AstraZeneca Canada Inc. et al. v. Pharmascience Inc. et al., (2012) 419 F.T.R. 240 (FC)

• Judge: O'Keefe, J.
• Court: Federal Court (Canada)
• Case Date: June 04, 2012
• Jurisdiction: Canada (Federal)
• Citations: (2012), 419 F.T.R. 240 (FC);2012 FC 1189

AstraZeneca Can. Inc. v. Pharmascience (2012), 419 F.T.R. 240 (FC)

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Temp. Cite: [2012] F.T.R. TBEd. NO.003

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

(T-1652-10; 2012 FC 1189; 2012 CF 1189)

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

Federal Court

O'Keefe, J.

October 11, 2012.

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 held that Pharmascience's NOA was valid. The court rejected Pharmascience 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).

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Notice of allegation (NOA) - The Federal Court stated that the Notice of Allegation frames the proceeding under the Notice of Compliance Regulations - Thus, any allegation not included thererin could not be addressed in the Notice of Compliance proceeding - See paragraph 167.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Notice of allegation (NOA) - The Federal Court referred to the guiding principles on Notices of Allegation as summarised by Hughes, J., in GlaxoSmithKline Inc. v. Pharmascience Inc. (FC 2011) - See paragraph 168.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Notice of allegation (NOA) - In Notice of Compliance proceedings, Pharmascience filed a Notice of Allegation (NOA), alleging that an AstraZeneca 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 Notice of Compliance (NOC) Regulations - The Federal Court, after reviewing the NOA, ruled that Pharmascience had provided a sufficiently detailed statement of the legal and factual basis for its allegations - Pharmascience provided extensive submissions on several grounds of invalidity in its NOA - In the NOC proceedings, Pharmascience limited itself to four areas, all of which were adequately raised in the NOA - Pharmascience met its evidentiary burden of putting its case into play - Thus the burden of proof shifted to Astra Zeneca to establish that Pharmascience's allegations on those issues were not justified (NOC Regulations, s. 6(2)) - See paragraphs 169 to 172.

Food and Drug Control - Topic 1111.1

Drugs - New drugs - Notice of compliance - Practice - [See first and third Food and Drug Control - Topic 1105 ].

Patents of Invention - Topic 8

General - Invention defined - 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, arguing that the '531 patent was not an invention (Patent Act, s. 2), because it merely ascertained the properties of a known substance (i.e., because it only pertained to the CP of low viscosity HPMC) - The Federal Court rejected Pharmascience's argument - The court agreed with AstraZeneca that the patent provided more information than merely identifying inherent physiochemical properties of a known substance - See paragraphs 173 to 178.

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - The Federal Court stated that "The specification in a patent must disclose sufficient information to enable a PSA [person skilled in the art] to make and use the claimed invention. Sufficiency is a question of fact, determined as of the date of publication. The sufficiency requirement is mandated under subsection 27(3) of the Patent Act" - The court thereafter discussed the test for sufficient disclosure - See paragraphs 197 to 199.

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - 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 insufficient disclosure - Pharmascience claimed that the '531 Patent inadequately described the invention and did not provide the public with any meaningful or new information on the making of a three layer tablet - Further, the patent failed to indicate the specific type of low viscosity HPMC used in the experiments - The Federal Court rejected Pharmascience's argument - See paragraphs 197 to 206.

Patents of Invention - Topic 1133

The specification and claims - The description - Particular patents - [See second Patents of Invention - Topic 1128 ].

Patents of Invention - Topic 1504

Grounds of invalidity - General - What constitutes an invention - [See Patents of Invention - Topic 8 ].

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular 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 obviousness (i.e., that there was nothing inventive in finding a solution to a problem that never existed as CP was an irrelevant parameter) - The Federal Court rejected Pharmascience's argument, holding that the '531 patent was not obvious on the claim date - See paragraphs 207 to 218.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General - The Federal Court stated that "The requirement that an invention have 'utility' has statutory grounding in section 2 of the Patent Act, which defines an invention as something that is 'new and useful'. At the outset, it is notable that utility does not depend on marketability ... Utility must be demonstrated or soundly predicted based on the information and science available at the time of the prediction, as of the relevant date ... The relevant date is the date of filing of the Canadian patent application ... Demonstrating or soundly predicting that an invention will produce at least one useful result, or 'a "mere scintilla" of utility' is sufficient where no particular result has been promised ... However, where a particular result has been promised in the patent specification, the claims must demonstrate or soundly predict that result or promise ..." - See paragraphs 179 to 181.

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 found that Pharmascience failed to demonstrate "that the invention will not work, either in the sense that it will not operate at all or, more broadly, that it will not do what the specification promises that it will do" - See paragraphs 179 to 196.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - The Federal Court stated that if the utility of an invention has not been demonstrated as of the relevant date, an inventor can still rely on the doctrine of sound prediction to justify his or her patent claims - The court discussed the test for determining whether a utility had been soundly predicted - See paragraphs 184 to 188.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - [See Patents of Invention - Topic 1721 ].

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - [See Patents of Invention - Topic 1723 ].

Cases Noticed:

Pfizer Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2012), 430 N.R. 326; 2012 FCA 103, refd to. [para. 166].

GlaxoSmithKline Inc. et al. v. Pharmascience Inc. et al. (2011), 385 F.T.R. 157; 2011 FC 239, refd to. [para. 168].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 306 F.T.R. 254; 59 C.P.R.(4th) 183; 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. 170].

Sanofi-Aventis Canada Inc. et al. v. Apotex Inc. (2009), 350 F.T.R. 165; 2009 FC 676, refd to. [para. 179].

Eli Lilly Canada Inc. et al. v. Novopharm Ltd. (2010), 405 N.R. 1; 85 C.P.R.(4th) 413; 2010 FCA 197, refd to. [para. 182].

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. 184].

Pfizer v. Canada Inc. et al. v. Novopharm Ltd. et al. (2010), 408 N.R. 166; 2010 FCA 242, refd to. [para. 190].

Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 122 D.L.R.(3d) 203, refd to. [para. 196].

Pioneer Hi-Bred Ltd. v. Commissioner of Patents, [1989] 1 S.C.R. 1623; 97 N.R. 185, refd to. [para. 198].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al. (2008), 381 N.R. 125; 2008 SCC 61, refd to. [para. 208].

Counsel:

Yoon Kang and Vik G. Tenekjian, for the applicants;

Carol Hitchman and Rosamaria Longo, for the respondent, Pharmascience Inc.;

No one appearing for the respondent, The Minister of Health.

Solicitors of Record:

Smart & Biggar, Toronto, Ontario, for the applicants;

Gardiner Roberts LLP, Toronto, Ontario, for the respondent, Pharmascience Inc.;

Myles J. Kirvan, Deputy Attorney General of Canada, Toronto, Ontario, for the respondent, The Minister of Health.

This application was heard in Toronto, Ontario, on June 4, 2012, before O'Keefe, J., of the Federal Court, who delivered the following decision in Ottawa, Ontario, on October 11, 2012.