Novo Nordisk Canada Inc. et al. v. Cobalt Pharmaceuticals Inc. et al., 2010 FC 746

• Judge: Mactavish, J.
• Court: Federal Court (Canada)
• Case Date: August 03, 2010
• Jurisdiction: Canada (Federal)
• Citations: 2010 FC 746;(2010), 376 F.T.R. 104 (FC)

Novo Nordisk Can. v. Cobalt Pharmaceuticals (2010), 376 F.T.R. 104 (FC)

MLB headnote and full text

Temp. Cite: [2010] F.T.R. TBEd. AU.008

Novo Nordisk Canada Inc. and Dr. Karl Thomae GmbH (applicants) v. Cobalt Pharmaceuticals Inc. and The Minister of Health (respondents)

(T-1221-08; 2010 FC 746)

Indexed As: Novo Nordisk Canada Inc. et al. v. Cobalt Pharmaceuticals Inc. et al.

Federal Court

Mactavish, J.

August 3, 2010.

Summary:

The '851 patent claimed a compound know as repaglinide, its use for the treatment of Type 2 Diabetes and the process to make repaglinide. Repaglinide was marketed in Canada by Novo Nordisk Canada under the brand name GlucoNorm in accordance with a notice of compliance. Cobalt Pharmaceuticals served a notice of allegation on Novo Nordisk. Cobalt admitted that its repaglinide product would infringe the '851 patent, but asserted that, inter alia, the '851 patent was not a valid selection patent and that it was invalid on a number of bases, including anticipation, obviousness, double patenting, lack of utility, and insufficiency. Cobalt also asserted that the '851 patent was void pursuant to s. 53(1) of the Patent Act as the inventors had made material false allegations about its utility, and that they omitted information from the patent which should have been disclosed. Novo Nordisk and the patent owner applied to prohibit the Minister of Health from issuing a notice of compliance to Cobalt until the expiration of the '851 patent.

The Federal Court concluded that the '851 patent was void for obviousness and dismissed the application. The court awarded Cobalt costs at the middle of Column IV, reduced by 25% to take into account its unsuccessful s. 53 allegations.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for - Notice of allegation - A generic pharmaceuticals company (Cobalt) filed a notice of allegation, asserting that, inter alia, the '851 patent was void under s. 53(1) of the Patent Act - The applicants applied to prohibit the Minister of Health from issuing a notice of compliance to Cobalt until the expiration of the '851 patent - The applicants asserted that the notice of allegation was vague and general in nature and did not met the required standard of particularity - The Federal Court noted that no affidavit had been filed on behalf of the applicants stating that they were not in a position to decide whether to challenge the notice of allegation because the statement lacked specificity, or that they were prejudiced in some way in that regard - The applicable test was whether the detailed statement was sufficient to make the patentee fully aware of the grounds on which the generic claimed that the relevant patent would not be infringed if a notice of compliance was issued - However, the court did not have to decide whether the s. 53 allegation should be summarily disposed of on the grounds of the insufficiency because it was satisfied that, in any event, the evidence did not support Cobalt's allegation - See paragraphs 337 to 343.

Food and Drug Control - Topic 1111.4

Drugs - New drugs - Notice of compliance - Evidence and proof - Burden of proof - A generic pharmaceutical company filed a notice of allegation and challenged the validity of the '851 patent - The applicants applied to prohibit the Minister of Health from issuing a notice of compliance to the generic pharmaceutical company until the expiration of the '851 patent - The Federal Court stated that insofar as the patent's validity was concerned, it would be presumed to be valid, absent evidence to the contrary - If the generic pharmaceutical company failed to adduce any evidence on a ground of invalidity, that presumption was not rebutted - However, if it adduced some evidence which, if accepted, was capable of establishing the patent's invalidity, thereby putting the allegations of invalidity "in play", the burden would then be on the applicants to establish on a balance of probabilities that all of the allegations of invalidity were not justified - See paragraphs 67 to 69.

Food and Drug Control - Topic 1302

Drugs - Evidence and proof - Burden of proof (incl. presumptions) - [See Food and Drug Control - Topic 1111.4 ].

Patents of Invention - Topic 705

Application for grant - General - Disclosure and examination (incl. duty of candour) - The '851 patent claimed a compound known as repaglinide, its use for the treatment of Type 2 Diabetes, and processes to make it - Cobalt Pharmaceuticals filed a notice of allegation, asserting that, inter alia, the '851 patent for was void pursuant to s. 53(1) of the Patent Act because of the accumulative effects of the inventors' wilful omissions and material false allegations about the patent's utility - Cobalt relied primarily on wilful omissions, especially the failure to disclose that the information regarding repaglinide's surprisingly quick onset in lowering blood sugar came from tests done on one of the inventors - The Federal Court stated that allegations of wilful omission had to be strongly supported with evidence - One omission relied on by Cobalt (a missing Legend) was due to inadvertence and would not have misled a person skilled in the art - Another allegation respecting study data was essentially a complaint that the inventors had not backed up the invention with the results of all of the tests that were performed and resulting data - The disclosure standard required to obtain a patent could not be equated to that needed to obtain regulatory approval for a drug or to publish an article in a peer review journal - As to the repaglinide's quick onset, there was no evidence that the results of the tests were inaccurate - The court was not satisfied that the omission came within the ambit of s. 53(1) - The court was similarly not persuaded that a failure to indicate that the studies were carried out on healthy volunteers amounted to an omission that engaged s. 53(1) - See paragraphs 344 to 364.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - The Federal Court reviewed the general principles governing the construction of patents, stating that "The Court is to determine objectively, through the eyes of the person skilled in the art, what such a person would have understood the inventors to mean as of the relevant date ... The claims of a patent are to be construed purposively, having regard to the intentions of the inventors as derived from the patent and with reference to the entire specification. Where necessary, the whole of the patent should be interpreted, and not just the claims ... A court should construe a patent with a judicial anxiety to support a useful invention ... Construction of any given claim will depend on the common knowledge of a person skilled in the art of the patent with a mind willing to understand what is put to him or her and the knowledge of the art at the time the patent was published ... Expert assistance may be provided with respect to the meaning of certain terms, as well as the knowledge that a person skilled in the art would have had as of the relevant date ..." - See paragraphs 71 to 75.

Patents of Invention - Topic 1030

The specification and claims - Construction of a patent - "Person skilled in the art" - What constitutes - The '851 patent claimed a compound know as repaglinide, its use for the treatment of Type 2 Diabetes and the process to make repaglinide - Repaglinide was marketed in Canada by Novo Nordisk Canada under the brand name GlucoNorm in accordance with a notice of compliance - Cobalt Pharmaceuticals served a notice of allegation on Novo Nordisk - Cobalt admitted that its repaglinide product would infringe the '851 patent, but asserted that, inter alia, the 851' patent was not a valid selection patent and that it was invalid on a number of bases, including anticipation, obviousness, double patenting, lack of utility, and insufficiency - Novo Nordisk and the patent owner applied to prohibit the Minister of Health from issuing a notice of compliance to Cobalt until the expiration of the '851 patent - The Federal Court, after stating that it was to construe the '851 patent through the eyes of the "person skilled in the art", stated that such a person would be the ordinary worker who was ordinarily skilled in the art to which the invention related who possessed the ordinary amount of knowledge incidental to that particular trade - Here they would be the composite person or drug development team, made up of individuals with at least a bachelor's degree in the relevant fields, as well as work related practical experience - The person should have some familiarity with pharmacokinetic and pharmacodynamic principles - As the '851 patent related to an enantiomer which had been separated from its parent racemate, it was reasonable that a member of that notional development team would possess knowledge and experience in enantiomeric separation - See paragraphs 81 to 87.

Patents of Invention - Topic 1030.1

The specification and claims - Construction of a patent - "Person skilled in the art" - Common general knowledge - [See Patents of Invention - Topic 1030 ].

Patents of Invention - Topic 1034

The specification and claims - Construction of a patent - Evidence (incl. extrinsic evidence) - [See Patents of Invention - Topic 1026 ].

Patents of Invention - Topic 1034

The specification and claims - Construction of a patent - Evidence (incl. extrinsic evidence) - The Federal Court stated that the purposive construction of patent claims required that they be interpreted in light of the whole of the disclosure, including the specification - That said, while one could have regard to the specification to understand what was meant by the language in the claims, it was well established in the jurisprudence that the specification could not be used to enlarge the scope of the claim as written and understood - See paragraphs 111 and 112.

Patents of Invention - Topic 1502

Grounds of invalidity - Onus and standard of proof - [See Food and Drug Control - Topic 1111.4 ].

Patents of Invention - Topic 1507

Grounds of invalidity - General - Untrue material allegations in petition, specification or drawings - [See Food and Drug Control - Topic 1105 and Patents of Invention - Topic 705 ].

Patents of Invention - Topic 1507

Grounds of invalidity - General - Untrue material allegations in petition, specification or drawings - Cobalt Pharmaceuticals filed a notice of allegation, asserting that, inter alia, the '851 patent was void pursuant to s. 53(1) of the Patent Act because of the inventors' wilful omissions and material false allegations about the patent's utility - The Federal Court rejected the assertion and raised concerns of fairness - Although Cobalt cross-examined two of the inventors at some length, its s. 53 allegations were never put directly to them - If an allegation was going to be made that an inventor had misled the Patent Office, elemental fairness required that the allegation be put squarely to the inventor and the inventor be provided with the opportunity to respond to the allegation - See paragraphs 365 to 368.

Patents of Invention - Topic 1507

Grounds of invalidity - General - Untrue material allegations in petition, specification or drawings - Cobalt Pharmaceuticals filed a notice of allegation, asserting that, inter alia, the '851 patent was invalid on a number of grounds and void pursuant to s. 53(1) of the Patent Act because of wilful omissions and material false allegations - The applicants applied to prohibit the issuance of a notice of compliance until the expiration of the '851 patent - The Federal Court found that the '851 was invalid for obviousness - The court addressed the s. 53 allegation because of its potential effect on costs - The court rejected the allegation - The court concluded that Cobalt was entitled to have its costs at the middle of Column IV - However, allegations under s. 53 implicated the notion of fraud and were not to be advanced lightly without a sufficient evidentiary foundation in the hope that evidence might turn up to support the allegations - The court referred to prior cases, including one where the court reduced a successful generic's costs by 25% because of its s. 53 allegations which it had abandoned prior to the hearing - Cobalt sought to distinguish itself from those cases on the basis that it had not abandoned its s. 53 allegations - The court stated that that distinction was an aggravating factor which could have arguably favoured a greater costs penalty - That said, the court ordered that Cobalt's fees and disbursement be reduced by 25% where the applicants had taken the position that that was an appropriate reduction - See paragraphs 370 to 379.

Patents of Invention - Topic 1514

Grounds of invalidity - General - Selection patents - The Federal Court noted that for a selection patent to be valid the selected compound or compounds must not have been made before - However, if the selected compound was novel and possessed a special property of an unexpected character, the required inventive step would be satisfied - In that regard a selection patent was no different than any other patent - See paragraphs 135 to 142

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - A Patent Co-Operation Treaty application was filed on June 21, 1991, which led to the '851 patent - The '851 patent claimed a compound know as repaglinide, its use for the treatment of Type 2 Diabetes and the process to make repaglinide - Repaglinide was marketed in Canada by Novo Nordisk Canada under the brand name GlucoNorm in accordance with a notice of compliance - Cobalt Pharmaceuticals served a notice of allegation on Novo Nordisk - Cobalt admitted that its repaglinide product would infringe the '851 patent, but asserted that, inter alia, the '851 patent was not a valid selection patent on the grounds of obviousness - Cobalt relied on the '398 patent and the '331 patent application, which already claimed "racemic repaglinide" and its enantiomers, and on four articles - The Federal Court stated that it had to consider whether the prior art, together with the general knowledge that a person skilled in the art would have been expected to have had as of June 21, 1991 (the date agreed to by the parties), made the invention claimed in the '851 patent more or less self-evident - The court concluded that, as of June 21, 1991, it was self-evident that a person skilled in the art would test enantiomers for their pharmacokinetic properties - Repaglinide's pharmacokinetic properties would inevitably have been discovered as a result of that routine testing - That testing was not an inventive step by the patent owner's drug development team - Accordingly, Cobalt's allegation of obviousness was justified - See paragraphs 176 to 323.

Patents of Invention - Topic 1587

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Selection patents - [See Patents of Invention - Topic 1582 ].

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. common general knowledge and mosaicing) - [See Patents of Invention - Topic 1582 ].

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. common general knowledge and mosaicing) - The Federal Court stated that "anticipation and obviousness are related concepts. However, although both require an examination of the prior art, that prior art must be treated differently, depending on whether the issue is anticipation or obviousness. ... In examining an allegation of anticipation (or lack of novelty), the Court must determine whether the claimed invention has already been disclosed to the public in a single disclosure in such a way as to enable it to be put into practice ... In contrast, where obviousness (or lack of invention) is alleged, the Court may consider a number of prior disclosures that would have been known or found by a person skilled in the art, in order to determine whether an inventive step has been taken" - See paragraphs 144 to 146.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - [See Patents of Invention - Topic 1593 ].

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - The '851 patent claimed a compound know as repaglinide, its use for the treatment of Type 2 Diabetes and the process to make repaglinide - Repaglinide was marketed in Canada by Novo Nordisk Canada under the brand name GlucoNorm in accordance with a notice of compliance - Cobalt Pharmaceuticals served a notice of allegation on Novo Nordisk - Cobalt admitted that its repaglinide product would infringe the '851 patent, but asserted that, inter alia, the '851 patent was not a valid selection patent on the grounds of anticipation - Cobalt relied on the '398 patent and the '331 patent application, which already claimed "racemic repaglinide" and its enantiomers - The Federal Court rejected the assertion - Although the racemate of repaglinide had been synthesized at the time of the '398 patent, repaglinide itself had not been made, let alone tested - Neither its absolute configuration nor its special advantages were previously known, and there was no suggestion that its particular pharmacokinetic properties could have been predicted with any degree of certainty - Moreover, no preference was expressed in the '398 patent for the use of the (S) enantiomer over the (R) enantiomer, nor was any direction provided for the use of the (S) enantiomer over the racemate - In contrast, the '851 patent taught that the hypoglycemic activity resided exclusively in the (S) enantiomer - The court rejected an assertion that if repaglinide's pharmacokinetic properties were considered to be inherent in the claims of the '851 patent, then they would also be inherent in the compounds claimed by both the '398 patent and the '331 patent application, with the result that the invention claimed by the '851 patent was anticipated - There was no disclosure in either the '398 patent or the '331 patent application that clearly defined the nature of the pharmacokinetic advantages allegedly possessed by repaglinide - See paragraphs 156 to 175.

Patents of Invention - Topic 1604

Grounds of invalidity - Anticipation - Selection patents - [See Patents of Invention - Topic 1603 ].

Patents of Invention - Topic 8186

Practice - Costs - Entitlement - [See third Patents of Invention - Topic 1507 ].

Practice - Topic 7037

Costs - Party and party costs - Entitlement to party and party costs - Factors or circumstances reducing entitlement (incl. waiver) - [See third Patents of Invention - Topic 1507 ].

Cases Noticed:

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 361 N.R. 308; 59 C.P.R.(4th) 30; 2007 FCA 153, refd to. [para. 69].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 60 C.P.R.(4th) 81; 2007 FCA 209, refd to. [para. 69].

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. 71].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 323 F.T.R. 56; 63 C.P.R.(4th) 406; 2008 FC 142, refd to. [para. 72].

Eli Lilly Canada Inc. v. Novopharm Ltd. et al., [2007] F.T.R. Uned. 828; 58 C.P.R.(4th) 214; 2007 FC 596, refd to. [para. 72].

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. 73].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 122 D.L.R.(3d) 203; 56 C.P.R.(2d) 145, refd to. [para. 73].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2007), 366 N.R. 290; 59 C.P.R.(4th) 116; 2007 FCA 217, refd to. [para. 75].

Halford et al. v. Seed Hawk Inc. et al. (2006), 353 N.R. 60; 54 C.P.R.(4th) 130; 275 D.L.R.(4th) 556; 2006 FCA 275, refd to. [para. 75].

Merck & Co. et al. v. Pharmascience Inc. et al. (2010), 368 F.T.R. 1; 2010 FC 510, refd to. [para. 95].

Monsanto Canada Inc. et al. v. Schmeiser et al., [2004] 1 S.C.R. 902; 320 N.R. 201; 2004 SCC 34, refd to. [para. 111].

Metalliflex Ltd. v. Wienenberger Aktiengesellschaft, [1961] S.C.R. 117; 35 C.P.R. 49, refd to. [para. 112].

Dimplex North America Ltd. v. CFM Corp. (2006), 292 F.T.R. 38; 54 C.P.R.(4th) 435; 2006 FC 586, affd. (2007), 370 N.R. 316; 60 C.P.R.(4th) 277; 2007 FCA 278, refd to. [para. 112].

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. 139].

Synthon BV v. Smithkline Beecham plc, [2005] N.R. Uned. 180; [2005] UKHL 59; [2006] 1 All E.R. 685, refd to. [para. 145].

Eli Lilly Canada Inc. v. Novopharm Ltd. et al. (2009), 346 F.T.R. 42; 2009 FC 301, refd to. [para. 145].

ratiopharm Inc. v. Pfizer Ltd. (2009), 350 F.T.R. 250; 76 C.P.R.(4th) 241; 2009 FC 711, refd to. [para. 156].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2006), 301 F.T.R. 166; 2006 FC 1234, refd to. [para. 157].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2007), 311 F.T.R. 21; 58 C.P.R.(4th) 353; 2007 FC 455, refd to. [para. 166].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2009), 385 N.R. 148; 72 C.P.R.(4th) 141; 2009 FCA 8, refd to. [para. 180].

Laboratoires Servier et al. v. Apotex Inc. et al. (2008), 332 F.T.R. 193; 67 C.P.R.(4th) 241; 2008 FC 825, affd. (2009), 392 N.R. 96; 75 C.P.R.(4th) 443; 2009 FCA 222, refd to. [para. 183].

Lundbeck Canada Inc. V. Canada (Minister of Health) et al. (2009), 343 F.T.R. 53; 73 C.P.R.(4th) 69; 2009 FC 146, refd to. [para. 268].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 323 F.T.R. 56; 63 C.P.R.(4th) 406; 2008 FC 142, affd. (2009), 392 N.R. 243; 2009 FCA 97, leave to appeal refused (2009), 401 N.R. 400 (S.C.C.), refd to. [para. 328].

Mobil Oil Corp. et al. v. Hercules Canada Inc. (1994), 82 F.T.R. 211; 57 C.P.R.(3d) 488 (T.D.), revd. (1995), 188 N.R. 382; 63 C.P.R.(3d) 473 (F.C.A.), refd to. [para. 330].

Bayer AG et al. v. Apotex Inc. et al. (1998), 156 F.T.R. 303; 84 C.P.R.(3d) 23 (T.D.), refd to. [para. 330].

Zambon Group S.p.A. v. Teva Pharmaceutical Industries Ltd. (2005), 284 F.T.R. 18; 2005 FC 1585, refd to. [para. 331].

Corning Glass Works v. Canada Wire & Cable Ltd. (1984), 81 C.P.R.(2d) 39 (F.C.T.D.), refd to. [para. 333].

AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 256 N.R. 172; 7 C.P.R.(4th) 272 (F.C.A.), refd to. [para. 337].

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. 338].

AstraZeneca AB et al. v. Apotex Inc. et al. (2005), 335 N.R. 1; 2005 FCA 183, refd to. [para. 338].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2005), 341 N.R. 330; 42 C.P.R.(4th) 97; 2005 FCA 270, refd to. [para. 339].

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. 339].

SmithKline Beecham Inc. et al. v. Apotex Inc. et al. (2001), 267 N.R. 101; 10 C.P.R.(4th) 338 (F.C.A.), refd to. [para. 339].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2004), 329 N.R. 152; 38 C.P.R.(4th) 400 (F.C.A.), refd to. [para. 339].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2009), 352 F.T.R. 35; 76 C.P.R.(4th) 83; 2009 FC 638, refd to. [para. 352].

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. 353].

Janssen-Ortho Inc. et al. v. Canada (Minister of Health) et al. (2010), 361 F.T.R. 268; 2010 FC 42, refd to. [para. 367].

Bristol-Myers Squibb Canada Co. et al. v. Apotex Inc. et al. (2009), 342 F.T.R. 161; 74 C.P.R.(4th) 85; 2009 FC 137, refd to. [para. 371].

Shire Biochem Inc. et al. v. Canada (Minister of Health) et al. (2008), 328 F.T.R. 123; 67 C.P.R.(4th) 94; 2008 FC 538, refd to. [para. 376].

Janssen-Ortho Inc. et al. v. Apotex Inc. et al. (2008), 332 F.T.R. 1; 2008 FC 744, revd. (2009), 392 N.R. 71; 75 C.P.R.(4th) 411; 2009 FCA 212, refd to. [para. 377].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 53 [para. 325].

Authors and Works Noticed:

De Camp, Wilson H., The FDA Perspective on the Development of Stereoisomers, (1989), 1(1) Charality, pp. 2 to 6 [para. 266].

Derendorf, H., Schaefer, H.G., Harrison, D., Hocking, M.P., and Limberg, J., Effects of Truncal Vagotomy and Partial Gastrectomy on the Pharmacokinetics of Propranolol Enantimomers in Dogs (1990), 79(4) J. Pharm. Sciences, pp. 292 to 294 [para. 253].

Derendorf, H., Simultaneous determination of propranolol and 4-hydroxypropranolol enantiomers after chiral derivatization using reversed-phase high performance liquid chromatography (1990), 527 J. Chrom. B: Biomedical Sciences and Applications, pp. 351 to 359 [para. 254].

Garrino, M.G., and Henquin, J.C., Highly potent and stereoselective effects of the benzoic acid derivative AZ-DF 265 on pancreatic B-cells (1988), 93 Br. J. Pharmacol, pp. 61 to 68 [para. 210].

Hughes, Roger T., and Woodley, John H., Patents (2nd Ed. 2005), § 24 [para. 330].

Jamali, F., Mehvar, R., and Pasutto, F.M., Enantioselective aspects of drug action and disposition: Therapeutic pitfalls (1989), 78(9) J. Pharm. Sciences, pp. 695 to 715 [para. 240].

Rufer, C., and Losert, W., Blood Glucose Lowering Sulfonamides with Asymmetric Carbon Atoms. Related N-Substituted Carbamoylbenzoic Acids (1979), 22(6) J. Med. Chem., p. 1445 [para. 198].

Rufer, C., Biere, H., Ahrens, H., Loge, O., and Schroeder, E., Blood Glucose Lowering Sulfonamides with Asymmetric Carbon Atoms (1974), 17(7) J. Med. Chem., p. 708 [para. 189].

Schentag, J.J., Jusko, W.J., Vance, J.W., Cumbo, T.J., Abrutyn, E., DeLattre, M., and Gerbracht, L.M., Gentamicin Disposition and Tissue Accumulation on Multiple Dosing (1977), generally [para. 196].

Shinkai, H., Nishikawa, M., Sato, Y., Toi, K., Kumashiro, I., Seto, Y., Fukuma, M., Dan, K., and Toyoshima, S., N-(Cyclohexylcarbonyl)-D-phenylalanines and Related Compounds. A New Class of Oral Hypoglycemic Agents (1989), 32 J. Med. Chem, pp. 1436 to 1441 [para. 223].

Verspohl, E.J., Ammon, H.P., and Mark, M., Evidence for more than One Binding Site for Sulfonylureas in Insulin-secreting Cells (1990), 42(4) J. Pharm. Pharmacol., pp. 230 to 235 [para. 218].

Counsel:

Neil Belmore, Lindsay Neidrauer and Greg Beach, for the applicants;

Tim Gilbert, Sana Halwani and Victor So, for the respondent (Cobalt Pharmaceuticals Inc.);

No one appearing for the respondent (Health Canada).

Solicitors of Record:

Belmore McIntosh Neidrauer, LLP, Toronto, Ontario, for the applicants;

Gilbert's, LLP, Toronto, Ontario, for the respondent (Cobalt Pharmaceutical Inc.);

Myles J. Kirvan, Q.C., Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent (Health Canada).

This application was heard in Toronto, Ontario, on May 17 to 20, 2010, by Mactavish, J., of the Federal Court, who delivered the following judgment on August 3, 2010, at Ottawa, Ontario.