Abbott Laboratories et al. v. Canada (Minister of Health) et al., 2009 FC 648

JudgeHeneghan, J.
CourtFederal Court (Canada)
Case DateApril 02, 2009
JurisdictionCanada (Federal)
Citations2009 FC 648;(2009), 347 F.T.R. 159 (FC)

Abbott Lab. v. Can. (2009), 347 F.T.R. 159 (FC)

MLB headnote and full text

Temp. Cite: [2009] F.T.R. TBEd. JL.018

Abbott Laboratories and Abbott Laboratories Limited (applicants) v. The Minister of Health and Sandoz Canada Inc. (respondents)

(T-1129-07; 2009 FC 648)

Indexed As: Abbott Laboratories et al. v. Canada (Minister of Health) et al.

Federal Court

Heneghan, J.

July 7, 2009.

Summary:

Sandoz Canada Inc. applied for a Notice of Compliance (NOC) to permit it to market its version of clarithromycin extended-release 500 mg tablets. Abbott Laboratories sold clarithromycin in an extended release 1,000 mg formulation. Sandoz alleged in a Notice of Allegation (NOA) that the '266 and '395 patents of Abbott Laboratories Ltd. were invalid on several grounds, including obviousness, lack of actual utility, lack of sound prediction utility and double patenting. Abbott applied under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations, challenging the NOA and seeking to prohibit the issuance of a NOC to Sandoz for its product until the expiry of the impugned patents.

The Federal Court issued an order of prohibition in relation to the '266 patent. Abbott had demonstrated on a balance of probabilities that the allegations of invalidity were not justified. While the court was satisfied that Abbott had rebutted the allegations respecting obviousness and the lack of utility of the '395 patent, they had failed to rebut the allegation of double patenting. Accordingly, the court dismissed the request for an order of prohibition in relation to the '395 patent.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - [See Food and Drug Control - Topic 1302 ].

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order (incl. compensation by first person) - A generic pharmaceutical company, Sandoz Canada Inc., alleged in a Notice of Allegation (NOA) that the '266 and '395 patents of Abbott Laboratories and Abbott Laboratories Ltd. were invalid on several grounds, including obviousness, lack of actual utility, lack of sound prediction utility and double patenting - In response, Abbott applied under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations, challenging the NOA and seeking to prohibit the issuance of a Notice of Compliance to Sandoz for its product until the expiry of the impugned patents -The Federal Court issued an order of prohibition in relation to the '266 patent - Abbott had demonstrated on a balance of probabilities that the allegations of invalidity were not justified - While the court was satisfied that Abbott had rebutted the allegations respecting obviousness and the lack of utility of the '395 patent, they had failed to rebut the allegation of double patenting - Accordingly, the court dismissed the request for an order of prohibition in relation to the '395 patent.

Food and Drug Control - Topic 1302

Drugs - Evidence and proof - Burden of proof (incl. presumptions) - Sandoz Canada Inc. applied for a Notice of Compliance (NOC) to permit it to market its version of clarithromycin extended-release 500 mg tablets - Sandoz alleged in a Notice of Allegation (NOA) that the '266 and '395 patents of Abbott Laboratories and Abbott Laboratories Ltd. were invalid - The patents contained clarithromycin, which Abbott sold in an extended release 1,000 mg formulation - Abbott applied for an order prohibiting the Minister of Health from issuing a NOC to Sandoz until the expiry of the patents - The Federal Court addressed the jurisprudence applicable to the burden of proof and stated that "the burden of proving that the second person's, that is, Sandoz's, allegations are not justified is on the person seeking the Prohibition Order, Abbott. Abbott must establish, on a balance of probabilities, that Sandoz's allegations are not justified. Sandoz must put its allegations 'in play' through its NOA. However, once that has been done, Abbott bears the burden of proving that such allegations are not justified, on a balance of probabilities ... Second, the Court must determine whether Sandoz's allegations of invalidity are justified or not" - See paragraphs 79 to 83.

Patents of Invention - Topic 1006

The specification and claims - General - Interpretation of - The respondent alleged in a Notice of Allegation that the applicants' patents were invalid - The Federal Court stated that the first step in determining whether the allegations of invalidity were justified was to construe the disputed claims of the patents - "The patent claim is to be construed in a 'purposive' way and the Court must look at the entire specification of the patent in order to understand the words as stated in a disputed claim, provided this does not enlarge or contract the scope of the actual patent claims. Claims construction is a question of law for the Court to decide ... The key to purposive construction involves a realistic construction of the language of the claims through the eyes, and with the learning, of a person skilled in the art ... The Court must identify the particular words or phrases in the patent claims that describe what the inventor considered to be the 'essential elements of his invention'" - The court emphasized that it "should keep within the four corners of the specification, limiting itself to the words of the claim, interpreted in the context of the specification as a whole. It should avoid the use of extrinsic evidence of intent ... While expert evidence is admissible, its use should be limited to assisting the Court in interpreting the claims in a knowledgeable way" - See paragraphs 88 to 91.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - [See Patents of Invention - Topic 1006 ].

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - The respondent alleged in a Notice of Allegation that the Abbott patents, '266 and '395, were invalid - Both patents were entitled "Extended Release Formulations of Erythromycin Derivatives" - Abbott applied for an order prohibiting a Notice of Compliance being issued to the respondent until the expiry of the patents - The relevant claims of the '266 patent were claims 11 and 12 - Abbott submitted that a skilled person would understand those claims to cover extended release compositions of clarithromycin that had between 45-60 percent clarithromycin (claim 11) or 50 percent clarithromycin (claim 12) - The relevant claim of the '395 patent was claim 22 - Abbott argued that the skilled person would understand claim 22 to have the same meaning as claim 12 of the '266 patent, with the added limitation that the composition had an improved taste profile - The Federal Court stated that claims must be construed upon the basis of the common knowledge of the person skilled in the art as of the date the patents were published - In the court's view, the person skilled in the art would read the '395 patent as revealing what was essentially the same invention as that claimed in the '266 patent, with the added limitation listed in claim 22 - See paragraphs 92 to 106.

Patents of Invention - Topic 1034

The specification and claims - Construction of a patent - Evidence (incl. extrinsic evidence) - [See Patents of Invention - Topic 1006 ].

Patents of Invention - Topic 1502

Grounds of invalidity - General - Onus and standard of proof - [See Food and Drug Control - Topic 1302 ].

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The Federal Court assessed the allegations of obviousness in respect of two patents, in light of s. 28.3 of the Patent Act (requiring that an invention disclosed in a patent not be obvious), and considered the leading jurisprudence setting out the prevailing test for obviousness - This required the court to look at the following elements: "(a) identify the skilled person to whom the patent is addressed and the state of the art known to that person; (b) identify the inventive concept in the claims, having regard to the disclosure if the claims do not expand on that concept; (c) determine the differences between what was previously known and the inventive concept in the claims; and (d) determine if those differences would be obvious without the benefit of hindsight" - If the "obvious to try" test was appropriate, the court noted the four additional but non-exhaustive factors that the jurisprudence identified to be considered under the fourth step - See paragraphs 107 to 109.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - A generic company (Sandoz Canada Inc.) applied for a Notice of Compliance to permit it to market its version of clarithromycin extended-release 500 mg tablets - Sandoz alleged in a Notice of Allegation that the '266 and '395 patents of Abbott Laboratories and Abbott Laboratories Ltd. were invalid - The patents contained clarithromycin, which Abbott sold in an extended release 1,000 mg formulation - Obviousness was the only allegation of invalidity raised against the '266 patent - It was also raised in respect of the '395 patent - Abbott applied for an order prohibiting the Minister of Health from issuing a NOC to Sandoz until the expiry of the patents - The Federal Court applied the prevailing test for obviousness, and concluded that it would not have been obvious to the skilled person to arrive at the compositions claimed by the '266 and '395 patents based upon the teachings contained within the prior art - As a result, the court was satisfied that Abbott had successfully shown that the allegations of obviousness were not justified - See paragraphs 110 to 168.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art - [See Patents of Invention - Topic 1589 ].

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - The respondent alleged that one of Abbott's patents at issue in this proceeding ('395 patent, improved taste) was invalid on the basis of double patenting over the '266 patent - The Federal Court addressed s. 36 of the Patent Act, and cited the main authority on double patenting, that a second patent could not be justified unless the claims exhibited "ingenuity or novelty" over the first patent - At issue, therefore, was whether the claims of the '395 patent were distinct from the claims of the '266 patent, as of the date of the patent's publication - Abbott argued that the Commissioner of Patents required it to divide its claims respecting the improved taste profile from the '266 patent into a separate divisional application (s. 36(2.1)) - The court did not find the '395 patent invalid for double patenting - Abbott provided evidence that claims respecting the improved taste profile were divided out of the '266 patent at the request of the Commissioner - That was an administrative action lying within the Commissioner's mandate - It would be unfair and inequitable to find that the '395 patent should be invalidated, only because Abbott had followed the Commissioner's directions - See paragraphs 186 to 189, 192 and 193.

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - A generic pharmaceutical company (Sandoz) served a Notice of Allegation (NOA) on the patentee (Abbott) on May 7, 2007 - It alleged that Abbott's '395 patent was invalid on the basis of double patenting; i.e., that it claimed the same improved taste profile as those of Abbott's '541 patent - Abbott sought an order prohibiting the issuing of a Notice of Compliance (NOC) to Sandoz until the expiry of the '395 patent and the '541 patent - Abbott submitted that the claims of the '541 patent had been dedicated to the public on January 20, 2009, giving rise to the legal effect that the claims were never issued - The Federal Court disagreed with that "novel" argument and held that the '395 patent was invalid for double patenting - Had the dedication been executed prior to the service of the NOA, Sandoz would not have had a ground for alleging double patenting - In the context of prohibition proceedings, the NOA was the critical document - In the end result, the court was not satisfied that Abbott had shown that the allegation of double patenting of the '395 patent over the '541 patent was not justified - The '395 patent claimed the same improved taste profile as that which was already claimed by the '541 patent - It was not distinct from that which was claimed in the '541 patent - See paragraphs 190 to 206.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - The respondent alleged in a Notice of Allegation that the applicants' '395 patent was invalid on the ground that it lacked sound prediction utility - The relevant claim of the patent was claim 22 - The Federal Court reviewed the doctrine of sound prediction and noted the leading jurisprudence explaining that "where the invention was a new use for an old product, the utility required for patentability must either be demonstrated or be a sound prediction based on the information and expertise then available. One doctrine of sound prediction has three components: first, there must be a factual basis for the prediction; second, the inventor must have a 'sound' line of reasoning from which the desired result can be inferred from the factual basis, as of the date of the patent application; and third, there must be proper disclosure ... The key date for consideration of the doctrine of sound prediction is the filing date of the patent application" - As the applicants had shown that the allegation of lack of utility was not justified, it was not necessary for the court to consider whether claim 22 was not soundly predicted - See paragraphs 183 to 185.

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - The respondent, a generic pharmaceutical company, alleged in a Notice of Allegation that the '395 patent of Abbott Laboratories and Abbott Laboratories Ltd. was invalid on the ground that it lacked actual utility - In response, Abbott applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to the respondent until the expiry of the patents, and argued that the studies showed the utility of its patent insofar as the extended release composition exhibited an improved taste profile - The respondent alleged that the patent simply repeated the state of the art - The Federal Court held that the evidence met the standards of utility - The claim of the patent that was relevant was claim 22, which only required an improvement in taste profile, not a statistically significant reduction in taste perversion - The evidence showed an improvement in taste profile as claimed - Further, the respondent's submissions undermined one of the central benefits it would realize by marketing its generic version - See paragraphs 169 to 182.

Cases Noticed:

Eli Lilly & Co. et al. v. Nu-Pharm Inc. et al. (1996), 199 N.R. 185; 69 C.P.R.(3d) 1 (F.C.A.), refd to. [para. 79].

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. 79].

SmithKline Beecham Pharma Inc. et al. v. Apotex Inc. et al., [2001] 4 F.C. 518; 208 F.T.R. 105; 2001 FCT 770, affd. [2003] 1 F.C. 118; 291 N.R. 168; 2002 FCA 216, refd to. [para. 79].

Bull (David) Laboratories (Canada) Inc. v. Pharmacia Inc. et al., [1995] 1 F.C. 588; 176 N.R. 48; 58 C.P.R.(3d) 209 (F.C.A.), refd to. [para. 80].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 9 C.P.R.(4th) 129, refd to. [para. 88].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 9 C.P.R.(4th) 168; 2000 SCC 66, refd to. [para. 88].

Searle (G.D.) & Co. et al. v. Novopharm Ltd. et al. (2007), 296 F.T.R. 254; 56 C.P.R.(4th) 1 (F.C.), refd to. [para. 98].

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. 108].

Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd., [1985] R.P.C. 59; 8 C.P.R.(3d) 241 (F.C.A.), refd to. [para. 127].

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. 169].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130, refd to. [para. 183].

Aventis Pharma Inc. v. Apotex Inc. et al. (2005), 278 F.T.R. 1; 43 C.P.R.(4th) 161 (F.C.), affd. (2006), 349 N.R. 183; 46 C.P.R.(4th) 401 (F.C.A.), refd to. [para. 184].

Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Braning, [1964] S.C.R. 49, refd to. [para. 187].

Bristol-Myers Squibb Canada Co. et al. v. Apotex Inc. et al. (2009), 342 F.T.R. 161; 2009 FC 137, refd to. [para. 195].

Searle (G.D.) & Co. et al. v. Merck & Co. et al. (2002), 219 F.T.R. 64; 20 C.P.R.(4th) 103; 2002 FCT 540, refd to. [para. 197].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2000), 256 N.R. 172; 7 C.P.R.(4th) 272 (F.C.A.), refd to. [para. 201].

Canadian Celanese Ltd. v. B.V.D. Co., [1939] 2 D.L.R. 289 (P.C.), refd to. [para. 202].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 28.3 [para. 107]; sect. 36(1), sect. 36(2.1), sect. 36(4) [para. 192].

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 6(1) [para. 78].

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

Counsel:

Andrew Reddon, Steven Mason and David Tait, for the applicants;

Edward Hore and Kevin Zive, for the respondent, Sandoz Canada Inc.

Solicitors of Record:

McCarthy Tétrault, LLP, Toronto, Ontario, for the applicants;

Hazzard & Hore, Toronto, Ontario, for the respondent, Sandoz Canada Inc.;

John H. Sims, Q.C., Deputy Attorney General of Canada, Toronto, Ontario, for the respondent, The Minister of Health.

This application was heard on March 30 to April 2, 2009, at Toronto, Ontario, before Heneghan, J., of the Federal Court. The following public reasons for judgment were filed on July 7, 2009.

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