Pfizer Canada Inc. v. Canada (Health), 2007 FCA 209

 

Date: 20070531

Docket: A-457-05

Citation: 2007 FCA 209

 

CORAM:       LINDEN J.A.

                        NADON J.A.             

                        SEXTON J.A.

 

BETWEEN:

PFIZER CANADA INC., WARNER-LAMBERT COMPANY LLC

and PARKE, DAVIS & COMPANY LLC

 

Appellants

and

THE MINISTER OF HEALTH

and APOTEX INC.

 

Respondents

 

 

 

Heard at Toronto, Ontario, on September 27 and 28, 2006.

Judgment delivered at Ottawa, Ontario, on May 31,, 2007.

 

REASONS FOR JUDGMENT BY:                                                                               NADON J.A.

CONCURRED IN BY:                                                                                                  LINDEN J.A.

                                                                                                                                     SEXTON J.A.

 

 

Date: 20070531

Docket: A-457-05

Citation: 2007 FCA 209

 

CORAM:       LINDEN J.A.

                        NADON J.A.             

                        SEXTON J.A.

 

BETWEEN:

PFIZER CANADA INC., WARNER-LAMBERT COMPANY LLC

and PARKE, DAVIS & COMPANY LLC

 

Appellants

and

THE MINISTER OF HEALTH

and APOTEX INC.

 

Respondents

 

 

REASONS FOR JUDGMENT

NADON J.A.

[1]               We are once again, but certainly not for the last time, called upon to determine a dispute between a patentee and a generic competitor which arises pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, March 12, 1993 (the “Regulations”).

 

[2]               More particularly, the matter before us arises from an application brought by the appellants (“Pfizer”) pursuant to section 6 of the Regulations for an order prohibiting the Minister of Health (the “Minister”) from issuing a notice of compliance (a “NOC”) to the respondent Apotex in respect of its drug product apo-quinapril until the expiration of Canadian letters patent numbers 1,341,330 (the “ ‘330 patent ”) and 1,331,615 (the “ ‘615 patent ”).

 

[3]               Pfizer’s application was heard by Heneghan J. of the Federal Court who, on September 28, 2005, dismissed it (2005 FC 1205). By its appeal, Pfizer seeks an order setting aside the Federal Court’s decision and declaring that the Minister is prohibited from issuing a NOC to Apotex until the expiration of the ‘330 and ‘615 patents.

 

[4]               For a proper understanding of the questions which this appeal raises, the following review of the facts will be helpful.

 

THE FACTS

[5]               Not surprisingly, the ‘330 patent, a genus patent for a novel group of compounds, including quinapril, and the ‘615 patent, a species patent for quinapril hydrochloride in various solid forms, are at the heart of this appeal.

 

[6]               Quinapril-hydrochloride is an angiotensin-converting enzyme (ACE inhibitor). By inhibiting the transformation of angiotensin I to angiotensin II (the form which raises blood pressure), quinapril hydrochloride is useful in the treatment of high blood pressure, congestive heart failure and the prevention of kidney failure.  Pfizer markets quinapril-hydrochloride in tablet form under the trade name Accupril.

 

[7]               The ‘330 patent, entitled “Substituted Acyl Derivatives of 1,2,3,4- tetrahydroisoquinoline-3-Carboxylic Acids”, was applied for in the Canadian Patent Office on September 30, 1981, with a priority date of October 3, 1980. Because of conflict proceedings which were initiated in respect of the ‘330 patent and a patent involving a German patent owned by Hoechst Aktiengessellschaft (Hoechst), the patent was not issued until January 1, 2002. This followed a consent judgment entered on December 22, 1999 which allowed the claims of the patent to issue in Canada. The patent was issued to Parke, Davis & Company LLC. The ‘330 patent is a genus patent which claims a novel group or family of chemical compounds, including quinapril and other ACE inhibitors. All of the compounds claimed share a common structure consisting of a THIQ head and an enalapril tail.

 

[8]               The ‘615 patent, entitled “Substituted Acyl Derivatives of 1,2,3,4,-Tetrahydroisoquinoline-3-Carboxylic Acids”  was applied for, as a divisional application derived from the ‘330 patent, on June 23, 1992, by the assignee, Warner-Lambert Company LLC. The patent, which issued on August 23, 1994 claims a narrow subclass of the compounds claimed in the ‘330 patent, including the hydrochloride salt of quinapril.

 

[9]               On July 18, 2003, pursuant to subsection 5(3) of the Regulations, Apotex filed and served a Notice of Allegation (“NOA”) which says that the ‘615 patent would not be infringed by the manufacturing and marketing of its drug product apo-quinapril in tablet form, on the grounds that its tablets would not comprise any of the compounds covered by the ‘615 patent, nor would such compounds be made, constructed or used in the manufacture of its tablets. As a result, Apotex says that the claims of the ‘615 patent would not be infringed.

 

[10]           On July 24, 2003, Apotex filed a second NOA which says that the ‘330 patent is invalid for lack of utility, lack of sound prediction, anticipation, obviousness, overly-broad claims and double patenting.

 

[11]           On September 5, 2003, Pfizer filed its application for an order of prohibition before the Federal Court, asserting that Apotex’s allegations of non-infringement and of invalidity were not justified.

 

[12]           In dismissing Pfizer’s application, the learned Judge held that the claims of the ‘330 patent were broader than the invention disclosed and, thus, that Apotex’s allegation of invalidity was justified. She further concluded that since there was no evidence that Apotex’s drug product contained any quinapril hydrochloride, Pfizer had not met its burden of demonstrating that Apotex’s allegation of non-infringement in regard to the ‘615 patent was not justified.

 

THE DECISION OF THE FEDERAL COURT

A.        Burden of Proof

[13]           Heneghan J. first considered the evidentiary burden of proof applicable in proceedings under the Regulations. Although Pfizer accepted that it had the legal burden of proving non-infringement, it argued that with respect to the allegations of invalidity, it was entitled to the benefit of section 45 of the former Patent Act which creates a presumption that the patent is valid. As a result, Pfizer argued that the burden of proof was that of the party challenging the validity of the patent.

 

[14]           Heneghan J. rejected Pfizer’s argument. Although, in her view, Apotex had an obligation to put the allegations of invalidity “in play”, the overall legal burden of proof was that of Pfizer.

 

B.        Invalidity of the ‘330 Patent

            (a)        Construction of the Disputed Claims:

[15]           In order to assess Apotex’s allegation of invalidity, Heneghan J. first construed claims 3 and 5 of the ’330 patent which were in dispute. Pfizer argued before her that a purposive construction of the claims would lead to a finding that the ’330 patent disclosed an invention relating to ACE inhibition. Conversely, Apotex argued that the invention only encompassed those compounds useful in relieving hypertension and not a broader group of ACE inhibitors, some of which did not have sufficient inhibition activity to be useful in treating hypertension.

 

[16]           Heneghan J. accepted Apotex’s submissions and concluded that the purpose of the invention disclosed in claims 3 and 5 of the ’330 patent was the use of the compounds described as active ingredients in medicine for the treatment of hypertension, not merely the inhibition of ACE activity.

 

 

 

b) Invalidity of the ’330 Patent:

[17]           Heneghan J. then went on to consider each of Apotex’s specific grounds for alleging invalidity of the ’330 patent. Only one such allegation succeeded. Heneghan J. concluded claims 3 and 5 of the ’330 patent were overly broad and, therefore, that Apotex’s allegation of invalidity was justified.

 

[18]           Heneghan J. first considered the argument that the ’330 patent lacked utility. Although she was not satisfied that the utility of the invention disclosed in the patent had been demonstrated by the date the patent was applied for, she concluded that the inventors had been able to soundly predict the utility of the claimed compounds by that date. Therefore, the inutility argument was rejected.

 

[19]           Next, Heneghan J. considered whether the invention was invalid because of anticipation. Apotex alleged that the Hoechst patent, which gave rise to conflict proceedings involving the ’330 patent, was anticipatory. The relevant date for assessing anticipation under the pre-1989 Patent Act was two years prior to the filing date of the patent at issue (former Patent Act at s. 27(1)). Since there was no evidence before her that the Hoechst patent had issued on or before that date, i.e. September 30, 1979, she concluded that Apotex had not adduced sufficient proof to put the anticipation argument “in play”.

 

[20]           Thirdly, Heneghan J. considered whether the patent was invalid by reason of obviousness which is assessed at the date of invention. Heneghan J. accepted that the date of invention was the priority date of October 3, 1980. In her opinion, the evidence showed that on that date, persons skilled in the art would not have considered the discovery of quinapril hydrochloride obvious.

 

[21]           Fourth, Heneghan J. considered whether claims 3 and 5 of the ’330 patent were broader than the invention or the disclosure. Apotex argued the disclosure limited the invention to those stereoisomers with a particular configuration (known as an “S-configuration”) but that claims 3 and 5 include all stereoisomers and therefore were overly broad. Heneghan J. accepted Apotex’s argument. She held that because she had construed claims 3 and 5 as including compounds useful for treating hypertension and because expert evidence illustrated that the S-configuration was the optimal configuration for high level ACE inhibition leading to anti-hypertensive results, the claims encompassing all stereoisomers were overly broad.

 

[22]           Finally, Heneghan J. considered whether the ’330 patent was invalid on the basis of obvious-type double patenting because it was not patently distinct from the ’615 patent. Heneghan J. rejected this allegation. She was persuaded by the fact that the ’615 patent had not been involved in the conflict proceedings to which the ’330 patent was subject. 

 

C.        Non-infringement of the ’615 Patent

(a)        Adequacy of the NOA:

[23]           Pfizer argued that the non-infringement allegation in Apotex’s July 18, 2003 NOA was inadequate because it did not sufficiently describe the entire basis upon which the allegation rested. The NOA did not allege that ACCUPRIL tablets contained quinapril magnesium and therefore Pfizer argued that Apotex was precluded from relying on that allegation in this application.

 

[24]           Heneghan J. concluded that the July 18, 2003 NOA partially complied with the legal test for adequacy. Apotex needed only to address the issue of non-infringement of claims for the medicine, quinapril hydrochloride, and it was justified in withholding certain information until a confidentiality order was in place. However, Heneghan J. concluded the NOA was insufficient in that if Apotex was alleging that ACCUPRIL contained quinapril magnesium, it should have said so. Nonetheless, Heneghan J. did not consider this defect fatal and went on to consider the merits of Apotex’s allegation of non-infringement.

 

(b)        Non-Infringement of the ’615 Patent:

[25]           Apotex’s drug, Apo-Quinapril, is allegedly comprised of a substance called quinapril magnesium. Apotex admits to using a solvated form of quinapril hydrochloride known as quinapril hydrochloride acetone solvate (“QHAS”) to make quinapril magnesium.

 

[26]           In the Court below, Pfizer argued that claim 1 of the ’615 patent, when properly construed, encompasses both the solvated and unsolvated forms of quinapril hydrochloride. Accordingly, because Apotex uses a solvated form of quinapril hydrochloride, i.e. QHAS, in making ApO Quinapril, it infringes the ’615 patent. Pfizer also argued that Apotex had failed to establish on a balance of probabilities that there was only quinapril magnesium in its drug product, not quinapril hydrochloride.

 

[27]           Apotex, on the other hand, argued that the medicine in Pfizer’s tablets is quinapril magnesium, not quinapril hydrochloride, and therefore the ’615 patent is irrelevant because it does not claim quinapril magnesium. In the alternative, Apotex argued that the ’615 patent did not encompass QHAS, which it uses in the production of quinapril magnesium, and therefore the patent was not infringed.

 

[28]           Heneghan J. concluded that the appellants had not discharged their burden of showing that Apotex’s product infringed the ’615 patent. She based her decision on the fact that although the appellants were provided with a sample of Apotex’s Apo-Quinapril product, they elected not to test the material to determine its composition. At paragraph 155 of her Reasons, the Judge said:

[155]       In my opinion, the inability to guarantee the success of a chosen testing process is no answer to the Applicants’ burden relative to the allegation of non-infringement. The '615 Patent claims quinapril hydrochloride as the medicine. The presence of that substance in Apotex's product would amount to infringement. One means of establishing that presence is testing and according to the applicants' evidence, no testing was done. In these circumstances, I conclude that the Applicants have failed to show that the allegation of non-infringement is not justified.

 

 

[29]           Heneghan J. then went on to hold that it was not necessary for her to decide whether Accupril, as argued by Apotex, contained quinapril hydrochloride because of her view that the NOA was insufficient in that regard.

 

 

 

THE ISSUES

[30]           With respect to the ‘615 patent, the issue is whether the learned Judge erred in concluding that Pfizer had failed to demonstrate that Apotex’s allegation of non-infringement was not justified. With respect to the ‘330 patent, the issue is whether the learned Judge erred in holding that the claims of the ‘330 patent were broader than the invention disclosed. If the Judge erred in that respect, the issue arises as to whether Pfizer’s application should be upheld on the basis of Apotex’s allegations of inutility, lack of sound basis to predict, anticipation, obviousness and double patenting.

 

THE RELEVANT LEGISLATION

[31]           The following provisions of the NOC Regulations are relevant to the disposition of the appeal.

 

[32]           Because the ‘330 patent was filed before October 1, 1989, it is primarily subject to the provisions of the Patent Act, R.S.C. 1985, c. P-4, as they read immediately before that date.

 

[33]           The current Patent Act provides for the following transitional provisions:

 

ANALYSIS

A.        The ‘615 Patent

[34]           I begin with the ‘615 patent in regard to which Pfizer submits that by reason of her failure to construe claim 1 thereof, the Judge did not consider its main submission, i.e. that by making and using QHAS, Apotex will infringe claim 1 of the patent. More particularly, Pfizer says that in failing to construe claim 1, the Judge failed to consider whether solvated forms of quinapril hydrochloride were covered by the patent.

 

[35]           It is undeniable that the Judge did not make any attempt to construe claim 1 as she disposed of the non-infringement issue on the sole basis that Pfizer had failed to test Apotex’s product. It is now settled law that construction of a patent must precede a determination of whether there is infringement thereof (see Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, and Free World Trust v. Electrosanté Inc., [2000] 2 S.C.R. 1024). It was therefore the Judge’s duty to construe claim 1 in the light of the expert evidence available to her and to segregate the non-essential elements of the patent from the essential ones. Thus, in failing to construe claim 1, the Judge erred in law and, as a result, it falls upon us to determine the matter de novo.

 

[36]           Before turning to that task, it will be useful to briefly examine the principles governing the construction of patents which were clarified by the Supreme Court in its recent decisions in Whirlpool, supra and Free World, supra.

 

[37]           In its decisions, the Supreme Court endorsed the purposive construction approach to patents and rejected the “grammatical” or “meticulous verbal analysis” approach which had prevailed in earlier times. In so concluding, the Court endorsed the description of “purposive construction” given by Lord Diplock at pages 242 and 243 of his Reasons for a unanimous House of Lords in Catnic Components Ltd. v. Hill and Smith Ltd., [1982] R.P.C. 183, where His Lordship made the following remarks:

My Lords, a patent specification is a unilateral statement by the patentee, in words of his own choosing, addressed to those likely to have a practical interest in the subject matter of his invention (i.e. “skilled in the art”), for which he informs them what he claims to be the essential features of the new product or process for which the letters patent grant him a monopoly. It is those novel features only that he claims to be essential that constitute the so-called “pith and marrow” of the claim. A patent specification should be given a purposive construction rather than a purely literal one derived from applying to it the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge. The question in each case is: whether persons with practical knowledge and experience of the kind of work in which the invention was intended to be used, would understand that strict compliance with a particular descriptive word or phrase appearing in a claim was intended by the patentee to be an essential requirement of the invention so that any variant would fall outside the monopoly claimed, even though it could have no material effect upon the way the invention worked.

 

 

[38]           In his Reasons for a unanimous Supreme Court in Whirlpool, supra, Binnie J. remarked that although the “purposive construction” approach was introduced into claims construction by Catnic, supra, it was consistent with the view expressed by Dickson J. (as he then was) in Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] S.C.R. 504, where he said at pages 520 and 521::

We must look to the whole of the disclosure and the claims to ascertain the nature of the invention and methods of its performance, (Noranda Mines Limited v. Minerals Separation North American Corporation, [1950] S.C.R. 36), being neither benevolent nor harsh, but rather seeking a construction which is reasonable and fair to both patentee and public. There is no occasion for being too astute or technical in the matter of objections to either title or specification for, as Duff C.J.C. said, giving the judgment of the Court in Western Electric Company, Incorporated, and Northern Electric Company v. Baldwin International Radio of Canada, [1934] S.C.R. 570, at p. 574, “where the language of the specification, upon a reasonable view of it, can be so read as to afford the inventor protection for that which he has actually in good faith invented, the court, as a rule, will endeavour to give effect to that construction.

 

 

[39]           The principles set forth by the Supreme Court in Whirlpool, supra,. and Free World,supra, can be summarized as follows:

• The task of the Court is to construe the claims of the patent with the aid of expert witnesses (Whirlpool at paragraphs 43, 45 and 57).
• Construction of the claims is not to be a result-oriented exercise and must be conducted by the Court prior to its consideration of the issue of infringement (Whirlpool at paragraphs 43 and 49(a)).
• The claims are to be construed as of the publication date of the patent (Whirlpool at paragraph 42; Free World at paragraph 44).
• In construing the claims of the patent, the Court is called upon to determine, on an objective basis, what a skilled reader would have understood the inventor to mean (Whirlpool, at paragraph 48; Free World at paragraph 51).
• The claim of the patent which is to be construed by the Court must be read in the context of the rest of the specification. I would add to this, however, that reference to the rest of the specification cannot be used to expand the patentee’s monopoly as expressed in the claim (Whirlpool at paragraphs 48, 49(f) and 52).
• The expert witnesses are there to help the Court understand the invention and its context, as well as the meaning of the terms used in the patent. Needless to say, it is the Court’s duty to construe the claims and not that of the experts (Whirlpool at paragraphs 45 and 57).
• In construing the claims, the Court is to keep in mind that the patent is addressed to the “ordinary person skilled in the art”, i.e. a hypothetical person possessing the ordinary skill and knowledge of the particular art to which the invention relates, and a mind willing to understand a specification that is addressed to him (Whirlpool at paragraphs 53, 70, 71 and 74).
• The “disclosure” found in the patent must describe the invention in a sufficiently complete and accurate manner so to allow the person skilled in the art to construct or use the invention when the period of monopoly has expired (Whirlpool at paragraph 42). The resulting construction of the claims should be one which is “in the interest of fairness both to the patentee and the public” (Free World at paragraph 50). As a result, the construction of the claim may lead to an expansion or limitation of the text of the claim. As Binnie J. said in Free World at paragraph 51:

51.     The involvement in claims construction of the skilled addressee holds out to the patentee the comfort that the claims will be read in light of the knowledge provided to the Court by expert evidence on the technical meaning of the terms and concepts used in the claims. The words chosen by the inventor will be read in the sense the inventor is presumed to have intended and in a way that is sympathetic to accomplishment of the inventor’s purpose express or implicit in the text of the claims. However, if the inventor has misspoken or otherwise created an unnecessary or troublesome limitation in the claims, it is a self-inflicted wound. The public is entitled to rely on the words used provided the words used are interpreted fairly and knowledgeably.

 

 

(a)        Claim 1 of the ‘615 Patent

[40]           The parties are in agreement that the only claim of the ‘615 patent which we need be concerned with in this appeal is claim 1. It reads as follows:

1.     A substituted acyl derivative of 1,2,3,4-tetrahydroisoquinone-3-carboxylic acid in the form of the (S,S,S) isomer having the following general formula:

where R² is a hydrogen atom or a methyl or an ethyl radical, in one of the following acid salt forms: the hydrochloride, hydrate; the hydrochloride; and the hydrochloride hemihydrate.

 

 

[41]           Although the word “quinapril” does not appear in claim 1, it is common ground that a person skilled in the art would understand the claim to describe quinapril in one of the following acid salt forms: the hydrochloride, hydrate, the hydrochloride, and the hydrochloride hemihydrate.

 

[42]           The only issue which arises from Apotex’s NOA is whether its APO QUINAPRIL tablets comprise any of the claimed compounds of the ‘615 patent or whether any such compounds will be made, constructed or used in the manufacture of APO QUINAPRIL tablets. More particularly, the issue is whether Apotex will infringe claim 1 of the patent by making and using QHAS, a “solvated” form of quinapril hydrochloride.

 

[43]           The answer to this question depends entirely on the construction of claim 1. Specifically, whether the making, use or constructing of QHAS by Apotex infringes the patent depends on the meaning of the words “the hydrochloride” found in claim 1.

 

[44]           Pfizer submits that a purposive construction of claim 1 leads to the conclusion that QHAS is covered by the claim. In its submission, a skilled person would appreciate that quinapril hydrochloride in a solvated form can be substituted without affecting the working of the invention.

 

[45]           Apotex disagrees with Pfizer that QHAS is covered by claim 1 of the ‘615 patent. In its view, the only solvate covered by claim 1 is water. Apotex further submits that even if the ‘615 patent covers QHAS, the NOC Regulations only prohibit the issuance of a NOC if the compounds in the final dosage form of the drug infringe the claims of the patent. Intermediates used in the production of the final dosage form, Apotex says, are irrelevant for the purpose of subparagraph 5(1)(b)(iv) of the Regulations. Finally, Apotex argues that even if intermediates fall within the scope of the Regulations, the appellant still had to prove that QHAS fell within the definition of “medicine” found in the Regulations, because subparagraph 6(1)(b)(iv) thereof provides that the only relevant claims in a prohibition proceeding are those that relate to a “medicine”. In Apotex’s submission, the appellant has failed to lead such evidence.

 

[46]           In order to make sense of these submissions, a brief overview of the chemistry at issue will be helpful.

 

[47]           Molecules exist in solid states in one of two forms, namely, crystalline (a regular, repeating lattice patent) or amorphous (i.e., where the molecules have no discernable pattern). A crystalline form of quinapril hydrochloride has a crystal lattice structure composed of quinapril molecules and hydrochloride molecules.

 

[48]           Because of its shape, a crystalline solid has “holes” in the lattice structure. When these holes contain liquid, the crystals are called “solvates”. Where the liquid is water, the solvate is of a special type, i.e. a “hydrate”. When the liquid is an organic solvent (i.e., other than water), it is either referred to as a “solvate” or by the name of the solvent, for example, an “acetone solvate”. Quinapril hydrochloride acetone solvate (“QHAS”) is thus a form of quinapril hydrochloride with acetone contained in its lattice.

 

[49]           When a hydrate contains two molecules of water for every molecule of crystal, it is a “dehydrate”. When a hydrate contains one molecule of water for every two molecules of crystal, it is a “hemihydrate”. The term “monohydrate” may be used when the hydrate contains one molecule of water for every molecule of crystal, but this can also be referred to simply as a “hydrate”.

 

[50]           Claim 1 of the ‘615 patent claims quinapril in a number of acid salt forms, namely the hydrochloride hydrate, the hydrochloride, and the hydrochloride hemi-hydrate. The claim does not expressly say whether “solvates” are included by the use of the words “the hydrochloride”. That is the precise question which must be answered in construing claim 1. However, before turning to the construction of the claim, a few words concerning QHAS are in order.

 

[51]           The process by which Apotex manufactures its APO QUINAPRIL comprises a number of steps, two of which are of interest for the present purpose; firstly, the manufacturing of the drug substance (or active pharmaceutical ingredient) and, secondly, the manufacturing of the drug product (the making of the active pharmaceutical ingredient into tablets). More particularly, Apotex’s drug substance is QHAS which it blends with excipients (inactive ingredients) and presses into APO QUINAPRIL tablets. Apotex’s Abbreviated New Drug Submission (“ANDS”) reveals that in making its APO QUINAPRIL tablets, QHAS is converted into quinapril magnesium, which Apotex refers to as “quinapril hydrochloride stabilized” or “quinapril 88%”. In its proposed product monograph, Apotex advises that the active ingredient in its APO QUINAPRIL tablets is quinapril hydrochloride.

 

[52]           I now turn to the construction of claim 1 of the ‘615 patent.

 

[53]           I start with the proposition that the claim must be read “purposively” in order to determine the inventor’s intention. Although it is clear that the words of the claim must be given effect, reference to the entire specification must be made so as to provide the context necessary to a proper understanding of the words used by the inventor.

 

[54]           To this first proposition must be added a second one, i.e. that the Court must identify, with the assistance of a person skilled in the art, those elements of the claim which the inventor considered essential to his invention. As a corollary to this proposition, it must be remembered that non-essential elements are those which can be substituted without having a material effect on the structure or operation of the invention.

 

[55]           With those principles in mind, I now turn to the expert evidence upon which both Pfizer and Apotex rely for their submissions.

 

[56]           In support of its proposed construction of claim 1, Pfizer presented the evidence of Dr. Gerald S. Brenner, an organic chemist and industrial formulation expert who spent his entire working life in the pharmaceutical field. From 1961 to 1994, Dr. Brenner worked for the Merck Research Laboratories in New Jersey and Pennsylvania, retiring therefrom as Senior Director of Pharmaceutical Research and Development and Department Head of Pharmaceutical Research with responsibility for pharmaceutical chemistry, biopharmaceutical chemistry and formulation development. More particularly, Dr. Brenner was one of those persons at Merck in charge of formulating “enolapril”, an angiotension-converting enzyme inhibitor, i.e. an “ACE inhibitor”.

 

[57]           As he states in his affidavit of January 14, 2004, Dr. Brenner was asked by Pfizer to opine regarding, inter alia, Apotex’s allegations that none of the compounds of the ‘615 patent are being used in the manufacture of its APO-QUINAPRIL tablets. Dr. Brenner’s answer to that question is that Apotex’s allegations are “incorrect”. In his view, the reference in claim 1 to quinapril hydrochloride includes QHAS, the compound used by Apotex in making its APO-QUINAPRIL tablets. Dr. Brenner’s reasons for so concluding are as follows.

 

[58]           After a review of the chemistry at issue, Dr. Brenner turned his attention to Apotex’s ANDS, which led him to the following remarks:

   (i)              Apotex had submitted an ANDS in respect of its APO-QUINAPRIL tablets;

  (ii)              Apotex had represented to the Minister of Health that the “drug substance” of its ANDS was QHAS;

(iii)              Quinapril hydrochloride stabilized or Quinapril 88% was its drug product

 

[59]           He then turned to the formulation by Apotex of its APO-QUINAPRIL which he understood to be that magnesium hydroxide was added to QHAS in a medium of ethanol and water, that this mixture after stirring and following evaporation, left a solid mixture of magnesium quinapril and magnesium chloride which Apotex named Quinapril 88%, or stabilized quinapril hydrochloride, that quinapril 88% was milled into a powder and dry-mixed with excipients and compressed to form a tablet, and that the tablet was given a brown-coloured film coating to form APO-QUINAPRIL.

 

[60]           With this information in mind, Dr. Brenner stated his view that in using QHAS to make APO-QUINAPRIL, Apotex was using the acid salt form of quinapril hydrochloride which was covered by claim 1 of the patent. This conclusion results from his understanding of claim 1 which he examined in the light of the specification.

 

[61]           In Dr. Brenner’s view, claim 1 of the patent, properly understood by a person skilled in the art, includes not only all non-hydrated forms of quinapril hydrochloride (amorphous and crystalline), but all forms solvated with a pharmaceutically-acceptable organic solvent.

 

[62]           More particularly, Dr. Brenner indicates that in attempting to determine the meaning of the word “hydrochloride”, he had no doubt whatsoever that the inventor had in mind, at the very least, anhydrous quinapril hydrochloride, i.e. not a hydrate or, to put in other words, not a crystal form containing water molecules. He was certain in that view because of the inventor’s use of the words “hydrochloride hydrate” and “hydrochloride hemihydrate”.

 

[63]           However, the use of the word “hydrochloride” did not immediately reveal what forms were intended to be covered. In Dr. Brenner’s view, the word could possibly include a non-solvated hydrochloride crystal, a hydrochloride crystallized with an organic solvent or amorphous hydrochloride.

 

[64]           In attempting to ascertain the correct meaning of “hydrochloride”, Dr. Brenner noted that the inventor had not expressly excluded non-solvated forms of quinapril hydrochloride and that by reason of the use of the words “hydrochloride hydrate” and “hydrochloride hemihydrate”, the inventor did not intend to include in the word “hydrochloride” compounds solvated with water.

 

[65]           However, claim 1 of the patent on its face did not, in his view, reveal an intention on the part of the inventor to exclude solvates. Hence, he turned his attention to the patent’s disclosure in order to understand whether the inventor intended to include anhydrous, solvated forms of quinapril hydrochloride. In that regard, Dr. Brenner took note of that part of the specification which states:

The compounds of the invention may exist in anhydrous form as well as in solvated, including hydrated forms. In general, the hydrated forms and the solvated forms with pharmaceutically acceptable solvents are equivalent to the anhydrous or unsolvated form for the purposes of the invention.

 

 

[66]           This prompted him to the following remarks: firstly, that the inventor did not intend to exclude unsolvated of quinapril hydrochloride and, secondly, that he intended to include solvated forms. In that regard, Dr. Brenner points out that the inventor makes it clear in the disclosure that his invention can exist in anhydrous form, as well as in solvated forms, including hydrated, forms. He further notes that the inventor also makes it clear that the hydrated forms and the solvated forms are equivalent to anhydrous and unsolvated forms.

 

[67]           All of this leads Dr. Brenner to the following conclusion, found at paragraph 25 of his affidavit of January 14, 2004:

It is my opinion that when the patentee/inventor used the word “hydrochloride” in claim 1, he intended to capture quinapril hydrochloride in its organic solvated, non-hydrated, and amorphous forms.

 

[Emphasis added]

 

 

[68]           In concluding as he does, Dr. Brenner adds that he finds comfort in the analysis that he performed in regard to Canadian patent 1,291,999 (the “ ‘999 patent”) which shows that the inventors thereof used the word “hydrochloride” with respect to a claim [claim 1 of the ‘999 patent] clearly intended to cover quinapril hydrochloride acetonitrile, i.e. quinapril hydrochloride solvated with acetonitrile.

 

[69]           In replying to Dr. Brenner’s evidence, Apotex adduced the evidence of Drs. Robert S. Langer and Robert A. McClelland, who both disagree with the conclusion reached by Dr. Brenner. In their view, claim 1 of the ‘615 patent cannot be read so as to include a solvated form of quinapril hydrochloride.

 

[70]           I start with the evidence of Dr. Langer. He obtained his doctorate in chemical engineering from the Massachusetts Institute of Technology (M.I.T.) in 1974 and he is presently professor of chemical and biomedical engineering at M.I.T.

 

[71]           In Dr. Langer’s opinion, the term “hydrochloride” does not cover organic solvate forms of the claimed compounds. Specifically, it is his opinion that a person skilled in the art, reading claim 1 of the ‘615 patent, would not interpret claim 1 to cover all unspecified organic solvate forms of quinapril hydrochloride, as such a person would have expected specific organic solvate forms to be listed if the inventors intended to include organic solvate forms under claim 1. The essence of Dr. Langer’s reasoning appears at paragraph 25 of his affidavit of May 12, 2004, which I reproduce:

25.           Thus, in my opinion, claim 1 of the ‘615 patent specifies the following three specific hydrochloride salt forms of compounds from the claimed class that includes quinapril: (i) the hydrochloride, hydrate, (ii) the hydrochloride and (iii) the hydrochloride hemihydrate. Based on my reading of the ‘615 patent, I understand the terms identified as (i) to (iii) above to represent and cover the following:

(i)  hydrochloride, hydrate: in my opinion, this term as used in claim 1 of the ‘615 patent covers monohydrate and partially hydrated forms of the claimed compounds such as those described in Examples 1 through 3 of the ‘615 patent. As I described above, the compounds described in Examples 1 through 3 of the ‘615 patent were all referred to as “hydrochloride, hydrate” forms. It is also my opinion that this term does not cover organic solvate forms of the claimed compounds.

(ii)  hydrochloride hemihydrate: In my opinion, this term covers hemihydrated (i.e., one water molecule per two equivalents of drug compound) forms of the claimed compounds such as the compound described in Example 4 of the ‘615 patent. As I described above, the compound described in Example 4 of the ‘615 patent was referred to as a “hydrochloride hemihydrate” form, i.e. C₂₃H₂₆N₂O₅●HCI●1/2H₂O. It is also my opinion that this term does not cover organic solvate forms of the claimed compound.

(iii)  Hydrochloride: In my opinion, this term covers anhydrous and unsolvated forms of the claimed compounds such as those described in Examples 5, 6 and 9 of the ‘615 patent were all referred to as “hydrochloride” forms; none of these forms were described to be either hydrated forms or organic solvate forms. Thus, it is my opinion that this term does not cover organic solvate forms of the claimed compounds.

 

[72]           He goes on to say that the use of the word “the” in lieu of the word “a” to describe the expressions “hydrochloride, hydrate”, “hydrochloride” and the “hydrochloride hemihydrate” indicates to the person skilled in the art that specific individual compounds were being claimed in lieu of a broad class of compounds, such as all pharmaceutically acceptable organic solvate forms of quinapril hydrochloride.

 

[73]           Further, Dr. Langer takes issue with the following statement made by Dr. Brenner found at paragraph 24 of his January 14, 2004 affidavit in regard to part of the patent’s disclosure:

The patentee also expressly advises that the invention may exist in anhydrous form, as well as in solvated, including hydrated, forms. Further, the patentee advises that the hydrated forms and the solvated forms are equivalent to anhydrous and unsolvated forms.

 

 

[74]           Dr. Langer begins by saying that according to his understanding of patent construction, an invention is disclosed in the patent claim and not in the patent disclosure. He then indicates that the disclosure may be used “to act as a reference for definition of terms in the patent claim”. This leads him to conclude that claim 1 discloses only a specific anhydrous and unsolvated form, i.e. the hydrochloride, and two distinct and specific hydrated forms, i.e. the hydrochloride, hydrate and the hydrochloride hemihydrate.

 

[75]           Apotex’s second expert witness was Dr. McLelland, a professor in the Department of Chemistry at the University of Toronto, whose particular expertise is in the field of physical organic chemistry, especially reactive intermediates generated in nucleophilic substitution and addition reactions, as well as in the field of biological and medicinal chemistry. In 1970, he was the winner of the Syntex Award of the Canadian Society for Chemistry for contributions to medicinal chemistry through research involving biochemical or organic chemical reaction mechanisms. Since 1974, he has been a Fellow of the Royal Society of Canada.

 

[76]           In Dr. McLelland’s opinion, QHAS does not fall within the scope of claim 1. In his view, the person skilled in the art would understand claim 1 as referring to different solid forms of quinapril hydrochloride. Specifically, his view is that “the hydrochloride” refers to different solid forms only of quinapril hydrochloride, i.e. with no water or other solvent present.

 

[77]           The use of the word “the” with the word “hydrochloride” gives strength to his view, since there is only one “the hydrochloride”, i.e. the unsolvated HCI acid addition salt. If the inventors intended to refer to solvated forms, they would, according to Dr. McLelland have used the words “a hydrochloride” or “the hydrochlorides”. Further, if the inventors intended, by the use of the words “the hydrochloride”, to include solvated forms, they would not have felt it necessary to use the words “the hydrochloride, hydrate” and “the hydrochloride, hemihydrate”, as these forms would have been covered by the words “the hydrochlorides”. In addition, Dr. McLelland finds support in the fact that neither claim 1 nor any of the other claims of the ‘615 patent make reference to solvated forms other than the hydrate and hemihydrate.

 

[78]           With respect to Dr. Brenner’s view concerning claim 1 of the ‘999 patent, Dr. McLelland, at paragraphs 61 to 63 inclusive of his affidavit, said the following:

61.     In paragraph B26 (with reference to B39 and B40), Dr. Brenner makes reference to the ‘999 patent. In his opinion, the absence of a reference to a solvent in this claim indicates that the inventors’ use of “hydrochloride” in a claim means that the term has a broad meaning in the ‘615 patent. I have two comments.

 

62.     The first is that claim 1 of the ‘999 patent is unambiguous. I say this since this claim sets out the spacings and intensities in an X-ray diffraction pattern. Only a particular crystalline form will exhibit such a pattern, and it is not necessary to indicate that a solvent is present.

 

63.     My second comment is the same as paragraph 43. If Dr. Brenner is correct, the quinapril hydrochloride claimed in claim 1 of the “999 patent is also claimed in claim 1 of the ‘615 patent.

 

 

[79]           In a further affidavit sworn September 10, 2004, Dr. Brenner responded to the affidavits of Drs. Langer and McLelland. First, with respect to Dr. McLelland’s affidavit, he recalled that part of his first opinion that the inventors of the ‘615 patent had used the word “hydrochloride” in claim 1 of the ‘999 patent, i.e. a claim clearly intended to cover quinapril hydrochloride acetonitrile and that the absence therein of a reference to a particular solvent supported his view of a broad interpretation of the word “hydrochloride” in claim 1 of the ‘615 patent.

 

[80]           He points out, correctly, that Dr. McLelland challenged that point of view when he stated at paragraph 62 of his affidavit that claim 1 of the ‘999 patent was unambiguous by reason of the fact that it “… sets out the spacings and intensities in an X-ray diffraction patent. Only a particular crystalline form will exhibit such a pattern, and it is not necessary to indicate that a solvent is present.”

 

[81]           Dr. Brenner disagrees with Dr. McLelland’s view of the ‘999 patent. More particularly, he relies on the fact that in some crystalline solvates the solvent can depart the crystal lattice without affecting the powder diffraction pattern. As a result, it is possible to have two distinct materials with the exact same X-ray powder diffraction pattern, “ … one which contains solvent and the other which does not contain solvent” (paragraph 16 of his affidavit).

 

[82]           This leads Dr. Brenner to say that there is therefore no support for Dr. McLelland’s view that the word “hydrochloride” should be interpreted narrowly, i.e. as referring only to a specific material. Consequently, Dr. Brenner reiterates his view, as set out in paragraph 26 of his earlier affidavit, that the inventors of the ‘999 patent must have intended for the word “hydrochloride” found in claim 1 of that patent to include the hydrochloride acetonitrile solvent.

 

[83]           Dr. Brenner then turned to Dr. Langer’s affidavit, with respect to which he opined that both Dr. Langer and Dr. McLelland had interpreted claim 1 of the ‘615 patent in a perspective different than that which a person of ordinary skill in the art would have. In his view, their interpretation is inconsistent with how such a person would understand claim 1 of the ‘615 patent.

 

[84]           I have struggled long and hard with these conflicting opinions given by scientists of repute. However, for the reasons that follow, I conclude that the better view is that of Dr. Brenner.

 

[85]           In considering the evidence of the expert witnesses, i.e. the “ordinary persons skilled in the art”, it is important to reemphasize that the Supreme Court of Canada in Whirlpool, supra, and Free World, supra, made it clear that a patent should be read by an open mind – i.e. a mind not bent on finding a way to circumvent the inventor’s invention, but one desirous of understanding the invention – and that in going through the exercise, the skilled reader had to examine the claim in its context – i.e. the words of the claim were to be read in the context of the specification. In Free World, supra, at paragraph 44 of his Reasons, Binnie J. adopted the definition of the “worker skilled in the art” given by Dr. Fox, found at page 184 of the Canadian Law and Practice Relating to Letters Patent for Inventions, 4^th ed., Toronto, Carswell, 1969:

a hypothetical person possessing the ordinary skill and knowledge of the particular art to which the invention relates, and a mind willing to understand a specification that is addressed to him. This hypothetical person has sometimes been equated with the “reasonable man” used a standard in negligence cases. He is assumed to be a man who is going to try to achieve success and not one who is looking for difficulties or seeking failure.

 

 

[86]           With these principles in mind, I now proceed to indicate why I believe that Dr. Brenner’s understanding of claim 1 is the proper one. I begin by saying that the area of disagreement between the experts is in respect of the meaning of the word “hydrochloride” found in claim 1 of the ‘615 patent. More particularly, the question is whether “hydrochloride” includes only “unsolvated” forms of quinapril hydrochloride or whether it also includes “solvated” forms thereof.

 

[87]           As appears clearly from my review of the opinions given by the experts, Dr. Brenner gave considerable importance to that part of the specification where the inventors stated that both the hydrated forms and the solvated forms, with pharmaceutically acceptable solvents, were equivalent to the unsolvated forms for the purpose of the invention. Dr. Langer does not agree with Dr. Brenner that the skilled reader may consider the specification in order to properly understand the claim at issue. First, he says at paragraph 21 of his affidavit that he was informed that “[I]f a term is used in a clear and unambiguous manner in the claim, then the term should be defined based solely on its usage in the claim itself” and that “if the definition of a term cannot be clearly and unambiguously determined from a claim, then a patent disclosure should be consulted to ascertain the definition of the term”. He then says the following at paragraph 33 of his affidavit:

33.     Despite this [i.e., that the use of the word “the” to describe the hydrochloride indicates to a skilled person that specific individual compounds are being claimed and not a broad class of compounds], Dr. Brenner also states in paragraph 24 of his January 14^th Affidavit with respect to the above passage from page 4 of the ‘615 patent that:

The patentee also expressly advises that the invention may exist in anhydrous form, as well in solvated, including hydrated, forms. Further, the patentee advises that the hydrated forms and the solvated forms are equivalent to anhydrous and solvated forms.

 

I again disagree with Dr. Brenner with respect to this point. As I understand it, the invention of a patent is specifically disclosed in the patent claims, not in the patent disclosures (noting that patent claims often undergo revision after initial submission of a patent application). As I also understand it, the patent disclosure can be utilized to act as a reference for definition of terms in the patent claims. …

 

 

[88]           Thus, according to Dr. Langer, it was wrong of Dr. Brenner to interpret claim 1 of the ‘615 patent in the light of the specification because claim 1 is clear and unambiguous. Hence, it is not proper to consider the specification. In my view, Dr. Langer’s approach is incorrect. In Whirlpool, supra, Binnie J. at paragraphs 49(e) and 52 made it clear that claims were to be construed in light of the entire specification in order to enable the reader to properly understand the claim at issue, bearing in mind that the specification could not serve as a device to expand the patentee’s monopoly. In expressing this opinion, Binnie J. referred to the remarks of William L. Hayhurst found in The Art of Claiming and Reading a Claim, J.F. Anderson editor, Patent Law of Canada, Scarborough, Ontario, Carswell, 1994, 177, made at page 190, to the effect that it was often unsafe to conclude that a term in a claim was plain and unambiguous without having carefully reviewed the specification.

 

[89]           As a result of his view regarding the disclosure, Dr. Langer does not give it any consideration in his attempt to explain the meaning of the word “hydrochloride”. I find this particularly troubling considering that the inventors make a clear statement to the effect that quinapril hydrochloride can exist in solvated and unsolvated forms and that in general, both the hydrated forms and the solvated forms with pharmaceutically acceptable solvents “are equivalent to the anhydrous or unsolvated forms for the purposes of the invention”. From this, I can only conclude that Dr. Langer has not read the claim with an open mind, a mind willing to attempt to achieve success and not failure. Consequently, although I am not totally discounting Dr. Langer’s opinion, I do not give it much weight.

 

[90]           In any event, Dr. Langer, like Dr. McLelland, placed considerable importance on the fact that the word “hydrochloride” was preceded by the word “the”. In their view, that was a clear indication that the inventors did not intend to claim a broad class of compounds, such as all pharmaceutically-accepted organic solvate forms of quinapril hydrochloride, but rather specific individual compounds. Otherwise, according to Dr. McLelland, the inventors would have used the words “a hydrochloride” or “the hydrochlorides”. Further, if the word “the hydrochloride” were meant to include solvated forms, there was no necessity, in his view, of using the words “the hydrochloride, hydrate” and “the hydrochloride hemihydrate” as these compounds would have been included in “the hydrochloride”.

 

[91]           After very careful consideration of the evidence given by both Dr. Langer and Dr. McLelland, I am persuaded that they have not approached claim 1 with an open mind, a mind willing to attempt to achieve success and not failure. With respect to Dr. Langer, I have already indicated, at paragraph 86 of these Reasons, that he deliberately did not consider the disclosure. In the case of Dr. McLelland, I come to the same conclusion because I do not believe that he seriously considered the disclosure at page 4 of the patent. In my view, although he took note of it, for all intents and purposes, he ignored it in interpreting the claim.

 

[92]           On the other hand, I am satisfied that Dr. Brenner did approach claim 1 with an open mind in that he could not but give serious consideration to the disclosure which reveals that for the inventors, solvates and hydrates are equivalent to the anhydrous unsolvated forms of quinapril hydrochloride. With that in mind, Dr. Brenner read claim 1 and concluded that by the use of the word “hydrochloride”, the inventors intended to capture quinapril hydrochloride in its organic solvated, non-hydrated and amorphous forms.

 

[93]           I am satisfied that that construction of claim 1, in the light of the disclosure, is the proper construction. As a result, I conclude that the words “the hydrochloride” found in claim 1 of the ‘615 patent include solvated forms of quinapril hydrochloride. Hence, QHAS is covered by claim 1 of the patent.

 

[94]           I would add that, in any event, on a purposive construction of claim 1, the extent of solvation or hydration is not an essential element of the invention. This conclusion appears to me inevitable, considering that the inventors clearly stated that hydrated forms and solvated forms with pharmaceutically acceptable solvents were equivalent to the anhydrous or unsolvated forms.

 

[95]           In concluding that Dr. Brenner’s understanding of claim 1 is the correct one, I am comforted by the fact that Drs. Langer and McLelland’s view leads to the conclusion that the ‘615 patent teaches a reader how to specifically avoid infringing claim 1 thereof, i.e. by making a solvated form of quinapril hydrochloride. That view cannot be characterized as one ensuring the attainment of the inventor’s intention, nor can it be viewed as a construction arrived at by a mind willing to understand and attempting to achieve success.

 

[96]           Apotex argues that even if QHAS falls within claim 1, it is still entitled to the issuance of a NOC because the NOC Regulations only prohibit the issuance thereof by the Minister if the compounds in the final dosage form infringe the claims of the patent. Apotex says that intermediates used in the production of the final dosage form, like QHAS, are not relevant for the purpose of subparagraph 5(1)(b)(iv) of the NOC Regulations which, for ease of reference, I again reproduce:

 

[97]           For this submission, Apotex relies on two decisions of the Federal Court, namely Abbott Laboratories v. Canada (Minister of Health), 2005 FC 1093, and Abbott Laboratories v. Canada (Minister of Health), 2006 FC 120. However, in Abbott Laboratories v. Canada (Minister of Health), 2006 FCA 187, an appeal from the earlier Abbott, supra, decision, this Court in interpreting the words of subparagraph 5(1)(b)(iv) of the NOC Regulations, concluded that the use of the patented substance at an intermediate stage in the production of a new drug fell within the subparagraph. At paragraph 16 of her Reasons, Sharlow J.A. expressed that view as follows:

[16]     I must respectfully disagree with the judge on that point. The phrase "making, constructing, using or selling" in subparagraph 5(1)(b)(iv) describes a range of activities that is broader than merely including a patented substance in the proposed new drug. In my view, that phrase is broad enough to include the use of the patented substance at an intermediate stage in the production of the proposed new drug. I reach that conclusion based on the ordinary and grammatical meaning of the phrase. I see nothing in the purpose or object of the NOC Regulations that compels a narrower interpretation.

 

[Emphasis added]

 

 

[98]           Apotex makes a further argument. It says that even if intermediates fall within the ambit of subparagraph 5(1)(b)(iv), it is still incumbent upon Pfizer to demonstrate that QHAS is a “medicine” within the meaning given to that term by section 2 of the NOC Regulations, i.e. a “substance intended or capable of being used for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or the symptoms thereof”. Apotex says that Pfizer has not met its burden.

 

[99]           In my view, Apotex’s argument is without merit since its ANDS and the accompanying product monograph for APO-QUINAPRIL clearly state that QHAS is Apotex’s medicine. Specifically, Apotex has represented to the Minister of Health that QHAS is its drug substance and that it is useful in the treatment of hypertension.

 

[100]       I therefore conclude that in making and using QHAS, Apotex will infringe claim 1 of the ‘615 patent. I now turn to the ‘330 patent.

 

B.        The ‘330 Patent

            (a)        Claims Broader than Invention Disclosed:

[101]       Pfizer argues that Heneghan J. made a number of errors of law in concluding that claims 3 and 5 of the ‘330 patent were broader than the invention disclosed. First, Pfizer says that the Judge erred in misallocating the burden of proof. Second, it says that she misconstructed the test for “claims broader” in holding that only the optimal compounds were to be included within the claim. Third, Pfizer says that the Judge misconstrued the claims and/or the disclosure of the patent in finding that the claims were for a new use (to treat hypertension) instead of a new compound.

 

[102]       The Judge’s approach to the applicable burden of proof appears at paragraph 53 of her Reasons, where she says:

[53]         The burden lies on Pfizer, as the Applicant, to refute the allegations set forth by Apotex in its NOAs dated July 18, 2003 and July 24, 2003. Therefore, like any plaintiff or applicant, Pfizer has the overall legal burden of proof. Apotex, as the Respondent, has an obligation to put the allegations set out in its NOAs “in play”.

 

 

[103]       In so concluding, the Judge relied on Mosley J.’s decision in Jansen-Ortho Inc. v. Novopharm (2004), 35 C.P.R. (4^th) 353, where he held that when a second person had adduced evidence that was not clearly incapable of establishing allegations of invalidity, the statutory presumption was countered and could no longer assist a first person in establishing the validity of its patent.

 

[104]       In Pfizer’s view, the correct approach to the burden of proof is that a second person must lead evidence which proves, on a balance of probabilities, that the patent is invalid.

 

[105]       In my view, the correct test is the one set out by Sharlow J.A. in Bayer Inc. v. Canada (Minister of National Health and Welfare) (2000), 6 C.P.R. (4^th) 285, where at paragraphs 6 and 9, she made the following remarks:

[6]           In seeking to discharge its burden of proving the allegation to be unjustified, Bayer relied on the statutory presumption of the validity of its patent. Because that presumption exists, it may be said that Apotex, as the party responding to the application for a prohibition order, has a burden of proof in this sense: if Apotex had adduced no evidence that was capable of establishing the invalidity of the patent, Bayer could have succeeded on the basis of the statutory presumption alone…

 

…

 

[9]           The operation of the statutory presumption in the face of evidence of invalidity depends upon the strength of the evidence. If the evidence proves on a balance of probabilities that the patent is invalid, the presumption is rebutted and is no longer relevant: Diversified Products Corp. v. Tye-Sil Corp. (1991), 35 C.P.R. (3d) 350 (F.C.A.) at 359. (Bayer at paras. 6, 9)

 

[106]       That standard was reiterated by Rothstein J.A. (as he then was), at paragraphs 15 and 16 of his decision in Procter and Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of Health), [2005] 2 F.C.R. 269 (FCA):

[15]         … Sharlow J.A. observed that because of that presumption of validity, the generic, as the party responding to the application for a prohibition order, has the burden of proof to displace the presumption.

 

[16]         As to the standard of proof, at paragraph 9, she wrote:

 

The operation of the statutory presumption in the face of evidence of invalidity depends upon the strength of the evidence. If the evidence proves on a balance of probabilities that the patent is invalid, the presumption is rebutted and is no longer relevant...

 

Therefore, the standard of proof applicable to proving invalidity has been found to be proof on a balance of probabilities. …

 

 

[107]       More recently, in Aventis Pharma v. Apotex, 2005 FC 1283 (F.C.), aff’d 2006 FCA 64 (F.C.A.),MacTavish J., relying on Bayer, supra and Procter and Gamble, supra, explained the applicable burden of proof as follows:

[77]         As the Applicant in these proceedings, Aventis has the overall burden of establishing that none of Apotex's allegations are justified. In this case, all of the issues raised by Apotex in its NOA relate to the validity of the '206 patent. In the absence of evidence to the contrary, there is a statutory presumption that a patent is valid: section 45 of the old Patent Act, subsection 43(2) of the post-1989 Patent Act, R.S.C. 1985, c.P-4.

 

[78]         Relying upon the presumption of validity, Aventis can thus meet its initial burden merely by proving the existence of the patent.

 

[79]         Once this is done, the burden shifts to Apotex to establish that the patent is invalid. The standard of proof that Apotex is required to satisfy is that of a balance of probabilities: Bayer v. Canada (Minister of National Health and Welfare), [2000] F.C.J. No. 464, 6 C.P.R. (4th) 285 (F.C.A.), para. 9.

 

 

[108]       In appeal, this Court affirmed MacTavish J.’s decision and did not take objection to her understanding of the proper burden of proof, simply saying at paragraph 8 of its Reasons:

[8]           The jurisprudence of the Federal Court of Appeal clearly establishes that the onus of proof in NOC proceedings rests on the applicant and is considered on a balance of probabilities, bearing in mind that on allegations of invalidity, there is a statutory presumption of validity in favour of the patentee.

 

[109]       Thus, a first person under the Regulations has the overall burden of establishing, on a balance of probabilities, that the allegations of invalidity contained in a second person’s NOA are not justified. Although the first person has the initial burden, because of the presumption of the validity of a patent set out in section 45 of the pre-1989 Act, it can meet this burden merely by proving the existence of the patent. The second person then has the burden of adducing evidence of invalidity and of putting the allegations of invalidity contained in its NOA “in play”. To do so, the second person must adduce evidence which is not clearly incapable of establishing its allegations of invalidity. Hence, not only must the second person’s NOA contain a sufficient factual and legal basis for its allegations, but it must also adduce evidence of invalidity at trial.

 

[110]       Once the second person has adduced sufficient evidence, on a balance of probabilities, the first person must, also on a balance of probabilities, disprove the allegations of invalidity set out in the NOA. As explained by my colleague Sharlow J.A. at paragraph 9 of her Reasons in Bayer, supra:

[9]           The operation of the statutory presumption in the face of evidence of invalidity depends upon the strength of the evidence. If the evidence proves, on a balance of probabilities, that the patent is invalid, the presumption is rebutted and is no longer relevant. …

 

 

[111]       I have not been persuaded that the Judge erred in her understanding of the burden of proof. She correctly referred to the legal principles enunciated by this Court, according to which the overall legal or persuasive burden of proof rests upon the first person, on a balance of probabilities, once the second person has met its evidentiary burden of adducing evidence sufficient to rebut the presumption of validity.

 

[112]       Even if Pfizer were correct in its submission that the Judge misunderstood the applicable burden of proof, I am of the opinion that the Judge’s ultimate conclusion on the issue of whether claims 3 and 5 were overly broad does not depend on her allocation of the burden of proof.

 

[113]       Pfizer’s second submission is that the Judge erred in applying the test for determining whether claims 3 and 5 of the ‘330 patent were broader than the invention disclosed. It argues that the Judge erred by failing to consider whether all claimed stereoisomers were disclosed as being included in the invention and, instead, erroneously focused on whether the stereoisomers claimed were all optimal for use in the invention. More specifically, Pfizer argues that all stereoisomers of the quinapril family of compounds are within the scope of the invention, as evidenced by the prior art and supported by expert opinion. In Pfizer’s view, the Judge should have asked herself which stereoisomers were part of the invention disclosed and which of these were claimed in the patent.

 

[114]       Apotex submits that Heneghan J. reached the correct conclusion, in that the disclosure of the ‘330 patent clearly teaches that the S-configuration is essential for biological activity. The Judge’s conclusion appears clearly from paragraphs 107 and 108 of her Reasons, where she says:

[107]       … Since I have concluded that claims three (3) and five (5) should be construed so as to include compounds useful for reducing hypertension and having regard to the expert evidence that the S-configuration is the optimal configuration for high level ACE inhibition leading to anti-hypertensive results, I conclude that the claims encompassing all possible stereoisomers are overly broad.

 

[108]       The aim of the purposive approach is to give meaning to the claim of a patent. Those claims which exceed the scope of the invention or the description of the patent’s specification are invalid; see Farbwerke Hoechst v. Commissioner of Patents, supra. Accordingly, I am satisfied that the Applicants have failed to show that the allegation of invalidity, on the basis of overly broad claims, is not justified.

 

 

[115]       It is now settled law that a patent which claims more than what was invented or disclosed can be found invalid for being overly broad. As explained in Lovell Manufacturing Co. and Maxwell Ltd. v. Beatty Brothers Ltd. (1962), 41 C.P.R. 18 (Ex. Ct.) at p. 66:

The other attack was that the claims were too wide and that they claimed more than had been invented. This repeats the central them to which I have referred, namely, the contention that all that had been invented were the specific wringer constructions described in the specification and that unless the claims were limited in their application to inventions of the said specific constructions they were too wide and, therefore, invalid. There is a simple answer to the contention, If the claims read fairly on what has been disclosed and illustrated in the specification and drawings, as they do, they are not wider than the invention. The specific wringer constructions described in the specification are simply embodiments or illustrations of the invention. The claims embrace them and might well embrace similar other embodiments or illustrations. There is nothing in any of the specifications that would limit the claims to one of the specific wringer constructions or to all of them.

 

[Emphasis added]

 

 

[116]       The test referred to by the Trial Judge, i.e. that “… a claim will be considered overly broad and accordingly, invalid, if it asserts an exclusive property or privilege in something the inventor did not actually invent; or something that the inventor did not fully disclose in the patent” (paragraph 99 of the Reasons), is, in my view, the correct one. However, I cannot but conclude that she did not apply that test to the evidence before her. In effect, her conclusion appears to be solely based on her finding that the S-configuration of the quinapril family of compounds is more effective than the R-configuration for the relief of hypertension.

 

[117]       In my view, the Judge erred in the following respects. First, she erred in treating as determinative the question of whether or not an invention or parts of an invention were optimal. Such a consideration is not relevant to the question of whether claims are overly broad. Second, she misapplied her construction of the claims to the question of whether they were overly broad. Third, she failed to recognize that patents for chemical compounds regularly claim, and are regularly issued for, all stereoisomers. Fourth, she failed to consider the overwhelming weight of evidence which shows that all stereoisomers fell within the scope of the invention and that the patent did not claim more than what was invented. Fifth, she failed to consider the prior art and, in particular, the fact that the inventors of captopril, enalapril and the Tanabe compound claimed and disclosed all stereoisomers of the ACE compounds covered by the invention.

 

[118]       In my view, these errors are critical and, as a result, it is necessary for this Court to construe the ‘330 patent. Claims 3 and 5 of the ‘330 patent each refer to groups of compounds sharing a specific formula, but they are silent as to the appropriate stereo configuration of these compounds. Apotex argues that the claims refer unambiguously to all stereoisomers and that it is therefore improper to resort to the disclosure to assert the scope of the claims. I cannot agree with that proposition.

 

[119]       As I indicated earlier, Binnie J., in Whirlpool, supra, cautioned against too easily concluding that claims were unambiguous: “[t]erms must be read in context, and it is therefore unsafe in many instances to conclude that a term is plain and unambiguous without careful review of the specification” (at paragraph 52).

 

[120]       Therefore, it is necessary to review the disclosure in the ‘330 patent and to assess how the claims should be read in the light of that disclosure. Several portions of the ‘330 patent shed light on the invention being claimed. First, the abstract specifies that the invention relates to anti-hypertensive agents:

The compounds of the invention, their salts and pharmaceutical compositions thereof are useful as antihypertensive agents.

 

Elsewhere, the disclosure refers to the use of the invention for the treatment of hypertension:

The compounds of this invention intervene in the renin - > angiotensin I - > angiotensin II sequence by inhibiting angiotensin I converting enzyme and reducing or eliminating the formation of the pressor substance angiotensin II, and therefore are useful in reducing or relieving hypertension. Thus by the administration of a composition containing one or a combination of compounds of formula I or pharmaceutically acceptable salts thereof, hypertension in the species of mammal suffering therefrom is alleviated…

 

…The compounds of the invention can be utilized to achieve the reduction of blood pressure by formulating in compositions such as tablets, capsules or elixirs for oral administration or in sterile solutions or suspensions for parenteral administration. (’330 patent at 6, 9).

 

 

[121]       These passages from the disclosure led the Judge to conclude that “… the claims of the ‘330 patent here in issue would be read by a person skilled in the art as referring to compounds useful for the relief of hypertension” (Heneghan J.’s Reasons, para. 64).She was not persuaded that the invention was directed to the broader purpose of ACE inhibition. In my opinion, this conclusion is reasonable in light of the passage cited above and the overall tenure of the disclosure. At paragraph 66 of her Reasons, the Judge concluded that the patent claimed “all possible stereoisomers” of the family of claimed compounds:

[66]         … I agree with the submissions of Apotex on this issue, that the '330 Patent claims a family of compounds with a shared common structure, that is having three chiral centres, and claiming all possible stereoisomers thereof. I conclude that the purpose of the inventions described in claims three (3) and five (5) of the '330 Patent is to use the described compounds as the active ingredient in medicine for the treatment of hypertension.

 

[122]       In construing the disclosure, Heneghan J. only referred to those parts of the patent quoted above referencing the purpose of the invention as a treatment for hypertension. Her conclusion that all possible stereoisomers are claimed apparently arose from the fact that claims 3 and 5 are not limited to specific stereoisomers. However, in my view, it was not possible for Heneghan J. to construe claims 3 and 5 in accordance with the teachings of Whirlpool, supra, without interpreting the part of the disclosure that both parties identify as governing the stereochemistry of the invention.

 

[123]       Whether the disclosed invention encompasses all or a limited set of stereoisomers was a contentious issue between the parties. In particular, both parties introduced expert evidence providing different interpretations of the following passage from the disclosure:

…The 1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid used in this invention has the L(S) configuration. This configuration has been shown to be required for biological activity, and thus active compounds of the invention are derived from either L(-) or DL-1,2,3,4-tetrahyudroisoquinoline-3-carboxylic acid.

 

Optical and diastereo isomers arising from the chirality at the centers marked with an asterisk [i.e. all three chiral centres] in Formula I and racemates and mixtures thereof are within the scope of this invention. The S-configuration at these centers is preferred. (’330 patent at 3)

 

The two paragraphs are difficult to reconcile. Read together, it appears the patentee is claiming all stereoisomers within the scope of the invention while acknowledging that the S-configuration at one of the chiral centres is necessary for the invention to be useful.

 

[124]       Pfizer submitted, on the basis of the evidence of its two experts, that a skilled reader would have concluded that all stereoisomers were included within the scope of the invention. Pfizer also argued that Dr. Marshall, Apotex’s expert on this issue, agreed with its experts during the course of his cross-examination, when he conceded that the inventors had defined the scope of the invention to include all stereoisomers.

 

[125]       I would describe the invention as a family of chemical compounds with varying levels of ACE inhibition and varying levels of effectiveness for the relief of hypertension. Such a construction, which is broader than that of Heneghan J., is, in my view, justified. It is not misconstruing the compound claims for use claims. I do not believe that the Trial Judge mistakenly construed the claims as use claims by describing the ‘330 patent as referring to compounds “ … useful for the relief of hypertension” (Reasons of Heneghan J., para. 64). It appears from the Judge’s decision that she clearly understood the claims to cover the compounds themselves.

 

[126]       On the basis of the evidence before the Court, however, Pfizer’s invention can be described as covering all stereoisomers of quinapril. The state of the art is to the effect that all stereoisomers were within the inventor’s contemplation, as revealed by the use of a Markish formula and the fact that patents for other ACE inhibitors claimed and disclosed all stereoisomers. The wording of the claims and the expert evidence suggest that all stereoisomers of quinapril are claimed in the patent. In fact, the Trial Judge, in her introduction on the ‘330 patent, says that “… [t]he compounds have three chiral centres and all the stereoisomers sharing this common structure, that is both the S- and R-configurations stereoisomers, are within the scope of the claims” (Reasons of Heneghan J., para. 9).

 

[127]       In my view, a person skilled in the art would read the two paragraphs from the disclosure which I have reproduced at paragraph 120 of these Reasons as disclosing that the invention includes all stereoisomers. The skilled reader would be persuaded particularly by the clear statement in the second paragraph that “… all optical isomers and diastereo isomers and mixtures thereof are within the scope of this invention”. Accordingly, in my view, a skilled reader would therefore understand that claims 3 and 5, although silent as to stereo configuration, include all stereoisomers. Thus, given that the invention clearly covers all stereoisomers and that the patent claims all stereoisomers, the patent cannot be described as claiming more than what was invented.

 

[128]       I would therefore conclude that Pfizer has met its burden of disproving the allegation that the ‘330 patent contains overly broad claims. In view of this conclusion, I must now address the issues of obviousness, anticipation, double patenting and lack of utility.

 

(b)        Obviousness:

[129]       Apotex challenges Heneghan J.’s dismissal of its claim that the invention disclosed in the ‘330 patent was obvious. It says that she erred (i) in accepting Pfizer’s evidence going to obviousness, even though it assessed the state of knowledge as of the wrong date; (ii) in considering only whether the creation of quinapril hydrochloride was obvious, rather than looking to the obviousness of all of the compounds claimed in the ‘330 patent; and (iii) in failing to take into

account the fact that two other groups of inventors had independently invented the subject matter of the ‘330 patent. With respect, I cannot conclude that Heneghan J.’s holding as to obviousness should be set aside.

 

[130]       The Trial Judge, after reviewing the applicable legal test, reviewed the expert evidence. She concluded that at the relevant priority date of October 3, 1980, others skilled in the art would not have known how to create, notice and document the benefits of the compound quinapril hydrochloride as an anti-hypertensive. On this basis, she concluded that Pfizer had met its burden of showing that the allegation of invalidity for obviousness was not justified.

 

[131]       Pfizer submits that if the Trial Judge erred, it was in finding that the relevant date for assessing obviousness was October 3, 1980 (the earliest filing date) and not June 19, 1980 (which they claim is the date of the conception of the invention and the articulation of a means of making it).

 

[132]       There was evidence adduced by both parties on this issue. Dr. Anderson, Pfizer’s expert, opined that as of June 19, 1980, only the praline head would have been obvious to a person of ordinary skill in the art. He did not consider whether it would have been obvious as of October 3, 1980. Dr. Marshall, for Apotex, was of the opinion that the disputed claims of the ‘330 patent include within their scope compounds that were obvious as of June 19, 1980 and October 3, 1980. However, he admitted on cross-examination that he was not qualified to give an opinion as to obviousness.

 

[133]       In my opinion, the Trial Judge did not commit a reviewable error. She considered and applied the correct legal test, according to which an invention is obvious if a person of ordinary skill in the art would, at the claimed date of the invention, be led “directly and without difficulty to the solution taught by the patent”. For an allegation of invalidity for obviousness to succeed in the context of NOC proceedings, sufficient evidence must be adduced to show that the range of compounds covered by any of the relevant claims would have been obvious to a person skilled in the art at the time of the invention. Although the Judge refers only to the obviousness of quinapril hydrochloride, the compounds covered by the invention are, in my view, closely related to one another and the evidence does not appear to provide any reason to conclude that the other compounds would have been more obvious than quinapril hydrochloride.

 

[134]       It appears that the Trial Judge considered all of the evidence before her. However, it is clear that she did not consider Dr. Marshall’s evidence to be very strong and, upon consideration of that evidence, I cannot but agree with her. There was clear evidence upon which the Trial Judge could conclude that Pfizer had disproved the allegation of invalidity for obviousness. This, in my view, is the case whether a June 19, 1980 or an October 3, 1980 date is used to assess obviousness. Consequently, I am of the view that the learned Judge, in concluding as she did, did not commit an overriding and palpable error.

 

 

 

(c)        Anticipation:

[135]       Apotex also challenges Heneghan J.’s dismissal of its allegation that the ‘330 patent was anticipated. In its NOA, Apotex alleged that the ‘330 patent was anticipated by the Hoechst patent filed with the Canadian Patent Office before the ‘330 patent and which gave rise to conflict proceedings.

 

[136]       The Trial Judge, after reviewing the parties’ submissions and the applicable legal test, found that Apotex, in failing to adduce evidence showing that the Hoechst patent had been filed with the Canadian Patent Office, or had been issued, before the relevant date of September 30, 1979, had not put the issue “in play”.

 

[137]       Apotex submits that the Trial Judge erred in applying the test of anticipation by prior publication (paragraph 57(1)(b) of the pre-1989 Patent Act) instead of the test of anticipation by prior use (subsection 27(1) of the pre-1989 Patent Act). It relies, as evidence of anticipation by prior use, on the fact that conflict proceedings were initiated in respect of the Hoechst patent and the ‘330 patent. Pfizer replies that the existence of conflict proceedings alone cannot resolve the issue. In any event, Pfizer submits that these proceedings were ultimately resolved in its favour.

 

[138]       It appears from paragraphs 85 and 86 of Heneghan J.’s Reasons that she did apply the anticipation by prior publication test. In this respect, I find particularly convincing paragraph 27 of Pfizer’s Reply Memorandum of Fact and Law which states:

27.           Apotex argues that Justice Heneghan erred by failing to consider s. 27(1)a) of the Patent Ac, which requires a patent to be “known or used” by any other person before the inventor invented it. This was not an error. Section 61(1) prevents a patent from being invalidated on the basis that it was “known or used” unless it was “disclosed or used … in such manner that it had become available to the public” or if it was the subject of an application for a patent in Canada on which “conflict proceedings should have been directed.” Neither of these conditions are met in this case. There is no evidence that the Hoechst patent application was known to the public. Moreover, this is not a case in which “conflict proceedings should have been directed”). Rather, conflict proceedings were directed, did occur, and the patent ultimately issued to Warner Lambert.

 

 

[139]       Even if I were to agree that the Judge erred in applying the wrong test, this error, in my opinion, is of no consequence in view of the paucity of the evidence adduced before Heneghan J. In any event, it is clear that Apotex did not file into evidence a copy of the Hoechst patent. Thus, Heneghan J. was unable to confirm the filing or issuance date of that patent. This, in my view, is fatal to Apotex regardless of whether the correct test is anticipation by prior use or anticipation by prior publication.

 

[140]       I therefore can find no fault in the Judge’s conclusion that Apotex’s allegation of invalidity for anticipation had not been put “in play”.

 

(d)        Double Patenting:

[141]       Apotex alleges the ‘330 and ‘615 patents relate to a single invention and do not cover subject matter which is patently distinct. It therefore submits that the relevant claims of the ‘330 patent are invalid for double patenting.

 

[142]       Apotex also argues that the Judge took into account irrelevant considerations in assessing whether there had been “obviousness” double patenting between the ‘330 and ‘615 patents. Under this type of double patenting, the second patent will be invalid if its claims are not “patently distinct” from those in the earlier patent (Whirlpool, supra, at para. 66).

 

[143]       The Trial Judge considered the rule against obviousness double patenting, according to which the question to be answered is whether the claims of one patent are patently distinct from those of the other patent(s). She found persuasive the fact that the ‘330 and ‘615 patents were not placed into conflict. She also noted that it was the Commissioner of Patents who suggested that a divisional application be made in respect of the ‘615 patent. On this basis, she concluded that Pfizer had met its burden of disproving the allegations of invalidity for double patenting.

 

[144]       Apotex argues that the Judge should not have taken into account the fact that the ‘615 had not been involved in the conflict proceedings with the Hoechst patent. It further argues that she should not have been persuaded by evidence that the Commissioner had suggested that divisional application be made in respect of the ‘615 patent because, in its view, it was the patentee who had requested the division. Finally, Apotex argues that it submitted uncontroverted evidence that the compounds claimed in the ‘615 patent did not constitute inventive selection over the ‘330 patent.

 

[145]       With respect to Apotex’s first argument, it was reasonable, in my view, for Heneghan J. to consider whether the ‘615 patent had been involved in the conflict proceedings in determining whether there was double patenting. This fact lends some support to the conclusion that the ‘615 and ‘330 patents do not have the same scope, at least with respect to the scope of the invention disclosed in the Hoechst patent. I also find it unlikely that such evidence alone could dispose of the issue, unless it was shown that all of the subject matter covered by the Hoechst patent and the ‘330 patent was the same, such that if the ‘615 patent covered the same subject matter as the ‘330 patent, it would almost certainly have been involved in the conflict proceedings.

 

[146]       Of some persuasiveness is a fact which Apotex points to in its Memorandum of Fact of Law. At paragraph 87 thereof, in attempting to explain its basis for stating that the Commissioner did not request the division of the ‘615 patent, Apotex states:

87.           … The Commissioner initially rejected the issuance of the ‘330 patent on the basis of double patenting over the ‘615 patent. The Commissioner, however, accepted Pfizer’s representation that double patenting did not apply as there was a species/genus relationship between the two patents and thus removed his double patenting objection.

 

 

[147]       This, in my view, demonstrates that the Commissioner specifically considered the possibility of double patenting, but was convinced that that was not the case.

 

[148]       With respect to Apotex’s allegation that it was the patentee, not the Commissioner, who requested the division, Apotex points to no evidence supporting that view. Heneghan J.’s finding that the Commissioner requested the division should therefore stand.

 

[149]       In the end, the application of the test for double patenting to the facts of the case is a question of mixed fact and law, subject to the overriding and palpable error standard. Heneghan J. committed no such error. It was reasonable for her, in my view, to rely on the fact that there were no conflict proceedings involving the ‘615 patent and that the Commissioner of Patents suggested that the ‘615 patent be filed as a divisional application. This appears to be the only evidence which was put before the Judge. Thus, in my opinion, these facts do not only indicate that the invention claimed in both patents were patently distinct, but also that the ‘615 patent was a valid selection patent.

 

(e)        Lack of Utility:

[150]       Although Heneghan J. found that Pfizer had not demonstrated utility at the date of invention, she nevertheless found that the patent was valid because of the doctrine of sound prediction.

 

[151]       Apotex argues that Heneghan J. was wrong to conclude that the utility of the compounds claimed in the ‘330 patent was soundly predicted at the relevant time of October 3, 1980 (the priority date). In its view, because there was no evidence that any of the claimed compounds had been tested as of that date, the prediction of utility was unsound. I cannot agree.

 

[152]       In support of its argument that some testing is required before the utility of an invention will be found to be sound, Apotex points to the decision of the Federal Court in Apotex v. Wellcome Foundation Ltd. (1998), 145 F.T.R. 161. However, on appeal, the Supreme Court (at [2002] 4 S.C.R. 153) took a different view of the doctrine of sound prediction. In its view, in order for a prediction to be sound, “… there must be a factual basis for the prediction” (at paragraph 70). Although in two earlier Supreme Court decisions, “… the factual basis was supplied by the tested compounds,” the Supreme Court in Apotex, supra was satisfied that “other factual underpinnings, depending on the

nature of the invention, may suffice” (at paragraph 70). Accordingly, testing is not an absolute requirement for a patent based on sound prediction. Moreover, in a case such as the one before us where there is considerable data about the utility of related compounds such as captopril, enalapril and the Tanabe compound, there was evidence on which Heneghan J. could find that there was a factual basis to predict the utility of the invention disclosed in the ’330 patent.

 

[153]       In any event, Pfizer points, correctly in my view, to this Court’s recent decision in Aventis Pharma Inc.v Apotex Inc., 2006 FCA 64, which held that the relevant date for assessing the soundness of a prediction was the Canadian filing date, in this case, September 30, 1981. Contrary to Apotex’s NOA and to Heneghan J.’s finding, the relevant date is not the priority date which, in this case, is October 3, 1980. Further, in ts NOA of July 24, 2003, Apotex refers to testing of quinapril that showed the compound reduced blood pressure in rats. The results of those tests were received on December 8, 1980, well before the Canadian filing date. Accordingly, even if some testing were required to establish a sound prediction, such testing was conducted in this case.

 

[154]       The issue of sound prediction is a mixed question of fact and law, in respect of which there was evidence in the record. In particular, Dr. Wasley and Dr. Anderson testified that a person of ordinary skill would have a sound basis to predict that all compounds claimed would have utility, on the basis of the captopril patents, enalapril disclosure and application, Tanabe patent and the inventor’s knowledge regarding certain other compounds. It cannot be said that in concluding as she did, that the Judge made an overriding and palpable error.

 

DISPOSITION

[155]       For these reasons, I would allow the appeal, set aside the order of Heneghan J. and prohibit the Minister of Health from issuing a NOC to Apotex in respect of APO-QUINAPRIL until the expiry of the ‘615 and the ‘330 patents. I would allow the appellant its costs herein and below.

 

 

“M. Nadon”

“I agree.

            A.M. Linden J.A.”

 

“I agree.

            J. Edgar Sexton J.A.”

 

 

FEDERAL COURT OF APPEAL

 

NAMES OF COUNSEL AND SOLICITORS OF RECORD

 

DOCKET:                                                                              A-457-05

 

STYLE OF CAUSE:                                                              Pfizer Canada Inc. et al v. Min. of Health and Apotex Inc.

 

PLACE OF HEARING:                                                        Toronto, Ontario

 

DATE OF HEARING:                                                          September 27-28, 2006

 

REASONS FOR JUDGMENT BY:                                     NADON J.A.

 

CONCURRED IN BY:                                                         LINDEN J.A.

                                                                                                SEXTON J.A.

 

DATED:                                                                                 May 31, 2007

 

 

APPEARANCES:

 

Sheila Block Andrew Shaugnessy Andrew Bernstein	FOR THE APPELLANTS
H.B. Radomski Andrew Brodkin Rich Tuzi Sorelle Simmons	FOR THE RESPONDENT, APOTEX INC.

 

 

SOLICITORS OF RECORD:

 

Torys LLP Toronto, ON	FOR THE APPELLANTS
Goodmans LLP Toronto, ON   John H. Sims, Q.C. Deputy Solicitor General of Canada	FOR THE RESPONDENT, APOTEX INC.   FOR THE RESPONDENT, MINISTER OF HEALTH