Laboratoires Servier et al. v. Canada (Minister of Health) et al., 2015 FC 108

• Judge: Roy, J.
• Court: Federal Court (Canada)
• Case Date: February 16, 2015
• Jurisdiction: Canada (Federal)
• Citations: 2015 FC 108;[2015] F.T.R. TBEd. FE.055

Lab. Servier v. Can., [2015] F.T.R. TBEd. FE.055

MLB being edited

Currently being edited for F.T.R. - judgment temporarily in rough form.

Temp. Cite: [2015] F.T.R. TBEd. FE.055

Les Laboratoires Servier and Servier Canada Inc. (applicants) v. The Minister of Health and Apotex Inc. (respondents)

(T-222-13; 2015 FC 108)

Indexed As: Laboratoires Servier et al. v. Canada (Minister of Health) et al.

Federal Court

Roy, J.

February 16, 2015.

Summary:

Servier Canada Inc. sold a 60 mg modified release (MR) gliclazide tablet in Canada under the name DIAMICRON MR, which was used in the treatment of diabetes. Apotex Inc. wished to sell a generic version of a 60 mg MR gliclazide tablet. Les Laboratoires Servier and Servier Canada Inc. (Servier) applied pursuant to the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex until after Canadian Patent No. 2,629,670 (the '670 Patent) expired. The '670 Patent sought to claim a new formulation that covered the 60 mg gliclazide MR divisible tablet. Apotex argued that its tablets did not infringe the '670 Patent. Apotex also argued that the '670 Patent was invalid on the basis of obviousness and utility. Apotex also argued that the patent was invalid because it lacked specificity and was overbroad and ambiguous.

The Federal Court held that the allegations of non-infringement were justified. The allegations of invalidity for obviousness and utility were also justified. Servier's application for an order of prohibition was therefore dismissed.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - Servier Canada Inc. sold a 60 mg modified release (MR) gliclazide tablet in Canada under the name DIAMICRON MR, which was used in the treatment of diabetes - Apotex Inc. wished to sell a generic version of a 60 mg MR gliclazide tablet - Les Laboratoires Servier and Servier Canada Inc. (Servier) applied to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex until after Canadian Patent No. 2,629,670 (the '670 Patent) expired - The '670 Patent sought to claim a new formulation that covered the 60 mg gliclazide MR divisible tablet - Apotex argued that its tablets did not infringe the '670 Patent - The parties did not disagree on what claim 1 identified as the essential elements of the invention - They were the active ingredient, identified as gliclazide, a cellulose derivative which provided the modified release of the active ingredient, a binder and, once subdivided, that the gliclazide tablet had an identical dissolution profile to that of the whole tablet - Servier contended that, with respect to the "profile de dissolution identique" (identical dissolution profile), the POSITA would understand that "[a] divided tablet exhibits similar in vivo plasma kinetics (bioequivalence) as a whole tablet, which may be predicted by in vitro dissolution" - The Federal Court rejected the submission - The words "in vivo" were not found in the specification - Furthermore the expression "identical dissolution profile" was defined in the disclosure - The applicant had not discharged its burden that the identical dissolution profile required in vivo dissolution kinetics in the eyes of the POSITA - The specification provided clearly that the essential element required that there be identical in vitro dissolution kinetics - See paragraphs 101 to 112.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - Servier Canada Inc. sold a 60 mg modified release (MR) gliclazide tablet in Canada under the name DIAMICRON MR, which was used in the treatment of diabetes - Apotex Inc. wished to sell a generic version of a 60 mg MR gliclazide tablet - Les Laboratoires Servier and Servier Canada Inc. (Servier) applied to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex until after Canadian Patent No. 2,629,670 (the '670 Patent) expired - The '670 Patent sought to claim a new formulation that covered the 60 mg gliclazide MR divisible tablet - Apotex argued that its tablets did not infringe the '670 Patent - The parties did not disagree on what claim 1 identified as the essential elements of the invention - They were the active ingredient, identified as gliclazide, a cellulose derivative which provided the modified release of the active ingredient, a binder and, once subdivided, that the gliclazide tablet had an identical dissolution profile to that of the whole tablet - Apotex argued that the patent required that there be a binder other than the cellulose derivative that was used in providing the modified release of the active ingredient - Servier argued that the cellulose derivative could serve both purposes once the specification was purposively constructed - The Federal Court stated that "It seems to me that the balance of probabilities favours that the POSITA would understand that the patent requires that the binder be a different excipient that, if it is to be HPMC [hydroxypropylmethylcellulose], would have to be an HPMC of very low viscosity (or of very low molecular weight). ... it is not for the Court to redraft claims. When claims are written to state four essential elements, and the specification is written to identify a binder as a different element, it will not be possible to construct the claims as allowing two of the essential elements to be the same, but with different properties unless, somehow, the party seeking that construction convinces the Court that the patent teaches that much. Here the applicant has failed to meet that burden" - See paragraphs 113 to 120.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - . Servier Canada Inc. sold a 60 mg modified release (MR) gliclazide tablet in Canada under the name DIAMICRON MR, which was used in the treatment of diabetes. Apotex Inc. wished to sell a generic version of a 60 mg MR gliclazide tablet - Les Laboratoires Servier and Servier Canada Inc. (Servier) applied to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex until after Canadian Patent No. 2,629,670 (the '670 Patent) expired - The '670 Patent sought to claim a new formulation that covered the 60 mg gliclazide MR divisible tablet - Apotex argued that the '670 Patent was invalid on the basis of obviousness - The Federal Court held that the difference between the prior art and the inventive concept, on this record, did not require inventive ingenuity - The burden on Servier to convince that the allegation of obviousness was not justified had not been discharged - See paragraphs 148 to 202.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - [See Patents of Invention - Topic 1725 ].

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - [See Patents of Invention - Topic 1725 ].

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - Servier Canada Inc. sold a 60 mg modified release (MR) gliclazide tablet in Canada under the name DIAMICRON MR, which was used in the treatment of diabetes - Apotex Inc. wished to sell a generic version of a 60 mg MR gliclazide tablet - Les Laboratoires Servier and Servier Canada Inc. (Servier) applied to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex until after Canadian Patent No. 2,629,670 (the '670 Patent) expired - The '670 Patent sought to claim a new formulation that covered the 60 mg gliclazide MR divisible tablet - Apotex argued that the '670 Patent was invalid as it did not disclose an invention that was new and useful - The Federal Court held that allegation of invalidity for utility was justified - As of the Canadian filing date (April 24, 2008), the patent had to either disclose demonstrated utility or a basis for a sound prediction of the utility - The '670 Patent had not demonstrated its utility because there was no evidence whatsoever of utility - Servier relied on two bioequivalence studies which it claimed proved utility - However, neither of those studies was alluded to, let alone referenced, in the specification - In Apotex Inc v. Pfizer Canada Inc. (2011 FCA) 236 ("Latanoprost"), the court stated that the law required such references - The court was bound to follow Latanoprost - Accordingly, the tests Servier pointed to that were not referred to in the '670 Patent were not relevant for establishing demonstrated utility - The claimed invention also failed on all three elements of sound prediction - See paragraphs 211 to 227.

Patents of Invention - Topic 2926

Infringement of patent - Acts not constituting an infringement - Of particular patents - [See Patents of Invention - Topic 2945 ].

Patents of Invention - Topic 2945

Infringement of patent - Chemical products and substances intended for food and medicine - Particular patents - Servier Canada Inc. sold a 60 mg modified release (MR) gliclazide tablet in Canada under the name DIAMICRON MR, which was used in the treatment of diabetes - Apotex Inc. wished to sell a generic version of a 60 mg MR gliclazide tablet - Les Laboratoires Servier and Servier Canada Inc. (Servier) applied to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex until after Canadian Patent No. 2,629,670 (the '670 Patent) expired - The '670 Patent sought to claim a new formulation that covered the 60 mg gliclazide MR divisible tablet - According to the '670 Patent, there were three components to the tablet: the active pharmaceutical ingredient (gliclazide), a cellulose derivative and a binder, which were all physical characteristics of the tablets - The patent claimed that the whole tablet as well as a fraction of a whole tablet would have an "identical dissolution profile" - Apotex alleged that it did not infringe the '670 Patent because its tablet did not contain a binder and its testing had not shown in vitro dissolution profiles that would be identical for undivided and subdivided tablets - The Federal Court found that Apotex did not infringe Servier's claims with respect to two different essential elements - See paragraphs 123 to 147.

Cases Noticed:

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2002), 298 N.R. 323; 2002 FCA 421, refd to. [para. 20].

Quadco Equipment Inc. v. Timberjack Inc. (2002), 216 F.T.R. 29; 17 C.P.R.(4th) 224; 2002 FCT 96, refd to. [para. 21].

Whitehouse v. Jordan, [1981] 1 All E.R. 267, refd to. [para. 25].

Bayer Inc. et al. v. Cobalt Pharmaceuticals Co. et al. (2013), 441 F.T.R. 72; 2013 FC 1061, refd to. [para. 33].

AstraZeneca AB et al. v. Apotex Inc. et al. (2005), 335 N.R. 1; 2005 FCA 183, refd to. [para. 35].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2005), 341 N.R. 330; 2005 FCA 270, refd to. [para. 35].

GlaxoSmithKline Inc. et al. v. Pharmascience Inc. et al. (2011), 385 F.T.R. 157; 2011 FC 239, refd to. [para. 46].

Alcon Canada Inc. et al. v. Apotex Inc. et al. (2014), 461 F.T.R. 259; 2014 FC 791, refd to. [para. 47].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 322 F.T.R. 86; 2008 FC 11, refd to. [para. 48].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1994), 169 N.R. 342; 55 C.P.R.(3d) 302 (F.C.A.), refd to. [para. 50].

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. 52].

Merck & Co. et al. v. Pharmascience Inc. et al. (2010), 368 F.T.R. 1; 2010 FC 510, refd to. [para. 52].

AstraZeneca Canada Inc. et al. v. Apotex Inc. et al. (2014), 457 F.T.R. 227; 2014 FC 638, refd to. [para. 52].

Apotex Inc. v. Sanofi-Aventis (2011), 402 F.T.R. 1; 101 C.P.R.(4th) 1; 2011 FC 1486, refd to. [para. 57].

Pfizer Canada Inc. et al. v. Pharmascience Inc. et al. (2013), 427 F.T.R. 6; 2013 FC 120, refd to. [para. 57].

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. 91].

Burton Parsons Chemicals Inc. et al. v. Hewlett-Packard (Canada) Ltd. et al., [1976] 1 S.C.R. 555; 3 N.R. 553, refd to. [para. 92].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390, refd to. [para. 93].

Catnic Components Ltd v. Hill & Smith Ltd., [1982] R.P.C. 183, refd to. [para. 94].

Lister v. Norton Brothers and Co. (1886), 3 R.P.C. 199, refd to. [para. 95].

Eli Lilly and Co. and Thomson Engineering Ltd. v. Novopharm Ltd. (1989), 99 N.R. 60; 26 C.P.R.(3d) 1 (F.C.A.), refd to. [para. 97].

Metalliflex Ltd. v. Rodi & Wienenberger Aktiengesellschaft, [1961] S.C.R. 117, refd to. [para. 99].

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. 100].

Bayer AG and Miles Canada Inc. v. Canada (Minister of Health and Welfare) and Apotex Inc. (1993), 163 N.R. 183; 51 C.P.R.(3d) 329 (F.C.A.), refd to. [para. 134].

Merck Frosst Canada Inc. et al. v. Canada (Minister of Health) et al., [2000] F.T.R. Uned. 663; 8 C.P.R.(4th) 87 (T.D.), refd to. [para. 135].

Merck & Co. et al. v. Canada (Minister of Health) et al. (1999), 249 N.R. 110; 3 C.P.R.(4th) 77 (F.C.A.), refd to. [para. 142].

Minerals Separation North American Corp v. Noranda Mines Ltd., [1947] Ex. C.R. 306, refd to. [para. 142].

Pfizer Canada Inc. et al. v. Apotex Inc. et al., [2009] 4 F.C.R. 223; 385 N.R. 148; 2009 FCA 8, refd to. [para. 179].

Laboratoires Servier et al. v. Apotex Inc. et al. (2008), 332 F.T.R. 193; 2008 FC 825, refd to. [para. 182].

Biovail Corp. et al. v. Canada (Minister of Health) et al. (2010), 361 F.T.R. 158; 2010 FC 46, refd to. [para. 182].

AstraZeneca Canada Inc. v. Teva Canada Ltd., 2013 FC 246, refd to. [para. 182].

KSR International Co. v. Teleflex Inc. (2007), 127 S. Ct. 1727, refd to. [para. 190].

Conor Medsystems Inc. v. Angiotech Pharmaceuticals Inc. et al., [2008] N.R. Uned. 259; [2008] UKHL 49, refd to. [para. 190].

Apotex Inc. v. Lundbeck (H.) A/S, [2013] F.T.R. Uned. 402; 111 C.P.R.(4th) 171; 2013 FC 192, refd to. [para. 203].

Lilly Icos LLC v. Pfizer Ltd., [2000] EWHC Patents 49, refd to. [para. 203].

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. 205].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2009), 377 N.R. 9; 2008 FCA 108, refd to. [para. 205].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2011), 423 N.R. 180; 2011 FCA 236, folld. [para. 206].

Pfizer Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2011), 394 F.T.R. 1; 2011 FC 547, refd to. [para. 207].

Eurocopter v. Bell Helicopter Textron Canada Ltd. et al. (2013), 449 N.R. 111; 2013 FCA 219, refd to. [para. 207].

Monsanto Co. v. Commissioner of Patents, [1979] 2 S.C.R. 1108; 28 N.R. 181, refd to. [para. 218].

Olin Mathieson Corporation v. Biorex Laboratories Ltd., [1970] R.P.C. 157, refd to. [para. 218].

Merck & Co. et al. v. Apotex Inc. et al. (2010), 381 F.T.R. 162; 2010 FC 1265, refd to. [para. 218].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2009), 392 N.R. 243; 78 C.P.R.(4th) 388; 2009 FCA 97, refd to. [para. 225].

Counsel:

Judith Robinson, Bryan Capogrosso and Nikita Stepin, for the applicants;

Andrew Brodkin, Dino Clarizio and Jaro Mazzola, for the respondent, Apotex Inc.

Solicitors of Record:

Norton Rose Fulbright Canada, LLP, Montreal, Quebec, for the applicants;

Goodmans, LLP, Toronto, Ontario, for the respondents.

This application was heard on October 6-9, 2014, at Montreal, Quebec, before Roy, J., of the Federal Court, who delivered the following decision on February 16, 2015.