Bristol-Myers Squibb Canada Co. v. Pharmascience Inc.

Bristol-Myers Squibb Canada Co. v. Pharmascience Inc.
Court (s) Database
Federal Court Decisions
Date
2021-01-12
Neutral citation
2021 FC 1
File numbers
T-503-19, T-504-19, T-97-19, T-98-19
Decision Content
Date: 20210112
Dockets: T-97-19
T-98-19
T-503-19
T-504-19
Citation: 2021 FC 1
Ottawa, Ontario, January 12, 2021
PRESENT: The Honourable Mr. Justice Zinn
Docket: T-97-19
BETWEEN:
BRISTOL-MYERS SQUIBB CANADA CO. AND BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED COMPANY
Plaintiffs
and
PHARMASCIENCE INC.
Defendant
Docket: T-98-19
AND BETWEEN:
BRISTOL-MYERS SQUIBB CANADA CO. AND BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED COMPANY, AND PFIZER INC.
Plaintiffs
and
PHARMASCIENCE INC.
Defendant
Docket: T-503-19
AND BETWEEN:
BRISTOL-MYERS SQUIBB CANADA CO. AND BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED COMPANY, AND PFIZER INC.
Plaintiffs
and
SANDOZ CANADA INC.
Defendant
Docket: T-504-19
AND BETWEEN:
BRISTOL-MYERS SQUIBB CANADA CO.
AND BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED COMPANY
Plaintiffs
and
SANDOZ CANADA INC.
Defendant
AMENDED PUBLIC JUDGMENT AND REASONS
(The Confidential Judgment and Reasons were issued on January 4, 2021, amended pursuant to Rule 397(2) on January 8, 2021, and no redactions are necessary)
[1] On consent, these four actions were tried “on a coordinated basis.” The Plaintiffs [collectively referred to as BMS] commenced these actions pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 to prevent the Defendants, Pharmascience Inc. [Pharmascience] and Sandoz Canada Inc. [Sandoz] from obtaining notices of compliance to market their generic versions of BMS’s product ELIQUIS™.
[2] ELIQUIS is an anticoagulant that blocks certain clotting proteins in the blood; specifically, it is a Factor Xa [FXa] inhibitor. Two patents relating to ELIQUIS are at issue. Canadian Patent No. 2,461,202 [the 202 Patent] relates to apixaban, the active pharmaceutical ingredient in ELIQUIS. It is at issue in Court Files T-97-19 and T-504-19. Canadian Patent No. 2,791,171 [the 171 Patent] relates to the formulation of the BMS 2.5 and 5 mg apixaban tablets. It is at issue in Court Files T-98-19 and T-503-19.
BRIEF BACKGROUND
[3] The factual evidence of Dr. Donald J. P. Pinto and Dr. Jantin Patel as to the history of the research and development of ELIQUIS by BMS, and its predecessors, is largely undisputed. Numerous pharmaceutical companies were doing research to find a compound to replace Warfarin, which was then the standard pharmaceutical used to treat and prevent blood clots. Warfarin was a difficult drug therapy to administer, for at least two reasons: It had dangerous side effects and put the patient at risk of heavy bleeding, and it required that patients constantly undergo testing. These factors were the impetus to find a replacement therapy that was more easily administered.
[4] Initial research by BMS in the early 1990s focused on drugs that would inhibit the enzyme thrombin. In 1996, its focus shifted to compounds that would inhibit the enzyme FXa.
[5] Dr. Pinto attests that in 2001, BMS “finally discovered apixaban: a structurally differentiated, potent, safe, and selective Factor Xa inhibitor with a unique and special set of pharmacokinetic properties.” The 202 Patent, which claims apixaban, was filed in Canada on September 17, 2002. It has a publication date of April 3, 2003, and was issued on July 12, 2011.
[6] The 171 Patent deals with the tablet formulation of apixaban. The development team was formed in 2001 and it took some 7 years to develop the now patented formulation for ELIQUIS. The 171 Patent was filed February 2, 2011. It has a publication date of September 1, 2011, and issued on August 29, 2017.
JOINT STATEMENT OF ISSUES
[7] The parties very helpfully prepared and submitted to the Court for its benefit, a Joint Statement of Issues, which is reproduced below:
1. The asserted claims in these actions are as follows (“Asserted Claims”):
a. 202 Patent (Court File Nos. T-97-19, T-504-19):
i. Claim 2; Claim 4 as it depends on claim 2; and Claims 5 to 7, as each depends on claim 4, as it depends on claim 2.
b. 171 Patent (Court File No. T-98-19):
i. Claim 18 as it depends on claim 14, as it depends on either claim 13 or 12, as either depends on claim 6, as it depends on claim 5, as it depends on claim 4; and
ii. Claims 30-32, as each depends on claim 29, as it depends on claim 25, as it depends on claim 24, as it depends on claim 23.
c. 171 Patent (Court File No. T-503-19):
i. Claim 18 as it depends on claim 14, as it depends on either claim 13 or 12, as either depends on claim 6, as it depends on claim 5, as it depends on claim 4; and
ii. Claims 30-31, as each depends on claim 29, as it depends on claim 25, as it depends on claim 24, as it depends on claim 23.
2. The Defendants have confirmed that their only non-infringement allegation is that none of the Asserted Claims will be infringed because they are invalid. Furthermore, the Defendants agree that should the Court find any of the Asserted Claims to be valid, then the orders sought by the Plaintiffs in these actions shall issue. In other words, there will be no trial on infringement issues other than with respect to the validity of the Asserted Claims, and the parties agree that the Plaintiffs are not required to establish any infringement of the essential elements of any asserted patent claim for the purposes of these actions.
3. Without prejudice to the Plaintiffs’ arguments about validity and the way in which the below validity allegations have been legally framed by the Defendants, the Defendants intend to raise the following validity allegations.
A. The ’202 Patent – Court File Nos. T-97-19 and T-504-19
4. The issue to be determined in Court File Nos. T-97-19 (BMS v. Pharmascience) and T-504-19 (BMS v. Sandoz) is whether any of the asserted claims of the ‘202 Patent is valid and thus would be infringed, and more specifically, the validity issues that Pharmascience and Sandoz presently intend to raise are:
(i) Insufficiency – Does the ‘202 Patent satisfy the requirements of subsections 27(3)(a) and (b) of the Patent Act?
(ii) Double Patenting – Are the asserted claims of the ‘202 Patent invalid for double patenting in light of Canadian Patent No. 2,349,330 (“the ‘330 Patent”)?
(iii) Anticipation – Is the subject matter defined by the asserted claims of the ‘202 Patent anticipated by the ‘330 Patent (or its equivalent international patent application, i.e. WO 00/39131)?
(iv) Obviousness – As of the claim date (September 21, 2001), would the subject matter defined by the asserted claims of the ‘202 Patent have been obvious to a person skilled in the art?
(v) Overbreadth – Are the asserted claims of the ‘202 Patent overbroad for claiming more than what the inventors made or disclosed?
(vi) Inutility – Are the asserted claims of the ‘202 Patent invalid for lack of utility, i.e. no demonstration or sound prediction of utility?
(vii) Insufficiency and Inutility of a Selection Patent – Is apixaban one of the compounds covered by the ‘330 Patent? If so, are the asserted claims of the ‘202 Patent invalid for failing to disclose a substantial advantage over the compounds covered by the ‘330 Patent, or are the asserted claims of the ‘202 Patent invalid because the claimed compound has no substantial advantage over the compounds covered by the ‘330 Patent?
B. The ’171 Patent – Court File Nos. T-98-19 (Pharmascience) and T-503-19 (Sandoz):
5. The issue to be determined in Court File Nos. T-98-19 (BMS v. Pharmascience) and T-503-19 (BMS v. Sandoz) is whether any of the asserted claims of Canadian Patent No. 2,791,171 (“the ‘171 Patent”) is valid and thus would be infringed, and more specifically, the validity issues that Pharmascience and Sandoz presently intend to raise are:
(i) Obviousness – As of the claim date (February 25, 2010), would the subject matter defined by the asserted claims of the ‘171 Patent have been obvious to a person skilled in the art?
(ii) Overbreadth – Are the asserted claims of the ‘171 Patent overbroad for claiming more than what the inventors made or disclosed?
(iii) Insufficiency – Does the ‘171 Patent satisfy the requirements of subsections 27(3)(a) and (b) of the Patent Act?
(iv) Inutility – Are the asserted claims of the ‘171 Patent invalid for lack of utility, i.e. no demonstration or sound prediction of utility?
(v) Ambiguity – Does the ‘171 Patent satisfy the requirements of subsection 27(4) of the Patent Act?
[8] As noted, the only non-infringement allegation raised by the Defendants is that none of the asserted claims identified above [the Asserted Claims] in these two patents will be infringed because they are invalid. Pursuant to subsection 43(2) of the Patent Act, RSC, 1985, c P-4, the 202 Patent, and the 171 Patent are presumed to be valid. The burden of proving invalidity rests with the Defendants.
EXPERT WITNESSES
[9] A number of expert witnesses were called by the parties. Based on the record before the Court, their agreement on qualifications was accepted:
A. Expert witnesses called by Pharmascience
Dr. Michael Rieder is an expert physician and clinical pharmacologist with expertise in in vitro and in vivo pharmacologic research and clinical trials.
Dr. Paul Laskar is an expert in pharmaceutical formulation and drug delivery, including with respect to pre-formulation assessment, formulation design and development, manufacture, characterization, testing and analysis, including for solid oral dosage forms.
B. Expert witnesses called by Sandoz
Dr. Eliot Ohlstein is an expert pharmacologist, with expertise in drug discovery and development, and with a particular focus in the area of cardiovascular biology.
Dr. Michael Chong is an expert organic chemist, with expertise in organic chemistry and synthetic organic chemistry.
Dr. John Gleason is an expert in medicinal chemistry, with expertise in drug discovery and development.
Dr. Gordon Moe is an expert cardiologist, with expertise in the treatment and prevention of thromboembolic diseases.
Dr. Arthur Kibbe is an expert in pharmaceutical formulation and drug delivery, including with respect to pre-formulation assessment, formulation design and development, manufacture, characterization, testing and analysis, including for solid oral dosage forms.
C. Expert witnesses called by BMS
Dr. Jeffrey Weitz is an expert hematologist, with expertise in the treatment and research of thrombosis, the coagulation cascade, as well as, pre-clinical and clinical trials relating to anticoagulants.
Dr. David Taft is an expert pharmacokineticist.
Dr. Martyn Davies is an expert in pharmaceutical formulation and drug delivery, including with respect to pre-formulation assessment, formulation design and development, manufacture, characterization, testing and analysis, including for solid oral dosage forms.
[10] The Defendants submit that their experts ought to be preferred over those called by BMS.
[11] With respect to Dr. Weitz, they note that (1) he has a “close relationship” with BMS that he wants to continue, (2) he “heaped praise on apixaban” while failing to disclose that it was in fact the entire class of direct oral anti-coagulants [DOACs] that shifted practice, and (3) he was evasive, rejecting a principle from his own paper “that the DOACs ‘which include dabigatran, rivaroxaban, apixaban and edoxaban’ have ‘similar efficacy, better safety and greater convenience’” than Warfarin, which he accepted only after the paper was put to him.
[12] I do not accept the Defendants’ submission regarding the weight to be given to Dr. Weitz’s evidence.
[13] Dr. Weitz readily acknowledged his relationship with BMS, and testified that he had done work with many pharmaceutical companies. He executed the Rule 52.2 Code of Conduct for Expert Witnesses, and gave the Court no reason to think that he failed to observe it.
[14] Dr. Weitz does state that apixaban is unique among DOACs. He attests that while he has prescribed all the DOACs approved in Canada, ELIQUIS is his preferred choice for patients at high risk of bleeding. He notes that the New England Journal of Medicine in 2019 recognized ELIQUIS as a practice-changing drug. He further attests that in his “own experiences with ELIQUIS reflect what a practice-changing drug it has been.” Respectfully, while DOACs may have collectively changed practice, it is clear to the Court, from this witness’s evidence and that of others, that ELIQUIS is the most significant of them.
[15] Dr. Weitz’s evidence when asked on cross-examination if the DOACs “have similar efficacy, better safety, and greater convenience than drugs such as Warfarin” was:
No, I wouldn't conclude that. … I think that there are differences amongst these agents in how they performed against Warfarin, and to say that one is better than another, well, you would have to have head-to-head trials. But they did show differences as in the trials, and we use that information as clinicians to select one versus the other when treating our patients.
[16] In his paper put to him in cross-examination, he wrote:
The direct oral anticoagulants, DOACs, which include dabigatran, rivaroxaban, apixaban and edoxaban, can be given in fixed doses without routine coagulation monitoring. In clinical trials the DOACs have been shown to be at least as effective as vitamin K antagonists such as Warfarin for stroke prevention in non-valvular atrial fibrillation and for treatment of venous thromboembolism and to produce less serious bleeding. With similar efficacy, better safety, and greater convenience, the DOACs are now replacing VKAs for these indications."
[17] He accepted that as accurate when he wrote it, and when asked if that was not inconsistent with his oral evidence, stated:
When I made that statement I'm looking, if you put all the data together with all the DOACs compared with Warfarin, that is the conclusion you come up with. But again, each DOAC compared with Warfarin, some different results in each of these trials. As a class, yes, what I'm saying here is accurate.
[18] I find that Dr. Weitz was not evasive in his evidence, nor inconsistent. As a class of drugs, he accepted that the DOACs were superior to Warfarin, but noted that each, when compared with Warfarin, gave different results such that one cannot say that one is better than the others without a head-to-head trial.
[19] With respect to Dr. Taft, the Defendants submit, “he was woefully inexperienced compared to the Defendants’ experts when it came to the key issue of FXa inhibitors.” However, his evidence was not directed to FXa inhibitors:
Counsel asked for my opinion about what, if anything, the skilled person or team would understand the 202 Patent to teach or disclose about the objects of the invention and subject-matter of the claims of the 202 Patent, when read in light of their common general knowledge as of its publication date (April 3, 2003).
[20] He was also asked to review the prior art relied upon by the Defendants (Canadian Patent No. 2,349, 330 [the 330 Patent] and Patent Application WO 00/39131), from the perspective of the skilled person and offer his opinion whether either rendered obvious the 202 Patent. An in-depth knowledge of FXa inhibitors is not required for that purpose.
[21] The Defendants also submit that his reading of the 202 Patent was “skewed” as “he ignored the clear language of the patent, or read-in concepts that are totally absent, whenever it served the position of BMS.” I reject the suggestion that he tailored his evidence to support the position of BMS. He offered his opinion and there is no evidence, in my view, that it was not arrived at honestly. At the end of the day, the question of the proper interpretation, which we shall come to shorty, is that of the trial judge and not that of any witness.
[22] The Defendants lastly submit that this witness was evasive and they point to his rejection of a principle from his own earlier writings. The relevant portion of the cross-examination follows:
Q. Would you also agree that knowledge of protein binding is necessary to determine the suitable dosage for initial testing in humans? [emphasis added]
A. Again, I don't believe the initial testing in humans would require consideration of protein binding. Initial testing in humans are phase 1 studies, and phase 1 studies are done at low doses, at least at the beginning, to establish safety and evaluate pharmacokinetics. And so no, I don't necessarily think protein binding would be a critical determination of that dose. [emphasis added]
…
Q. [The article] starts:
"Nevertheless protein binding measurements are important during drug development for several reasons first, interspecies differences will effect allometric predictions of PK parameters. Second, knowledge of drug protein binding is necessary for establishing a suitable dose in humans."
And is that an accurate statement?
A. I have no reason to discount that statement, no. I think if you look at the beginning of the paragraph it's referring to Dr. Bennett's publication and the discussion of whether protein binding is important for drug-drug interactions. But I have no reason to dispute that statement, no.
[23] I find that the statement in the article about a “suitable dose” in humans is directed to the same issue as the question posed about the dosage in the initial testing in humans. There is no “rejection” as alleged. In any event, I do not find that Dr. Taft was evasive in his testimony.
[24] I did find that Dr. Laskar, an expert called by the Defendants, was often unresponsive in cross-examination. Rather than answer the question asked, he often responded with an answer to a different question. He had to be reminded that he was called as a witness to assist the Court (and not the party paying him), and that responses that failed to address the questions asked were unhelpful. For this reason, whenever his testimony varied from another, I prefer the evidence of the other witness.
PERSON OF SKILL IN THE ART
[25] A patent is to be read purposively, through the eyes of a skilled person, with a mind willing to understand: Whirlpool Corp v Camco Inc, 2000 SCC 67 [Whirlpool] and Free World Trust v Electro Santé Inc, 2000 SCC 66 [Free World Trust]. There is no material dispute between the parties as to the person of skill in the art. As regards the 202 Patent, the skilled person is a team comprising a medicinal chemist, a pharmacologist or pharmacokineticist, and a clinician. As regards the 171 Patent, the skilled person is a skilled formulator.
[26] The Court’s first task is to construe the claims in light of the patent specification as a whole to ascertain the scope of the invention as claimed.
THE 202 PATENT
[27] The claims of the 202 Patent in issue are Claims 2 and 4 to 7, which read as follows:
2. A compound represented by the following formula:
4. Use of a compound of claim 1 or 2 in the treatment of a thromboembolic disorder.
5. Use according to claim 4 wherein the thromboembolic disorder is ischemic sudden death, transient ischemic attack or stroke.
6. Use according to claim 4 wherein the thromboembolic disorder is deep vein thrombosis.
7. Use according to claim 4 wherein the thromboembolic disorder is pulmonary embolism.
[28] Apixaban is the compound represented in Claim 2.
[29] The Defendants submit that BMS called no evidence on the interpretation of the claims of the 202 Patent and thus their experts’ opinions that is reproduced below is all that is before the Court:
The opinions of Drs. Ohlstein and Rieder indicate the claims should be construed as follows:
• Claim 2: The composition of matter, now known as apixaban, assumed to be used to treat or prevent thromboembolic disorders in humans and non-human mammals.
• Claim 4: Use of apixaban, to treat or prevent thromboembolic disorders, in humans and non-human mammals, with the exception of conditions that are only treated in humans (i.e. acute coronary syndrome, ischemic sudden death, transient ischemic attacks, and deep vein thrombosis).
• Claim 5-7: The same as claim 4, but where the thromboembolic disorder is as follows: Claim 5 – ischemic sudden death, transient ischemic attack or stroke; Claim 6 – deep vein thrombosis; and Claim 7 – pulmonary embolism.
[emphasis added]
[30] I agree with BMS that the “Defendants’ attempt to read into the claims of the 202 Patent that the invention must treat both humans and non-human mammals is contrary to the 202 Patent’s clear teaching that treatment is directed to ‘mammals’ – and any mammal will do.” The term “treatment” is defined in the disclosure of the 202 Patent as being treatment of a disease in a mammal:
As used herein, "treating" or "treatment" cover the treatment of a disease-state in a mammal, particularly in a human, and include: (a) preventing the disease-state from occurring in a mammal, in particular, when such mammal is predisposed to the disease-state but has not yet been diagnosed as having it; (b) inhibiting the disease-state, i.e., arresting it development; and/or (c) relieving the disease-state, i.e., causing regression of the disease state. [emphasis added]
[31] If apixaban worked only in non-human mammals, it would still fall within the 202 Patent.
[32] In my view, the proper construction of the Asserted Claims in the 202 Patent is two-fold. Claim 2 of the 202 Patent is a claim to the chemical known as apixaban. Claims 4 to 7 claim the use of apixaban in a mammal in the treatment or prevention of thromboembolic disorders, including ischemic sudden death, transient ischemic attack or stroke (Claim 5), deep vein thrombosis (Claim 6), and pulmonary embolism (Claim 7).
Insufficiency of Disclosure
[33] Subsection 27(2) of the Patent Act provides that an application for a patent must contain a petition and a specification of the invention. The specification is comprised of the disclosure and the claims. If all the requirements for the issuance of a patent under that Patent Act are met, then, as required by subsection 27(1) of the Act, the Commissioner of Patents “shall grant a patent for an invention.”
[34] Subsections 27(3) and (4) of the Patent Act set out the requirements for a proper disclosure:
(3) The specification of an invention must
(3) Le mémoire descriptif doit :
(a) correctly and fully describe the invention and its operation or use as contemplated by the inventor;
a) décrire d’une façon exacte et complète l’invention et son application ou exploitation, telles que les a conçues son inventeur;
(b) set out clearly the various steps in a process, or the method of constructing, making, compounding or using a machine, manufacture or composition of matter, in such full, clear, concise and exact terms as to enable any person skilled in the art or science to which it pertains, or with which it is most closely connected, to make, construct, compound or use it;
b) exposer clairement les diverses phases d’un procédé, ou le mode de construction, de confection, de composition ou d’utilisation d’une machine, d’un objet manufacturé ou d’un composé de matières, dans des termes complets, clairs, concis et exacts qui permettent à toute personne versée dans l’art ou la science dont relève l’invention, ou dans l’art ou la science qui s’en rapproche le plus, de confectionner, construire, composer ou utiliser l’invention;
(c) in the case of a machine, explain the principle of the machine and the best mode in which the inventor has contemplated the application of that principle; and
c) s’il s’agit d’une machine, en expliquer clairement le principe et la meilleure manière dont son inventeur en a conçu l’application;
(d) in the case of a process, explain the necessary sequence, if any, of the various steps, so as to distinguish the invention from other inventions.
d) s’il s’agit d’un procédé, expliquer la suite nécessaire, le cas échéant, des diverses phases du procédé, de façon à distinguer l’invention en cause d’autres inventions.
(4) The specification must end with a claim or claims defining distinctly and in explicit terms the subject-matter of the invention for which an exclusive privilege or property is claimed.
(4) Le mémoire descriptif se termine par une ou plusieurs revendications définissant distinctement et en des termes explicites l’objet de l’invention dont le demandeur revendique la propriété ou le privilège exclusif.
[35] In Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60, [Sildenafil SCC] at paras 69-71, the Supreme Court of Canada, pointing to its earlier judgment in Consolboard Inc v MacMillan Bloedel (Saskatchewan) Limited, [1981] SCR 504, makes it clear that for there to be sufficiency of disclosure, “the specification, which includes the claims and the disclosure, must define the ‘precise and exact extent’ of the privilege being claimed so as to ensure that the public can, having only the specification, make the same use of the invention as the inventor [italics in original].” There are three questions to be asked: (1) What is your invention?, (2) How does it work?, and (3) Does the description enable a person skilled in the art or the field of the invention to produce it using only the instructions contained in the disclosure? If the public cannot do that, then the disclosure is insufficient, and the patent invalid.
[36] The Defendants note that in Sildenafil SCC, the Supreme Court at paragraph 90 observed, “the relevant question is whether the disclosure was sufficient as of the date of filing [emphasis added].”
[37] Dr. Chong testified that the application for the 202 Patent, as filed and published (that is, the patent application), claimed 10100 compounds. It was only just before the 202 Patent issued that BMS narrowed the claims to one compound - apixaban. The Defendants submit that prior to narrowing the claim, the disclosure was insufficient because as of the date of publication one could not make the invention.
[38] BMS agrees that this Court has held in Novartis Pharmaceuticals Canada Inc v Teva Canada Limited, 2013 FC 283 [Zoledronate FC]; aff’d 2013 FCA 244, that sufficiency of the disclosure is to be assessed as of the date of publication. However, BMS submits that the Defendants confuse the date of assessment with the document to be assessed as of that date.
[39] The Defendants write that Zoledronate FC was the first comprehensive review of the issue since the Supreme Court’s decision in Sildenafil SCC:
Hughes J. determined that the date of publication was the most appropriate date as this was “the date that the public is seized with the application”, and also the date the patentee “has committed to claims for the invention in a manner available to the public”. Thus, Hughes J. considered the content of the patent as published, not the content of the patent as filed. [emphasis added]
[40] There is a passage in Zoledronate FC that appears to support the Defendants’ submission as to the document to be assessed for sufficiency as of the date of publication. Justice Hughes notes at paragraph 178 that the patent he was considering, when originally filed as an application, contained claims to many compounds, including zoledronate, but the issued patent claimed only zoledronate. He states:
If I were to consider sufficiency as of the date of filing the application, I would find that the application was no different than that considered by the Supreme Court in Teva, and thus invalid for lack of sufficient disclosure. [emphasis added]
[41] The Supreme Court of Canada in Sildenafil SCC did not consider the application, but the issued patent. I do not accept that Zoledronate FC stands for the proposition urged on this Court by the Defendants. The question that is always before the Court is whether the patent is valid or whether or not an Asserted Claim is valid or not. It is not whether some document that pre-existed it is valid or whether some subsequently abandoned “claim” is invalid or not.
[42] The Defendants submit, at paragraph 32 of their written submissions, that the “date of publication was the date used to assess sufficiency of disclosure in other Federal Court cases.” They reference Alcon Canada Inc v Cobalt Pharmaceuticals Co, 2014 FC 149 at para 236, and Hospira Healthcare v Kennedy Trust for Rheumatology, 2018 FC 259 at paras 6 and 246, aff’d on this ground 2020 FCA 30 at paras 101-104.
[43] I agree that in each of those decisions the Court stated that sufficiency was to be determined as of the date of publication; however, none indicates that the document examined for sufficiency was that available on that date, rather then the patent as issued.
[44] The Defendants further submit that “the date of filing has also been relied on in several cases, and according to the FCA, ‘anything which occurred subsequent thereto is of no relevance’:” Novopharm Limited v Pfizer Canada, 2010 FCA 242 [Sildenafil FCA], at para 79. They also reference Cobalt Pharmaceuticals v Bayer Inc, 2015 FCA 116, para 67, and Eli Lilly Canada v Apotex, 2018 FC 736, para 123.
[45] The passage in paragraph 79 of Sildenafil FCA that the Defendants quote is the following:
As to the appellant’s arguments regarding certain of the Judge’s comments, which the appellant labels “extraneous”, I have no difficulty agreeing with the Pfizer that these comments do not lead to a reviewable error. Pfizer correctly points out that the Judge was required to determine whether the disclosure was sufficient as of the date of filing. As a result, anything, which occurred subsequent thereto, is of no relevance. Nevertheless, in my view, the Judge’s comments, although misguided in the circumstances, do not form the basis of a reviewable error. As the relevant invention is the compound found in Claim 7, the disclosure is sufficient.
[46] The “extraneous” comments are described at paragraph 46, and are these:
Second, the appellant asserts that the Judge took into account irrelevant and extraneous factors, specifically that the appellant waited 13 years to challenge the validity of the patent (until 2007), that Pfizer identified sildenafil as the active ingredient 11 years ago and that Viagra was introduced in the United States nine years ago.
[47] With this context, the statement that anything that occurred subsequent to the date of filing is irrelevant does not support the Defendants’ submission. All that is being noted is that the Judge’s comments related to facts occurring after the filing date and they are irrelevant to whether as of the filing date, the disclosure was sufficient. The Federal Court of Appeal examined the patent as issued, something that occurred subsequent to filing.
[48] I agree with BMS’s submission that this Court’s role is to examine sufficiency of the issued claims for the reasons BMS offers:
[T]he Patent Act expressly contemplates and permits post-filing changes to the specification, including changes as occurred in this case. It is not the role of the Court to reassess what occurred during prosecution. It is for the Commissioner of Patents to determine whether a patent application is sufficient. It is for the court to determine whether the granted patent is sufficient. [emphasis added]
…
Were it otherwise, it would lead to the absurd result that the post-filing procedures contemplated by the Patent Act (e.g. claim amendments, divisional amendments, reissuance, disclaimer) would be rendered moot for sufficiency but not for other grounds of invalidity.
[49] The test for sufficiency is whether, applying the knowledge of the person skilled in the art at the relevant time (date of publication), he or she is in a position to work the invention. The invention is that claimed in the patent, and until it is issued, there is no patent.
[50] The Defendants submit that wording of the 202 Patent as issued, fails for insufficiency for four reasons. First, it does not teach that apixaban is potent or selective. Second, it is silent on apixaban’s risk of causing excessive bleeding. Third, it is silent on apixaban’s pharmacokinetic profile. Fourth, it included dosing information in relation to humans that BMS knew to be wrong.
[51] Throughout the trial, the Defendants asked witnesses “Where’s the data?” meaning where is the data in the patent that supports that apixaban is useful in treating thromboembolic disorders. The question relates to the first three of the reasons the Defendants advance in support of their insufficiency submission.
[52] The Federal Court of Appeal in Pfizer Canada Inc v Canada (Health), 2008 FCA 108 [Lipitor FCA] makes it clear that whether there is data in the patent that substantiates the invention is irrelevant:
The Applications Judge was wrong in interpreting the disclosure requirement of subsection 27(3) of the Act as requiring that a patentee back up his invention by data. By so doing, he confused the requirements that an invention be new, useful and non-obvious with the requirement under subsection 27(3) that the specification disclose the “use” to which the inventor conceived the invention could be put: see Consolboard, supra, at 527. Whether or not a patentee has obtained enough data to substantiate its invention is, in my view, an irrelevant consideration with respect to the application of subsection 27(3). An analysis thereunder is concerned with the sufficiency of the disclosure, not the sufficiency of the data underlying the invention. Allowing Ranbaxy to attack the utility, novelty and/or obviousness of the 546 patent through the disclosure requirement unduly broadens the scope of an inventor’s obligation under subsection 27(3) and disregards the purpose of this provision. [emphasis added]
[53] I accept the evidence of Dr. Weitz in cross-examination, that by singling out apixaban in the claims, the patent tells the skilled person that the inventors had determined apixaban to be a safe, potent and selective FXa inhibitor with antithrombotic efficacy:
Q. So a skilled person looking at a pharmaceutical patent wouldn't assume that the compound worked, because they would also know that the majority of them don't work, isn't that fair?
A. Right, but when you go from this huge genus down to one compound, I think the skilled person would think it's extremely unlikely that they're going to put forward a compound that didn't work and to claim that amongst this huge genus, because then you're putting your eggs in one basket here. You've gotta have -- the thinking has got to be that this is a compound that has the desired characteristics and is the one that you're going to take forward.
…
So no, I think that the skilled person would take this and say these people must have found a compound that has the properties they're looking for, that's why they're claiming this particular compound out of this huge genus for a treatment of thromboembolic disorders. Of course I would like to see the data, but just because I'm not seeing it doesn't mean the data don't exist, and it doesn't mean that they haven't done it.
[54] The fourth reason submitted by the Defendants for the patent’s insufficiency of disclosure is that the 202 Patent provided false dosing information in relation to humans. That information is found at page 182 of the 202 Patent:
By way of general guidance, the daily oral dosage of each active ingredient, when used for the indicated effects, will range between about 0.001 to 1000 mg/kg of body weight, preferably between about 0.01 to 100 mg/kg of body weight per day, and most preferably between about 1.0 to 20 mg/kg/day.
[55] This passage is not directed specifically to humans. Indeed, it is preceded by the statement, “A physician or veterinarian can determine and prescribe the effective amount of the drug required to prevent, counter, or arrest the progress of the thromboembolic disorder” [emphasis added].
[56] The Defendants’ expert, Dr. Ohlstein, in cross-examination agreed that the skilled person would read this as being only general guidance:
Q. And so a person of skill in the art reading this would understand that it's really for the physician or veterinarian to determine the right or correct dose, right?
A. Agreed.
Q. Right. And just like your patent, the skilled physician would be expected to be able to determine the correct dose, yes?
A. Yes.
Q. And they could do that as part of their routine skill and judgment, yes?
A. Yes.
Q. And what follows then by way of general guidance is just that general guidance, correct?
A. Yes.
Q. And when it gives the dosage ranges below from point 1 to 1000 milligrams, they're not recommending a particular dose for apixaban there, are they?
A. No.
Q. And when they give the preferred range, not recommending a dose for apixaban are they?
A. No.
Q. And when they give the most preferred range they're not recommending a dose for apixaban?
A. Okay, no.
[57] I find that the impugned passage, being only general guidance, cannot be said to be providing false dosing information.
[58] For these reasons, I reject the submission that the 202 Patent is invalid for insufficiency of disclosure.
Inutility
[59] Section 2 of the Patent Act provides that an invention must be “new and useful.” Utility must have been demonstrated or soundly predicted as of the filing date: AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36, paras 49, 54–57 and Sildenafil SCC, para 40.
[60] The Defendants submit that “[i]n cases of demonstrated utility, the reference to the study demonstrating utility must be contained within the patent disclosure so that the public will know that utility has been demonstrated even though the actual evidence or proof of demonstrated utility need not be set out in the patent disclosure” [emphasis in original]. They cite and rely on Apotex Inc v Pfizer Canada Inc, 2011 FCA 236, at para 30 which follows Sildenafil FCA at para 90:
The appellant’s argument that Pfizer was required to include evidence of demonstrated utility in the patent disclosure is without merit. The requirements for demonstrated utility can be provided in evidence during invalidity proceedings as opposed to in the patent itself. So long as the disclosure makes reference to a study demonstrating utility, there do not appear to be any other requirements to fulfil section 2. [emphasis added]
[61] This statement by the Federal Court of Appeal has been expressly rejected by the Supreme Court of Canada in Sildenafil SCC at paras 39-40:
That the invention must be useful as of the date of the claim or as of the time of filing is consistent with this Court’s comments in AZT, at para. 56:
Where the new use is the gravamen of the invention, the utility required for patentability (s. 2) must, as of the priority date, either be demonstrated or be a sound prediction based on the information and expertise then available. If a patent sought to be supported on the basis of sound prediction is subsequently challenged, the challenge will succeed if . . . the prediction at the date of application was not sound, or, irrespective of the soundness of the prediction, “[t]here is evidence of lack of utility in respect of some of the area covered”. [Italics in original; underlining added.]
Nothing in this passage suggests that utility is a disclosure requirement; all it says is that “the utility required for patentability (s. 2) must, as of the priority date, either be demonstrated or be a sound prediction”. Utility can be demonstrated by, for example, conducting tests, but this does not mean that there is a separate requirement for the disclosure of utility. In fact, there is no requirement whatsoever in s. 27(3) to disclose the utility of the invention: see, e.g., Consolboard, at p. 521, per Dickson J.: “I am further of the opinion that s. 36(1) [now s. 27(3)] does not impose upon a patentee the obligation of establishing the utility of the invention”. [emphasis added]
[62] More recently, and to the same effect, is the Supreme Court of Canada’s statement at para 58 of AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 [Esomepr