Smithkline Beecham Pharma Inc. v. Apotex Inc., 2002 FCA 216

Date: 20020528

Docket: A-422-01

                                          Neutral citation: 2002 FCA 216

CORAM:      LINDEN J.A.

EVANS J.A.

MALONE J.A.

BETWEEN:

SMITHKLINE BEECHAM PHARMA INC.

and

BEECHAM GROUP P.L.C.

                                                                Appellants

                                                                       (Applicants)

                                       and

                               APOTEX INC.

and

THE MINISTER OF HEALTH

Respondents

(Respondents)

Heard at Toronto, Ontario, on Thursday, May 9, 2002.

Judgment delivered at Ottawa, Ontario, on Tuesday, May 28, 2002

REASONS FOR JUDGMENT BY:                                                                               LINDEN J.A.

CONCURRED IN BY:                                                                                                        EVANS J.A.

                                                                                                                                             MALONE J.A.

                                                                                                                                            Date: 20020528

                                                                                                                                        Docket: A-422-01

                                                                                                                Neutral citation: 2002 FCA 216

CORAM:        LINDEN J.A.

EVANS J.A.

MALONE J.A.

BETWEEN:

SMITHKLINE BEECHAM PHARMA INC.

and

BEECHAM GROUP P.L.C.

                                                                Appellants

                                                                       (Applicants)

                                       and

APOTEX INC.

and

THE MINISTER OF HEALTH

Respondents

(Respondents)

                                                        REASONS FOR JUDGMENT

LINDEN J.A.

INTRODUCTION

[1]                 This is an appeal from an order of Gibson J. (the "Applications Judge") in which he dismissed an application brought pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/98 - 166, (the "Regulations"). The appellants, SmithKline Beecham Pharma Inc. and Beecham Group p.l.c. ("SmithKline"), sought an order prohibiting the Minister of Health from issuing a notice of compliance to the respondent, Apotex Inc. ("Apotex"), in connection with paroxetine hydrochloride tablets. The Applications Judge declined to grant the order.

[2]                 At the heart of this appeal is the relationship between two patents for paroxetine, a therapeutic drug commonly used to treat depression. The sole question to be resolved, according to the appellant, is whether one patent was anticipated by the other and is, therefore, invalid. In my view, the Applications Judge did not err in holding that it was.

FACTS

[3]                 Canadian Letters Patent 1,287,060 (the "'060 Patent"), entitled "Crystalline Paroxetine HCL", was issued to SmithKline on July 30, 1991. The abstract of the '060 Patent indicates that it relates to "crystalline paroxetine hydrochloride hemihydrate, processes for its preparation and compositions containing it." The disclosure of the '060 Patent includes the following statements that are particularly relevant to this appeal (emphasis added):

In its preferred aspect the present invention provides paroxetine hydrochloride hemihydrate in pharmaceutically acceptable form.

The present invention also provides a pharmaceutical composition comprising crystalline paroxetine hydrochloride hemihydrate and a pharmaceutically acceptable carrier.

The compositions of this invention are usually adapted for oral administration, but formulations for dissolution for parenteral administration are also within the scope of this invention.

The composition is usually presented as a unit dose composition containing from 1 to 200 mg, more usually from 5 to 100 mg, for example 10 to 50 mg such as 12.5, 15, 20, 25 or 30 mg. Such composition is normally taken from 1 to 6 times daily, for example 2, 3 or 4 times daily so that the total amount of active agent administered is within the range 5 to 400 mg.

Preferred unit dosage forms include tablets or capsules.

The composition of this invention may be formulated by conventional methods of admixture such as blending, filling and compressing.

[4]                 After the issuance of the '060 Patent, some of the tablets of paroxetine produced by SmithKline had a pink hue or colouration, which was a major concern to SmithKline. This problem was remedied by using a formulation process in which water is absent, such as "direct compression" or "dry granulation". Upon discovering that such a process solved the problem, SmithKline applied for and was issued Canadian Letters Patent 2,178,637 (the "'637 Patent"), which purported to disclose "novel formulations" of the drug paroxetine.

[5]                 The '637 Patent, entitled "Paroxetine Tablets and Process to Prepare Them", was filed on December 14, 1994, and has a priority date of December 15, 1993. The abstract of the '637 Patent indicates that it relates to "paroxetine which is formulated into tablets using a process in which water is absent." The disclosure of the '637 Patent refers to the "pink hue which is highly undesirable" and asserts that "it has also been surprisingly found that paroxetine formulated into a tablet using a process in which water is absent, is much less likely to develop a pink hue." The disclosure acknowledges that such techniques are "generally known in the art of pharmaceutical science." None of the claims of the '637 Patent refer to the pink hue problem; all build upon claim 1, which reads: "A paroxetine formulation which is prepared on a commercial scale into tablets using a formulation process in which water is absent."

[6]                 Apotex made an abbreviated new drug submission for a notice of compliance under section C.08.004 of the Food and Drug Regulations, C.R.C. 1978, c. 870, for its own version of paroxetine hydrochloride tablets. On March 1, 1999, pursuant to the Patented Medicines (Notice of Compliance) Regulations, supra, Apotex alleged, among other things not at issue in this appeal, that SmithKline's '637 Patent is not valid because it was anticipated by the '060 Patent. On April 16, 1999, in response to Apotex's allegation, SmithKline applied for an order prohibiting the Minister of Health from issuing the notice of compliance.

THE DECISION OF THE APPLICATIONS JUDGE

[7]                 The Applications Judge first noted that, while Apotex possessed the initial evidentiary burden of proving its allegations, once it had put the issues "in play", SmithKline then carried the legal burden of disproving Apotex's allegations. According to the Applications Judge, SmithKline was not required to justify the validity of the patent or establish infringement, but merely to disprove the allegations made by Apotex and, in doing so, was entitled to rely on the "presumption of validity".

[8]                 The Applications Judge held that Apotex produced sufficient evidence to put the anticipation issue in play and that the appellants failed to show that the '637 Patent was not anticipated by the '060 Patent. Therefore, he held that SmithKline had failed to establish that Apotex's allegation of invalidity was unjustified, stating:

[40] Having determined that a wet formulation of paroxetine tablets gives rise to a ‘pink hue problem', a problem of significant enough magnitude to cause a skilled person to seek out at least a partial solution to the problem, I am satisfied that a logical first step for a person skilled in the art would be to turn to the alternative formulation methods disclosed by the '060 Patent and to determine whether each or any of those alternative formulation methods would solve, or at least partially solve, the problem. Such an enquiry would, I am satisfied, involve no inventive step of skill. It would simply involve application of the invention taught by the '060 Patent.

...

[44] In summary then, I conclude that a person skilled in the art, on the basis of cited prior art, namely, the '060 Patent, and the existing common knowledge at the relevant time, would, in every case and without possibility of error, have arrived at the formulation claimed in the '637 Patent. There was no inventive step disclosed by the claims of that Patent read in a generous manner. SmithKline has simply failed, on the evidence before me, to discharge the ‘persuasive burden' or ‘legal burden' borne by it to establish that the allegation of invalidity is not justified.

[9]                 However, the Applications Judge rejected the other grounds of invalidity contained in Apotex's notice of allegation, including obviousness and lack of utility, and the assertion that, if the '637 Patent were valid, Apotex's paroxetine hydrochloride tablets did not infringe the patent.

ISSUE

[10]            The sole issue raised by the appellants is whether the Applications Judge properly decided that SmithKline failed to disprove Apotex's allegation that the '637 Patent was invalid due to anticipation. Because the Applications Judge decided in favour of the appellants the other issues that had been in dispute between the parties, SmithKline does not appeal from those findings.

ANALYSIS

[11]            Patents are often described as a bargain in which an inventor agrees to disclose his/her invention to the public in exchange for the exclusive right to exploit it for a limited time (Free World Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024 at para. 13). If the invention purported to be disclosed is not new, then the public would receive no consideration in exchange for the inventor's monopoly. This rationale underlies the concepts of prior knowledge, prior use, prior publication and prior sale, which are together referred to as "anticipation" (Tye-Sil Corp. Ltd. v. Diversified Products Corp. et. al. (1991), 35 C.P.R. (3d) 350 at 360-61). Thus, if an invention is anticipated, its inventor will not be rewarded with a monopoly for it would not be earned by disclosing an invention not previously available to the public.

[12]            Anticipation is embodied in subsection 28.2(1) of the Patent Act, R.S.C. 1985, c. P-4, the relevant portion of which reads as follows:

[13]            It is generally accepted that the various ways in which a claimed invention may be anticipated that have been outlined in other cases are alternative, rather than cumulative, requirements (see Reeves Brothers Inc. v. Toronto Quilting & Embroidery Ltd. (1978), 43 C.P.R. (2d) 145 (F.C.T.D.) at 157; Tye-Sil, supra, per Décary J.A. at 361; Pfizer Canada Inc. v. Apotex Inc. (1997), 77 C.P.R. (3d) 547 (F.C.T.D.), per Richard J. (as he then was) at 553; and R. Hughes et al., Hughes & Woodley on Patents, looseleaf (Ontario: Butterworths, 1984) at 328). It is not necessary to dwell on these various tests in detail, as the Supreme Court of Canada recently addressed the issue of anticipation in Free World Trust, supra.

[14]            In that case, Binnie J. explained that anticipation is difficult to establish. He affirmed that the legal question is whether the prior publication, in this case the '060 Patent, "contains sufficient information to enable a person of ordinary skill and knowledge in the field to understand ... ‘the nature of the invention and carry it into practical use without the aid of inventive genius but purely by mechanical skill'" (ibid. at paras. 25-6, citing H.G. Fox, The Canadian Law and Practice Relating to Letters Patent for Inventions, (4^th ed., 1969) at 126-7). He affirmed the touchstone test set out by Hugessen J.A. in Beloit Canada Ltd. v. Valmet OY (1986), 8 C.P.R. (3d) 289 (F.C.A.) at 297, which requires that

One must, in effect, be able to look at a prior single publication and find in it all the information which, for practical purposes, is needed to produce the claimed invention without the exercise of any inventive skill. The prior publication must contain so clear a direction that a skilled person reading and following it would in every case and without the possibility of error be led to the claimed invention.

[15]            In the absence of an error in the Judge's formulation or application of the legal test of anticipation, whether a claimed invention has been anticipated is typically regarded as a question of fact (R. Hughes et al., supra at 328). More precisely, it is a question of mixed fact and law, as it requires the application of a legal standard to a set of facts (Housen v. 2002 SCC 33">Nikolaisen, 2002 SCC 33 at para. 26). Because a determination of anticipation is "intertwined with the weight assigned to the evidence, the numerous policy reasons which support a deferential stance to the trial judge's inferences of fact, also, to a certain extent, support showing deference to the trial judge's inferences of mixed fact and law" (ibid. at para. 32). It is not disputed that the Applications Judge used the correct legal test of anticipation as set out in Beloit, supra, and Free World Trust, supra. Since no general legal proposition of precedential value can be extricated from the Applications Judge's conclusion regarding anticipation, this Court must afford considerable deference to his decision and intervene only if his finding constitutes a palpable and overriding error (ibid. at para. 37).

[16]            In essence, Apotex contends that the Applications Judge properly held that the invention claimed in the '637 Patent was disclosed in and, therefore, was anticipated by the '060 Patent. Apotex takes the position that the Applications Judge did not commit palpable and overriding error in relying on "the unanimous view of the experts" as evidence to support his conclusion. The '060 Patent relates to paroxetine formulated by "conventional methods of admixture such as blending, filling and compressing." The '637 Patent relates to paroxetine formulated by a "process in which water is absent." According to Apotex, a "process in which water is absent" is specifically and precisely included among the "conventional methods of admixture such as blending, filling and compressing." Apotex submits that the '637 Patent is, therefore, encompassed within and anticipated by the '060 Patent.

[17]            SmithKline's position is that the invention claimed in the '637 Patent was not "disclosed ... in such a manner that the subject-matter became available to the public ...". SmithKline submits that the '060 Patent teaches a wide array of formulations clearly outside the scope of the '637 Patent, including solutions for parenteral administration, capsules and tablets made using a formulation process in which water is present. Therefore, according to SmithKline, the '060 Patent does not inevitably teach the use of a formulation of paroxetine through a process in which water is absent. Because the instructions in the '060 Patent could result in inventions other than that claimed in the '637 Patent, SmithKline argues that it is not true that a "skilled person reading and following [the '060 Patent] would in every case and without the possibility of error be led to the ['637 Patent]" (Beloit, supra).

[18]            As support for this position, SmithKline refers to [1979] S.C.R. 929">Pfizer, supra, Farbwerke Hoechst v. Halocarbon (Ont.) Ltd., [1979] S.C.R. 929 at 942, and General Tire & Rubber Co. v. Firestone Tyre & Rubber Co., [1972] R.P.C. 457 (Eng. C.A.). SmithKline argues that those cases stand for the proposition that a prior art does not anticipate a later invention if the instructions provided by the prior art could bring about a product that is outside the claims of the later invention. SmithKline suggests that a claim to a specific chemical compound cannot be anticipated by a prior art reference that only teaches a broad genus of compounds into which the particular compound falls because the prior art reference does not give directions that inevitably result in the specific compound. According to SmithKline, this reasoning applies to the '060 Patent, which teaches a broad variety of possible formulation methods, and the'637 Patent, which describes only one of those possible formulation methods.

[19]            I do not agree. The cases referred to by SmithKline are distinguishable from the situation before this Court. In each of the cases cited by SmithKline, the instructions of the prior art set out a general class of compounds or reactions from which one could arrive at the later invention. The later inventions were not anticipated in those cases because the particular compounds in the claimed invention were not identified in the prior art and, therefore, the identification of the particular compounds used in the claimed invention was novel and inventive. In those cases, the prior art did not "enable a person of ordinary skill and knowledge in the field to understand ... the ‘nature of the invention and carry it into practical use without the aid of inventive genius but purely by mechanical skill'" (Free World Trust, supra at para. 26). Since the prior art in those cases did not clearly and simply describe the latter alleged invention, a further inventive step was required.

[20]            However, in this case, the Applications Judge found as a fact that "no inventive step or skill" was required to arrive at the '637 Patent. In other words, one could arrive at the '637 Patent "without the aid of inventive genius but purely by mechanical skill." The instructions for arriving at the formulation claimed by the '637 Patent are, therefore, clearly and unmistakeably present in the '060 Patent. The Applications Judge determined that it is not at all surprising that any person skilled in the art who was confronted by the "pink hue problem" would invariably turn to the alternative formulation methods disclosed by the '060 Patent to arrive at a solution without any inventive step. Mechanical skill rather than inventive genius is required in order to apply the '060 Patent to arrive at the '637 Patent. The appellants have not persuaded me that the Applications Judge erred in his consideration of the evidence as a whole to arrive at this conclusion. Moreover, the fact that the '060 Patent contains additional information and instructions not present in the '637 Patent is immaterial to whether or not one could "look at [the '060 Patent] and find in it all the information which, for practical purposes, is needed to produce [the '637 Patent] without the exercise of any inventive skill" (Beloit, supra at 297).

[21]            SmithKline argues that the result of upholding the Applications Judge's conclusion would be to overturn a large number of cases related to selection patents, including Re: E.I. Dupont Nemours & Co. Application, [1982] F.S.R. 303 (H.L.). I do not agree. It is clear that section 32 of the Act provides that "any person who has invented any improvement on any patented invention may obtain a patent for the improvement." However, given that the Applications Judge determined that there is nothing set out in the claims of the '637 Patent which is not also set out in the '060 Patent, there is no "improvement" claimed in the '637 Patent. The only "improvement" referenced in the disclosure merely verifies properties of a known substance formulated using common techniques. Even construing the '637 Patent generously to bring the advantage of reduction of the "pink hue problem" within a broad interpretation of its claims, the Applications Judge found that "no inventive step or skill" was involved in selecting one process over another. Whatever may be regarded as novel in the' 637 Patent was disclosed in the '060 Patent in a manner that enabled a reasonable uninventive person skilled in the art, after attributing the "pink hue problem" to a process in which water is present, to produce the claimed invention "in every case without the possibility of error" (Beloit). In short, there is nothing new or novel in the '637 Patent. This Court is not inclined to disturb this essentially factual finding, which turns on the particular circumstances of this case.

[22]            SmithKline also alludes to the ostensible inconsistency in the Applications Judge's determination that the '637 Patent is anticipated yet unobvious. This result does seem curious at first glance. However, given that the '637 Patent was anticipated, if SmithKline is indeed correct that an invention cannot be both anticipated and unobvious, then the only possible inference could be that it was obvious. Not surprisingly, SmithKline does not challenge the Applications Judge's finding that the invention was not obvious. Consequently, this Court need not resolve the issue. I do note, however, that anticipation and obviousness are distinct concepts (R. Hughes et al, supra at 328). As Hugessen J.A. explained in Beloit, supra, obviousness alleges that "any fool could have done that", while anticipation alleges that "your invention, though clever, was already known."

[23]            I should end by noting that, since the issue of the validity of the '637 Patent has arisen only in the context of an application for an order of prohibition under subsection 6(1) of the Regulations, supra, the outcome of this proceeding does not necessarily determine the outcome of any future action for a declaration that the patent is invalid or any potential action for its infringement.

CONCLUSION

[24]            For these reasons, I would dismiss this appeal with costs to the respondent, Apotex.

                                                                                            "A.M. Linden"                                 

                                                                                                              J.A.                      

"I agree

     John M. Evans J.A."

"I agree

     B. Malone J.A."

                          FEDERAL COURT OF APPEAL

    NAMES OF COUNSEL AND SOLICITORS OF RECORD

DOCKET:                                                                       A-422-01

APPEAL FROM A JUDGMENT OF THE TRIAL DIVISION DATED JULY 6, 2001, TRIAL DIVISION FILE NO. T-677-99

STYLE OF CAUSE:                                                     SMITHKLINE BEECHAM PHARMA INC. and BEECHAM GROUP P.L.C. v. APOTEX GROUP P.L.C.

PLACE OF HEARING:                                                Toronto, Ontario

DATE OF HEARING:                                                  May 9, 2002

REASONS FOR JUDGMENT BY:                          Linden, J.A.

CONCURRED IN BY:                                                 Evans, J.A.

Malone, J.A.

DATED:                                                                           May 28, 2002

APPEARANCES:

Mr. Anthony G.Creber                                        for the Appellants

Mr. James E. Mills                                                            

Mr. H. B. Radomski                                                          for the Respondent, Apotex Inc.

Mr. Andrew Brodkin

Mr. Ivor Hughes

SOLICITORS OF RECORD:

Gowling Lafleur Henderson LLP                                      for the Appellants

Barristers & Solicitors

Ottawa, Ontario

Goodmans LLP                                                                 for the Respondent, Apotex Inc.

Barristers & Solicitors

Toronto, Ontario