. It cannot craft new arguments, or raise new allegations or new facts or new prior art documents not set out in the Notice of Allegation. ... While this may seem draconian since, undoubtedly, new matters may be raised as experts are consulted and evidence emerges, it is equally draconian for the first person who decides to institute proceedings to face shifting allegations and facts. The process is in need of change, but no interested person seems to be pressing for that change." - See paragraphs 34 and 35.

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 product until the expiry of the applicants' '426 and '728 patents - With respect to the '426 patent, Cobalt asserted non-infringement as its products would not be "micronized" - The Federal Court construed the '426 patent as not being restricted to a "micronized" tablet, but restricted only in respect of dissolution parameters - Cobalt had provided no information as to those dissolution parameters - Given that Cobalt was obliged in its notice of allegation to provide sufficient information so that the applicants could come to grip with Cobalt's allegations and it had not supplied sample tablets nor any evidence as to the dissolution parameters of its tablets, the court had to conclude that Cobalt's non-infringement allegations were not justified - See paragraphs 61 to 68.

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 the '426 patent, Cobalt made allegations respecting obviousness and the common general knowledge in the prior art as of August 1999 - The Federal Court 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 concepts 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 - See paragraphs 69 to 88.

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 the '426 patent, Cobalt made allegations respecting inutility and a lack of sound prediction - The Federal Court held that the paragraph of the '426 patent relied on by Cobalt to argue inutility could not be construed as a promise - Rather it was an effort, without being limited to a particular theory, to explain why a rapid dissolution form of the acid-labile substance drospirenone worked even in the acidic environment of the stomach - Cobalt's allegations were not justified - See paragraphs 89 to 100.

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 the '426 patent, Cobalt alleged the use of "about" in specifying the dosage ranges of drospirenone rendered the claims ambiguous - The Federal Court rejected the allegation, accepting that a skilled person would refer to the definition in the USP which defined "about" as indicating a quantity within 10% - See paragraphs 103 to 106.

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 the '728 patent, Cobalt alleged double patenting based on the '426 patent - The application for the '426 patent was filed August 31, 2000 - The patent was issued and granted on February 27, 2006 - The Federal Court held that, given the expiry of the '426 patent (August 31, 2020) and the '728 patent (December 22, 2019), the '426 patent could be challenged for double patenting in light of the '728 patent, but not the other way around - Cobalt had only challenged the '728 patent in light of the '426 patent - Thus, the challenge was not justified - See paragraph 144.

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 the '728 patent, Cobalt alleged double patenting based on the '780 patent issued to the applicants on July 11, 2007, based on an application filed November 16 1990 - The application for the '728 patent was filed December 22, 1994 - The patent was issued on September 1, 2009 - The Federal Court stated that the question was whether the monopoly claimed in the '780 patent was improperly extended by the '728 patent - The question to be asked was whether the claims of one were identical or conterminous with the other or, if not, whether the claims were not patentably distinct - The court accepted that the '680 patent was clearly distinguishable from what was claimed in the '728 patent and the '780 patent did not teach anything that would make that which was claimed in the '728 patent obvious - The double patenting allegation was not justified - See paragraphs 140 to 149.

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 the '728 patent, Cobalt alleged inutility and lack of sound prediction - The Federal Court referred to a list of advantages in the '728 patent and stated that advantages should not be elevated to promises - The list was simply an observation as to advantages expected to be achieved - In alluding to a possibility, an inventor was not promising a result to be achieved - A goal was not necessarily a promise - Cobalt's allegations as to lack of utility and sound prediction were not justified - The utility as to gestodene was established, and the utility of the other gestagens was soundly predicted - See paragraphs 150 to 155.

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 the '728 patent, Cobalt alleged that the claims at issue (claims 1, 2, 6, 7 and 8) were all directed at a method of medical treatment - The Federal Court held that claims 1, 2, 6 and 7 were not the proper matter for a patent as they did not claim a vendible product - Those claims provided for those prescribing or providing contraceptive drugs to choose between a variety of components and a variety of dosage ranges - Only claim 8 survived, as it was directed to a single dosage of each of two compounds - See paragraphs 156 to 162.

Patents of Invention - Topic 1128.2

The specification and claims - The description - Ambiguity - [See fifth Food and Drug Control - Topic 1105 ].

Patents of Invention - Topic 1532

Grounds of invalidity - Want of subject matter - Method of medical treatment - [See ninth Food and Drug Control - Topic 1105 ].

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. common general knowledge and mosaicing) - [See third Food and Drug Control - Topic 1105 ].

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention - Double patenting - [See sixth and seventh Food and Drug Control - Topic 1105 ].

Patents of Invention - Topic 1723

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

Patents of Invention - Topic 1724

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

Cases Noticed:

Gedeon Richter Plc. v. Bayer Schering Pharma G.G., [2011] EWHC 583 (Pat), affd. [2012] EWCA Civ 235, refd to. [para. 20].

Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Co. et al. (2013), 440 F.T.R. 1; 2013 FC 985, refd to. [para. 31].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2011), 420 N.R. 337; 2011 FCA 215, refd to. [para. 32].

AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 256 N.R. 172; 7 C.P.R.(4th) 272 (F.C.A.), refd to. [para. 34].

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. 34].

Apotex Inc. v. Sanofi-Aventis (2013), 447 N.R. 313; 2013 FCA 186, refd to. [para. 92].

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. 145].

Apotex Inc. v. Sanofi-Aventis (2013), 447 N.R. 313; 2013 FCA 186, refd to. [para. 152].

Muhammad v. Canada (Minister of Public Safety and Emergency Preparedness), [2013] F.T.R. Uned. 71; 2013 FC 203, refd to. [para. 164].

Counsel:

Neil Belmore, Lindsay Neidrauer and Ariel Neuer, for the applicants;

Douglas Deeth and Heather Watts, for the respondent Cobalt.

Solicitors of Record:

Belmore Neidraurer LLP, Toronto, Ontario, for the applicants;

Deeth Williams Wall LLP, Toronto, Ontario, for the respondent Cobalt.

This application was heard at Toronto, Ontario, on October 7-10, 2013, by Hughes, J., of the Federal Court, who delivered the following reasons for judgment October 22, 2013.