Alcon Canada Inc. et al. v. Apotex Inc. et al., (2014) 461 F.T.R. 259 (FC)

• Judge: Kane, J.
• Court: Federal Court (Canada)
• Case Date: August 11, 2014
• Jurisdiction: Canada (Federal)
• Citations: (2014), 461 F.T.R. 259 (FC);2014 FC 791

Alcon Can. Inc. v. Apotex Inc. (2014), 461 F.T.R. 259 (FC)

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[French language version follows English language version]

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Temp. Cite: [2014] F.T.R. TBEd. SE.038

Alcon Canada Inc. and Alcon Research Ltd. (applicants) v. Apotex Inc. and The Minister of Health (respondents)

(T-1667-12; 2014 FC 791; 2014 CF 791)

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

Federal Court

Kane, J.

August 25, 2014.

Summary:

The applicants (Alcon) applied under the Patented Medicines (Notice of Compliance) Regulations, seeking to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in respect of its generic product (Apo-Travoprost Z) until the expiry of Canadian Letters Patent No 2,606,370 (the '370 Patent) on September 20, 2027. The '370 Patent claimed formulations of travoprost, an anti-glaucoma drug, with a non-conventional preservative system to permit multi-use application. In its Notice of Allegation, Apotex alleged that claims 10 and 13 of the '370 Patent were invalid on the basis of obviousness and lack of utility.

The Federal Court found that the allegation with respect to the invalidity of the claims at issue for obviousness was justified. However, the court found that the allegation of lack of demonstrated or soundly predicted utility was not justified. The application was dismissed with costs to Apotex.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for - Notice of allegation - The applicants (Alcon) applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in respect of its generic product (Apo-Travoprost Z) until the expiry of Canadian Letters Patent No 2,606,370 (the '370 Patent) on September 20, 2027 - The '370 Patent claimed formulations of travoprost, an anti-glaucoma drug, with a non-conventional preservative system to permit multi-use application - In its Notice of Allegation, Apotex alleged that claims 10 and 13 of the '370 Patent were invalid on the basis of obviousness and lack of utility - The Federal Court stated that "Apotex raises new and different underlying facts to support the allegations of invalidity by asserting the promised utility of an acceptable formulation, meaning one without particulate matter. ... The issue of the revised promise of utility of an acceptable formulation is a new basis for the allegation of lack of demonstrated or soundly predicted utility. ... The jurisprudence is clear; the proceedings are limited to the legal grounds and specific factual allegations set out in a Notice of Allegation. ... The Court will not address the allegation of lack of utility based on the promise of an 'acceptable' formulation. However, much of Apotex's detailed arguments regarding the particulate issue is in response to Alcon's argument that this is part of the inventive concept. Therefore, Apotex may respond to Alcon's position on the inventive concept but it cannot assert a revised promise of an 'acceptable' (i.e. no particulate matter) formulation as the basis for its allegations of invalidity based on lack of utility" - See paragraphs 83 to 97.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - [See Food and Drug Control - Topic 1105 ].

Food and Drug Control - Topic 1111.4

Drugs - New drugs - Notice of compliance - Evidence and proof (incl. burden of proof) - The applicants (Alcon) applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in respect of its generic product (Apo-Travoprost Z) until the expiry of Canadian Letters Patent No 2,606,370 (the '370 Patent) on September 20, 2027 - The '370 Patent claimed formulations of travoprost, an anti-glaucoma drug, with a non-conventional preservative system to permit multi-use application - In its Notice of Allegation, Apotex alleged that claims 10 and 13 of the '370 Patent were invalid on the basis of obviousness and lack of utility - The Federal Court stated that "The jurisprudence has settled who bears the burden of proof of the allegations. ... where the validity of a patent is at issue, the patent will be presumed to be valid. However, where a generic manufacturer (a second person), in this case Apotex, raises allegations of invalidity and adduces some evidence capable of establishing the invalidity of the patent, the generic is said to put the issue 'into play'. The burden then moves to the brand or applicant (first person), in this case, Alcon, to establish on a balance of probabilities that all of the allegations of invalidity are not justified ... In the present case, Apotex raised allegations in its NOA and led sufficient evidence as to the invalidity of the Patent on the basis of obviousness and lack of demonstrated or soundly predicted utility to put those broad allegations and issues into play. ... Alcon now bears the burden of establishing on a balance of probabilities that the allegations are not justified" - See paragraphs 98 to 106.

Patents of Invention - Topic 1129

The specification and claims - The description - Scope of invention - The applicants (Alcon) applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in respect of its generic product (Apo-Travoprost Z) until the expiry of Canadian Letters Patent No 2,606,370 (the '370 Patent) on September 20, 2027 - The '370 Patent claimed formulations of travoprost, an anti-glaucoma drug, with a non-conventional preservative system to permit multi-use application - In its Notice of Allegation, Apotex alleged that claims 10 and 13 of the '370 Patent were invalid on the basis of obviousness and lack of utility - The Federal Court stated that "Overall, the expert evidence is not particularly helpful in identifying the inventive concept. The bare chemical formulas of claims 10 and 13 are specific in setting out the ingredients or elements of the composition or formulation and the applicable concentrations or limits where these are essential, for example, the concentration of zinc chloride and anionic species and the range for osmolality and pH levels. The Summary of Invention notes that certain formulation parameters must be maintained in order to utilize low levels of zinc ions. The Summary refers to the pH and osmolality values and to the need to limit the concentration of buffering anions to less than 15 mM. I attach significance to these elements which were repeated several times in the Patent. I find that the inventive concept includes these essential aspects. The Inventive Concept is a (self-preserved) multi-dose ophthalmic composition or formulation containing travoprost that does not include BAK and which uses a non-conventional preservative system that includes low levels of zinc chloride, a borate/polyol complex (or propylene glycol and sorbitol), low levels of anionic species (less than 15 mM) and specific osmolality values" - See paragraphs 194 to 197.

Patents of Invention - Topic 1030

The specification and claims - Construction of a patent - "Person skilled in the art" - The applicants (Alcon) applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in respect of its generic product (Apo-Travoprost Z) until the expiry of Canadian Letters Patent No 2,606,370 (the '370 Patent) on September 20, 2027 - The '370 Patent claimed formulations of travoprost, an anti-glaucoma drug, with a non-conventional preservative system to permit multi-use application - In its Notice of Allegation, Apotex alleged that claims 10 and 13 of the '370 Patent were invalid on the basis of obviousness and lack of utility - The Federal Court stated that the person of skill in the art (the POSITA) for the '370 Patent could be described as "The team of person that includes pharmaceutical scientists / formulators and microbiologists. These persons have knowledge of how to formulate ophthalmic compositions, in particular, preserved multi dose ophthalmic solutions for topical application. Representative individuals on the team would have a Ph.D. in chemistry, pharmacy, microbiology or a related field with limited experience (up to 3 years) or a B.Sc. or M.Sc. with more practical experience (5 or more years) in the formulation of such preserved ophthalmic formulations" - See paragraph 111.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - The applicants (Alcon) applied under the Patented Medicines (Notice of Compliance) Regulations, seeking to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in respect of its generic product (Apo-Travoprost Z) until the expiry of Canadian Letters Patent No 2,606,370 (the '370 Patent) on September 20, 2027 - The '370 Patent claimed formulations of travoprost, an anti-glaucoma drug, with a non-conventional preservative system to permit multi-use application - In its Notice of Allegation, Apotex alleged that claims 10 and 13 of the '370 Patent were invalid on the basis of obviousness and lack of utility - The Federal Court construed the claims as follows "Claim 13 is an independent claim directed to topical ophthalmic solutions containing travoprost. The solutions also contain a preservative system that includes boric acid, propylene glycol, sorbitol and zinc chloride at concentrations from 0.04 to 0.4 mM. These solutions are free of BAK or other antimicrobial preservatives. The solutions have limited concentrations of anionic species, that is, concentrations of less than 15 mM, and have osmolality values between 250 and 330 mOsm/kg. The solutions also contain polyoxyl 40 hydrogenated castor oil. Claim 10 is a dependent claim which depends on cascading dependencies among Claims 1 to 9. Claim 10 claims a multi-dose, self-preserved ophthalmic composition containing travoprost and a preservative system that includes zinc chloride, propylene glycol and sorbitol, and limited concentrations of anionic species, multivalent buffering anions, multivalent metal ions and ionized salts" - See paragraphs 162.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - [See Patents of Invention - Topic 1593 ].

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. common general knowledge and mosaicing) - The applicants (Alcon) applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in respect of its generic product (Apo-Travoprost Z) until the expiry of Canadian Letters Patent No 2,606,370 (the '370 Patent) on September 20, 2027 - The '370 Patent claimed formulations of travoprost, an anti-glaucoma drug, with a non-conventional preservative system to permit multi-use application - In its Notice of Allegation, Apotex alleged that claims 10 and 13 of the '370 Patent were invalid on the basis of that the claimed invention was obvious in view of the prior art and certain Alcon products - The Federal Court held that "Based on the submissions of the parties and the evidence of the experts, the application of the Plavix test leads me to the conclusion that Alcon has not established that Apotex's allegations that the '370 was obvious are not justified" - See paragraphs 312 to 350.

Patents of Invention - Topic 1723

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

Patents of Invention - Topic 1724

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

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - The applicants (Alcon) applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in respect of its generic product (Apo-Travoprost Z) until the expiry of Canadian Letters Patent No 2,606,370 (the '370 Patent) on September 20, 2027 - The '370 Patent claimed formulations of travoprost, an anti-glaucoma drug, with a non-conventional preservative system to permit multi-use application - In its Notice of Allegation, Apotex alleged that claims 10 and 13 of the '370 Patent were invalid on the basis of lack of utility - The Federal Court considered the promised utility - The court stated that "The expert evidence all seems to land on the view that while there may be a reasonable expectation of a promise to eliminate or minimize the side effects associated with BAK, given the goal of the inventors to replace BAK, there is no such explicit promise and any notion of a promise is implied or inherently taught. Moreover, the wording of the claims is clear. There is no promise of reduced side effects in Claims 10 or 13 or in the Patent. There is no promise of any particular use in Claims 10 or 13. While a promise may be expected given the need to avoid BAK and its side effects, and while some of the experts would imply such a promise, this cannot be read into the claims. The promised utility is simply to provide a self-preserved ophthalmic formulation without BAK that passes the USP preservative efficacy testing, and provides a useful alternative preservative system: i.e. another choice for ophthalmic formulations. The question to be determined next is whether the Patent lives up to its promised utility" - See paragraphs 407 to 418.

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - The applicants (Alcon) applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. in respect of its generic product (Apo-Travoprost Z) until the expiry of Canadian Letters Patent No 2,606,370 (the '370 Patent) on September 20, 2027 - The '370 Patent claimed formulations of travoprost, an anti-glaucoma drug, with a non-conventional preservative system to permit multi-use application - In its Notice of Allegation, Apotex alleged that claims 10 and 13 of the '370 Patent were invalid on the basis of lack of utility - The Federal Court stated that "Having found that the promised utility is simply to provide a self-preserved ophthalmic formulation without BAK that passes the USP preservative efficacy testing, and provides a useful alternative preservative system, i.e., another choice for ophthalmic formulations, I find that this utility was soundly predicted. ... I agree that the Patent provides a factual basis and a sound line of reasoning that self- preserved formulations would result. In addition, the '370 provides the proper disclosure; the specification clearly describes the nature of the invention and how it can be made. The specification also discloses the test results for various formulations and provides over 30 examples. As a result, I find that the allegation of lack of soundly predicted utility is not justified" - See paragraphs 439 to 446.

Cases Noticed:

AstraZeneca AB et al. v. Apotex Inc. et al. (2005), 335 N.R. 1; 2005 FCA 183, refd to. [para. 72].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2005), 341 N.R. 330; 2005 FCA 270, refd to. [para. 72].

Bayer Inc. et al. v. Cobalt Pharmaceuticals Co. et al. (2013), 441 F.T.R. 72; 2013 FC 1061, refd to. [para. 75].

Pfizer Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2011), 394 F.T.R. 1; 2011 FC 547, refd to. [para. 77].

Pfizer Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2012), 430 N.R. 326; 2012 FCA 103, refd to. [para. 78].

Aventis Pharma Inc. v. Apotex Inc. et al. (2006), 349 N.R. 183; 2006 FCA 64, refd to. [para. 81].

Lundbeck Canada Inc. et al. v. ratiopharm Inc. et al. (2009), 357 F.T.R. 75; 2009 FC 1102, refd to. [para. 100].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 361 N.R. 308; 2007 FCA 153, refd to. [para. 100].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 2007 FCA 209, refd to. [para. 100].

Allergan Inc. et al. v. Canada (Minister of Health) et al. (2012), 414 F.T.R. 56; 2012 FC 767, affd. (2012), 440 N.R. 269; 2012 FCA 308, refd to. [para. 100].

Pfizer Canada Inc. et al. v. Pharmascience Inc. et al. (2013), 427 F.T.R. 6; 2013 FC 120, refd to. [para. 100].

Bayer Inc. et al. v. Cobalt Pharmaceuticals Co. et al. (2013), 433 F.T.R. 211; 2013 FC 573, refd to. [para. 100].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 306 F.T.R. 254; 2007 FC 26, affd. (2007), 367 N.R. 98; 2007 FCA 195, leave to appeal refused (2007), 381 N.R. 399 (S.C.C.), refd to. [para. 101].

GlaxoSmithKline Inc. et al. v. Pharmascience Inc. et al. (2011), 385 F.T.R. 157; 2011 FC 239, refd to. [para. 104].

Biovail Corp. et al. v. Canada (Minister of Health) et al. (2010), 361 F.T.R. 158; 2010 FC 46, refd to. [para. 105].

Pfizer Canada Inc. et al. v. Pharmascience Inc. et al. (2013), 427 F.T.R. 6; 2013 FC 120, refd to. [para. 142].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 2008 SCC 61, appld. [para. 163].

AbbVie Corp. et al. v. Janssen Inc., [2014] F.T.R. Uned. 23; 2014 FC 55, refd to. [para. 164].

Pozzoli SPA v BDMO SA, [2007] FSR 37; [2007] EWCA Civ 588 (BAILII), refd to. [para. 202].

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. 205].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 206].

Abbott Laboratories et al. v. Canada (Minister of Health) et al., [2009] 4 F.C.R. 401; 337 F.T.R. 17; 2008 FC 1359, affd. (2009), 387 N.R. 347; 73 C.P.R.(4th) 444; 2009 FCA 94, refd to. [para. 207].

Shire Biochem Inc. et al. v. Canada (Minister of Health) et al. (2008), 328 F.T.R. 123; 2008 FC 538, refd to. [para. 208].

Rothmans, Benson & Hedges Inc. et al. v. Imperial Tobacco Ltd. (1993), 152 N.R. 292; 47 C.P.R.(3d) 188 (F.C.A.), refd to. [para. 208].

Eli Lilly Canada Inc. et al. v. Novopharm Ltd., [2012] 1 F.C.R. 349; 405 N.R. 1; 2010 FCA 197, refd to. [para. 354].

AstraZeneca Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2012), 432 N.R. 292; 2012 FCA 109, refd to. [para. 354].

Apotex Inc. v. Sanofi-Aventis (2013), 447 N.R. 313; 2013 FCA 186, leave to appeal granted (2014), 471 N.R. 390 (Motion), refd to. [para. 354].

Fournier Pharma Inc. et al. v. Canada (Minister of Health) et al. (2012), 413 F.T.R. 277; 2012 FC 741, refd to. [para. 359].

Pfizer Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2014), 446 F.T.R. 274; 2014 FC 38, refd to. [para. 361].

Apotex Inc. v. Sanofi-Aventis (2013), 447 N.R. 313; 2013 FCA 186, refd to. [para. 362].

AstraZeneca Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2011), 396 F.T.R. 162; 2011 FC 1023, refd to. [para. 362].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390, refd to. [para. 368].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2011), 423 N.R. 180; 2011 FCA 236, refd to. [para. 419].

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. 422].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 323 F.T.R. 56; 2008 FC 142, affd. (2009), 392 N.R. 243; 2009 FCA 97, refd to. [para. 423].

Authors and Works Noticed:

McCarthy, Metal Ions and Microbial Inhibitors (1985), generally [para. 49].

McCarthy, The Effect of Zinc Ions on Antimicrobial Activity of Selected Preservatives (1989), generally [para. 49].

Counsel:

Sheldon Hamilton and Andrew Mandlsohn, for the applicants, Alcon Canada Inc. et al.;

Andrew Brodkin, Dino Clarizio and Jordan Scopa, for the respondent, Apotex Inc.;

Nil, for the respondent, The Minister of Health.

Solicitors of Record:

Smart & Biggar LLP, Toronto, Ontario, for the applicants, Alcon Canada Inc. et al.;

Goodman's LLP, Toronto, Ontario, for the respondent, Apotex Inc.;

William F. Pentney, Deputy Attorney General of Canada, Toronto, Ontario, for the respondent, The Minister of Health.

This application was heard on May 14 and 15, 2014, at Toronto, Ontario, before Kane, J., of the Federal Court, who delivered confidential reasons for judgment on August 11, 2014, and the following public reasons for judgment on August 25, 2014.