Rhoxalpharma Inc. v. Novartis Pharmaceuticals Canada Inc.

Rhoxalpharma Inc. v. Novartis Pharmaceuticals Canada Inc. Court (s) Database Federal Court of Appeal Decisions Date 2005-02-14 Neutral citation 2005 FCA 11 File numbers A-213-04 Notes Reported Decision Decision Content Federal Court Reports Novartis Pharmaceuticals Canada Inc. v. RhoxalPharma Inc. (F.C.A.) [2005] 3 F.C. 261 Date: 20050214 Docket: A-213-04 Citation: 2005 FCA 11 CORAM: DESJARDINS J.A. NADON J.A. PELLETIER J.A. BETWEEN: RHOXALPHARMA INC. Appellant (Respondent) and NOVARTIS PHARMACEUTICALS CANADA INC. and NOVARTIS AG Respondents (Applicants) and THE MINISTER OF HEALTH Respondent (Respondent) Heard at Ottawa, Ontario, on November 2, 2004. Judgment delivered at Ottawa, Ontario, on February 14, 2005. REASONS FOR JUDGMENT BY: DESJARDINS J.A. CONCURRED IN BY: NADON J.A. DISSENTING REASONS BY: PELLETIER J.A. Date: 20050214 Docket: A-213-04 Citation: 2005 FCA 11 CORAM: DESJARDINS J.A. NADON J.A. PELLETIER J.A. BETWEEN: RHOXALPHARMA INC. Appellant (Respondent) and NOVARTIS PHARMACEUTICALS CANADA INC. and NOVARTIS AG Respondents (Applicants) and THE MINISTER OF HEALTH Respondent (Respondent) REASONS FOR JUDGMENT DESJARDINS J.A. [1] These proceedings are brought under the Patented Medicine (Notice of Compliance) Regulations, SOR/93-133 (the Regulations). [2] Novartis Pharmaceuticals Canada Inc. and Novartis AG (collectively, Novartis) own patent no. 1308656 (the '656 patent) which covers a pharmaceutical preparation containing a hydrosol i.e. a dispersion of small solid particles in a liquid ("hydro" meaning water, "sol" meaning a solid). The small solid particles are particles of cyclosporin, which is the active ingredient. (In these reasons for judgment, I use the term "cyclosporin" which is the term used in the '656 patent, while the trial judge and the parties used the term "cyclosporine".) [3] Novartis acknowledge that the 25mg and 50 mg cyclosporin capsules marketed by RhoxalPharma Inc. (Rhoxal) do not contain a hydrosol. They nonetheless argue that the sale of Rhoxal's capsules infringe the '656 patent because such capsules form a hydrosol in the patient's body, once the capsule is ingested. [4] On March 17, 2004, Lemieux J. (see Novartis Pharmaceuticals Canada Inc. v. RhoxalPharma (2004), 250 F.T.R. 218) held that the '656 patent did indeed cover a post-ingestion hydrosol. He allowed Novartis' application and issued an order of prohibition to the Minister of Health prohibiting the issuance of a notice of compliance to Rhoxal in respect of its 25mg and 50mg cyclosporin capsules. [5] The issue in the present appeal relates to the scope of claim 2(a) of the '656 patent and whether it can be construed as covering a hydrosol which is formed in situ, that is, in the human stomach. THE JUDGMENT UNDER APPEAL [6] On January 31, 2002, Rhoxal forwarded a notice of allegation to the respondents pertaining to 25mg and 50mg cyclosporin soft gel capsules for oral administration. Rhoxal alleged that it was not in infringement of the '656 patent because its pharmaceutical preparation, which contains a solution (the Rhoxal formulation), does not contain a hydrosol as described and claimed in the '656 patent. In support of this, Rhoxal alleged that its 25mg and 50mg capsules were essentially identical in composition to its 100mg capsules, differing only in the quantity of the ingredients contained therein, and that a decision rendered by Tremblay-Lamer J. (Novartis Pharmaceuticals Canada Inc. v. RhoxalPharma Inc. (2001), 194 F.T.R. 143), between the same parties, concluded that the 100mg capsules did not infringe Novartis' '656 patent. [7] Claim 2(a) of Novartis' patent, the only claim at issue, reads thus: 2. A pharmaceutical preparation the active agent of which comprises a cyclosporin said preparation comprising either: (a) a hydrosol, the particles of which comprises said active agent in solid form, have a diameter of from 1 to 10,000 nanometres, and which are stabilized whereby the particle size distribution of said particles is maintained constant; [my emphasis] [8] Lemieux J. found as a fact, at paras. 194, 221 and 237 of his reasons, that the described hydrosol inevitably formed in the human stomach once the Rhoxal capsule came into contact with the water or gastric juices therein. [9] He noted, at para. 75 of his reasons, that Novartis had led extensive evidence before him, through Drs. Michael Ambühl and James McGinity, as to how claim 2(a) of patent '656 should be construed with regard to the meaning of the term "pharmaceutical preparation" by those skilled in the art of formulation of pharmaceutical preparations. This evidence, he said, was not before Tremblay-Lamer J., who had only the evidence of Dr. Louis Cartilier when she decided that the 100mg capsules did not infringe Novartis' patent. Lemieux J. gave great weight to the testimony of Drs. Ambühl and McGinity and rejected that of Drs. Harry Brittain and Cartilier for Rhoxal. With regard to Dr. Cartilier's testimony, he said, at para. 185 of his reasons: [185] ... it is clear he provided his evidence from the perspective of a dispensing pharmacist and not one skilled in the art of a drug formulator. [10] Lemieux J. stated his conclusion at para. 221 of his reasons: [221] Construing claim 2(a) of the '656 Patent in a purposive way by considering the whole of the disclosure and the claims and being instructed as to the meaning of its terms by experts skilled in the art of formulation of pharmaceutical preparations, I reached the conclusion a hydrosol form in situ is within the claim as a pharmaceutical preparation consisting of a hydrosol. Properly interpreted "pharmaceutical preparation" is not limited to a hydrosol prepared before ingestion and claim 2(a) is not limited to parenteral applications. [my emphasis] [11] He explained the crux of the invention in the following manner: [224] I do not think there can be any question the crux of the invention to which the '656 Patent relates lies in the creation of a hydrosol of solid particles of cyclosporine in stable form and within the nanometres specified. The purpose of the hydrosol is to make the medicine cyclosporine more soluble and more stable so as to facilitate its absorption into the human body thereby increasing its efficacy. [12] He rejected Rhoxal's argument that the term "pharmaceutical preparation" should be limited to pre-ingestion preparations. He stated: [236] Finally, I find artificial Rhoxal's argument the term "pharmaceutical preparation" should be limited to pre-ingestion preparations; such an argument favours form rather than substance. [237] The evidence of Drs. Ambühl and McGinity make it clear that a pharmaceutical preparation may have several forms because of the transformations which take place. It is well-known by persons skilled in the art that such transformations can occur in situ so as to deliver an invention's benefit in situ, i.e. make it functional for its intended purpose. Rhoxal's capsule, when ingested, inevitably forms a hydrosol when coming into contact with the water or gastric juices in the stomach. [238] I conclude a hydrosol formed in situ is a pharmaceutical preparation within claim 2(a) of the '656 Patent. [my emphasis] [13] He further based his conclusion on the doctrine of equivalents: [247] Based on his evidence, I find equivalency between a hydrosol of cyclosporine particles within the specified nanometre range formed in situ and a hydrosol of cyclosporine particles with the same specifications formed outside the body. RHOXAL'S CONTENTION [14] Rhoxal claims that the application judge erred in interpreting the '656 patent. It says the patent did not cover a hydrosol formed in the patient's stomach after ingestion. The purpose of the patent, it claims, is not the creation of a hydrosol to improve the absorption of cyclosporin but the creation of a stabilized hydrosol of fixed particle size which can be safely administered by injection, such as intravenously. [15] Rhoxal argues that claim 2(a) covers only "a pharmaceutical preparation ... comprising ... a hydrosol". The claim does not cover pharmaceutical preparations that do not contain a hydrosol and does not refer to a hydrosol formed in situ . It is clear from the claims, it says, having regard to the disclosure and to the examples, that it was intended by the patentee that a hydrosol be formed prior to ingestion. [16] Finally, Rhoxal contends that the 25mg and 50mg capsules were identical to the 100mg capsules that was the object of the decision rendered by Tremblay-Lamer J., who found in favour of Rhoxal. In that case, Novartis appealed the ruling, but before the appeal was heard, the Minister issued the notice of compliance. The appeal was later dismissed, by reason of mootness, in Novartis Pharmaceuticals Canada Inc. v. RhoxhalPharma Inc. (2001), 16 C.P.R. 4th 188 (F.C.A.). In the case at bar, the Minister has not already issued a notice of compliance. Considering, however, that except for strength, the 25mg and 50mg capsules at issue are identical to the 100mg capsules, Rhoxal argues that the matter has already been decided by Tremblay-Lamer J. Consequently, Rhoxal says, Lemieux J. should have applied the doctrine of res judicata. NOVARTIS' CONTENTION [17] The respondents' case rests on the proposition that the situation at bar is distinguishable from the earlier proceeding before Tremblay-Lamer J. Not only was the capsule dosage in the earlier proceeding different, but the evidence in both cases was different. Novartis saysthey have now had the opportunity to file evidence as to how a person skilled in the art would understand the term "pharmaceutical preparation" and whether that person would understand the term to include a hydrosol formed in the body. PRELIMINARY MATTER: The doctrine of res judicata [18] Does the doctrine of res judicata apply to this case? [19] Lemieux J. refused to apply the doctrine of res judicata. He assumed, without deciding, that the conditions for the application of cause of action estoppel and issue estoppel had been met. But he said that, even then, the Court was required to determine whether, as a matter of discretion, estoppel ought to be applied. This proposition, he wrote, was based on the decision of the Supreme Court of Canada in Danyluk v. Ainsworth Technologies Inc., [2001] 2 S.C.R. 460, (Danyluk), where Binnie J., at para. 63 of his reasons, quoted from Finch J.A. (later C.J. B.C.) in Bugbusters Pest Management Inc. (1998), 50 B.C.L.R. (3d) 1, at para. 32, who stated that "issue estoppel is an equitable doctrine ... closely related to abuse of process" and that "[t]he doctrine of issue estoppel is designed as an implement of justice, and a protection against injustice. It inevitably calls upon the exercise of a judicial discretion to achieve fairness according to the circumstances of each case". [20] Binnie, J., in Danyluk, at para. 33, warns against a mechanical application of issue estoppel. He enumerates a number of factors to be weighed by the judge in the exercise of his discretion when confronted with decisions rendered in the context of administrative tribunals, as such was the case in Danyluk. Lemieux J. recognized that some of these factors were not relevant when a decision at issue is one of a court, such as the decision of Tremblay-Lamer J. in the case at bar. He retained the two following factors: availability of an appeal and potential injustice, potential injustice being the most important factor. [21] Lemieux J. concluded (at para. 192 of his reasons) that the application of res judicata would be a clear injustice to Novartis considering the representations made by Rhoxal before the Federal Court of Appeal when Tremblay-Lamer's judgment was argued. There, Rhoxal recognized that, if it were to issue notices of allegation for dosage forms different from the 100mg, new evidence related to those dosage forms would necessarily have to be submitted in court proceedings (A.B. vol. II, p. 337 at 340). [22] It would appear that Lemieux J. was not wrong in his assumptions that the conditions of issue estoppel were met (an enumeration of these preconditions is found in Danyluk, supra, para. 25). The issue was between the same parties. It was the same in both cases. And because the appeal of Tremblay-Lamer's J. decision was moot, her decision became final. [23] A word of explanation should be said however with regard to the identical nature of the issue before Lemieux J. and Tremblay-Lamer J. [24] According to subparagraphs 5(1)(b)(i) - (iv) of the Regulations, a second person must allege, in its notice of allegation, one of four things. In the case at bar, Rhoxal alleges, with reference to subparagraph 5(1)(b)(iv), that "no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by us of soft gel capsules containing cyclosporine". The language is virtually identical to the language used in the notice of allegation before Tremblay-Lamer, J. [25] Rhoxal's notice of allegation also contains the necessary information pursuant to paragraphs 5(3)(a) and (c) including "the legal and factual basis for the allegation" and "a description of the dosage form, strength and route of administration of the drug". The legal and factual basis for the allegation with respect to the '656 patent in the notice of allegation before Tremblay-Lamer J. was identical. [26] The information with respect to the dosage, strength and route of administration before Lemieux J. states "The capsules, for oral administration, will have dosage strengths of 25mg and 50mg" while before Tremblay-Lamer J. it stated "The capsules will have dosage strength of 25mg and 100mg and for oral administration". Tremblay-Lamer J. however pronounced only on the 100mg strength. [27] The difference between the two notices of allegation with respect to the '656 patent is one of dosage. Although, dosage might be an important difference in the context of the Food and Drugs Act , R.S.C., 1985, c. F-27, it is not important in the context of the Regulations. This is obvious when one considers the purposes of the legislation. [28] The Regulations were passed pursuant to subsection 55.2(4) of the Patent Act, R.S.C., 1985, c. P-4, . According to this subsection, the purpose of the Regulations is for "preventing the infringement of a patent by any person who makes, constructs, uses or sells a patented invention in accordance with subsection (1)". Dosage will therefore be relevant only to the extent that it relates to the infringement of a particular patent. In this case, dosage appears to be irrelevant since patent '656, which is a formulation patent, is not a patent with respect to any particular dosage. [29] On the other hand, the Food and Drug Regulations (C.RC., c. 870), were enacted pursuant to section 30 of the Food and Drugs Act. That section enables the Governor in Council to make regulations "to prevent", inter alia, "injury to the health of the purchaser or consumer". It is readily apparent that dosage will often be an important factor in determining if a notice of compliance should be issued under the Food and Drug Regulations (see Food and Drug Regulations, C.08.002.(2)(k) and (l); C.08.003(2)(h) and (i); C.08.004(1)(a) and (b)). [30] The only issue before Tremblay-Lamer J. and before Lemieux J. was whether the formation of a hydrosol after ingestion of a Rhoxal capsule infringed Novartis' '656 patent. Dosage is irrelevant to this analysis. [31] Having assumed that the conditions for issue estoppel had been met, Lemieux J. decided to exercise his discretion. His conclusion can therefore only be reversed if, in doing so, he proceeded on a wrong principle, misapprehended the facts, or where an obvious injustice would result from his decision (Jansen Phamaceutica v. Apotex Inc. (1998), 82 C.P.R. (3d) 574, (F.C.A.); Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) 209 (F.C.A.) at 213. [32] Did Lemieux J. proceed on some wrong principle? [33] Lemieux J. properly identified (para. 191 of his reasons) the two most important factors applicable in the case at bar: the availability of an appeal and the potential injustice. While he may have been justified in taking into account Rhoxal's representations before this Court when Tremblay-Lamer's J. decision was appealed, in the end result, these representations carried little weight considering that our Court decided that the appeal was moot on account of the issuance of the notice of compliance. [34] Lemieux J. was however well positioned to exercise his discretion. [35] He noted in his reasons for judgment (para. 22) that, on May 27, 2002, (see [2002] F.C.J. No. 1006, paras. 23 to 26) he heard a motion by Rhoxal, pursuant to paragraph 6(5) of the Regulations. Rhoxal was seeking an order dismissing Novartis' application for an order prohibiting the Minister of Health from issuing notices of compliance in connection with Novartis' 25mg and 50mg capsules. Rhoxal argued that Novartis' application was redundant, frivolous, vexatious or otherwise an abuse of process, and also, that the doctrine of res judicata should apply. In oral argument, Rhoxal abandoned its argument based on the doctrine of res judicata. [36] Lemieux J. found that the application of the doctrine of abuse of process depended on the circumstances. He held that the circumstances surrounding Novartis' application were unique, and arose when Rhoxal was successful in having Novartis' appeal from Tremblay-Lamer's judgment dismissed for mootness. In the end, Lemieux J. dismissed Rhoxal's motion. Rhoxal did not appeal. [37] Rhoxal is therefore raising res judicata for the second time. It raised it, the first time, in the abuse of process proceedings but abandoned it. Moreover, it never appealed the decision of Lemieux J. rejecting its abuse of process argument. [38] From this, I can only conclude that Lemieux J. exercised his discretion in the context of this case, knowing that res judicata was raised twice and that "issue estoppel is an equitable doctrine ... closely related to abuse of process" (see Binnie J. in Daniluk at para. 63, referred to above). [39] In these circumstances, I find it unwarranted to interfere with the discretion exercised by the motions judge. [40] This appeal should therefore proceed on its merits. ANALYSIS OF THE MERITS OF THIS APPEAL [41] Claim 2(a) is not limited to intravenous injection. It claims "a pharmaceutical preparation ... said preparation comprising either ... a hydrosol ...". [42] Lemieux J. relied on experts skilled in the art to construe the meaning of the term "pharmaceutical preparation". [43] Dr. Michael Ambühl, expert from Novartis, explained in his affidavit (A.B. vol. II, at tab 10, paras. 7 to 17), the following: 7. Finally, Dr. Cartilier indicates that claim 2 of Canadian Patent 1,308,656 (the '656 patent) purports to claim only pharmaceutical preparations which are completed at the time of manufacturing and that once ingested by a patient, what occurs is delivery of the active ingredient, as opposed to an ongoing preparation. For these reasons, Dr. Cartilier indicates that he disagrees with the very concept that the '656 patent could be infringed by what happens to a liquid capsule once ingested by a patient. 8. I disagree with these comments. A pharmaceutical preparation means a number of things to a person skilled in the art. One aspect of a pharmaceutical preparation refers to what is completed at the time of manufacturing and shipped out the door. However, there are a number of other pharmaceutical preparations which exist. For example, one pharmaceutical preparation may be transformed into a second pharmaceutical preparation, and perhaps even a third, by virtue of further actions taken by persons other than the manufacturer. 9. For example, a pharmaceutical preparation such as amoxicillin is sold by the manufacturer as a powder. This product is not yet in the form which may be taken by the patient. Typically what occurs is the pharmacist makes up a further pharmaceutical preparation by adding an appropriate amount of water to the powder and shaking up the product so that the product forms a suspension. This is the product which is sold to the patient by the pharmacist and it constitutes a different form of the pharmaceutical preparation than that which was shipped by the manufacturer. Often there is a relatively large amount of water compared to the amount of solids. 10. Additionally, when the patient goes to take the product, the product may have settled and therefore it is no longer in the form of a suspension but is again in the form of a solution, with some particles aggregated at the bottom of the bottle. The patient therefore creates a further pharmaceutical preparation by shaking, thereby recreating the suspension. 11. An additional example of a product sent out by the manufacturer which becomes a further pharmaceutical preparation includes Neo-Citran_, another Novartis product. In particular, my company sells Neo-Citran_ in a powder form in a foil package. It is not intended to be taken in this form. Therefore, while the powder form is considered a pharmaceutical preparation, a further pharmaceutical preparation is prepared by the consumer by the addition of a relatively large amount of boiling water. 12. Upon adding the boiling water to the powder in a glass, the patient creates a mixture. Indeed, a sort of tea is created which is then drunk by the person. This tea I would consider to be a pharmaceutical preparation in the same way as a pharmaceutical preparation is created by the pharmacist or patient in the case of amoxycillin. 13. Yet, a further example is looking at Novartis' product NEORAL_ cyclosporine. NEORAL cyclosporine comes in the form of an oral liquid as well as in capsule form. In respect of the oral liquid, the product which is sold by Novartis is not intended to be taken in that form. Thus, while as sold by Novartis, the product is a pharmaceutical preparation, the product is not yet in the form to be administered and absorbed by the patient. In particular, the directions which accompany NEORAL_ oral solution indicate that it should be taken with orange juice or water or other such beverage. The cyclosporine formulation, upon addition of orange juice or water, takes a different form from that which it was packaged. In particular, as packaged, the cyclosporine formulation is in the form of a microemulsion pre-concentrate and, like the RhoxalPharma product, is a solution in a capsule. Upon addition of the orange juice, the product spontaneously forms a microemulsion entirely analogously to the transformation of the RhoxalPharma product to a hydrosol. It is in the form of the microemulsion preparation which is then swallowed by the patient which permits the absorption of the active ingredient cyclosporine into the blood stream. 14. NEORAL_ cyclosporine oral capsules work in a similar manner, but with some slight modification. In particular, while the oral capsules themselves are a pharmaceutical preparation however, this preparation is not in the final form which will permit the absorption of the cyclosporine. It is only after ingestion of the oral liquid capsules, wherein the liquid inside the capsules has contact with the relatively large amount of fluids of the stomach and forms the microemulsion in the stomach, that it is in the form of a preparation which may allow the absorption of the cyclosporine into the blood stream. 15. This is entirely analogous to administration of the RhoxalPharma formulation. 16. Therefore, it is in this manner that the RhoxalPharma liquid cyclosporine capsules is transformed into a hydrosol which then may permit absorption into the blood stream. In both the examples of the NEORAL_ capsules and the RhoxalPharma capsules, the preparation as sold, or contemplated to be sold, respectively by the manufacturer is not yet in a form which can permit the administration of the drug. The capsule package avoids contact with water and throat, and targets the centre fill to the stomach where it is exposed to a relatively large amount of water. It is only upon contact with relatively large amount of water in the stomach that these preparations are transformed into different pharmaceutical preparations which either in the form of a microemulsion or hydrosol permit the delivery of the active ingredient to the blood stream. 17. Therefore, in my opinion, the RhoxalPharma product is within claim 2 of the '657 patent by virtue of the action of the product to form hydrosols in the stomach. Further, as I understand them, the words "pharmaceutical preparation" in claim 2 are not limited to the pharmaceutical preparation which is sold by the manufacturer, but include steps taken by the pharmacist or consumer to put the product into the final form of the pharmaceutical preparation for administration. I see no reason why a product in the oral liquid capsule form should not be covered by the claim when the oral liquid solution form would be covered. [my emphasis) [44] Dr. McGinity, expert for Novartis, in his affidavit (A.B., Vol. III, 423 at 426-427-428) testified to the following: [21] I have reviewed the Rhoxal formulation provided in this case and I have reviewed the affidavit of Michael Ambühl. The Rhoxal formulation includes cyclosporin and dehydrated alcohol. The Ambühl affidavit describes making up the Rhoxal formulation product and finding a hydrosol upon addition of this formulation to water. This is precisely how the Rhoxal product is to be used. In particular, the Rhoxal soft gel capsules will be swallowed by patients and will form a hydrosol upon contact with the water of the stomach. Thus, what Rhoxal is doing is within claim 2 and some of the other claims dependent from claim 2. [22] This is what the patent teaches at page 10. The sole purpose of Rhoxal's capsule is to be ingested so that its shell can be dissolved and the contents of the capsule mixed with water to form the hydrosol which is the form in which the cyclosporin is available to be absorbed in the intestine. Indeed, a skilled formulator readily understands that part of the purpose of a capsule is to ensure that the required actions occur in the stomach or intestine for delivery of the active ingredient into the blood stream. Thus, frequently, products as sold are intended to be transformed in the stomach or intestine to enable the active ingredient to be absorbed into the bloodstream. ... [28] Furthermore, even though Rhoxal has not currently sought approval of an oral liquid, I am aware that their product must be considered to be bioequivalent to the Novartis capsules of a similar strength which in turn, I understand, are bioequivalent to Novartis' oral solution product. As such, it would also be clear that the Rhoxal soft gel capsules are thereby an obvious variant to an oral liquid formulation. ... [31] ... If a pharmaceutical scientist knows that a specific product needs to be mixed with an aqueous media to form the dosage form required for delivery of the active ingredient, this scientist has two clear choices, namely prepare the hydrosol and then encapsulate the material, or encapsulate a preconcentrate of the hydrosol knowing that it will form the hydrosol in the stomach. [32] Indeed, Dr. Cartilier, after being presented with a number of examples of products which are transformed before they are absorbed in the body, including examples of amoxicillin being suspended and NeoCitran_ being mixed with water before taken, agreed that the essence of a pharmaceutical preparation is to get the drug to the right spot in the body to be effective (q.51). Whether the preparation is ready in the capsule or when the capsule opens in the stomach does not change this. [my emphasis] [45] Expert evidence, although essential to the construction of a claim, does not govern the construction of a claim. Claims construction is a question of law for the judge who is even entitled to adopt a construction of the claims that differs from that put forward by the parties (Whirlpool Corp. v. Camco Inc.(Whirlpool), [2000] 2 S.C.R. 1067 at para. 61; Canamould Extrusions Ltd., v. Driangle Inc. (2004), 237 D.L.R. (4th) 157 at para. 3, per Stone J.A.; Nekoosa Packaging Corp. v. AMCA International Ltd. (1994), 172 N.R. 387 at paras. 12, 13 and 14, per Robertson J.A.). [46] Whirlpool in particular (see also Free World Trust v. Electro Santé Inc., [2000] 2 S.C.R. 1024 at paras. 28 and 44) teaches us the principles of patent claims construction. [47] At para. 42 and 43 of Whirlpool, Binnie J. states: [42] The content of a patent specification is regulated by s. 34 of the Patent Act. The first part is a "disclosure" in which the patentee must describe the invention "with sufficiently complete and accurate details as will enable a workman, skilled in the art to which the invention relates, to construct or use that invention when the period of the monopoly has expired": Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504, at p. 517. The disclosure is the quid provided by the inventor in exchange for the quo of a 17-year (now 20-year) monopoly on the exploitation of the invention. The monopoly is enforceable by an array of statutory and equitable remedies and it is therefore important for the public to know what is prohibited and where they may safely go while the patent is still in existence. The public notice function is performed by the claims that conclude the specification and must state "distinctly and in explicit terms the things or combinations that the applicant regards as new and in which he claims an exclusive property or privilege" (s. 34(2))". An inventor is not obliged to claim a monopoly on everything new, ingenious and useful disclosed in the specification. The usual rule is that what is not claimed is considered disclaimed. [43] The first step in a patent suit is therefore to construe the claims. ... [my emphasis] [48] Binnie J. confirmed that the purposive approach developed in Catnic Components Ltd. v. Hill and Smith Ltd., [1982] R.P.C. 183 (H. of L.) and adopted by this Court in Eli Lilly & Co. v. O'Hara Manufacturing Ltd. (1989), 26 C.P.R. (3d) 1 (F.C.A.) was the proper approach to claims construction. [49] "The key to a purposive construction ....", Binnie J. wrote at para. 45, "... is therefore the identification by the Court, with the assistance of the skilled reader, of the particular words or phrases in the claims that describe what the inventor considered to be the "essential elements" of his invention". [50] Binnie J. wrote further at para. 49(e) that when a patent is issued, it is an enactment within the definition of "regulation" in subsection 2(1) of the Interpretation Act, R.S.C. 1985, c. I-21, and, as such, according to section 12 of the Interpretation Act, it must be given an interpretation "as best ensures the attainment of its objects". [51] Binnie J. rejected the dictionary approach. He wrote that we must look at the whole of the specification (including the disclosure and the claims) "to ascertain the nature of the invention" (see para. 52 of Whirlpool). [52] He further added, at para. 53: [53] ... However, the patent specification is not addressed to grammarians, etymologists or to the public generally, but to skilled individuals sufficiently versed in the art to which the patent relates to enable them on a technical level to appreciate the nature and description of the invention: H. G. Fox, The Canadian Law and Practice Relating to Letters Patent for Inventions (4th ed. 1969), at p. 185. The court, writes Dr. Fox, at p. 203, must place itself in the position of some person acquainted with the surrounding circumstances as to the state of the art and the manufacture at the time, and making itself acquainted with the technical meaning in that art or manufacture that any particular word or words may have. [my emphasis] [53] The motions judge had the responsibility of enlightening himself with the meaning suggested to him by the experts. He was entitled to prefer the evidence of Novartis' experts who were skilled in the art of formulation of pharmaceutical preparations and to reject that of Dr. Cartilier (Rhoxal) who was a dispensing pharmacist. But in doing so, he had to keep his eyes on the words of the claim themselves and not let the experts dictate the conclusion. [54] Dr. Ambühl, at para. 17 of his affidavit, stated: 17. ... I see no reason why a product in the oral liquid capsule form should not be covered by the claim when the oral liquid solution form would be covered. Yet he did not explain why, as an expert skilled in the art, he saw "no reason" preventing him from coming to the conclusion he did. [55] When Dr. McGinity, at para. 32 of his affidavit, stated that: 32. Whether the preparation is ready in the capsule or when the capsule opens in the stomach does not change this. [my emphasis] he did not explain on what basis he could conclude that "when the capsule opens in the stomach", another form of pharmaceutical preparation occurs. [56] Each of the examples provided by these two experts presupposed some action by an individual, whether a manufacturer, a pharmacist or the consumer. At para. 8 of his affidavit, when Dr. Ambühl refers to different forms of pharmaceutical preparations done after the manufacturing, he speaks exclusively about those made "by virtue of further actions taken by persons ...". Again, at para. 17 of his affidavit, he spoke about "... steps taken by the pharmacist or consumer to put the product into the final form of the pharmaceutical preparation for administration" [my emphasis]. [57] Once ingested, a chemical reaction which occurs in the stomach of a patient on account of the presence of water or gastric juices therein does not depend on someone's action. Certainly none of the two experts went so far as saying that the mere act of swallowing amounted to a form of "pharmaceutical preparation". [58] At the time of ingestion, it is admitted by Novartis that Rhoxal's capsules do not comprise a hydrosol. What happens in the human stomach afterwards, although expected, is completely outside of the scope of the forms of a "pharmaceutical preparation", as explained by the experts the motions judge chose to believe. [59] Assuming without deciding that Novartis' experts were correct in extending the scope of "pharmaceutical preparation" to forms resulting from non-professional actions such as those of consumers, it was not open to the motions judge to adopt blindly their conclusions as he did in paragraph 237 of his reasons reproduced above. He could not abdicate his judicial function. It was for him to decide in the end the ultimate question, namely, the proper scope to be given to claim 2(a) of the '656 patent. At that stage, he was left with unsubstantiated conclusions from the experts. It was his duty to refer back to the words of the claim itself. He could only then have concluded that those words made no reference to a pharmaceutical preparation occurring in situ and that "what is not claimed is considered disclaimed" (para. 42 of Whirpool) . [60] In view of this conclusion, I need not consider the application of the doctrine of equivalents. CONCLUSION [61] I would allow this appeal with costs, I would set aside the decision of the motions judge, and I would dismiss Novartis' application. "Alice Desjardins" J.A. "I agree M. Nadon J.A." PELLETIER J.A. (dissenting reasons) [62] For the reasons which follow, I find that I am unable to agree with the disposition of this appeal proposed by my colleague Desjardins J.A. [63] I find there is a great deal of common sense in the suggestion that the formulator's art ends at the patient's lips. Once a pharmaceutical product is administered to the patient, the formulator's art is exhausted in the sense that the formulator has done all that the formulator can do. If one formulator is able to harness the body's internal processes to produce a result which another formulator can only produce in a laboratory, I would not be inclined to hold that the first formulator has appropriated the second formulator's invention. Quite the contrary. [64] Had I been the trial judge, this is the conclusion to which I would have been drawn. But the trial judge came to another conclusion. He had to decide whether a compound produced in the stomach after a patient had ingested a pharmaceutical preparation infringed a patent which claimed a pharmaceutical preparation containing that compound. He concluded that it did because he accepted expert evidence that a pharmaceutical preparation which, once ingested, produced a compound which did not exist in the original capsule was simply a different form of the original pharmaceutical preparation. This conclusion is based upon a certain understanding of the term "pharmaceutical preparation." [65] I agree with my colleague Desjardins J.A. that the construction of a patent is a task reserved to the trial judge, as opposed to the experts. Like her, I am bound by the jurisprudence which holds that the judge must construe the patent as it would be by a person skilled in the art and, to that end, the judge can hear evidence as to the meaning, to a person skilled in the art, of the words used in the patent See Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, 2000 SCC 67, para. 53 cited in para. 52 of my colleague's reasons. [66] In this case, the trial judge accepted the evidence of Novartis' experts as to the understanding which a person skilled in the art would have of the term "pharmaceutical preparation." The evidence which he accepted introduced the notion of "forms" of pharmaceutical preparations, a notion which was critical to the trial judge's decision on the merits: [237] The evidence of Drs. Ambühl and McGinity make it clear that a pharmaceutical preparation may have several forms because of transformations which take place. It is well known by persons skilled in the art that such transformations can take place in situ so as to deliver an invention's benefit in situ, i.e. make it functional for its intended purpose. Rhoxa's capsule, when ingested, inevitably forms a hydrosol when coming into contact with the water or gastric juices in the stomach. [238] I conclude a hydrosol formed in situ is a pharmaceutical preparation within claim 2(a) of the '656 patent. [67] In deciding what the term "pharmaceutical preparation" means to a person skilled in the art, the trial judge was making a finding of mixed fact and law, at the very least, if not a finding of fact. In the absence of an extricable question of law, both of these questions attract the most restrictive standard of review, that of "palpable and overriding error." See Housen v. Nikolaisen, [2002] 2 S.C.R. 235, 2002 SCC 33, at para. 10 and 28. The following passage is particularly apposite: [28] However, where the error [in relation to a question of mixed law and fact] does not amount to an error of law, a higher standard is mandated. Where the trier of fact has considered all the evidence that the law requires him or her to consider and still comes to the wrong conclusion, then this amounts to an error of mixed law and fact and is subject to a more stringent standard of review: Southam, supra, at paras. 41 and 45. While easy to state, this distinction can be difficult in practice because matters of mixed law and fact fall along a spectrum of particularity... [68] If the trial judge was entitled to come to the conclusion he did on the meaning of "pharmaceutical preparation", he cannot be overturned for having utilized it in construing the patent in the way in which he did. [69] For these reasons, I am unable to agree with my learned colleague's conclusion. I would therefore dismiss the appeal with costs. "J.D. Denis Pelletier" J.A. FEDERAL COURT OF APPEAL NAMES OF COUNSEL AND SOLICITORS OF RECORD DOCKET: A-213-04 STYLE OF CAUSE: RHOXALPHARMA INC. and NOVARTIS PHARMACEUTICALS CANADA INC. and NOVARTIS AG and THE MINISTER OF HEALTH PLACE OF HEARING: Ottawa, Ontario DATE OF HEARING: November 2, 2004 REASONS FOR JUDGMENT : DESJARDINS, J.A. CONCURRED IN BY: NADON J.A. . DISSENTING REASONS BY: PELLETIER J.A. DATED: February 14, 2005 APPEARANCES: Ms. Marie Lafleur FOR THE APPELLANT and Mr. Martin Sheehan Mr. Anthony G. Creber FOR THE RESPONDENTS NOVARTIS and Ms. Jennifer Wilkie PHARMACEUTICALS CANADA INC. and NOVARTIS AG Mr. Rick Woyiwada FOR THE RESPONDENT MINISTER OF HEALTH SOLICITORS OF RECORD: Fasken Martineau DuMoulin LLP FOR THE APPELLANT Montreal, Quebec Gowling Lafleur Henderson LLP FOR THE RESPONDENTS NOVARTIS Ottawa, Ontario PHARMACEUTICALS CANADA INC. and NOVARTIS AG John H. Sims, Q.C. FOR THE RESPONDENT MINISTER OF HEALTH Deputy Attorney General of Canada