Pfizer

Teva Canada Limited (appellant) v. Pfizer Canada Inc., Pfizer Inc., Pfizer Ireland Pharmaceuticals, Pfizer Research and Development Company N.V./S.A. and Minister of Health (respondents) and Canadian Generic Pharmaceutical Association and Canada's Research-Based Indexed As: Pfizer Canada Inc. et al. v. Novopharm Ltd. et al.
McLachlin, C.J.C., LeBel, Deschamps, Abella, Rothstein, Cromwell and Moldaver, JJ.
Summary:
Pfizer Canada Inc. and others (collectively, Pfizer) applied for an order under the Patented Medicines (Notice of Compliance) Regulations prohibiting the Minister of Health fromissuing a Notice of Compliance to Novopharm Ltd. for a generic version of Viagra until Pfizer'sCanadian Patent 2,163,446 (the '446 patent) expired. Novopharm alleged that the '446 patent wasinvalid for obviousness, lack of utility and insufficiency of disclosure.
The Federal Court, in a decision reported at 352 F.T.R. 35, allowed the application.
The Federal Court of Appeal, in a decision reported at 408 N.R. 166, dismissed the appeal. Novopharm appealed. The main issue in the appeal was whether Pfizer failed to properlydisclose its invention when it obtained the patent for Viagra.
The Supreme Court of Canada allowed the appeal. Pfizer's patent application did not satisfy the disclosure requirements provided for in s. 27(3) of the Patent Act.
Patents of Invention - Topic 5
General - Nature and purpose of grant of patent - The Supreme Court of Canada statedthat "[t]he patent system is based on a 'bargain', or quid pro quo: the inventor is grantedexclusive rights in a new and useful invention for a limited period in exchange fordisclosure of the invention so that society can benefit from this knowledge. This is thebasic policy rationale underlying the [Patent] Act. The patent bargain encouragesinnovation and advances science and technology. . Therefore, adequate disclosure in thespecification is a precondition for the granting of a patent." - See paragraphs 31 to 35.
Patents of Invention - Topic 705
Application for grant - General - Disclosure and examination (incl. duty of candour) -
[See Patents of Invention - Topic 5].
Patents of Invention - Topic 1128
The specification and claims - The description - Sufficiency of disclosure - [See Patents
of Invention - Topic 5 and all Patents of Invention - Topic 1779].
Patents of Invention - Topic 1501
Grounds of invalidity - General - Pfizer Canada Inc. and others (collectively, Pfizer)applied for an order under the Patented Medicines (Notice of Compliance) Regulationsprohibiting the Minister of Health from issuing a Notice of Compliance to NovopharmLtd. for a generic version of Viagra until Pfizer's Canadian Patent 2,163,446 (the '446patent) expired - The '446 patent claimed the use of many compounds in claims 1 to 7 forthe treatment of erectile dysfunction (ED), including sildenafil citrate, the activecompound in Viagra - The Supreme Court of Canada held that Pfizer's patent applicationdid not satisfy the disclosure requirements provided for in s. 27(3) of the Patent Act - Atissue was what was the appropriate remedy - Although s. 27 of the Act did not specify aremedy for insufficient disclosure, the logical consequence of a failure to properlydisclose the invention and how it worked would be to deem the patent in question invalid- This flowed from the quid pro quo principle underpinning the Act - If there was no quid- proper disclosure - then there can be no quo - exclusive monopoly rights - Seeparagraphs 81 to 87.
Patents of Invention - Topic 1724
Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction -
[See first Patents of Invention - Topic 1779].
Patents of Invention - Topic 1779
Grounds of invalidity - Insufficiency - Particular cases - Pfizer Canada Inc. and others(collectively, Pfizer) applied for an order under the Patented Medicines (Notice ofCompliance) Regulations prohibiting the Minister of Health from issuing a Notice ofCompliance to Novopharm Ltd. for a generic version of Viagra until Pfizer's CanadianPatent 2,163,446 (the '446 patent) expired - The '446 patent claimed the use of manycompounds in claims 1 to 7 for the treatment of erectile dysfunction (ED), includingsildenafil citrate, the active compound in Viagra - Novopharm alleged that the '446 patentwas invalid for insufficiency - Novopharm also submitted that the '446 patent was invalidfor insufficient disclosure of sound prediction - The Supreme Court of Canada held thatthis was not a case about sound prediction and Novopharm's argument on this point hadto fail - Utility could be demonstrated by, for example, conducting tests, but this did notmean that there was a separate requirement for the disclosure of utility - In fact, there wasno requirement whatsoever in s. 27(3) of the Patent Act to disclose the utility of theinvention - In any event, Pfizer disclosed the utility of sildenafil by disclosing that testshad been conducted - Sildenafil was found to be useful before the priority date - Seeparagraphs 36 to 43.
Patents of Invention - Topic 1779
Grounds of invalidity - Insufficiency - Particular cases - Pfizer Canada Inc. and others(collectively, Pfizer) applied for an order under the Patented Medicines (Notice ofCompliance) Regulations prohibiting the Minister of Health from issuing a Notice ofCompliance to Novopharm Ltd. for a generic version of Viagra until Pfizer's CanadianPatent 2,163,446 (the '446 patent) expired - The '446 patent claimed the use of manycompounds in claims 1 to 7 for the treatment of erectile dysfunction (ED), includingsildenafil citrate, the active compound in Viagra - Novopharm alleged that the '446 patent was invalid for insufficiency - Pfizer asserted that the disclosure was sufficient becausethe requirements of s. 27(3) of the Patent Act were met - Pfizer further submitted that s.
58 of the Act allowed courts to consider valid claims separately from those that were notvalid - The Supreme Court of Canada held that this was a misinterpretation of s. 58 -Section 58 simply stated that valid claims survived in the face of one or more invalidclaims - This section was engaged once it had been determined, on the basis of the patentas a whole, whether the requirements, including the disclosure requirements, had beencomplied with - Section 58 did not allow a court to consider the validity of a single claim,Claim 7 in this case, independently of the rest of the specification, even if the claim inquestion was the only one that might be valid - This section was engaged only after thevalidity analysis was carried out - See paragraph 56.
Patents of Invention - Topic 1779
Grounds of invalidity - Insufficiency - Particular cases - Pfizer Canada Inc. and others(collectively, Pfizer) applied for an order under the Patented Medicines (Notice ofCompliance) Regulations prohibiting the Minister of Health from issuing a Notice ofCompliance to Novopharm Ltd. for a generic version of Viagra until Pfizer's CanadianPatent 2,163,446 (the '446 patent) expired - The '446 patent claimed the use of manycompounds in claims 1 to 7 for the treatment of erectile dysfunction (ED), includingsildenafil citrate, the active compound in Viagra - Novopharm alleged that the '446 patentwas invalid for insufficiency - Pfizer asserted that the disclosure was sufficient becausethe requirements of s. 27(3) of the Patent Act were met - It contended that what had to bedisclosed was the invention and that, since the invention in this case was sildenafil, thedisclosure had to be assessed only in relation to that claimed invention - According toPfizer, even if a skilled person were to consider Patent '446 as a whole, he or she wouldunderstand the invention to be a class of compounds useful to treat ED, where ninespecific compounds (including sildenafil) were especially preferred and two specificcompounds (including sildenafil) were individually claimed - The Supreme Court ofCanada held that Pfizer's patent application did not satisfy the disclosure requirementsprovided for in s. 27(3) - The Act required that the court consider the specification as awhole to determine whether the disclosure of the invention was sufficient - Here, therewas nothing to support the view that the use of sildenafil for the treatment of ED was aseparate invention from the use of any of the other claimed compounds for that samepurpose - No specific attributes or characteristics were ascribed to sildenafil that wouldset it apart from the other compounds - Even if the court took into consideration the factthat sildenafil was an "especially preferred compound", there was still nothing thatdistinguished it from the other eight "especially preferred compounds" - The use ofsildenafil and the other compounds for the treatment of ED comprised one inventiveconcept - Although patent '446 included the statement that "one of the especiallypreferred compounds induces penile erection in impotent males", the specification did notindicate that sildenafil was the effective compound, that Claim 7 contained the compoundthat worked, or that the remaining compounds in the patent had been found not to beeffective in treating ED - "The disclosure in the specification would not have enabled thepublic 'to make the same successful use of the invention as the inventor could at the timeof his application', because even if a skilled reader could have narrowed the effectivecompound down to the ones in Claim 6 and Claim 7, further testing would have been required to determine which of those two compounds was actually effective in treatingED." - See paragraphs 44 to 80. Cases Noticed:
C.H. Boehringer Sohn v. Bell-Craig Ltd., [1962] Ex. C.R. 201, affd. [1963] S.C.R. 410, Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al., [2009] 1 F.C.R. 253; 377 N.R. 9; 2008 FCA 108, refd to. [para. 10].
Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390, Noranda Mines v. Minerals Separation North America Corp., [1947] Ex. C.R. 306, refd Merck & Co. et al. v. Apotex Inc. (2006), 282 F.T.R. 161; 53 C.P.R.(4th) 1; 2006 FC 524, affd., [2007] 3 F.C.R. 588; 354 N.R. 51; 55 C.P.R.(4th) 1; 2006 FCA 323, refd to.
[para. 21].
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. 25].
Tubes, Ld. v. Perfecta Seamless Steel Tube Co. (1902), 20 R.P.C. 77, refd to. [para. 33].
Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 323 F.T.R. 56; 63 C.P.R.(4th) 406; 2008 Eli Lilly Canada Inc. v. Apotex Inc. et al. (2009), 392 N.R. 243; 78 C.P.R.(4th) 388; 2009 Monsanto Canada Inc. et al. v. Schmeiser et al., [2004] 1 S.C.R. 902; 320 N.R. 201; 2004 Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 SCC Pioneer Hi-Bred Ltd. v. Commissioner of Patents, [1989] 1 S.C.R. 1623; 97 N.R. 185, Hoechst Pharmaceuticals of Canada Ltd. v. Gilbert & Co., [1965] 1 Ex. C.R. 710, affd.
[1966] S.C.R. 189, refd to. [para. 62].
Authors and Works Noticed:
Hughes, Roger T., and Woodley, John H., Patents (2nd Ed.) (Looseleaf), vol. 1, p. 333 Perry, Stephen J. and Currier, T. Andrew, Canadian Patent Law (2012), §§ 7.11 [para.
38]; 7.12 [para. 41]; 8.55 [para. 78]; 8.57 [para. 79]; 15.2 [para. 55]; 15.26 [para.
69].
Counsel:
David W. Aitken, Marcus Klee and Ildiko Mehes, for the appellant;Andrew Shaughnessy, Andrew Bernstein and Yael Bienenstock, for the respondents, Pfizer Canada Inc., Pfizer Inc., Pfizer Ireland Pharmaceuticals and PfizerResearch and Development Company N.V./S.A; Jonathan Stainsby and Andrew Skodyn, for the intervener, the Canadian Generic Patrick S. Smith and Jane E. Clark, for the intervener, Canada's Research-Based No one appeared for the respondent, the Minister of Health.
Solicitors of Record:
Osler, Hoskin & Harcourt, Ottawa, Ontario, for the appellant;Torys, Toronto, Ontario, for the respondents, Pfizer Canada Inc., Pfizer Inc., Pfizer Ireland Pharmaceuticals and Pfizer Research and Development CompanyN.V./S.A.; Heenan Blaikie, Toronto, Ontario, for the intervener, the Canadian Generic Gowling Lafleur Henderson, Ottawa, Ontario, for the intervener, Canada's Research- This appeal was heard on April 18, 2012, by McLachlin, C.J.C., LeBel, Deschamps, Abella, Rothstein, Cromwell and Moldaver, JJ., of the Supreme Court of Canada. The followingjudgment of the Supreme Court was delivered in both official languages by LeBel, J., onNovember 8, 2012.
Patents of Invention - Topic 705
Application for grant - General - Disclosure and examination (incl. duty of candour) -TheSupreme Court of Canada stated that "[t]he patent system is based on a 'bargain', or quidpro quo: the inventor is granted exclusive rights in a new and useful invention for alimited period in exchange for disclosure of the invention so that society can benefit fromthis knowledge. This is the basic policy rationale underlying the [Patent] Act. The patentbargain encourages innovation and advances science and technology. . Therefore,adequate disclosure in the specification is a precondition for the granting of a patent." -See paragraphs 31 to 35.
Patents of Invention - Topic 1128
The specification and claims - The description - Sufficiency of disclosure - The SupremeCourt of Canada stated that "[t]he patent system is based on a 'bargain', or quid pro quo:the inventor is granted exclusive rights in a new and useful invention for a limited periodin exchange for disclosure of the invention so that society can benefit from thisknowledge. This is the basic policy rationale underlying the [Patent] Act. The patentbargain encourages innovation and advances science and technology. . Therefore,adequate disclosure in the specification is a precondition for the granting of a patent." -See paragraphs 31 to 35.
Patents of Invention - Topic 1128
The specification and claims - The description - Sufficiency of disclosure - Pfizer CanadaInc. and others (collectively, Pfizer) applied for an order under the Patented Medicines (Notice of Compliance) Regulations prohibiting the Minister of Health from issuing aNotice of Compliance to Novopharm Ltd. for a generic version of Viagra until Pfizer'sCanadian Patent 2,163,446 (the '446 patent) expired - The '446 patent claimed the use ofmany compounds in claims 1 to 7 for the treatment of erectile dysfunction (ED),including sildenafil citrate, the active compound in Viagra - Novopharm alleged that the'446 patent was invalid for insufficiency - Novopharm also submitted that the '446 patentwas invalid for insufficient disclosure of sound prediction - The Supreme Court ofCanada held that this was not a case about sound prediction and Novopharm's argumenton this point had to fail - Utility could be demonstrated by, for example, conducting tests,but this did not mean that there was a separate requirement for the disclosure of utility -In fact, there was no requirement whatsoever in s. 27(3) of the Patent Act to disclose theutility of the invention - In any event, Pfizer disclosed the utility of sildenafil bydisclosing that tests had been conducted - Sildenafil was found to be useful before thepriority date - See paragraphs 36 to 43.
Patents of Invention - Topic 1128
The specification and claims - The description - Sufficiency of disclosure - Pfizer CanadaInc. and others (collectively, Pfizer) applied for an order under the Patented Medicines(Notice of Compliance) Regulations prohibiting the Minister of Health from issuing aNotice of Compliance to Novopharm Ltd. for a generic version of Viagra until Pfizer'sCanadian Patent 2,163,446 (the '446 patent) expired - The '446 patent claimed the use ofmany compounds in claims 1 to 7 for the treatment of erectile dysfunction (ED),including sildenafil citrate, the active compound in Viagra - Novopharm alleged that the'446 patent was invalid for insufficiency - Pfizer asserted that the disclosure wassufficient because the requirements of s. 27(3) of the Patent Act were met - Pfizer furthersubmitted that s. 58 of the Act allowed courts to consider valid claims separately fromthose that were not valid - The Supreme Court of Canada held that this was amisinterpretation of s. 58 - Section 58 simply stated that valid claims survived in the faceof one or more invalid claims - This section was engaged once it had been determined, onthe basis of the patent as a whole, whether the requirements, including the disclosurerequirements, had been complied with - Section 58 did not allow a court to consider thevalidity of a single claim, Claim 7 in this case, independently of the rest of thespecification, even if the claim in question was the only one that might be valid - Thissection was engaged only after the validity analysis was carried out - See paragraph 56.
Patents of Invention - Topic 1128
The specification and claims - The description - Sufficiency of disclosure - Pfizer CanadaInc. and others (collectively, Pfizer) applied for an order under the Patented Medicines(Notice of Compliance) Regulations prohibiting the Minister of Health from issuing aNotice of Compliance to Novopharm Ltd. for a generic version of Viagra until Pfizer'sCanadian Patent 2,163,446 (the '446 patent) expired - The '446 patent claimed the use ofmany compounds in claims 1 to 7 for the treatment of erectile dysfunction (ED),including sildenafil citrate, the active compound in Viagra - Novopharm alleged that the'446 patent was invalid for insufficiency - Pfizer asserted that the disclosure wassufficient because the requirements of s. 27(3) of the Patent Act were met - It contendedthat what had to be disclosed was the invention and that, since the invention in this case was sildenafil, the disclosure had to be assessed only in relation to that claimed invention- According to Pfizer, even if a skilled person were to consider Patent '446 as a whole, heor she would understand the invention to be a class of compounds useful to treat ED,where nine specific compounds (including sildenafil) were especially preferred and twospecific compounds (including sildenafil) were individually claimed - The SupremeCourt of Canada held that Pfizer's patent application did not satisfy the disclosurerequirements provided for in s. 27(3) - The Act required that the court consider thespecification as a whole to determine whether the disclosure of the invention wassufficient - Here, there was nothing to support the view that the use of sildenafil for thetreatment of ED was a separate invention from the use of any of the other claimedcompounds for that same purpose - No specific attributes or characteristics were ascribedto sildenafil that would set it apart from the other compounds - Even if the court took intoconsideration the fact that sildenafil was an "especially preferred compound", there wasstill nothing that distinguished it from the other eight "especially preferred compounds" -The use of sildenafil and the other compounds for the treatment of ED comprised oneinventive concept - Although patent '446 included the statement that "one of theespecially preferred compounds induces penile erection in impotent males", thespecification did not indicate that sildenafil was the effective compound, that Claim 7contained the compound that worked, or that the remaining compounds in the patent hadbeen found not to be effective in treating ED - "The disclosure in the specification wouldnot have enabled the public 'to make the same successful use of the invention as theinventor could at the time of his application', because even if a skilled reader could havenarrowed the effective compound down to the ones in Claim 6 and Claim 7, furthertesting would have been required to determine which of those two compounds wasactually effective in treating ED." - See paragraphs 44 to 80. Patents of Invention - Topic 1724
Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction-Pfizer Canada Inc. and others (collectively, Pfizer) applied for an order under thePatented Medicines (Notice of Compliance) Regulations prohibiting the Minister ofHealth from issuing a Notice of Compliance to Novopharm Ltd. for a generic version ofViagra until Pfizer's Canadian Patent 2,163,446 (the '446 patent) expired - The '446 patentclaimed the use of many compounds in claims 1 to 7 for the treatment of erectiledysfunction (ED), including sildenafil citrate, the active compound in Viagra -Novopharm alleged that the '446 patent was invalid for insufficiency - Novopharm alsosubmitted that the '446 patent was invalid for insufficient disclosure of sound prediction -The Supreme Court of Canada held that this was not a case about sound prediction andNovopharm's argument on this point had to fail - Utility could be demonstrated by, forexample, conducting tests, but this did not mean that there was a separate requirement forthe disclosure of utility - In fact, there was no requirement whatsoever in s. 27(3) of thePatent Act to disclose the utility of the invention - In any event, Pfizer disclosed theutility of sildenafil by disclosing that tests had been conducted - Sildenafil was found tobe useful before the priority date - See paragraphs 36 to 43.

Source: http://files.slaw.ca/cases/pfizer_2012-11-21.pdf