Merck & Co. et al. v. Pharmascience Inc. et al., (2010) 368 F.T.R. 1 (FC)

• Judge: Hughes, J.
• Court: Federal Court (Canada)
• Case Date: April 26, 2010
• Jurisdiction: Canada (Federal)
• Citations: (2010), 368 F.T.R. 1 (FC);2010 FC 510

Merck & Co. v. Pharmascience Inc. (2010), 368 F.T.R. 1 (FC)

MLB headnote and full text

Temp. Cite: [2010] F.T.R. TBEd. MY.021

Merck & Co., Inc. and Merck Frosst Canada Ltd. (applicants) v. Pharmascience Inc. and The Minister of Health (respondents)

(T-1476-08; 2010 FC 510)

Indexed As: Merck & Co. et al. v. Pharmascience Inc. et al.

Federal Court

Hughes, J.

May 11, 2010.

Summary:

Merck & Co., Inc. and Merck Frosst Canada Ltd. were the owner and the Canadian licensee, respectively, of Canadian Patent No. 2,173,457 (the '457 patent), entitled "Use of 5-Alpha Reductase Inhibitors and Compositions for Treating Androgenic Alopecia", including male pattern baldness. Merck received a first patent (the '277 patent) which was directed to a range of compounds, of which finasteride was one, and the use of such compounds for the treatment of androgenic alopecia with finasteride. Pharmascience Inc., a generic drug company, sought approval from the Minister of Health to market finasteride for the treatment of male baldness. Merck brought an application for an order of prohibition under the Patented Medicines (Notice of Compliance) Regulations. Claim 5 of the '457 patent addressed "the use of finasteride for the preparation of a medicament adapted for oral administration useful for the treatment of male pattern baldness in a person and wherein the dosage is about 1.0 mg." At issue was whether Pharmascience's allegations that claim 5 was invalid, on a variety of grounds, was "justified" within s. 6(2) of the NOC Regulations.

The Federal Court concluded that Pharmascience's allegation that claim 5 was invalid was justified on the basis that the claim lacked novelty and constituted double patenting having regard to the '277 patent. The court dismissed Merck's application.

Evidence - Topic 7002

Opinion evidence - Expert evidence - General - Acceptance, rejection and weight to be given to expert opinion - The applicants (collectively Merck) were the owner and Canadian licensee of the patent at issue - The respondent generic drug company led the evidence of Doctors Steiner and Taylor, offered as expert witnesses - Since the proceedings were conducted by way of an application, the evidence was led by way of affidavits; transcripts of the cross-examinations were filed - Merck's counsel attacked the evidence of Doctors Steiner and Taylor, citing R. v. Mohan (1994) (S.C.C.), saying that the expert must show "special or peculiar" knowledge before the evidence could be admitted - The Federal Court admitted the evidence of Doctors Steiner and Taylor as expert evidence - "Their evidence is material to the issues and goes beyond the knowledge that this Court is expected to have. I do not view Mohan, supra, as requiring superlative or exceptional expertise before such evidence is admissible. The matter can be left to assessment as a matter of weight" - See paragraphs 28 to 31.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - The Federal Court stated that "[t]he function of a Notice of Allegation served by a second party ... under the provisions of the NOC Regulations is to raise all the relevant facts and law upon which it intends to rely in clear and unequivocal terms ... In this sense, the Notice of Allegation is like a pleading. Once a second party has taken a position as to fact or law, it cannot be seen to resile from that position. This is particularly so since a Notice of Allegation cannot be amended once Court proceedings have been commenced" - See paragraphs 95 to 99.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - [See Patents of Invention - Topic 1724 ].

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - Merck & Co., Inc. and Merck Frosst Canada Ltd. were the owner and the Canadian licensee, respectively, of Canadian Patent No. 2,173,457 (the '457 patent), entitled "Use of 5-Alpha Reductase Inhibitors and Compositions for Treating Androgenic Alopecia", including male pattern baldness - Merck received a first patent (the '277 patent) which was directed to a range of compounds, of which finasteride was one, and the use of such compounds for the treatment of androgenic alopecia with finasteride - Pharmascience Inc., a generic drug company, sought approval from the Minister of Health to market finasteride for the treatment of male baldness - Merck applied for an order of prohibition - Claim 5 of the '457 patent addressed "the use of finasteride for the preparation of a medicament adapted for oral administration useful for the treatment of male pattern baldness in a person and wherein the dosage is about 1.0 mg." - The Federal Court concluded that Pharmascience's allegation that claim 5 was invalid was justified within s. 6(2) of the Notice of Compliance Regulations - The claim lacked novelty and constituted double patenting having regard to the '277 patent - In the result, the court dismissed Merck's application.

Food and Drug Control - Topic 1302

Drugs - Evidence and proof - Burden of proof (incl. presumptions) - [See Patents of Invention - Topic 1502 ].

Patents of Invention - Topic 5

General - Nature and purpose of grant of patent - The Federal Court stated that "a patent is not something simply to be acquired as of right. It is a monopoly voluntarily sought by an applicant seeking a time-limited but state-supported exclusivity. The applicant must fulfill the statutory requirements in order to acquire the monopoly" - See paragraph 145.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - The Federal Court discussed the history of a claims requirement in Canada, including that the "new" version of the Patent Act applicable to applications for a patent filed after October 1, 1989 and patents maturing from such applications, "requires that a patent contain both a specification which describes the invention and claims which define the monopoly claimed by the patentee ... The function of the specification is to describe the invention so that a person skilled in the art can understand what the invention is and, when the patent expires, put it into practice. The function of the claims is to define the monopoly that the patentee is asserting" - See paragraphs 43 to 45, 48, 50 to 54.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - The Federal Court discussed the history of a claims requirement in Great Britain, after stating that "[m]uch of the Canadian jurisprudence respecting patent law, particularly until the latter part of the last century, has relied upon the jurisprudence coming from Great Britain. In so doing, our Courts have, from time to time, been distracted when it comes to claims and claim construction because the laws of Great Britain ... have come rather later to the concept of an independent claim or claims whose function it is to set out clearly what the monopoly is" - See paragraphs 55 to 65.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - The Federal Court set out the principles of the current approach to claim construction in Canada - The court began by stating that "[i]t has become virtually mandatory in a proceeding respecting patent infringement or validity, or both, that the Court in arriving at its determination first embark upon construction of the claim(s) at issue" - See paragraphs 66 and 67.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - The Federal Court stated that "claims construction today in the Canadian Courts is an easier task than in earlier days, because the function of the claims has been made clearer by statute. That function is to define distinctly and in explicit terms what the claimed monopoly is. To the extent that the claim is now to be 'construed', that is the function of the Court alone. Experts may assist in two ways; first, they may inform the Court as to the knowledge that a person skilled in the art would have had at the relevant time, so as to bring that knowledge to bear reading both the description and the claims; second, an expert may assist in explaining any technical terms not within the experience expected of a Court. Thus, while construction is for a Court alone, the Court may have to make certain factual findings as to the knowledge of a person skilled in the art. The findings of the Court in this respect may best be considered as findings of mixed fact and law" - See paragraph 70.

Patents of Invention - Topic 1030

The specification and claims - Construction of a patent - "Person skilled in the art" - What constitutes - The Federal Court set out the attempts by Canadian courts and courts elsewhere to define a person of ordinary skill in the art (POSITA) - Further, the court had been provided with a copy of the submissions made by the Canadian Group of the Association Internationale pour la Protection de la Propriete Intellectuelle (a non-profit organization seeking to develop and improve laws relating to intellectual property), as to what, under Canadian law, a POSITA was understood to be - The court put the organization's summary to counsel for the parties and each had a point to make - See paragraphs 32 to 37.

Patents of Invention - Topic 1030

The specification and claims - Construction of a patent - "Person skilled in the art" - What constitutes - The Federal Court stated that "[i]n dealing with individual cases, the Court must guard against making too fine a distinction as to identifying the 'ideal' POSITA ... The Court must generally define the person or group to whom the patent is addressed" - The court rejected the suggestion that the court must consider who had the "loudest voice" when considering a team of persons or group of different persons - "To require fine precision and ranking of voices is to place a series of 'trip wires' upon which a Court may be expected to stumble or risk sanctions by a higher Court. There must be some generalized treatment of the question of defining a POSITA and a level of generalization applied" - See paragraphs 38 to 40.

Patents of Invention - Topic 1030

The specification and claims - Construction of a patent - "Person skilled in the art" - What constitutes - The Federal Court looked at the opening words of the patent at issue to obtain "reasonable guidance as to the person(s) to whom the patent is directed" - Specifically, the invention was concerned with "the treatment of androgenic alopecia, including male pattern baldness, with compounds that are 5α-reductase isozyme 2 inhibitors" - The court concluded that a person of ordinary skill in the art (POSITA) in considering the patent was directed to persons concerned with the treatment of male pattern baldness and, in particular, a person or group who were interested in using compounds such as 5α-reductase inhibitors for that person - "It could be a researcher or clinician, or both ... That person is the average person in the group. Just as a 'reasonable man' is expected to be reasonable, the POSITA is expected to possess the ordinary skill in the art - See paragraphs 41 and 42.

Patents of Invention - Topic 1030.1

The specification and claims - Construction of a patent - "Persons skilled in the art" - Common general knowledge - [See fourth Patents of Invention - Topic 1026 ].

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - In this proceeding under the provisions of the Patented Medicines (Notice of Compliance) Regulations, the Federal Court dealt with the effect of drafting the claim in a "Swiss type" style, i.e., in a style which said: "The use of [an old compound] in the manufacture of a medicament for the treatment of [a new disorder]" - The court considered four decisions of the U.K. Courts and one of the European patent Office Enlarged Board of Appeal as to Swiss type claims, as well as the "somewhat conflicting" Canadian decisions as to their construction - See paragraphs 71 to 94.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - The Swiss-type claim of the patent-in-suit was "the use of finasteride for the preparation of a medicament adopted for oral administration useful for the treatment of male baldness pattern and wherein the dosage is about 1.0 mg." (claim 5) - At issue was whether the generic drug company's allegation that claim 5 was invalid, was "justified" within s. 6(2) of the Patented Medicines (Notice of Compliance) Regulations - Two items of controversy were: (1) did the claim contemplate finasteride alone as the active ingredient; and (2) was the dosage a daily dosage - The Federal Court concluded that: (1) claim 5 was not limited to the use of finasteride alone as an active drug, given the specific reference in the description of the patent to the inclusion of other active drugs; and (2) the 1.0 mg. was a daily dosage, given that the experts for each party understood that the dosage was a daily dosage and the patent, in the description, referred to the dosages as daily dosages - See paragraphs 100 to 108.

Patents of Invention - Topic 1502

Grounds of invalidity - General - Onus and standard of proof - The Federal Court considered the issue as to who bore the burden of proof as to validity of a patent in the context of proceedings brought under the Patented Medicines (Notice of Compliance) Regulations - The court stated that "I must decide the issue of validity before me on the weight of the evidence and arguments presented. If that weight is evenly balanced in respect of any allegation, I must find that particular allegation ... not to be justified" - See paragraphs 26 and 27.

Patents of Invention - Topic 1532

Grounds of invalidity - Want of subject matter - Method of medical treatment - A generic drug company attacked the validity of the "Swiss" type claim 5 of the patent-in-suit on the basis that it was simply directed to a method of medical treatment which, it alleged, was not valid subject matter for a patent in Canada - The Federal Court held that the 1.0 mg. tablet taken as a daily dose was a vendible product, namely, a medicament, and not a method of medical treatment - The reasoning used in the U.K. cases and in the earlier European cases, was the same reasoning as applied here - The court discussed the Canadian jurisprudence in considering claims directed to a dosage range within which a physician was to make a selection, and found that in the present case, there was no such range; there was a fixed dosage claimed - "A distinction must be made between claims that rely upon the skill and judgment of a medical practitioner and those that deal with a vendible product" - See paragraphs to 114.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - [See Patents of Invention - Topic 1602 ].

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - [See Patents of Invention - Topic 1675 ].

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - The patent at issue (the '457 patent) dealt with the treatment of male pattern baldness with the drug finasteride - Claim 5 was "the use of finasteride for the preparation of a medicament adopted for oral administration useful for the treatment of male baldness pattern and wherein the dosage is about 1.0 mg." - The Federal Court found that claim 5 was inventive but that it lacked novelty - Applying the law to the facts, the court concluded that it had been proven that the allegation that claim 5 was obvious, was not justified - "The difference lies in the legal test for novelty and obviousness. Novelty invokes a consideration as to whether the public is already possessed of what is claimed. It does not matter whether it is invented or not" - Here, the court found that the public was already in possession of what was claimed in claim 5 - The fact that any suspicion or discouragement raised by the published papers would have to be dispelled was irrelevant - See paragraphs 178 to 182.

Patents of Invention - Topic 1591

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Time to determine obviousness (incl. date of invention) - The Federal Court stated that "[t]o determine whether what is claimed as an invention is truly an invention, and not obvious to a person skilled in the art, the Court is to place itself in the position of such a person at the relevant time, here the 'claim date'" - See paragraph 178.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art - [See Patents of Invention - Topic 1675 ].

Patents of Invention - Topic 1602

Grounds of invalidity - Anticipation - Test for - The Federal Court addressed novelty and obviousness together - "There is no question that for a claim of a patent to be valid, it must encompass that which is both novel and inventive or, to use the other language often associated with this exercise, the claim must encompass that which is both not anticipated and not obvious. The two are similar but require somewhat different approaches. Anticipation, or lack of novelty, means that the public is already in possession of what is claimed as an invention; regardless as to how inventive the concept may be ... On the other hand, inventiveness means that the invention has gone beyond what the public already has by going farther than the ordinary person skilled in the art would have been expected to go in providing something new and useful or dispelling an old preconception" - See paragraphs 143 and 144.

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - The Federal Court discussed the prohibition against double patenting, in the following manner - "Canadian law has developed a concept whereby a patent will be invalid if it is found to be 'double patenting' having regard to an earlier patent granted to the same patentee. This concept is based on the premise that a person is entitled to 'a' patent for each invention and should not be able to gain a second monopoly for what is, in reality, the same thing. One cannot 'evergreen' the patent monopoly" - The court next considered the question of double patenting as addressed by the Supreme Court of Canada - "[W]hat a Court must do is compare the claims of the earlier patent with those of the later patent and determine whether they are 'identical or co-terminus' or whether they are 'obvious' having regard to the earlier claims"- See paragraphs 115 to 119, 124.

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - The Federal Court discussed the concept of double patenting in the United States, specifically its statutory law and judicial jurisprudence respecting double patenting - The court concluded that the United States concept, with the exception of the ability to make a terminal disclaimer, "is not very different from the Canadian concept" as expressed in the leading Canadian jurisprudence - See paragraphs 122 and 123.

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - Merck & Co. Inc. received a first patent (the '277 patent) which was directed to a range of compounds, of which finasteride was one, and their use for the treatment of androgenic alopecia, including male pattern baldness - The only difference between claim 5 of Merck's patent at issue (the '457 patent) and claims of the '277 patent was that claim 5 specified 1 mg/day - The Federal Court disagreed with Merck's argument that the earlier claims had to be read together with the description and thus were restricted to a dosage range of between 5 and 2000 mg. - "Simply to attach a number to the dosage level, even if that number is outside the range 'exemplified' in the earlier patent, does not mean that claim 5 is not ... 'identical or co-terminus' with the claims of the earlier patent" - The court found claim 5 to be invalid for that reason - As well, the court concluded that claim 5 was also invalid for obviousness double patenting - See paragraphs 125 to 142.

Patents of Invention - Topic 1675

Grounds of invalidity - Lack of novelty - Particular patents - As to novelty and invention, the patent at issue (the '457 patent) dealt with the treatment of male pattern baldness with the drug finasteride - The inventors had "surprisingly and unexpectedly" discovered that a low dosage of finasteride was "particularly useful" in treating baldness - The Federal Court held that the claim was not novel - The prior art disclosed and enabled that which was claimed in the '457 patent, including the dosage - Given the state of the law in Canada, the use of finasteride in an oral composition to treat male baldness had been disclosed, and the selection of a dosage range was within the skill of an ordinary person skilled in the art - Claim 5 did nothing more than confirm that it worked at a dosage of 1 mg./day - No new technical feature had been disclosed or claimed - To the extent that the published papers suggested that finasteride might not work, there was no clear teaching that it would not work - In the absence of those papers, claim 5 had no novelty - With those papers, the patent, including claim 5, was merely confirmatory, without undue experimentation, as to what was already known - See paragraphs 155 to 177.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - A generic drug company (Pharmascience Inc.) argued that claim 5 of the patent at issue was invalid for overbreadth and lack of sound prediction - The patentee stated that Pharmascience had an obligation to put the allegations "in play" in its Notice of Allegation and had not done so, and further, that it had not put in any evidence to support the allegations - Pharmascience pointed out that the patentee's own witness purported to address the allegations in his affidavit - The Federal Court did not allow Pharmascience to address the issue - The Notice of Allegation did not address the issue with respect to claim 5, but with respect to other claims - Pharmascience could not raise the issue now with respect to claim 5 - "It had an obligation to raise the issue clearly in its Notice of Allegation. It cannot now rely on general statements or general evidence directed to other claims in an effort to redirect those statements and evidence to claim 5" - See paragraphs 183 to 189.

Cases Noticed:

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. 8].

Whirlpool Corp. et al. v. Camco Inc. et al. (1997), 274 N.R. 187; 76 C.P.R.(3d) 150 (T.D.), affd. [2000] 2 S.C.R. 1067; 263 N.R. 88; 9 C.P.R.(4th) 129; 2000 SCC 67, refd to. [para. 8].

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. 8].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2005), 281 F.T.R. 159; 42 C.P.R.(4th) 502; 2005 FC 1299, refd to. [para. 8].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 323 F.T.R. 56; 63 C.P.R.(4th) 406; 2008 FC 142, consd. [para. 87]; refd to. [paras. 26, 184].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 322 F.T.R. 86; 69 C.P.R.(4th) 191; 2008 FC 11, consd. [para. 87]; refd to. [para. 26].

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, consd. [para. 89]; refd to. [para. 26].

Actavis UK Ltd. v. Merck 7& Co., [2007] EWHC 1311, consd. [paras. 28, 70]; refd to. [para. 36].

R. v. Mohan, [1994] 2 S.C.R. 9; 166 N.R. 245; 71 O.A.C. 241, refd to. [para. 29].

R. v. Marquard (D.), [1993] 4 S.C.R. 223; 159 N.R. 81; 66 O.A.C. 161; 85 C.C.C.(3d) 193; 25 C.R.(4th) 1; 108 D.L.R.(4th) 47, refd to. [para. 30].

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; 2000 SCC 67, consd. [paras. 33, 66, 115].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2006), 301 F.T.R. 166; 57 C.P.R.(4th) 6; 2006 FC 1234, affd. [2007] 3 S.C.R. xii; 366 N.R. 290; 59 C.P.R.(4th) 116; 2007 FCA 217, consd. [para. 67]; refd to. [para. 36].

Markman v. Westview Instruments Inc. (1996), 517 U.S. 370 (Sup. Ct.), consd. [para. 46].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390, consd. [para. 50].

Gillette Safety Razor Co. v. Pal Blade Corp., [1933] S.C.R. 142; [1933] 2 D.L.R. 29, consd. [para. 51].

Lister v. Leather (1858), 8 Bl. & El. 1004; 120 E.R. 373 (C.A.), refd to. [para. 55].

Dudgeon v. Thomson (1877), 3 App. Cas. 34 (H.L.), refd to. [para. 56].

Plimpton v. Spiller (1876), 6 Ch. D. 412, refd to. [para. 57].

Tubes Ltd. v. Perfecta Seamless Steel Tube Co. (1902), 20 R.P.C. 77 (H.L.), refd to. [para. 58].

Catnic Components Ltd. v. Hill & Smith Ltd., [1982] R.P.C. 183 (H.L.), refd to. [para. 60].

Kirin-Amgen Inc. et al. v. Hoechst Marion Roussel Ltd. et al., [2005] R.P.C. 9; 331 N.R. 1 (H.L.), refd to. [para. 63].

Bristol-Myers Squibb Co. v. Baker Norton Pharmaceutics Inc., [1998] EWHC Patents 300 (Ch. D.), consd. [para. 71].

Bristol-Myers Squibb Co. v. Baker Norton Pharmaceutics Inc., [2001] R.P.C. 1 (C.A.), consd. [para. 71].

Actavis UK Ltd. v. Merck & Co. Inc., [2008] EWCA Civ. 444; [2009] 1 All E.R. 196 (C.A.), consd. [para. 71].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 370 N.R. 109; 59 C.P.R.(4th) 1(F.C.A.), refd to. [para. 88].

Eli Lilly Canada Inc. v. Novopharm Ltd. et al. (2009), 346 F.T.R. 42; 76 C.P.R.(4th) 407; 2009 FC 301, consd. [para. 95].

AstraZeneca AB et al. v. Apotex Inc. et al. (2007), 314 F.T.R. 177; 60 C.P.R.(4th) 199; 2007 FC 688, affd. (2007), 61 C.P.R.(4th) 97 (F.C.A.), refd to. [para. 105].

Axcan Pharma Inc. v. Pharmascience Inc. et al. (2006), 291 F.T.R. 160; 50 C.P.R.(4th) 321 (F.C.), consd. [para. 111].

Merck & Co. et al. v. Apotex Inc. et al. (2005), 274 F.T.R. 113; 41 C.P.R.(4th) 35 (F.C.), consd. [para. 112].

Allergan, Re (2009), 79 C.P.R.(4th) 161 (Pat. App. Bd.), refd to. [para. 113].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 2008 SCC 61, consd. [paras. 116, 162].

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, consd. [para. 120].

Borehringer Ingelheim International GMBH v. Barr Laboratories Inc. (2010), 592 F.3d 1340 (C.A. Cir. Ct.), refd to. [para. 122].

AstraZeneca Canada Inc. v. Canada (Minister of Health) et al., [2006] 2 S.C.R. 560; 354 N.R. 88; 2006 SCC 49, refd to. [para. 124].

Apotex Inc. v. AstraZeneca Canada Inc. - see AstraZeneca Canada Inc. v. Canada (Minister of Health) et al.

M-Systems Flash Disk Pioneers Ltd. v. Commissioner of Patents (2010) 367 F.T.R. 133; 2010 FC 441, refd to. [para. 145].

Pozzoli SPA v. BDMO SA, [2007] EWCA Civ. 588, refd to. [para. 170].

Dr. Reddy's Laboratories (UK) Ltd. v. Eli Lilly and Co., [2009] EWCA Civ. 1362, refd to. [para. 171].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2010), 367 F.T.R. 179; 2010 FC 447, refd to. [para. 172].

Merck & Co. et al. v. Apotex Inc. (1994), 88 F.T.R. 260; 59 C.P.R.(3d) 133 (T.D.), refd to. [para. 173].

ratiopharm inc. v. Pfizer Ltd. (2009), 350 F.T.R. 250; 76 C.P.R.(4th) 241; 2009 FC 711, refd to. [para. 174].

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. 179].

Authors and Works Noticed:

Fox, Harold George, The Canadian Law and Practice Relating to Letters Patent for Invention (4th Ed. 1969), pp. 5 ff. [para. 45]; 193 to 194 [para. 44].

Counsel:

Steven G. Mason and Steven Tanner, for the applicants;

Nicholas McHaffie, Geoffrey J. North and Ryan Sheahan, for the respondent, Pharmascience;

No one appearing for the respondent, Minister of Health.

Solicitors of Record:

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

Stikeman Elliott, LLP, Ottawa, Ontario, for the respondent, Pharmascience;

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

This application was heard at Toronto, Ontario, on April 26, 2010, by Hughes, J., of the Federal Court, who delivered the following reasons for judgment and judgment, dated May 11, 2010.