Pfizer Canada Inc. et al. v. Apotex Inc. et al., (2007) 319 F.T.R. 48 (FC)

• Judge: Mosley, J.
• Court: Federal Court (Canada)
• Case Date: June 01, 2007
• Jurisdiction: Canada (Federal)
• Citations: (2007), 319 F.T.R. 48 (FC);2007 FC 971

Pfizer Can. Inc. v. Apotex Inc. (2007), 319 F.T.R. 48 (FC)

MLB headnote and full text

Temp. Cite: [2007] F.T.R. TBEd. OC.008

Pfizer Canada Inc. and Pfizer Ireland Pharmaceuticals (applicants) v. Apotex Inc. and The Minister of Health (respondents)

(T-1314-05; 2007 FC 971)

Indexed As: Pfizer Canada Inc. et al. v. Apotex Inc. et al.

Federal Court

Mosley, J.

September 27, 2007.

Summary:

The applicants (Pfizer) marketed a drug for the treatment of erectile disfunction under the brand name Viagra. Pfizer obtained Canadian Patent No. 2,163,446 (the '446 patent) for the use of the compound sildenafil for that purpose. The respondent (Apotex) argued that the '446 patent was invalid and that it should be allowed to market its own generic version. Pfizer applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex in accordance with s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations for sildenafil, sildenafil citrate, or any drug which had a connection to the drug known as sildenafil citrate, until after the expiry of the '446 patent. Apotex filed a motion, seeking dismissal of the application pursuant to s. 6(5)(a) of the Regulations on the ground that the claims in issue were not eligible for inclusion in the patent list as they were neither claims to a medicine, nor claims to the use of a medicine within the meaning of the Regulations.

The Federal Court held that Pfizer met the burden to establish the validity of the '446 patent on a balance of probabilities. The court granted Pfizer's application for an order to prohibit the issuance of an NOC to Apotex until after the expiry of the '446 patent.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - Pfizer marketed a drug for the treatment of erectile disfunction under the brand name Viagra and it obtained a patent (the '446 patent) for the use of the compound sildenafil for that purpose - Apotex argued that the '446 patent was invalid and that it should be allowed to market its own generic version - Pfizer applied for an order prohibiting the issuance of a Notice of Compliance to Apotex in accordance with s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations until after the expiry of the '446 patent - Apotex filed a motion, seeking dismissal of the application pursuant to s. 6(5)(a) of the Regulations on the ground that the claims in issue were not eligible for inclusion in the patent list - The Federal Court stated that "on a plain language reading of paragraph 6(5)(a), the court would have no jurisdiction to dismiss the entire application were it to conclude that some of the claims of the '446 patent do not meet the eligibility requirements. The wording of paragraph 6(5)(a) is clear that it pertains only to 'patents that are not eligible'. In my view, this would require a finding that none of the claims in a particular patent satisfied the criteria. So long as one or more claims in the patent is eligible, the patent remains eligible" - See paragraph 146.

Food and Drug Control - Topic 1111.4

Drugs - New drugs - Notice of compliance - Evidence and proof (incl. burden of proof) - [See Patents of Invention - Topic 1503 ].

Patents of Invention - Topic 1004

The specification and claims - Substances intended for food and medicine - [See all Patents of Invention - Topic 1032 ].

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - Pfizer marketed a drug for the treatment of erectile disfunction (ED) under the brand name Viagra and it obtained a patent (the '446 patent) for the use of the compound sildenafil for that purpose - Apotex argued that the '446 patent was invalid and that it should be allowed to market its own generic version - Pfizer applied for an order prohibiting the issuance of a Notice of Compliance to Apotex until after the expiry of the '446 patent - Apotex moved to dismiss the application on the ground that the claims in issue were not eligible for inclusion on the patent list - A claim construction issue was raised with respect to the meaning of the phrase "curative or prophylactic", the question being whether those words were meant to apply to the treatment of ED as a symptom, or were meant to apply to the underlying condition causing the ED - Pfizer asserted the former while Apotex asserted the latter - The Federal Court stated that "reading the claims in a purposive way, and having determined from the evidence what the inventors had in mind when they spoke of a 'curative or prophylactic' treatment of ED, I find that the words 'curative' and 'prophylactic' relate to providing a remedy for the symptoms of ED as opposed to the underlying illness or condition" - See paragraphs 28 to 31.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - Pfizer marketed a drug for the treatment of erectile disfunction under the brand name Viagra and it obtained a patent (the '446 patent) for the use of the compound sildenafil for that purpose - Apotex argued that the '446 patent was invalid and that it should be allowed to market its own generic version - Pfizer applied for an order prohibiting the issuance of a Notice of Compliance to Apotex until after the expiry of the '446 patent - Apotex moved to dismiss the application on the ground that the claims in issue were not eligible for inclusion on the patent list - A claim construction issue was raised with respect to the phrase "for the manufacture of a medicament" within claim 1 of the patent - Apotex's argument distinguished between the phrase "use of sildenafil 'for the manufacture of a medicament'" and what was meant by a "claim for the use of the medicine" found in the Patented Medicines (Notice of Compliance) Regulations - The Federal Court stated that "Taking a purposive approach to interpretation of the phrase, I do not see a practical difference. The concepts of medicament and medicine are closely related and often interchangeable ... In referring to either a medicament or medicine employing sildenafil as the active ingredient, it is the sildenafil that would give the medicament or medicine its curative or prophylactic properties" - See paragraphs 32 to 35.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - Pfizer marketed a drug for the treatment of erectile disfunction (ED) under the brand name Viagra and it obtained a patent (the '446 patent) for the use of the compound sildenafil for that purpose - Apotex argued that the '446 patent was invalid and that it should be allowed to market its own generic version - Pfizer applied for an order prohibiting the issuance of a Notice of Compliance to Apotex until after the expiry of the '446 patent - Apotex argued, inter alia, that the '446 patent was invalid on the basis of being broader than the invention made or disclosed - The issue was a matter of claims construction and it turned on the meaning to be given to the words curative and prophylactic, and whether they could pertain to a "treatment" as opposed to a "cure" - The Federal Court stated that "I do not believe that a skilled reader would have thought that the patent was indicating that sildenafil would 'cure' the underlying condition causing the ED. I think a skilled reader would have read the patent as indicating a treatment for ED that was curative or prophylactic in nature with regard to the symptoms of ED. As such, on a balance of probabilities the applicants have demonstrated that this allegation is unsubstantiated" - See paragraphs 136 to 141.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - Pfizer marketed a drug for the treatment of erectile disfunction under the brand name Viagra and it obtained a patent (the '446 patent) for the use of the compound sildenafil for that purpose - Apotex argued that the '446 patent was invalid and that it should be allowed to market its own generic version - Pfizer applied for an order prohibiting the issuance of a Notice of Compliance to Apotex until after the expiry of the '446 patent - Apotex submitted that certain claims of the patent were not eligible for listing on the patent register as the use claimed was not use as a medicine, but rather use for "the manufacture of a medicament" - The Federal Court held that the "use" in the claims should not be interpreted as being the "use" of sildenafil simply "for the manufacture of a medicament" - All of the claims clearly referred to the use of sildenafil, regardless of form - The claims addressed the use of the medicine - See paragraphs 142 to 154.

Patents of Invention - Topic 1352

Disclaimer - Filing of - Pfizer marketed a drug for the treatment of erectile disfunction under the brand name Viagra and it obtained a patent (the '446 patent) for the use of the compound sildenafil for that purpose - Apotex argued that the '446 patent was invalid and it should therefore be allowed to market its own generic version - Pfizer applied for an order prohibiting the issuance of a Notice of Compliance to Apotex until after the expiry of the '446 patent - Two disclaimers had been filed and recorded with respect to the '446 patent - Section 48(1) of the Patent Act allowed for the filing of a disclaimer where, by mistake or inadvertence, a patent specification had been drafted too broadly and provided it was not made with the intent of defrauding or misleading the public - Apotex argued that the requirements of s. 48(1) were not met and that the disclaimed claims were therefore invalid - The Federal Court held that, on the balance of probabilities standard, Pfizer met the burden to demonstrate that this allegation was unsubstantiated - See paragraphs 36 to 43.

Patents of Invention - Topic 1502

Grounds of invalidity - General - Onus and standard of proof - [See Patents of Invention - Topic 1503 ].

Patents of Invention - Topic 1503

Grounds of invalidity - General - Presumption of validity - Pfizer marketed a drug for the treatment of erectile disfunction under the brand name Viagra and it obtained a patent (the '446 patent) for the use of the compound sildenafil for that purpose - Apotex argued that the '446 patent was invalid and that it should be allowed to market its own generic version - Pfizer applied for an order prohibiting the issuance of a Notice of Compliance to Apotex until after the expiry of the '446 patent - The Federal Court discussed the issue of burden of proof and the presumption of validity - While the legal burden remained on Pfizer, Apotex had an "evidentiary burden" to rebut the presumption of validity - The evidentiary burden was a minimal one - Apotex merely had to put its case "into play" by presenting sufficient evidence to give its allegations of invalidity an air of reality - Should it meet that threshold, Pfizer had the legal or persuasive burden to prove the validity of the patent on a balance of probabilities - See paragraphs 44 to 51.

Patents of Invention - Topic 1583

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Commercial success - Effect of - [See Patents of Invention - Topic 1589 ].

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - Pfizer marketed a drug for the treatment of erectile disfunction (ED) under the brand name Viagra and it obtained a patent (the '446 patent) for the use of the compound sildenafil for that purpose - Apotex argued that the '446 patent was invalid for several reasons, including obviousness, and that it should be allowed to market its own generic version - Pfizer applied for an order prohibiting the issuance of a Notice of Compliance to Apotex until after the expiry of the '446 patent - The Federal Court held that Pfizer had proven on a balance of probabilities that Apotex's allegation of invalidity on the basis of obviousness was unsubstantiated - The court stated that "Although there was a significant amount of evidence indicating that cGMP PDE inhibitors should be further explored with regards to the treatment of ED in the months leading up to the Pfizer discovery, the evidence does not in my view establish that the solution taught by the patent was obvious at the time ... The cumulative effect of secondary indicia such as the commercial success of the product, its wide use, and the surprise that accompanied its first publication further support my conclusion" - See paragraphs 52 to 129.

Patents of Invention - Topic 1590

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Evidence (incl. onus of proof) - Pfizer marketed a drug for the treatment of erectile disfunction under the brand name Viagra and it obtained a patent (the '446 patent) for the use of the compound sildenafil for that purpose - Apotex argued that the '446 patent was invalid for several reasons, including obviousness, and that it should be allowed to market its own generic version - Pfizer applied for an order prohibiting the issuance of a Notice of Compliance to Apotex until after the expiry of the '446 patent - The Federal Court stated that where publication of alleged prior art was questioned, as in this case, Apotex had to provide some admissible evidence that the document was available to a person skilled in the art at the relevant time - It then fell to Pfizer to demonstrate that the document in question did not meet the "reasonable and diligent search" test as part of its legal burden to demonstrate that Apotex's allegation regarding obviousness was not justified - See paragraph 110.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - [See Patents of Invention - Topic 1653 ].

Patents of Invention - Topic 1653

Grounds of invalidity - Anticipation by prior patent - What constitutes anticipation - Pfizer marketed a drug for the treatment of erectile disfunction (ED) under the brand name Viagra and it obtained a patent (the '446 patent) for the use of the compound sildenafil for that purpose - Apotex argued that the '446 patent was invalid for several reasons, including anticipation, and that it should be allowed to market its own generic version - Pfizer applied for an order prohibiting the issuance of a Notice of Compliance to Apotex until after the expiry of the '446 patent - The Federal Court held that the allegation of anticipation failed - The court stated that "The allegations of anticipation directed to claims 7, 8, 10, 18, 22 and 23 are based on two of Pfizer's previously published patent applications ... In my view, neither discloses the use of sildenafil for the treatment of ED. As such, a skilled person would not, reading either document, in every case and without possibility of error arrive at the subject matter of the invention" - Apotex did not meet its evidentiary burden to demonstrate that this issue was "in play" - See paragraphs 130 to 135.

Cases Noticed:

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. 21].

Roche Palo Alto LLC et al. v. Apotex Inc., [2005] O.T.C. 268 (Sup. Ct.), refd to. [para. 23].

Canadian Celanese Ltd. v. B.V.D. Co., [1939] 2 D.L.R. 289 (P.C.), refd to. [para. 23].

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. 31].

ICN Pharmaceuticals Inc. et al. v. Patented Medicine Prices Review Board et al., [1997] 1 F.C. 32; 200 N.R. 376 (F.C.A.), refd to. [para. 36].

Richards Packaging Inc. v. Canada (Attorney General) (2007), 305 F.T.R. 99; 2007 FC 11, refd to. [para. 37].

Trubenizing Process Corp. v. Forsythe (John) Ltd., [1942] O.R. 271; 2 C.P.R. 89 (C.A.), revd. [1943] S.C.R. 422, refd to. [para. 38].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 361 N.R. 308; 2007 FCA 153, refd to. [para. 44].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 306 F.T.R. 254; 2007 FC 26, refd to. [para. 45].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2007), 311 F.T.R. 21; 2007 FC 455, refd to. [para. 45].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 2007 FCA 209, refd to. [para. 46].

R. v. Schwartz, [1988] 2 S.C.R. 443; 88 N.R. 90; 56 Man.R.(2d) 92; 45 C.C.C.(3d) 97, refd to. [para. 49].

R. v. Fontaine (J.), [2004] 1 S.C.R. 702; 318 N.R. 371; 2004 SCC 27, refd to. [para. 50].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al. (2006), 358 N.R. 135; 2006 FCA 421, refd to. [para. 52].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 52].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2007), 366 N.R. 290; 2007 FCA 217, refd to. [para. 53].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2006), 301 F.T.R. 166; 2006 FC 1234, refd to. [para. 53].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd. (1998), 145 F.T.R. 161; 79 C.P.R.(3d) 193 (T.D.), revd. in part [2001] 1 F.C. 495; 262 N.R. 137 (F.C.A.), affd. [2002] 4 S.C.R. 153; 296 N.R. 130, refd to. [para. 64].

Bayer Aktiengesellschaft et al. v. Apotex Inc. (1995), 60 C.P.R.(3d) 58 (Gen. Div.), varied (1998), 113 O.A.C. 1; 82 C.P.R.(3d) 526 (C.A.), leave to appeal refused (1999), 239 N.R. 200; 124 O.A.C. 199 (S.C.C.), refd to. [para. 64].

Farbwerke Hoechst Aktiengessellschaf v. Halocarbon (Ontario) Ltd. and Halocarbon Products Corp., [1979] 2 S.C.R. 929; 27 N.R. 582; 104 D.L.R.(3d) 51, refd to. [para. 64].

Bayer AG et al. v. Apotex Inc. et al. (2007), 366 N.R. 246; 2007 FCA 243, refd to. [para. 66].

Illinois Tool Works Inc. v. Cobra Fixations Cie - see Illinois Tool Works Inc. et al. v. Cobra Anchors Co.

Illinois Tool Works Inc. et al. v. Cobra Anchors Co. (2002), 221 F.T.R. 161; 2002 FCT 829, affd. in part (2003), 312 N.R. 184; 2003 FCA 358, refd to. [para. 108].

Mahurkar v. Vas-Cath of Canada Ltd. and Gambro Canada Ltd. (1988), 16 F.T.R. 48; 18 C.P.R.(3d) 417 (T.D.), affd. (1990), 105 N.R. 138; 32 C.P.R.(3d) 409 (F.C.A.), refd to. [para. 109].

Bressette v. Kettle and Stony Point First Nations Band Council (1997), 137 F.T.R. 189 (T.D.), refd to. [para. 112].

Merck & Co. v. Apotex Inc., [1998] 3 F.C. 400; 146 F.T.R. 148; 79 C.P.R.(3d) 501 (T.D.), refd to. [para. 112].

Merck & Co. et al. v. Apotex Inc. et al. (2005), 274 F.T.R. 113; 41 C.P.R.(4th) 35; 2005 FC 755, refd to. [para. 113].

Ethier v. Royal Canadian Mounted Police (Commissioner), [1993] 2 F.C. 659; 151 N.R. 374 (F.C.A.), refd to. [para. 114].

R. v. Khan, [1990] 2 S.C.R. 531; 113 N.R. 53; 41 O.A.C. 353; 59 C.C.C.(3d) 92, refd to. [para. 114].

R. v. Smith (A.L.), [1992] 2 S.C.R. 915; 139 N.R. 323; 55 O.A.C. 321; 94 D.L.R.(4th) 590, refd to. [para. 114].

Hoffmann-La Roche & Co. v. Commissioner of Patents, [1955] S.C.R. 414; 23 C.P.R. 1, refd to. [para. 132].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2005), 281 F.T.R. 74; 45 C.P.R.(4th) 81; 2005 FC 1332, affd. (2007), 361 N.R. 308; 2007 FCA 153, refd to. [para. 132].

Shell Oil Co. v. Commissioner of Patents, [1982] 2 S.C.R. 536; 44 N.R. 541; 142 D.L.R.(3d) 117, refd to. [para. 133].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 370 N.R. 109; 2007 FCA 187, refd to. [para. 143].

Wyeth Canada et al. v. Ratiopharm Inc. et al. (2007), 370 N.R. 89; 2007 FCA 264, refd to. [para. 144].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 6(5)(a) [para. 146].

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

Counsel:

Andrew Shaughnessy, Andrew Bernstein, Christine Pallotta and Sandra Perri, for the applicants;

Harry B. Radomski, Andrew Brodkin, Richard Neiberg and Sorelle A. Simmons, for the respondents.

Solicitors of Record:

Torys LLP, Toronto, Ontario, formerly represented by Bereskin & Parr, Toronto, Ontario, for the applicants;

Goodmans LLP, Toronto, Ontario, for the respondents.

This application was heard on May 28 to June 1, 2007, at Toronto, Ontario, before Mosley, J., of the Federal Court, who delivered the following decision on September 27, 2007.