AstraZeneca Canada Inc. et al. v. Pharmascience Inc. et al., (2014) 460 N.R. 343 (FCA)

• Judge: Sharlow, Pelletier and Mainville, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: October 28, 2013
• Jurisdiction: Canada (Federal)
• Citations: (2014), 460 N.R. 343 (FCA);2014 FCA 133

AstraZeneca Can. Inc. v. Pharmascience (2014), 460 N.R. 343 (FCA)

MLB headnote and full text

Temp. Cite: [2014] N.R. TBEd. JN.011

Pharmascience Inc. (appellant) v. AstraZeneca Canada Inc. and AstraZeneca AB and The Minister of Health (respondents)

(A-470-12; 2014 FCA 133)

Indexed As: AstraZeneca Canada Inc. et al. v. Pharmascience Inc. et al.

Federal Court of Appeal

Sharlow, Pelletier and Mainville, JJ.A.

May 22, 2014.

Summary:

AstraZeneca had a patent (the '531 patent) for its NEXIUM brand of 20 and 40 mg. esomeprazole magnesium trihydrate tablets. Pharmascience filed an Abbreviated New Drug Submission (ANDS) with the Minister of Health seeking a Notice of Compliance (NOC) for its 20 and 40 mg. dosage esomeprazole magnesium capsules, intended to treat duodenal ulcer disease associated with Helicobater pylori infection (the Pharmascience capsules). In its ANDS, Pharmascience compared the Pharmascience capsules to AstraZeneca's 20 and 40 mg. dosage capsules of NEXIUM to demonstrate bioequivalence under s. 5(1) of the NOC Regulations. In its Notice of Allegation (NOA) Pharmascience alleged that AstraZeneca's '531 patent was invalid. AstraZeneca applied for a declaration that the Pharmascience NOA was neither a valid notice of allegation nor a detailed statement as contemplated by the NOC Regulations. In the alternative, AstraZeneca sought an order prohibiting the Minister of Health (the Minister) from issuing a notice of compliance respecting the Pharmascience capsules until the expiry of the '531 Patent.

The Federal Court, in a decision reported 419 F.T.R. 240, held that Pharmascience's NOA was valid. The court rejected Pharmascience's claims of invalidity respecting the '531 patent. In the result, the Minister of Health was prohibited from issuing a notice of compliance to Pharmascience for its capsules until after the expiration of the '531 patent (i.e., May 18, 2018). Pharmascience appealed.

The Federal Court of Appeal allowed the appeal, set aside the order of the Federal Court and dismissed the application for a prohibition order.

Food and Drug Control - Topic 1108.3

Drugs - New drugs - Notice of compliance - Prohibition order - Setting aside - Appeals - Standard or review - The Federal Court of Appeal stated that "An appeal from the decision of a Federal Court judge on a prohibition application is the equivalent of an appeal from a judgment rendered after trial. An application judge is a primary fact-finder who draws conclusions after having reviewed all of the evidence; his position is indistinguishable from that of a trial judge. There is accordingly no reason to depart from this Court's existing practice of applying the standards of review established in Housen v. Nikolaisen, 2002 SCC 33 ..." - See paragraph 31.

Food and Drug Control - Topic 1111.4

Drugs - New and innovative drugs - Notice of compliance - Evidence and proof (incl. burden of proof) - The Federal Court of Appeal discussed the standard of proof in notice of compliance proceedings - See paragraphs 32 to 42.

Food and Drug Control - Topic 1111.4

Drugs - New and innovative drugs - Notice of compliance - Evidence and proof (incl. burden of proof) - [See first Patents of Invention - Topic 1723 ].

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine (incl. selection patents) - Pharmascience sought a Notice of Compliance for its esomeprazole magnesium capsules and in its Notice of Allegation (NOA) alleged that AstraZeneca's '531 patent for esomeprazole magnesium trihydrate tablets was invalid for lack of utility - AstraZeneca sought to prohibit the Minister of Health from issuing a notice of compliance - The applications judge found that AstraZeneca had shown that Pharmascience's allegations of lack of utility were not justified - Pharmascience appealed - The Federal Court of Appeal held the applications judge erred in law with respect to both the legal standard to be met by Pharmascience in order to put its allegations into play, and the legal standard AstraZeneca was required to meet to prove that its invention was useful - Due to those errors, the applications judge did not apply his mind to the question of whether Pharmascience led sufficient evidence to put its allegation of lack of utility into play and, if it had, whether AstraZeneca showed, on a balance of probabilities, that Pharmascience's allegations of lack of utility were not justified - See paragraphs 32 to 43.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine (incl. selection patents) - AstraZeneca had a patent (the '531 patent) for NEXIUM esomeprazole magnesium trihydrate tablets - The patent claimed an enteric coated oral pharmaceutical formulation, including a claim respecting the use of a low viscosity polymer, hydroxypropyl methylcellulose (HPMC), of a specific quality as reflected by its "Cloud Point" (CP) which affected the rate of release - Pharmascience challenged the patent's validity in Notice of Compliance proceedings, alleging a lack of utility - The Federal Court of Appeal held that there was sufficient evidence to put Pharmascience's allegation of lack of utility into play - As a result AstraZeneca was called upon to prove the utility of the invention - However, AstraZeneca did not satisfy the onus of showing that Pharmascience's allegations on invalidity were not justified (i.e., proof on a balance of probabilities) - See paragraphs 44 to 59.

Cases Noticed:

Housen v. Nikolaisen et al., [2002] 2 S.C.R. 235; 286 N.R. 1; 219 Sask.R. 1; 272 W.A.C. 1; 2002 SCC 33, refd to. [para. 31].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2010), 404 N.R. 356; 85 C.P.R. (4th) 279; 2010 FCA 168, refd to. [para. 31].

Sandoz Canada Inc. v. Abbott Laboratories et al. - see Abbott Laboratories et al. v. Canada (Minister of Health) et al.

Apotex Inc. v. Pfizer Canada Inc., 2014 FCA 54, refd to. [para. 31].

Novartis Pharmaceuticals Canada Inc. v. Teva Canada Ltd. et al. (2013), 451 N.R. 246; 2013 FCA 244, refd to. [para. 31].

Aventis Pharma Inc. v. Apotex Inc. et al. (2006), 349 N.R. 183; 46 C.P.R.(4th) 401; 2006 FCA 64, refd to. [para. 31].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 319 F.T.R. 48; 61 C.P.R.(4th) 305; 2007 FC 971, affd. (2009), 385 N.R. 148; 72 C.P.R.(4th) 141; 2009 FCA 8, refd to. [para. 33].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 2007 FCA 209, refd to. [para. 38].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al., [2012] 3 S.C.R. 625; 436 N.R. 299; 2012 SCC 60, reving. (2010), 408 N.R. 166; 2010 FCA 242, refd to. [para. 39].

Counsel:

Carol Hitchman and Rosamaria Longo, for the appellant;

Yoong Kang and Kyle Ferguson, for the respondents.

Solicitors of Record:

Gardiner Roberts LLP, Toronto, Ontario, for the appellant;

Smart & Biggar, Toronto, Ontario, for the respondents.

This appeal was heard in Ottawa, Ontario, on October 28, 2013, before Sharlow, Pelletier and Mainville, JJ.A., of the Federal Court of Appeal. The following decision was delivered in Ottawa, Ontario, for the court, by Pelletier, J.A., on May 22, 2014.