Abbott Laboratories v. Canada (Health)

Abbott Laboratories v. Canada (Health) Court (s) Database Federal Court of Appeal Decisions Date 2006-05-18 Neutral citation 2006 FCA 187 File numbers A-384-05 Notes Digest Decision Content Date: 20060518 Docket: A-384-05 Citation: 2006 FCA 187 CORAM: DÉCARY J.A. SHARLOW J.A. MALONE J.A. BETWEEN: ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED Appellants and THE MINISTER OF HEALTH and RATIOPHARM, A DIVISION OF RATIOPHARM INC. Respondents Heard at Toronto, Ontario, on April 5 and 6, 2006. Judgment delivered at Ottawa, Ontario, on May 18, 2006. REASONS FOR JUDGMENT BY: SHARLOW J.A. CONCURRED IN BY: DÉCARY J.A. MALONE J.A. Date: 20060518 Docket: A-384-05 Citation: 2006 FCA 187 CORAM: DÉCARY J.A. SHARLOW J.A. MALONE J.A. BETWEEN: ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED Appellants and THE MINISTER OF HEALTH and RATIOPHARM, A DIVISION OF RATIOPHARM INC. Respondents REASONS FOR JUDGMENT SHARLOW J.A. [1] The appellants Abbott Laboratories and Abbott Laboratories Limited (collectively, "Abbott") are appealing a judgment of the Federal Court (2005 FC 1093) dismissing their application under the Patented Medicines (Notice of Compliance Regulations), SOR/93-133 (the NOC Regulations). That application was for an order prohibiting the Minister of Health from issuing a notice of compliance to the respondent Ratiopharm for its Clarithromycin 250 mg or 500 mg tablets until after the expiry of six patents owned by Abbott. When the application was heard in the Federal Court, the only patents in issue were Canadian Patent Numbers 2,277,274 (the 274 patent), 2,258,606 (the 606 patent), and 2,387,361 (the 361 patent), all of which expire in 2017. Facts [2] Abbott is the manufacturer of a drug named Biaxin Bid. The active medicinal ingredient in Biaxin Bid is clarithromycin, an antibiotic. Its chemical name is 6-0-methylerythromycin A. [3] Abbot sells Biaxin Bid in 250 mg and 500 mg tablets pursuant to a notice of compliance issued by the Minister. Ratiopharm has applied to the Minister for a notice of compliance for its version of clarithromycin, based on a comparison of its product with Biaxin Bid. [4] There is no patent for clarithromycin. However, there are a number of patents listed for Biaxin Bid on the patent register maintained by the Minister under the NOC Regulations. Three of the listed patents are those in issue in this case (the 274 patent, the 606 patent, and the 361 patent). [5] Abbott claims to have discovered three forms of clarithromycin, which it has named "Form O", "Form I" and "Form II". It is undisputed that clarithromycin, whether in Form 0, Form I, or Form II, is an antibiotic, and that each of those forms of clarithromycin is within the definition of the word "medicine" in the NOC Regulations, which reads as follows: "medicine" means 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. « médicament » Substance destinée à servir ou pouvant servir au diagnostic, au traitement, à l'atténuation ou à la prévention d'une maladie, d'un désordre, d'un état physique anormal, ou de leurs symptômes. [6] Ratiopharm's proposed clarithromycin product contains Form II. It is common ground that Form 0 is produced in the process of making Form I or Form II. However, the Form 0 so produced is unstable, in the sense that if nothing is done to it, it becomes a different form of clarithromycin within a short period of time. It appears that Form 0 was not identified as a unique substance until it was stabilized by the inventors named in the 274 patent. The 274 patent [7] The claims of the 274 patent that are relevant to this case are Claim 1 and its dependent claims. Abbott describes the 274 patent as being a patent for Form 0, per se. Form 0 is necessarily made in the process of making the Form II that is contained in the Ratiopharm product. [8] The judge concluded that the 274 patent is eligible to be listed on the patent register because Claim 1 and its dependent claims are claims "for the medicine itself" (that is, Form 0) as required by section 4 of the NOC Regulations. That conclusion is not challenged in this appeal. [9] The judge also concluded, on the basis of what the parties have called the "assertibility" argument, that Ratiopharm's non-infringement allegation was justified. The assertibility argument is described as follows at paragraph 47 of the judge's reasons: [47] Ratiopharm asserts [...] that even if Clarithromycin Form 0 is eligible for listing under the NOC Regulations, it can only be asserted against the final product produced by [Ratiopharm], it cannot be asserted against an intermediate product used by the second person. [10] Abbott argues that the judge erred in accepting Ratiopharm's assertibility argument because it is based on a misinterpretation of the NOC Regulations and, in the alternative, because the notice of allegation did not raise it. [11] The NOC Regulations apply only to a patent that contains a "claim for the medicine itself" or a "claim for the use of the medicine". I reach that conclusion based on paragraph 4(2)(b) and subparagraph 5(1)(b)(iv) of the NOC Regulations. [12] Paragraph 4(2)(b) of the NOC Regulations says among other things that only a patent containing a "claim for the medicine itself" or a "claim for the use of the medicine" is eligible for listing on the patent register maintained by the Minister under the NOC Regulations. Paragraph 4(2)(b) reads as follows (my emphasis): 4. (2) A patent list submitted in respect of a drug must [...] 4. (2) La liste de brevets au sujet de la drogue doit contenir les renseignements suivants : [...] (b) set out any Canadian patent that is owned by the person, or in respect of which the person has an exclusive licence or has obtained the consent of the owner of the patent for the inclusion of the patent on the patent list, that contains a claim for the medicine itself or a claim for the use of the medicine and that the person wishes to have included on the register [...]. b) tout brevet canadien dont la personne est propriétaire ou à l'égard duquel elle détient une licence exclusive ou a obtenu le consentement du propriétaire pour l'inclure dans la liste, qui comporte une revendication pour le médicament en soi ou une revendication pour l'utilisation du médicament, et qu'elle souhaite voir inscrit au registre [...]. [13] Subparagraph 5(1)(b)(iv) of the NOC Regulations says among other things that a notice of allegation is required to address only the infringement of a "claim for the medicine itself" or a "claim for the use of the medicine". Subparagraph 5(1)(b)(iv) reads as follows (my emphasis): 5. (1) Where a person files or has filed a submission for a notice of compliance in respect of a drug and compares that drug with, or makes reference to, another drug for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics and that other drug has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent on the register in respect of the other drug, [...] 5. (1) Lorsqu'une personne dépose ou a déposé une demande d'avis de conformité pour une drogue et la compare, ou fait référence, à une autre drogue pour en démontrer la bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, cette autre drogue ayant été commercialisée au Canada aux termes d'un avis de conformité délivré à la première personne et à l'égard de laquelle une liste de brevets a été soumise, elle doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre qui se rapporte à cette autre drogue : [...] (b) allege that [...] b) soit une allégation portant que, selon le cas : [...] (iv) 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 that person of the drug for which the submission for the notice of compliance is filed. (iv) aucune revendication pour le médicament en soi ni aucune revendication pour l'utilisation du médicament ne seraient contrefaites advenant l'utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l'objet de la demande d'avis de conformité. [14] However, subparagraph 5(1)(b)(iv) also requires a non-infringement allegation to address the "making, constructing, using or selling" of the drug for which the second person, in this case Ratiopharm, is seeking a notice of compliance. Ratiopharm's non-infringement allegation in relation to the 274 patent is that no claim for the medicine itself (that is, no claim in the 274 patent for clarithromycin Form O) will be infringed by the making, constructing, using or selling by Ratiopharm of its clarithromycin product. [15] The evidence is that Form 0 is created inevitably in the process of making the Form II that is contained in the Ratiopharm product. In principle, a patent for a substance is infringed when someone makes that substance without the consent of the holder of the patent. The judge did not doubt that principle, but reasoned that any infringement of the 274 patent by Ratiopharm would occur at an intermediate step in the production of the Ratiopharm product, and that is not the sort of infringement that is caught by the NOC Regulations. [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. [17] I conclude that the making of Form 0, the substance that is the subject of Claim 1 of the 274 patent, is within the scope of subparagraph 5(1)(b)(iv) of the NOC Regulations, whether it is actually found in the finished Ratiopharm product or is made in the course of making Ratiopharm's product and ceases to exist once the product is finished. There is no doubt that if Claim 1 of the 274 patent is valid, it would be infringed by the making of the Ratiopharm product. In that event, the inescapable conclusion would be that Ratiopharm's non-infringement allegation is not justified. [18] I turn now to Ratiopharm's allegations of invalidity in relation to the 274 patent. The judge considered those allegations in the event he was found to be incorrect in his conclusion on the assertibility argument. He concluded that Ratiopharm's allegations of invalidity were not justified. Ratiopharm argues that the judge erred in reaching that conclusion. [19] Ratiopharm's strongest argument is based on the following allegation of invalidity: Form 0 and its use as an antibiotic as claimed in each of claims 1 to 36 of [the 274 patent] were described in patents, patent applications and printed publications that were published more than one year before the filing date or prior to the claim date of [the 274 patent] or were obvious in view thereof. Ratiopharm relies on the disclosures contained in the prior art references listed in Schedule 1 hereto. The preparation of Form 0 solvate including the ethanolate is disclosed in the prior art references in Schedule 1 hereto, and by way of example in documents 10, 11, 13, 15, 16, 17, 18, 31 and 32. A complex comprising a carbomer with Form 0 would have been obvious to a person skilled in the art. To the extent that the references in Schedule I disclose 6-O-methylerythromycin A Form I, the use of Form 0 to produce Form I would have been inherent or obvious. The preparation of Form I would inherently or obviously involved [sic] the drying/and or heating of Form 0 solvate which would produce Form I. The judge correctly understood the word "inherent", as used in Ratiopharm's notice of allegation, to be synonymous with anticipation (see his reasons, paragraph 70). [20] A patent is invalid for anticipation if it is disclosed in a prior publication, such as a prior patent, and that disclosure gives a person skilled in the art all of the information needed by that person to produce the claimed invention without the exercise of any inventive skill (see Beloit Canada v. Valmet (1986), 8 C.P.R. (3d) 289 (F.C.A.), per Hugessen J.A.). [21] There are numerous patents and inventions relating to clarithromycin, and many publications, including prior patents, were submitted in this case as prior art. The evidence (in particular the affidavit of Professor Hollingsworth) is that Form 0 is inevitably made in the process of making Form I or II, although that fact was unknown prior to the teaching disclosed in the 274 patent. [22] The judge in this case found that Ratiopharm's allegation of invalidity due to anticipation was not justified. As I understand his reasons, he reached that conclusion because anyone following the teaching of the prior art would not know that they had a previously unknown substance that is so unstable that it would disappear unless certain steps were taken. He then embarked on an analysis of the conflicting evidence as to whether a person skilled in the art could or would employ known stabilization techniques that would lead inevitably to the stabilization of Form 0. [23] It seems to me that the judge misdirected himself. He asked himself whether a skilled practitioner, referring to the prior art, would inevitably and without error be led to stabilize the Form 0 that is created in the process of making Form I or Form II. However, the patent claims in issue (that is, the claims of the 274 patent that caused the NOC Regulations to be engaged) are the claims for Form 0 itself, not any of the claims relating to the means of stabilizing Form 0. [24] The relevant question, in relation to the claim of the 274 patent for Form 0, is this: Is Form 0 formed in the process of making Form I or Form II? That is a question of fact, to which the undisputed answer is yes. A skilled practitioner who makes Form I or II following the teaching of the prior art inevitably would make Form 0, even if no steps are taken to stabilize it. The Form 0 might not be recognized, but that does not matter: see Smithkline Beecham PLC's (Paroxetine Methanesulfonate) Patent, [2005] UKHL 59, per Lord Hoffman, at paragraph 22: [...] the matter relied upon as prior art must disclose subject-matter which, if performed, would necessarily result in an infringement of the patent. That may be because the prior art discloses the same invention. In that case there will be no question that performance of the earlier invention would infringe and usually it will be apparent to someone who is aware of both the prior art and the patent that it will do so. But patent infringement does not require that one should be aware that one is infringing: "whether or not a person is working [an] ... invention is an objective fact independent of what he knows or thinks about what he is doing": Merrell Dow Pharmaceuticals Inc v N.H. Norton & Co. Ltd. [1996] R.P.C. 76, 90. It follows that, whether or not it would be apparent to anyone at the time, whenever subject-matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied. The flag has been planted, even though the author or maker of the prior art was not aware that he was doing so. [25] Because a person who makes Form I or Form II following the teaching of the prior art inevitably would make Form 0, that person would infringe the 274 patent as surely as Ratiopharm would infringe it by making the Form II for its product, as it proposes to do, by a method that results in the creation of Form 0. The situation is aptly described by the learned authors of Hughes and Woodley on Patents (2nd edition), at page 134 (paraphrasing Rinfret J. in Lightning Fastener Co. v. Colonial Fastener Co., [1933] S.C.R. 377 at page 381): [...] what would infringe if later, anticipates if earlier. The same thought is expressed as follows by Jacob L.J. in Technic France S.A.'s Patent, [2004] R.P.C. 919 at paragraph 77: And yet another way of looking at the problem is to ask whether what is disclosed [in the prior art] falls within the claim - if it had been later would it infringe? [26] In my view, the only reasonable conclusion on the evidence in this case is that the Ratiopharm's allegation of invalidity due to anticipation is justified. [27] In summary, I agree with the judge's decision to dismiss Abbott's application for a prohibition order in respect of the 274 patent, but I reach that conclusion for different reasons. In my view, the application should not have been dismissed on the basis that Ratiopharm's allegation of non-infringement was justified. It should have been dismissed on the basis that Ratiopharm's allegation of invalidity due to anticipation was justified. Ratiopharm made a number of other allegations of invalidity, but it is not necessary to consider them. The 606 patent [28] Abbott describes the 606 patent as being a patent for Form II, per se. Form II is the form of clarithromycin used in Ratiopharm's product. It is undisputed for the purposes of this proceeding that if the 606 patent is valid, it will be infringed by the Ratiopharm product. [29] Ratiopharm, in its notice of allegation, made a number of allegations of invalidity relating to the 606 patent. In this appeal, it is necessary to consider only Ratiopharm's allegation of invalidity due to anticipation. That allegation is based on a particular construction of Claim 1 of the 606 patent. The judge concluded on the basis of that construction of Claim 1 that the allegation of invalidity was justified because the 606 patent was anticipated by an article by H. Iwasaki published on June 15, 1993. [30] Abbott argues that the judge erred by failing to consider the evidence of a worker skilled in the art. There is no merit in this argument. It is clear from the judge's reasons that he understood that the construction of Claim 1 of the 606 patent is a question of law, and that he was required to read the claim through the eyes of a worker skilled in the art (Whirlpool, cited above, at paragraph 53). The judge had before him conflicting evidence on what a skilled worker would understand from the language of the patent. The construction that the judge finally adopted is supported by evidence upon which he was entitled to rely. [31] Abbott's essential argument is that the judge erred in his construction of Claim 1 of the 606 patent. Claim 1 of the 606 patent reads as follows: 6-0-methylerythromycin A Form II characterized by peaks in the powder x-ray diffraction pattern having the following 2θ values: 8.5 ° ±0.2, 9.5 ° ±0.2, 10.8 ° ±0.2, 11.5 ° ±0.2, 11.9 ° ±0.2, 12.4 ° ±0.2, 13.7 ° ±0.2, 14.1 ° ±0.2, 15.2 ° ±0.2, 16.5 ° ±0.2, 16.9 ° ±0.2, 17.3 ° ±0.2, 18.1 ° ±0.2, 18.4 ° ±0.2, 19.0 ° ±0.2, 19.9 ° ±0.2, and 20.5 ° ±0.2. [32] The words of Claim 1 of the 606 patent following the words "characterized by" describe a distinctive line on a graph (representing the specified 2θ values) that results when the product that is the subject of Claim 1 is submitted to a test called a powder x-ray diffraction. That line is depicted in Figure 2a of the disclosure. [33] The judge concluded that Claim 1 of the 606 patent refers to Form II as characterized by the specified 2θ values. Abbott argues that this construction of Claim 1 of the 606 patent is wrong because it gives no meaning to the words "Form II". Abbott argues that the words "Form II", as a coined word with no intrinsic meaning, must be given the meaning ascribed to them in the disclosure. [34] The disclosure of the 606 patent explains that Form II can be identified in three ways. It can be identified by the line produced by the powder x-ray diffraction, as stated in Claim 1. It can also be identified by two other chemical tests, one resulting in a distinctive "infrared spectrum" (depicted in Figure 2b of the disclosure), and the other resulting in a distinctive "differential scanning calorimetric thermogram" (depicted in Figure 2c of the disclosure). Abbott argues that the subject of Claim 1 is a substance that is identified by all three of those methods, not only powder x-ray diffraction. [35] Abbott proposes an analogy between Claim 1 of the 606 patent and the claim construed in Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067. Binnie J., writing for the Supreme Court of Canada in Whirlpool, said that it is permissible to look at the specifications and drawings in the disclosure in order to understand what is meant by a particular word used in a claim of the patent. Reference to the disclosure in that case led Binnie J. to conclude that the word "vane", in the context in which it was used in the patent claim in issue, did not mean any kind of vane, but only a "flexible vane". Abbott argues that in this case, the meaning to be given to the words "Form II" as used in Claim 1 of the 606 patent is implicit in the disclosure, and necessarily imports the results of all three chemical tests, so that in effect, Claim 1 of the 606 patent should be construed as though it read: 6-0-methylerythromycin A [Form II] characterized by: (1) peaks in the powder x-ray diffraction pattern having the following 2θ values: 8.5 ° ±0.2, 9.5 ° ±0.2, 10.8 ° ±0.2, 11.5 ° ±0.2, 11.9 ° ±0.2, 12.4 ° ±0.2, 13.7 ° ±0.2, 14.1 ° ±0.2, 15.2 ° ±0.2, 16.5 ° ±0.2, 16.9 ° ±0.2, 17.3 ° ±0.2, 18.1 ° ±0.2, 18.4 ° ±0.2, 19.0 ° ±0.2, 19.9 ° ±0.2, and 20.5 ° ±0.2, (2) peaks in the infrared pattern as depicted in Figure 2b of the disclosure, and (3) peaks in the differential scanning calorimetric thermograph as depicted in Figure 2c of the disclosure. [36] The evidence suggests that if Claim 1 of the 606 patent is construed this way, then the skilled reader would know from figures 2b and 2c that Form II is not a solvate. That is important because if the claimed substance is not a solvate, then it cannot have been anticipated by the Iwasaki article. The Iwasaki article disclosed a form of Form II characterized by peaks in the powder x-ray diffraction pattern having the 2θ values specified in Claim 1 of the 606 patent, but it is common ground that the Form II referred to in the Iwasaki article is a solvate. [37] Abbott's construction of Claim 1 of the 606 patent leaves an important question unanswered. Why is the result of the powder x-ray diffraction described specifically in Claim 1, while the results of the other two tests are not mentioned? In the absence of a satisfactory answer to that question, it is difficult to find any fault with the judge's analysis, or his conclusion. Counsel for Abbott did not provide a satisfactory answer to that question. [38] Abbott argues that the judge, in finding that Claim 1 of the 606 patent includes a solvate form of Form II, arrived at a conclusion that was the opposite of the conclusion he reached in a case involving Canadian Patent No. 2,261,723 (the 723 patent): Abbott Laboratories v. Minister of Health, 2005 F.C. 1095. I am not persuaded that the judge's conclusion in the case involving the 723 patent necessarily required him to adopt, in this case, the construction of Claim 1 of the 606 patent that would exclude solvates. The issues and the evidence in the two cases were substantially different. Although the 606 patent and the 723 patent both involve Form II, the 606 patent claims Form II characterized by the specified 2θ values (it is a claim for a particular substance), while the 723 patent claims methods of producing clarithromycin "crystal Form II" (it is a claim for a method of producing a particular substance). Claim 1 of the 606 patent (the claim in issue in this case) describes Form II by reference to certain characteristics, while the claims of the 732 patent do not. [39] I conclude that the judge made no error in finding that Ratiopharm's allegation of invalidity in relation to the 606 patent was justified. The 361 patent [40] Abbott describes the 361 patent as a patent claiming a method of making Form II from Form 0. It is not disputed that Ratiopharm's product uses Form II that is made from Form 0. In its notice of allegation, Ratiopharm asserted that its product would not infringe the 361 patent. The judge found the non-infringement allegation to be justified, based on his construction of the patent. It is the position of Abbott that the judge erred in law in his construction of certain words in Claim 1 of the 361 patent. This ground of appeal was rejected at the hearing without requiring oral submissions from Ratiopharm. [41] Claim 1 of the 361 patent reads as follows: A process for the preparation of 6-0-methylerythromycin A Form II comprising heating 6-0-methylerythromycin A Form 0 solvate under vacuum at a temperature of between about 70 ° C and 110 ° C. [42] In its notice of allegation, Ratiopharm asserted that its product would not infringe the 361 patent because its product was made using a process of drying at a temperature other than "a temperature of between about 70 ° C and 110 ° C". The judge was required to construe the word "about" as used in Claim 1 of the 361 patent. He was presented with conflicting evidence as to what a person skilled in the art would understand that word to mean. He did not accept the evidence of Abbott's experts on that point, for reasons he explained fully and which I need not repeat. I see no error in the judge's analysis of that evidence. As the process used by Ratiopharm involved drying at a temperature outside the range described in Claim 1 of the 361 patent, as construed by the judge, it follows that Ratiopharm's non-infringement allegation is justified. Conclusion [43] I would dismiss this appeal with costs to the respondent Ratiopharm. "K. Sharlow" "I agree Robert Décary J.A." "I agree B. Malone J.A." FEDERAL COURT OF APPEAL NAMES OF COUNSEL AND SOLICITORS OF RECORD DOCKET: A-384-05 STYLE OF CAUSE: ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMTED and THE MINISTER OF HEALTH and RATIOPHARM, A DIVISION OF RATIOPHARM INC. PLACE OF HEARING: TORONTO, ONTARIO DATE OF HEARING: APRIL 5 & 6, 2006 REASONS FOR JUDGMENT BY: SHARLOW J.A. CONCURRED IN BY: DÉCARY J.A. MALONE J.A. DATED: MAY 18, 2006 APPEARANCES: Andrew Reddon Stephen Mason Marcus Klee FOR THE APPELLANTS David Aitken Geoffrey North FOR THE RESPONDENTS SOLICITORS OF RECORD: McCarthy Tetrault Toronto, Ontario FOR THE APPELLANTS Osler, Hoskin & Harcourt Ottawa, Ontario FOR THE RESPONDENTS