Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research

Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research
Court (s) Database
Federal Court of Appeal Decisions
Date
2020-01-30
Neutral citation
2020 FCA 30
File numbers
A-326-16, A-328-16, A-329-18, A-338-18
Notes
A correction was made on March 30, 2021
Decision Content
Date: 20210330
Dockets: A-338-18 (lead file);
A-326-16; A-328-16; A-329-18
Citation: 2020 FCA 30
CORAM:
NADON J.A.
RIVOALEN J.A.
LOCKE J.A.
BETWEEN:
HOSPIRA HEALTHCARE CORPORATION, CELLTRION HEALTHCARE CO., LTD., CELLTRION, INC. and PFIZER CANADA INC.
Appellants
and
THE KENNEDY TRUST FOR RHEUMATOLOGY RESEARCH, JANSSEN BIOTECH, INC., JANSSEN INC., CILAG GmbH INTERNATIONAL and CILAG AG
Respondents
Heard at Toronto, Ontario, on October 28, 2019.
Judgment delivered at Ottawa, Ontario, on January 30, 2020.
REASONS FOR JUDGMENT BY:
LOCKE J.A.
CONCURRED IN BY:
NADON J.A.
RIVOALEN, J.A.
Date: 20210330
Dockets: A-338-18 (lead file);
A-326-16; A-328-16; A-329-18
Citation: 2020 FCA 30
CORAM:
NADON J.A.
RIVOALEN J.A.
LOCKE J.A.
BETWEEN:
HOSPIRA HEALTHCARE CORPORATION, CELLTRION HEALTHCARE CO., LTD., CELLTRION, INC. and PFIZER CANADA INC.
Appellants
and
THE KENNEDY TRUST FOR RHEUMATOLOGY RESEARCH, JANSSEN BIOTECH, INC., JANSSEN INC., CILAG GmbH INTERNATIONAL and CILAG AG
Respondents
AMENDED REASONS FOR JUDGMENT
LOCKE J.A.
I. Overview
[1] This decision concerns four appeals of decisions by Justice Michael L. Phelan of the Federal Court (the Judge) in the context of an action by Hospira Healthcare Corporation (Hospira) to impeach Canadian Patent No. 2,261,630 (the 630 Patent) and a counterclaim for infringement of that patent. The initial plaintiffs in the counterclaim were the patent owner, The Kennedy Trust for Rheumatology Research, and alleged licensees Janssen Biotech, Inc., Janssen Inc. and Cilag GmbH International. The initial defendants to the counterclaim were Hospira and suppliers Celltrion Healthcare Co., Ltd. and Celltrion, Inc. (collectively, Celltrion).
[2] The principal decision under appeal (2018 FC 259 dated March 7, 2018) addressed the merits of the action and the counterclaim, and concluded that the 630 Patent was valid and infringed. Another decision under appeal (2018 FC 960 dated September 28, 2018) granted a motion after trial by the plaintiffs by counterclaim to add a new plaintiff by counterclaim (another alleged licensee, Cilag AG) and a new defendant to the counterclaim (Pfizer Canada Inc., which imports and distributes the allegedly infringing product in Canada). The last two decisions under appeal, both dated September 8, 2016, dismissed motions before trial by Hospira:
1) for a commission and letter of request to the U.K. High Court to compel the giving of evidence by Dr. Ravinder Maini (one of the named inventors of the 630 Patent) for purposes of discovery; and
2) to adjourn the trial (or part thereof) to permit continued examination for discovery of Dr. Marc Feldmann (the other of the named inventors of the 630 Patent).
[3] For all four appeals, the defendants to the counterclaim are the appellants.
[4] For the reasons set out below, I would allow the appeal on the merits, and remit the matter to the Federal Court for reconsideration of certain issues. I would dismiss the other appeals.
[5] Each of the four appeals is dealt with in turn in the sections below after a brief discussion of the 630 Patent and its factual background.
II. The 630 Patent and its Context
[6] As indicated by the Judge, the 630 Patent “essentially details the adjunctive use of methotrexate (MTX) and the anti-tumour necrosis factor-α (anti-TNF-α) antibody “infliximab” for the treatment of rheumatoid arthritis (RA) and other autoimmune diseases.” The Judge elaborated as follows:
RA is an autoimmune disorder that characteristically impacts the joints causing pain and disfigurement, even death.
MTX is a drug that impedes the growth of certain cells.
Infliximab is a chimeric monoclonal antibody biologic drug that prevents TNF-α from binding to TNF-α cell surface receptors. TNF-α is a cytokine (chemical messenger) that plays an important role in the autoimmune reaction.
[7] The application for the 630 Patent was filed on August 1, 1997 naming Drs. Feldmann and Maini as inventors, and claiming priority from a U.S. application (No. 08/690,775) that was filed on August 1, 1996. The 630 Patent was published on February 12, 1998; it issued on December 4, 2012; and it expired on August 1, 2017.
[8] Prior to the 630 Patent, MTX was well known as a treatment for serious cases of RA. Though it was not considered to be a traditional immunosuppressive drug, and its mechanism of action was not well understood, it was understood to have immunosuppressive properties. MTX is an example of a disease modifying anti-rheumatic drug (DMARD). Treatment of RA with drugs other than DMARDs was also known at the time. These included non-steroidal anti-inflammatory drugs (NSAIDs) and steroids.
[9] Unfortunately, many patients with RA do not respond completely to treatment with MTX. These patients are known as MTX Incomplete Responders or MTX IRs. For many years prior to the 630 Patent, there had been no significant advances to assist such patients despite a pressing need for a new and improved treatment. The inventors theorized that an anti-TNF-α antibody like infliximab could be helpful in the treatment of RA. At the time, no biologics had yet been approved. Initial trial results were encouraging, but all patients eventually relapsed, likely because of patients’ immune systems responding to the treatment through human anti-chimeric antibodies (HACA). The inventors then tried combining infliximab and MTX. The positive results of these efforts formed the basis for the 630 Patent.
[10] The 630 Patent includes 42 claims of which 23 are in issue. Claims 1, 2, 17, 18, 39, 40, 41 and 42 are independent. The remainder of the claims in issue are dependent on one of these independent claims. Claim 1 is exemplary:
Use of an anti-human tumor necrosis factor-α monoclonal antibody or a human tumor necrosis factor-α binding Fab fragment thereof for the manufacture of a medicament for performing adjunctive therapy with a medicament comprising methotrexate on an individual suffering from rheumatoid arthritis whose active disease is incompletely controlled despite already receiving methotrexate, to reduce or eliminate signs and symptoms associated with the rheumatoid arthritis, wherein the anti-human tumor necrosis factor-α antibody or human tumor necrosis factor-α binding Fab fragment (a) binds to an epitope on human tumor necrosis factor-α, and (b) inhibits binding of human tumor necrosis factor-α to human tumor necrosis factor-α cell surface receptors.
[11] Except as discussed below, the parties do not take issue with the list of essential elements as identified and adopted by the Judge in Appendix B to his reasons on the merits (Reasons). The essential elements of claim 1 are identified as follows:
(a) use of TNFα inhibiting monoclonal antibody (or Fab fragment thereof) for making a medicine;
(b) for performing adjunctive therapy with MTX;
(c) on a patient with active RA whose disease is incompletely controlled despite already receiving MTX;
(d) to reduce or eliminate the signs and symptoms of RA;
(e) wherein the TNFα-inhibiting monoclonal antibody (or Fab fragment) (a) binds to an epitope on human TNFα, and (b) inhibits binding of human TNFα to human TNFα cell surface receptors.
III. The Appeal on the Merits (A-338-18)
[12] The appellants raised many issues at trial, including many sub-issues within each issue. They were unsuccessful in virtually every case. Most of the issues that the appellants raised before the Judge they raise once again before this Court.
[13] The issues before this Court can be identified as follows:
1) Claim construction issues:
Whether the Judge erred in failing to construe the claims in issue as use claims.
Whether the Judge erred in construing the phrase “whose active disease is incompletely controlled despite already receiving [MTX]” to contemplate individuals receiving MTX and other DMARDs.
2) Patent infringement issues
Whether the Judge erred in finding that MTX IRs were treated.
Whether the Judge erred in finding that certain elements of certain dependent claims of the 630 Patent were present.
Whether the Judge erred in concluding that the activities of Celltrion outside Canada could infringe the 630 Patent.
Whether the Judge erred in finding inducement to infringe.
Claims 37 and 38
The appellants argue that claims 37 and 38 were not asserted by the respondents at trial. The respondents do not oppose this argument. In view of the Federal Courts’ explicit statements at paragraph 268 and Appendix B in the reasons at trial listing the claims in dispute (and not including claims 37 and 38), I conclude that the Federal Court erred in finding infringement of these claims.
3) Patent validity issues:
Whether the Judge erred in failing to find the 630 Patent invalid for claiming a method of medical treatment.
Whether the Judge erred in failing to find the 630 Patent invalid for anticipation (lack of novelty).
Whether the Judge erred in failing to find the 630 Patent invalid for obviousness (lack of inventiveness).
Whether the Judge erred in failing to find the 630 Patent invalid for double patenting.
Whether the Judge erred in failing to find the 630 Patent invalid for insufficiency of disclosure.
[14] There is no dispute on the principles applicable to the standard of review in this case. As indicated in Housen v. Nikolaisen, 2002 SCC 33, [2002] 2 S.C.R. 235, the standard of correctness applies to questions of law (see para. 8), but findings of fact or of mixed fact and law are reviewable only where the court of first instance has made a palpable and overriding error (see paras. 10 and 36).
[15] Because of the number of sub-issues raised by the appellants, it will not be practical to address each one specifically. The reader should understand that I have considered all of the appellants’ arguments, and my silence on any of them does not indicate otherwise. I find no merit in the arguments that I have not addressed.
A. Claim construction issues
(1) Construction of claims in issue as use claims
[16] The appellants argue that the Judge erred in not looking behind the plain language of the claims, which are written as Swiss-type claims, i.e. claims to the use of composition X for the preparation of a medicament to be used for Y. The appellants argue that patent claims should be construed purposively, and they cite jurisprudence in which Swiss-type claims have been purposively construed as use claims.
[17] While I accept that patent claims are to be construed purposively, I note that the parties do not disagree on this point, and the Judge was clearly guided by this principle (see para. 118 of the Reasons). Accordingly, it appears that the parties disagree not on the applicable legal principle, but on how that principle was applied to the facts in this case. In light of that, this Court should not interfere in the absence of a palpable and overriding error.
[18] I see no such error in the Judge’s decision to interpret the words of the claims to have their plain meaning (see para. 153 of the Reasons): Lundbeck Canada Inc. v. Ratiopharm Inc., 2009 FC 1102 at para. 41; Zero Spill Systems, (Int’l) Inc. v. Heide, 2015 FCA 115 at paras. 74-78.
(2) Construction of the claims to include individuals receiving MTX and other DMARDs
[19] The appellants argue that the phrase “whose active disease is incompletely controlled despite already receiving [MTX]” refers to patients receiving MTX only, and that construing the phrase to encompass patients receiving MTX and other DMARDs impermissibly broadens it beyond what would have been understood by a person skilled in the art (PSA) at the relevant time.
[20] The Judge noted that nothing in the 630 Patent indicates that it contemplates treatment only of patients receiving MTX alone. He also pointed to the following passage from the 630 Patent to indicate the contrary:
Other therapeutic regimens and agents can be used in combination with the therapeutic co-administration of TNF antagonists and methotrexate or other drugs that suppress the immune system.
[21] The appellants argue that the Judge should not have had reference to this passage in the 630 Patent to construe a term in a claim without some ambiguity concerning the meaning of that term. In support of this argument, the appellants cite Mylan Pharmaceuticals ULC v. Eli Lilly Canada Inc., 2016 FCA 119, [2016] F.C.J. No. 406, at para. 39 (Mylan), which adopted the following statement:
In construing the claims, recourse to the rest of the specifications is (1) permissible to assist in understanding the terms used in the claims; (2) unnecessary where the words and [sic] plain and unambiguous and (3) improper to vary the scope or ambit of the claims.
[22] However, the appellants’ argument that there is no ambiguity in the meaning of the phrase in question is substantially weakened by the fact that the claims are not explicit as to whether MTX IRs are limited to those taking MTX only. Certainly, the parties disagree. In my view, it was entirely open to the Judge, when construing this phrase, to have resort to the above-quoted passage from the disclosure of the 630 Patent.
[23] The appellants also point to evidence that DMARD combinations were known to be risky and uncertain. Despite this evidence, which was disputed, it was open to the Judge to be persuaded by other evidence of the use of combination therapy with other medications for the treatment of patients with RA, and the absence of any indication in the patent itself that an MTX IR could not be receiving some other DMARD in combination with MTX.
[24] I see no error by the Judge on this issue.
B. Patent infringement issues
(1) Were MTX IRs treated?
[25] It is not disputed that treatment of an MTX IR is an essential element of all of the claims in issue. This means that it would not be an infringement of any of the claims in issue to administer the adjunctive therapy contemplated therein to someone other than an MTX IR. Accordingly, in order to establish infringement, there must be evidence that the claimed treatment is for administration to an MTX IR.
[26] That said, it should be noted that the infringement action that has given rise to the present appeals has been bifurcated such that questions of liability (e.g. whether the 630 Patent was valid and infringed) were dealt with in the first phase, and questions of the quantum of damages/profits will be dealt with in the second phase. Therefore, it was not for the Judge in his Reasons to address how much infringement occurred. It was enough that he was convinced that there was some infringement.
[27] The appellants argue that their allegedly infringing product, called Inflectra, has seven indications, only one of which is for RA, and that though its product monograph contemplates use in combination with MTX, it does not specify that it is for MTX IRs. The appellants also argue that the Judge improperly considered IMS evidence that Inflectra is used in combination with MTX in MTX IRs. The appellants say this evidence should have been excluded as hearsay.
[28] Even without the IMS evidence in dispute, there was ample support for the Judge’s conclusion that Inflectra was used in MTX IRs. Firstly, it would seem fair to assume that an advanced treatment for RA, such as infliximab in combination with MTX, would be used principally in patients who have not responded completely to standard treatments, such as MTX. This assumption is supported by the Reasons where the Judge noted that (i) the clinical trial relied upon to obtain regulatory approval for Inflectra included MTX IRs; and (ii) only MTX IRs are reimbursed for treatment with Inflectra. This assumption is also consistent with the appellants’ argument on the issue of obviousness that prior art suggested that patients receiving infliximab in clinical studies should be MTX IRs, and should continue receiving MTX during such studies.
[29] I see no error in the Judge’s conclusion that Inflectra is to be used for treatment of MTX IRs.
(2) Elements of dependent claims
[30] The appellants argue that there was no evidence, and the Judge made no finding, of the presence of the following essential elements of claims 12, 15, 28 and/or 31, and therefore these claims should have been found not infringed:
1) the TNFα-inhibiting medicine is formulated for administration by infusion at weeks 0, 2, 6, 10 and 14; and
2) the MTX-containing medicine contains 7.5 mg (or 10 mg) of MTX.
[31] The parties devote little of their arguments to this issue. This may reflect the fact that the issue could be of importance only if these claims were found to be valid while the claims from which they depend were found invalid.
[32] The respondents have not disputed the absence of evidence to support a finding of infringement of claims 12, 15, 28 and 31, and the Court has not been directed to any evidence of the presence of the essential elements identified in paragraph [30] above. It does indeed appear that there is no such evidence. Therefore, I conclude that the Judge erred in finding infringement of these claims.
(3) Activities of Celltrion
[33] The appellants argue that the Judge made no finding that Celltrion conducted any activities in Canada, and therefore he erred in finding that Celltrion infringed. The respondents acknowledge that there was no direct evidence regarding where Celltrion conducted its activities, but they argue that the Judge did not err when he focussed on whether those activities deprived the patentee of the full enjoyment of the invention defined in the 630 Patent rather than on where those activities took place.
[34] Of importance to this issue is the Saccharin doctrine, which gets its name from a decision of the U.K. High Court of Justice – Chancery Division called Saccharin Corporation, Ld. v. Anglo-Continental Chemical Works, Ld. (1900), 17 R.P.C. 307. This decision concerned a U.K. patent for a process for manufacturing saccharin, and the issue was whether it was an infringement of that patent to import into the U.K. saccharin made abroad using the patented process. A key passage in the decision appears at page 319: “By the sale of saccharin, in the course of the production of which the patented process is used, the Patentee is deprived of some part of the whole profit and advantage of the invention, and the importer is indirectly making use of the invention.” The Saccharin doctrine has been recognized in Canada for many years: see Monsanto Canada Inc. v. Schmeiser, 2004 SCC 34, [2004] 1 S.C.R. 902, at para. 44; Eli Lilly and Company v. Apotex Inc., 2010 FCA 240, [2010] F.C.J. No. 1199, at paras.17-20.
[35] On this issue, the appellants challenge not whether the importation and/or sale in Canada of Inflectra is an infringement of the 630 Patent, but rather whether Celltrion’s activities conducted entirely outside Canada can be found to infringe the Canadian patent. On this point, a follow-up to the Saccharin decision identified above is helpful. Just two months later, the U.K. High Court of Justice – Chancery Division issued another decision involving the same plaintiff but a different defendant: Saccharin Corporation, Ld. v. Reitmeyer & Co. (1900), 17 R.P.C. 606. Here, the defendant had used the patented process outside the U.K. and had sold the resulting product for importation into the U.K., but it had done none of this in the U.K. At page 612 of this decision, the Court stated:
The acts done by the Defendant on the Continent were lawful there, and – being done on the Continent – were not unlawful here. The Plaintiffs have sought to extend the principle laid down in Elmslie v. Boursier (L.R. 9 Eq. 217) and Von Heyden v. Neustadt (14 Ch. D. 230) that the importation into and sale in England of an article manufactured abroad according to a process protected by an English Patent is an infringement of the English Patent, to a case where the Defendant has neither imported into nor sold in England. … I am not disposed for the first time thus to extend the rights of the Patentee.
[36] Accordingly, the finding of infringement under the Saccharin doctrine was limited to those who conduct activities in the territory of the patent, activities such as importing, selling or using the product in question. This limitation to the Saccharin doctrine has been recognized in Canada: Eli Lilly and Company v. Apotex Inc., 2009 FC 991, [2009] F.C.J. No. 1229, at paras. 283-284, aff’d 2010 FCA 240, [2010] F.C.J. No. 1199. This limitation also recognizes the general principle that patents are territorial and that Canadian patents cannot be infringed outside Canada: Beloit Canada Ltd. v. Valmet-Dominion Inc., [1997] 3 F.C. 497 at 520, 73 C.P.R. (3d) 321 (F.C.A.); Varco Canada Limited v. Pason Systems Corp., 2013 FC 750, 236 A.C.W.S. (3d) 714, at paras. 265-266; Canadian National Railway Company v. BNSF Railway Company, 2018 FC 614, 156 C.P.R. (4th) 1, at para. 46.
[37] Accepting that there is indeed no evidence that Celltrion has conducted any activities in Canada, the facts in the present case appear to be indistinguishable from those in the second Saccharin decision. I conclude that there is no evidence to support the conclusion that Celltrion has infringed the 630 Patent, and that the Judge erred in including Celltrion among the companies found to have infringed.
(4) Inducement to infringe
[38] The parties do not take issue with the three-prong legal test for inducing infringement as set out in Corlac Inc. v. Weatherford Canada Inc., 2011 FCA 228, 95 CPR (4th) 101, at para. 162, and adopted by the Judge:
First, the act of infringement must have been completed by the direct infringer. Second, the completion of the acts of infringement must be influenced by the acts of the alleged inducer to the point that, without the influence, direct infringement would not take place. Third, the influence must knowingly be exercised by the inducer, that is, the inducer knows that this influence will result in the completion of the act of infringement […].
[39] The Judge found that all of the elements of this test were satisfied. The appellants take issue with all three.
[40] The appellants criticize the Judge’s reliance on the following passage from AB Hassle v. Genpharm Inc., 2003 FC 1443, 243 F.T.R. 6, at para. 127, aff’d 2004 FCA 413, [2004] F.C.J. No. 2079 (AB Hassle): “Infringement of a use patent … is not limited to the act of the generic producer; it includes infringement by patients.” The appellant argues that the Judge read this passage to permit a finding of inducing infringement even without the element of influence by the alleged inducer. In my view, the appellants misread both the passage and the Judge’s use of it. By my reading, the Court in AB Hassle was simply observing that direct infringement of a use patent may be committed by a patient. It follows from this that use by a patient may satisfy the first prong of the test for inducing infringement. It is clear from a reading of the Reasons that the Judge understood that influence by the alleged inducer was necessary for a conclusion of inducing infringement.
[41] The requirement for an act of infringement completed by the direct infringer was addressed by the Judge’s analysis of direct infringement, and is dealt with here in discussion above of the other infringement issues. The Judge made no error in finding that this prong of the test was satisfied.
[42] The appellants’ argument against the second prong of the test (influence by the alleged inducer) is similar to that discussed above in the context of the first patent infringement issue (beginning at paragraph [25] above). They argue that the Judge should have recognized that the product monograph for Inflectra does not mention MTX IRs, even though it does instruct use in combination with MTX. In my view, and as alluded to above, it is no great leap to conclude that instructions to use Inflectra in combination with MTX will be followed by patients who have not responded completely to treatment with MTX. The distinction is an attempt at splitting hairs.
[43] In light of the findings that (i) the appellants instructed patients, including MTX IRs, in the infringing use of Inflectra, and (ii) patients, including MTX IRs, followed those instructions, I find no error in the Judge’s conclusion that the appellants influenced direct infringement so as to satisfy the second prong of the test for inducing infringement.
[44] The third prong of the test (the influence was knowingly exercised) is not difficult in this case. It follows from the fact that the source of the influence (the product monograph) was created and distributed by the appellants themselves that they were aware of the influence being exercised.
[45] The Judge easily found that this prong was satisfied. I see no error in this conclusion, but I do take this opportunity to clarify a point that is not clear in the Reasons: the knowledge at issue in the third prong of the test is knowledge that the influence is being exercised, rather than knowledge that the resulting activity will be an infringement. It is true that there are several decisions in the jurisprudence in which an alleged inducer’s knowledge (or lack of knowledge) of the patent in issue has been considered in deciding the issue of inducement. However, these decisions have not discussed the knowledge issue in any depth. This issue was discussed in depth by Justice Johanne Gauthier (then of the Federal Court) in Bauer Hockey Corp. v. Easton Sports Canada Inc., 2010 FC 361, [2010] F.C.J. No. 341, at paras. 193-203, aff’d 2011 FCA 83, [2011] F.C.J. No. 331. Justice Gauthier observed that knowledge that a particular activity is an infringement is not an element of direct infringement and, since inducing infringement is not a tort distinct from direct infringement, it should not be an element of inducing infringement either. I agree.
[46] In summary, the Judge did not err in finding that all three prongs of the test for inducing infringement were satisfied, and concluding that the appellants induced infringement.
C. Patent validity issues
(1) Method of medical treatment
[47] I preface this section by noting that the appellants’ arguments on the subject of methods of medical treatment rely to a large extent on their argument that the Swiss-type claims in this case should have been construed as use claims. That argument has been dismissed in section III.A.(1) above and will not be revisited here.
[48] I begin this section with a brief history which may be helpful. The authority for the principle that a method of medical treatment is not patentable in Canada has its roots in the decision of the Supreme Court of Canada in Tennessee Eastman Co. et al. v. Commissioner of Patents (1972), [1974] S.C.R. 111, 8 C.P.R. (2d) 202 (Tennessee Eastman), which concerned a patent application based on the discovery that a known adhesive substance was adaptable for surgical use. Section 41 of the Patent Act in force at the time limited the scope of patent claims relating to substances intended for food or medicine; claims had to be limited to such substances prepared or produced by particular chemical processes. In Tennessee Eastman, the claims in issue were essentially to a new surgical method of joining tissues by means of a known substance. Based on section 41 of the Patent Act, the Court concluded that neither such a surgical method, nor a method of medical treatment, fell within the definition of “invention” therein. The Court concluded that such methods are therefore not patentable.
[49] Though the Supreme Court in Tennessee Eastman did not explicitly base its decision on the idea that the invention in question was essentially non-economic and unrelated to trade, industry, or commerce (an idea the Exchequer Court and the patent examiner in that case had previously discussed), subsequent decisions of the Supreme Court have accepted that idea: see Shell Oil Co. v. Commissioner of Patents, [1982] 2 S.C.R. 536 at 554, 67 C.P.R. (2d) 1; Apotex Inc. v. Wellcome Foundation Ltd., 2002 SCC 77, [2002] 4 S.C.R. 153, at para. 49 (AZT).
[50] The Court in AZT also noted that section 41 of the Patent Act (which had been the focus of the decision in Tennessee Eastman) had since been repealed. Therefore, the reasoning in AZT would seem to apply despite this repeal.
[51] Though the method of medical treatment issue has been raised in a number of matters before the Federal Court since AZT, there has been limited discussion of this issue at the level of the Federal Court of Appeal. Federal Court jurisprudence has developed the principle that a claim to a vendible product, including a substance intended for the treatment of a medical condition, can be good subject matter for a patent claim, but not if the claim encompasses the skill of a medical professional such as a dosage range rather than a fixed dosage (or presumably also a range of intervals of administration rather than a fixed interval): Merck & Co. Inc. v. Apotex Inc., 2005 FC 755, [2005] F.C.J. No. 937, at para. 137; Axcan Pharma Inc. v. Pharmascience Inc., 2006 FC 527, 50 C.P.R. (4th) 321, at para. 51; Merck & Co., Inc. v. Pharmascience Inc., 2010 FC 510, 85 C.P.R. (4th) 179, at para. 114; Janssen Inc. v. Mylan Pharmaceuticals ULC, 2010 FC 1123, 88 C.P.R. (4th) 359, at para. 26; Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Company, 2013 FC 985, 115 C.P.R. (4th) 399, at paras. 91-92, aff’d 2014 FCA 17, 236 A.C.W.S. (3d) 1001 (Novartis).
[52] This state of the jurisprudence has a tempting simplicity. However, it is not clear to me that the decisions of the Supreme Court of Canada that form the basis of the principle that methods of medical treatment are not patentable justify a distinction between a fixed dosage (or interval of administration) and a range of dosages (or intervals). It would seem that a medical professional will be constrained in their exercise of skill in either case. Also, a drug is arguably no less a vendible product simply because its dosage or interval of administration is not fixed.
[53] At paragraph 145 of the Reasons, the Judge noted a suggestion by this Court, and supported by Professor Norman Siebrasse, that the policy and logic surrounding methods of medical treatment be given “full consideration before this Court or the Supreme Court of Canada in a case where the issue is squarely raised on the facts”: Cobalt Pharmaceuticals Company v. Bayer Inc., 2015 FCA 116, [2015] F.C.J. No. 555, at para. 101. I agree that this issue deserves deep analysis. Unfortunately, this does not appear to be the case for such an analysis. Most of the claims in issue here are limited to fixed dosages and intervals of administration, or do not specify any dosage or interval of administration. I agree with the Judge that these claims concern a vendible product, and are not invalid as methods of medical treatment.
[54] One of the claims in issue arguably encompasses a dosage range: claim 33 defining “a dosage form containing from about 0.1 milligram to about 500 milligrams of infliximab.” Other claims in issue arguably encompass a range of intervals of administration: claims 9, 10, 25 and 26 defining “interval of weeks” or “intervals of weeks.” However, the parties’ arguments do not focus on these claims.
[55] The Reasons likewise do not address the dosage range of claim 33 or the intervals of administration of claims 9, 10, 25 and 26. It may be that neither the Judge nor the parties saw the need to focus on these claims because they are dependent on other claims that do not encompass a range of dosages or a range of intervals of administration. The parties may have seen little practical effect of a finding that these claims were invalid.
[56] Having considered the evidence and the limited argument on this issue, I am not prepared to find that the Judge erred in finding none of the claims in issue invalid as a method of medical treatment. In my view, the record is insufficient to show that the Judge erred in law, or that he made a palpable and overriding error of fact or of mixed fact and law, on this issue.
(2) Anticipation (lack of novelty)
[57] There are two aspects to the appellants’ argument on anticipation that require discussion. The first is that the Judge erred in recognizing the priority date of the 630 Patent, and hence in excluding certain prior art as not citable. The second aspect of the appellants’ argument on anticipation concerns the Judge’s conclusion that two other prior art references were not anticipatory because they did not describe the “special advantage” of the 630 Patent. Each of these aspects will be addressed in turn.
(a) The priority date of the 630 Patent
[58] Pursuant to paragraph 28.2(1)(b) of the Patent Act, R.S.C. 1985, c. P-4, the subject-matter of a patent claim must not have been disclosed before the claim date by a person other than the applicant for the patent (or a person who obtained knowledge from the applicant) in such a manner that the subject matter became available to the public. The “claim date”, which effectively defines a cut-off date for citable prior art, is defined in section 28.1 to be the earlier of the Canadian filing date and the filing date of a previously filed application on which a valid priority claim has been made. One of the requirements for a valid priority claim is that the application claiming priority was filed within twelve months after priority application. In addition, subsection 28.4(4) provides that, where there are two or more previous applications on which priority could be claimed, the twelve months counts from the earliest filing.
[59] As indicated in paragraph [7] above, the application for the 630 Patent was filed on August 1, 1997, and a priority claim was made based on U.S. Patent Application No. 08/690,775 which was filed on August 1, 1996 (the 1996 priority).
[60] The appellants argue that the Judge should not have recognized this priority claim as valid because the 1996 priority itself claims priority from another U.S. application (07/958,248) which was filed on October 8, 1992 (the 1992 priority). The appellants argue that the named inventors themselves argued successfully before the U.S Patent Office that this 1992 priority supported a priority claim by the 1996 priority. If the appellants are right in these arguments, then the priority claim on the 630 Patent would be invalid because it was filed more than twelve months after the 1992 priority. The invalidity of the priority claim in the 630 Patent would move the claim date for the 630 Patent from August 1, 1996 to August 1, 1997, which would make certain additional prior art relevant.
[61] The appellants also argue that the Judge recognized the 1992 priority as the earliest priority application for the subject matter of the claims in issue of the 630 Patent (in particular, the co-administration of an anti-TNF-α antibody and MTX). This is not so. The paragraphs cited by the appellants from the Reasons summarize, but do not adopt, the appellants’ arguments on this point. In fact, there is insufficient evidence on the record to determine whether the subject matter of the claims in issue was described in the 1992 priority so as to make it the earliest priority application, as asserted by the appellants.
[62] The appellants argue that the respondents had the burden to establish the priority claim for the 630 Patent, and that they failed to meet that burden by putting the 1996 priority application into evidence. For their part, the respondents argue that the burden of proof was instead on the appellants in that the 630 Patent benefits from a presumption of validity per subsection 43(2) of the Patent Act.
[63] Neither of these arguments has merit. With respect to the appellants’ argument, even if the respondents had introduced the 1996 priority into evidence, the Judge would not have been in a position to determine what the 1992 priority discloses. Therefore, there is no reason to draw any negative inference from the respondents’ failure to introduce the 1996 priority. Turning to the question of the presumption of validity of the 630 Patent, it is notable that the question of priority is not directly relevant to the validity of the 630 Patent. Rather, it affects which prior art may be relevant for the purposes of an attack on its validity. The respondents cite no authority that the presumption of patent validity extends to a priority claim.
[64] In my view, the appellants’ reliance on the 1992 priority is remote enough from the issue of the priority claim on the 630 Patent that, even if that priority claim does not benefit from a presumption of validity, the appellants had the burden to prove the contents of the 1992 priority. To conclude otherwise would overcomplicate the exercise of establishing a priority claim because a patentee would be obliged to try to anticipate which prior applications an adversary might allege disclose the subject matter of the patent in issue.
[65] With no dispute that the 1996 priority supports the subject matter of the claims in issue of the 630 Patent, and in the absence of evidence of the contents of the 1992 priority, I see no error in the Judge’s recognition of the claim date of August 1, 1996 for the 630 Patent.
(b) Prior art references that do not describe the “special advantage” of the 630 Patent
[66] Before entering into the details of this issue, it is useful to note that there are two requirements for establishing that a prior art reference anticipates:
1) The prior art reference must disclose the claimed invention such that, if performed, it would necessarily result in infringement; and
2) The prior art reference must be sufficiently detailed to enable a PSA to perform the claimed invention without the exercise of inventive ingenuity or undue experimentation.
(See Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61, [2008] 3 S.C.R. 265 (Sanofi))
[67] The two prior art references of relevance to this issue are:
1) The 1994 Scientific Report of the Mathilda and Terence Kennedy Institute of Rheumatology (the 1994 Kennedy Report); and
2) G. Higgins, “Cytokine antagonism: still a main attraction in rheumatology R&D”, InPharma, 8 July 1995, p. 10 (Higgins).
[68] The Judge noted that the 1994 Kennedy Report discloses the idea of co-administration of stable low doses of MTX and monthly infusions of infliximab, but that no results were yet available, and therefore the special advantage of such adjunctive therapy was not disclosed. The Judge described this special advantage as “reduced HACA responses and improved pharmacokinetics enabling long-term treatment of infliximab with good efficacy and tolerability.” The 1994 Kennedy Report stated as follows:
The aim is to further investigate the tolerability and efficacy of repeated use of [infliximab] in a randomised, blinded fashion, both in comparison with standard therapy [MTX] and in combination with this drug. It is expected that the results will be available by autumn 1995 and should provide an indication of the likely utility of [infliximab] as a long-term disease suppressing agent in clinical practice.
[69] The Judge also noted that Higgins discloses the possibility of combining an anti-TNF-α antibody with MTX. The Judge noted that the anti-TNF-α antibody mentioned was not infliximab. He also noted that Higgins disclosed neither the special advantage of the combination nor the doses or administration schedule of either drug.
[70] The Judge found both the 1994 Kennedy Report and Higgins not to anticipate the claims in issue because they were speculative. Regarding the 1994 Kennedy Report, he specifically noted that it was impermissibly speculative to expect benefits from combination treatment of in