Janssen Inc. v. Apotex Inc.

Janssen Inc. v. Apotex Inc.
Court (s) Database
Federal Court Decisions
Date
2022-07-06
Neutral citation
2022 FC 996
File numbers
T-555-20
Decision Content
Date: 20220706
Docket: T-555-20
Citation: 2022 FC 996
Toronto, Ontario, July 6, 2022
PRESENT: Madam Justice Pallotta
BETWEEN:
JANSSEN INC. AND
ACTELION PHARMACEUTICALS LTD
Plaintiffs
and
APOTEX INC.
Defendant
PUBLIC REASONS FOR JUDGMENT
(Judgment issued May 20, 2022 – 2022 FC 995)
(Confidential Judgment and Reasons issued May 20, 2022)
Table of Contents
I. Overview 3
II. Background 5
A. The Parties and the Nature of this Proceeding 5
B. The 770 Patent 7
C. PAH and Diseases Involving Vasoconstriction 8
III. Issues 9
IV. Witnesses 12
A. Dr. Mielniczuk (Plaintiffs’ Expert Witness) 13
B. Dr. Kapasi (Plaintiffs’ Expert Witness) 14
C. Dr. McIvor (Apotex’s Expert Witness) 16
D. Ms. Picard (Apotex’s Expert Witness) 17
V. The Skilled Person and Their Common General Knowledge 23
VI. Claim Construction 28
A. Legal Principles 28
B. The Asserted Claims 30
C. Experts’ Opinions on Claim Construction 33
D. Parties’ Positions on Claim Construction 36
E. Analysis on Claim Construction 42
(a) Claims 1-5 43
(b) Claims 10-20 46
(c) Claims 21-31 49
VII. Infringement 50
A. Direct Infringement 51
(1) Parties’ Submissions 51
(2) Analysis 52
B. Inducing Infringement 54
(1) Parties’ Submissions 55
(2) Analysis 62
(a) Corlac Test: Prong 1 62
(b) Corlac Test: Prong 2 64
(c) Corlac Test: Prong 3 74
VIII. Conclusion 75
IX. Postscript 76
SCHEDULE A 79
I. Overview
[1] The plaintiffs, Janssen Inc. (Janssen) and Actelion Pharmaceuticals Ltd (Actelion), bring this patent infringement action against Apotex Inc. (Apotex) pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 [PMNOC Regulations], made under the Patent Act, RSC 1985, c P-4 [Patent Act].
[2] Janssen markets a prescription medication in Canada known as OPSUMIT®, a film-coated tablet containing 10mg of macitentan as the active ingredient, to treat patients afflicted with pulmonary arterial hypertension (PAH). PAH is a serious and incurable condition of high blood pressure in the blood vessels of the lungs, caused by changes to the arteries that transport deoxygenated blood from the heart to the lungs for reoxygenation. If left untreated, the high blood pressure strains the heart, leading to heart failure and death.
[3] OPSUMIT belongs to a class of drugs known as endothelin receptor antagonists (ERAs). ERAs work by binding to endothelin receptors within the walls of blood vessels, preventing endothelin from binding to these receptors. Endothelin binding is one of the steps in the endothelin pathway, a biological pathway that causes smooth muscle cells in blood vessel walls to constrict and proliferate, forcing the heart to work harder to push blood through the narrowed and thickened arteries. By blocking the endothelin binding step, ERAs interfere with the vasoconstricting and proliferative effects of the endothelin pathway.
[4] OPSUMIT can be prescribed alone or in combination with another class of drugs known as phosphodiesterase type-5 inhibitors (PDE5-Is). Like ERAs, PDE5-Is affect blood pressure, but they do so by enhancing the vasorelaxation and anti-proliferative effects of the nitric oxide pathway. Sildenafil and tadalafil are two PDE5-Is prescribed for PAH.
[5] Currently, Janssen is the only company authorized by Health Canada to sell macitentan as a prescription medication. Apotex seeks Health Canada’s approval to sell a generic prescription medication containing 10mg of macitentan as the active ingredient (APO-MACITENTAN).
[6] The plaintiffs allege that if Apotex sells APO-MACITENTAN, it will infringe claims 1-5, 10-20, and 21-31 (Asserted Claims) of Actelion’s Canadian Patent No. 2,659,770 titled “Therapeutic Compositions Comprising a Specific Endothelin Receptor Antagonist and a PDE5 Inhibitor” (770 Patent).
[7] Claims 1, 10, and 21 are independent claims of the 770 Patent that relate to macitentan in combination with a PDE5-I to treat a disease wherein vasoconstriction is involved. The other Asserted Claims depend directly or indirectly on claims 1, 10, or 21, and they are narrower in scope. The dependent claims include limitations on the specific PDE5-I, the specific disease, or both.
[8] According to the plaintiffs, Apotex will infringe certain Asserted Claims directly, or indirectly by making statements in the APO-MACITENTAN product monograph (PM) that will induce others to infringe, notably prescribing physicians. With respect to inducement, the plaintiffs allege that the APO-MACITENTAN PM communicates that APO-MACITENTAN should not be used any differently than OPSUMIT. They allege the APO-MACITENTAN PM includes bioequivalence data and results from a multicentre, double blind, placebo-controlled Phase 3 clinical trial (SERAPHIN) involving 742 PAH patients that established the safety and efficacy of macitentan as a monotherapy and as combination therapy with a PDE5-I. As such, the APO-MACITENTAN PM will encourage physicians to use APO-MACITENTAN just as OPSUMIT is used, in combination with PDE5-Is.
[9] For the purposes of this proceeding only, Apotex concedes that the Asserted Claims are valid. Apotex defends the plaintiffs’ allegations on the basis that it will not infringe any of the Asserted Claims. Apotex alleges that it will not infringe any Asserted Claims directly because it will not perform all of the essential elements of the claims, and it will not infringe any Asserted Claims indirectly because the “Indications and Clinical Use” section of the APO-MACITENTAN PM states that |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| and the PM does not suggest that physicians or patients should use APO-MACITENTAN in combination with a PDE5-I.
[10] For the reasons below, the plaintiffs have not established that Apotex will directly infringe any of the Asserted Claims. The plaintiffs have established that Apotex will induce infringement of claims 1-5 and 21-31.
II. Background
A. The Parties and the Nature of this Proceeding
[11] Janssen is a pharmaceutical company with a head office in Toronto, Ontario. Actelion is a pharmaceutical and biotechnology company with a head office in Allschwil, Switzerland. Janssen is wholly owned by Johnson & Johnson, which acquired Actelion in 2017. Both Janssen and Actelion are members of the Johnson & Johnson group of companies. Janssen is a “first person” within the meaning of subsections 4(1) and 6(1) of the PMNOC Regulations. Actelion is the registered owner of the 770 Patent and is a necessary party to this action under subsection 6(2) of the PMNOC Regulations.
[12] Apotex is a pharmaceutical corporation with its head office in Toronto, Ontario. Apotex is a “second person” within the meaning of subsections 5(1) and 6(1) of the PMNOC Regulations.
[13] Apotex filed an Abbreviated New Drug Submission (ANDS) with Health Canada, seeking authorization to market APO-MACITENTAN tablets based on their equivalent pharmaceutical and bioavailability characteristics, when compared to OPSUMIT.
[14] The Minister of Health maintains a list of patents related to drugs that have been authorized for sale under a notice of compliance (NOC). As a condition of obtaining market authorization for its macitentan product, the PMNOC Regulations required Apotex to address the patent list for OPSUMIT. Apotex served a Notice of Allegation on April 6, 2020 and the plaintiffs commenced this action in response.
[15] When this action was commenced, three patents were listed in relation to OPSUMIT: Canadian Patent No. 2,437,675, Canadian Patent No. 2,621,273, and the 770 Patent. Canadian Patent No. 2,437,675 has expired, and Canadian Patent No. 2,621,273 is not at issue in this action. Only the 770 Patent is at issue.
[16] By commencing this action, the plaintiffs triggered a stay that prevents the Minister of Health from issuing an NOC to Apotex for up to 24 months in order to allow time for the action to be heard and decided.
B. The 770 Patent
[17] The 770 Patent was issued on November 18, 2014. It relates to a specific compound, referred to throughout the patent as “formula (I)”, in combination with a PDE5-I to treat diseases wherein vasoconstriction is involved. Formula (I) is identified by the following diagram of its chemical structure:
[18] There is no dispute that formula (I) is the compound now known as macitentan, the active ingredient in OPSUMIT, and that formula (I)/macitentan is an ERA.
[19] The first paragraph of the 770 Patent specification describes the invention as relating to a product containing a compound of formula (I) in combination with at least one compound having PDE5-inhibitory properties for therapeutic use in the treatment of a disease wherein vasoconstriction in involved. The specification states that “disease wherein vasoconstriction is involved” means in particular hypertension, pulmonary hypertension (including PAH), diabetic arteriopathy, heart failure, erectile dysfunction or angina pectoris. Some of the Asserted Claims do not include a limitation on the particular disease wherein vasoconstriction is involved, while others are limited to: the particular diseases of vasoconstriction listed above, hypertension and pulmonary hypertension, pulmonary hypertension (PH) specifically, or PAH specifically.
[20] The patent specification defines “compound having PDE5-inhibitory properties” to be a compound that meets or exceeds a threshold measurement of its ability to inhibit PDE5 according to an experimental test protocol described in the patent, and it provides four examples of PDE5-Is: sildenafil, vardenafil, tadalafil, and udenafil. Some of the Asserted Claims do not include a limitation on the PDE5-I, and others are limited to: the four example PDE5-Is, sildenafil or tadalafil, sildenafil specifically, or tadalafil specifically.
C. PAH and Diseases Involving Vasoconstriction
[21] Vasoconstriction is the constriction of the vasculature (arteries and veins) of the circulatory system. The vasculature can be divided into two systems that circulate blood between the body, heart, and lungs. The systemic circuit involves the left side of the heart, which pumps oxygenated blood from the heart to the rest of the body (except the lungs). The pulmonary circuit involves the right side of the heart, which pumps deoxygenated blood from the heart to the lungs for reoxygenation.
[22] Although some of the Asserted Claims cover other diseases of vasoconstriction and are not limited to PAH, PAH is the only disease that is relevant to the issues in this action because the allegations of direct and indirect infringement are restricted to PAH.
[23] PAH is a subtype of PH, a general term that describes abnormally high blood pressure in the pulmonary circulatory system. As noted above, PAH is a progressive and incurable disease where the artery walls in the lungs constrict and thicken, increasing vascular resistance to blood flow and making the right side of the heart work harder to push blood through narrowed arteries. The extra stress causes the right ventricle of the heart to enlarge and dilate. Over time, the changes become unsustainable. The right ventricle weakens, its ability to push blood out of the heart to the lungs is compromised, and eventually, the heart fails.
III. Issues
[24] The issues in this action relate to claim construction and infringement of the Asserted Claims. As noted above, validity of the 770 Patent is not an issue that is before the Court.
[25] The Asserted Claims of the 770 Patent must be construed—that is, interpreted—before there is an assessment of whether they are infringed: Whirlpool Corp v Camco Inc, 2000 SCC 67 at para 43 [Whirlpool]. Doing so requires that the claims be read in an informed and purposive way, from the perspective of a notional person of ordinary skill in the art or science to which the patent relates, and to whom the patent is addressed (skilled person): Free World Trust v Électro Santé Inc, 2000 SCC 66 at para 44 [Free World].
[26] While the parties in this case and their expert witnesses largely agree (with some variation) on the qualifications of the skilled person and the relevant experience and knowledge that person would bring to bear on the issues in the action, the first issue for the Court is to define the skilled person.
[27] The parties filed a joint claim chart. Despite their identical proposed constructions of the essential elements of the Asserted Claims, the parties do not agree on what the claims mean. Two aspects of claim construction are in dispute: (i) whether claims 1, 10 and their dependent claims are, in substance, claims to the use of macitentan to treat a disease including PAH; and (ii) for all Asserted Claims, whether “combination” contemplates the use of macitentan and a PDE5-I as something that a physician intended at the outset of a patient’s treatment.
[28] The Court’s claim construction analysis is not confined to the aspects of claim construction that are in dispute. The Court is not required to accept the parties’ or the experts’ proposed claim construction. Claim construction is a matter of law for the Court to decide: Whirlpool at para 61; Zero Spill Systems (Int'l) Inc v Heide, 2015 FCA 115 at para 41 [Zero Spill]. The construction of the Asserted Claims is the second issue.
[29] The application for the 770 Patent was published on March 6, 2008. This is the relevant date for construing the claims: Free World at paras 53-54. The skill and knowledge that the skilled person brings to bear when interpreting the claims is their skill and knowledge as of March 6, 2008. For simplicity, I will sometimes refer to the 770 Patent’s publication date as March 2008 or I will refer to the year only.
[30] The plaintiffs bear the burden of proving infringement on a balance of probabilities. The parties’ joint statement of issues frames the infringement issue as follows:
The Court will be required to decide whether, if approved, the making, constructing, using, or selling of APO-MACITENTAN 10 mg film-coated tablets, by Apotex Inc. in accordance with its Abbreviated New Drug Submission No. 2365227 constitutes infringement of any of the Asserted Claims of the 770 Patent, either directly or indirectly by inducing others to infringe.
[31] As the third issue, the Court must decide whether the plaintiffs have established that Apotex would directly infringe claims 1-5 and 10-20, if it is authorized to market APO-MACITENTAN.
[32] As the fourth issue, the Court must decide whether the plaintiffs have established that Apotex would indirectly infringe claims 1-5 and 21-31 by inducing others, notably prescribing physicians, to infringe. As noted above, the plaintiffs assert that statements made in the APO-MACITENTAN product monograph (PM) will induce prescribing physicians to infringe the Asserted Claims.
[33] At the outset of trial, the plaintiffs stated that they were alleging Apotex would infringe claims 10-20 indirectly, however, their written closing argument did not address indirect infringement of claims 10-20. In view of my construction of claims 10-20, I would not have found indirect infringement for these claims.
IV. Witnesses
[34] Each of the parties introduced expert evidence in support of their respective positions on claim construction and infringement. The plaintiffs relied on the expert opinion evidence of Dr. Mielniczuk and Dr. Kapasi. Apotex relied on the expert opinion evidence of Dr. McIvor and Ms. Picard.
[35] The parties agree on a number of facts. As a result, neither party called fact witnesses. They provided a joint scientific primer and an agreed statement of facts.
[36] That said, the plaintiffs submit that Apotex should have called a fact witness from the company. They argue an adverse inference should be drawn because the only evidence regarding Apotex’s actions and intentions—which are centrally important to the issue of infringement—was Dr. McIvor’s and Ms. Picard’s speculation. The plaintiffs therefore argue that this Court should infer that Apotex did not call a company witness because their evidence would not have been helpful to Apotex’s position.
[37] I decline to draw an adverse inference based on Apotex’s alleged failure to call a company witness. According to the joint statement of issues, the question on infringement is whether the making, constructing, using or selling of APO-MACITENTAN in accordance with Apotex’s ANDS would constitute direct or indirect infringement. In this regard, the plaintiffs asked Drs. Mielniczuk and Kapasi to review the proposed APO-MACITENTAN PM and product label that Apotex submitted as part of its ANDS, and opine on: (i) how APO-MACITENTAN will be used by physicians and patients if it is approved, sold, and used in Canada; and (ii) what Apotex’s influence will be on the use of APO-MACITENTAN in Canada by physicians and patients. Both experts opined that Apotex would represent that APO-MACITENTAN can be used in place of OPSUMIT through the information within the proposed APO-MACITENTAN PM.
[38] The following provides a brief description of each expert witness’ qualifications and testimony.
A. Dr. Mielniczuk (Plaintiffs’ Expert Witness)
[39] Dr. Mielniczuk is a Staff Cardiologist and Medical Director of the Pulmonary Hypertension Clinic at the University of Ottawa Heart Institute. She has been in this role since 2007. Dr. Mielniczuk received her M.D. from McMaster University in 1998. She completed a residency in internal medicine at Queen’s University in 2001, and a fellowship in cardiology at the University of Ottawa Heart Institute in 2004. Dr. Mielniczuk also completed a fellowship in advanced heart failure and cardiac transplantation at the Brigham and Women’s Hospital in Boston, Massachusetts in 2006. She received a Master of Science degree in Clinical Science and Epidemiology from the Harvard School of Public Health in 2007.
[40] Dr. Mielniczuk’s research activities focus on heart failure, clinical outcomes relating to heart failure associated with PH, and the evaluation of myocardial energetics in right heart failure.
[41] Apotex did not object to Dr. Mielniczuk’s proposed qualifications. I was satisfied Dr. Mielniczuk was qualified to provide expert evidence according to the proposed qualifications that were put forward by the plaintiffs:
Dr. Mielniczuk is a medical doctor, researcher, and professor of cardiology with expertise in (i) pulmonary hypertension (“PH”) (including pulmonary arterial hypertension (“PAH”)); (ii) the development and science of treatment of PH (including PAH); and (iii) the treatment of PH (including PAH) in Canada, past and present.
[42] Dr. Mielniczuk prepared an expert witness report dated July 15, 2021. The report sets out Dr. Mielniczuk’s opinions on mandates related to the qualifications and knowledge of the skilled person, construction of the Asserted Claims, how PAH is treated today, how APO-MACITENTAN will be used by physicians and patients in Canada, and what Apotex’s influence will be on the use of APO-MACITENTAN by physicians and patients. Dr. Mielniczuk’s report was taken as read.
B. Dr. Kapasi (Plaintiffs’ Expert Witness)
[43] Dr. Kapasi is an Associate Professor of Medicine at the University of British Columbia. Dr. Kapasi received his M.D. from the University of Alberta in 2003 and completed a residency in family medicine in 2004. He also completed a residency in internal medicine at the University of Manitoba in 2006, a respirology subspeciality training program in 2008, and a fellowship in lung and heart/lung transplantation in 2009. Dr. Kapasi received a Masters in Pulmonary Vascular Disease from the Università di Bologna in 2012.
[44] Since the beginning of his practice of medicine in 2009, Dr. Kapasi’s focus has been on treating cardiovascular diseases, with a particular interest in diseases affecting the pulmonary circulatory system.
[45] The plaintiffs proposed that Dr. Kapasi be qualified to testify as an expert as follows:
Dr. Kapasi is a medical doctor, researcher, and professor of pulmonary medicine with expertise in (i) pulmonary hypertension (“PH”) (including pulmonary arterial hypertension (“PAH”)); (ii) the development and science of treatment of PH (including PAH); and (iii) the treatment of PH (including PAH) in Canada, past and present.
[46] Apotex did not object to the proposed qualifications, and I was satisfied that Dr. Kapasi was qualified to provide expert testimony in accordance with the proposed qualifications.
[47] Dr. Kapasi prepared an expert witness report dated July 15, 2021. Dr. Kapasi’s report covered his opinions on the same mandates as Dr. Mielniczuk’s report. Dr. Kapasi’s report was taken as read.
[48] Prior to Dr. Kapasi’s testimony at trial, Apotex registered an objection to Dr. Kapasi’s expert opinion evidence on the ground that his evidence is duplicative of Dr. Mielniczuk’s expert opinion evidence. Having noted the objection, Apotex stated that it would provide its submissions on the objection in the context of closing arguments.
[49] Apotex did not provide submissions on the objection in its written or oral closing arguments. Following a question from the Court, asking whether the objection was withdrawn, Apotex stated it was not objecting to the admissibility of Dr. Kapasi’s expert opinion evidence but it reserved the right to speak to the issue on costs. Apotex then added that the duplicative nature of the evidence should be a factor considered in assigning weight to Dr. Kapasi’s evidence, and the plaintiffs raised an objection. The plaintiffs’ position was that, having made no submissions in its closing arguments (and in fact, Apotex relied on both Dr. Kapasi’s and Dr. Mielniczuk’s evidence on various points), and having withdrawn the objection, it was not open to Apotex to argue that Dr. Kapasi’s opinion should be given less weight because it is duplicative. In any event, the plaintiffs submit Dr. Kapasi’s and Dr. Mielniczuk’s opinions are corroborative rather than duplicative.
[50] Apotex argued that an opinion from a second, similarly-situated PAH expert does not assist the Court according to the framework set out in R v Mohan, [1994] 2 SCR 9. In my view, that is a question of admissibility, and Apotex stated it was not objecting to the admissibility of Dr. Kapasi’s evidence. Apotex also argued that the Court should not decide issues on the basis that two experts are better than one. In my view, that caution was unnecessary. I have not given “extra weight” to the opinions of either of the plaintiffs’ experts simply because there were two of them.
C. Dr. McIvor (Apotex’s Expert Witness)
[51] Dr. McIvor is a respirologist (also referred to as a pulmonologist, especially in the United States) whose clinical practice and research focuses on a range of respiratory disorders. Dr. McIvor was trained in internal medicine in the United Kingdom from 1984 to 1989, and enrolled in the Respirology Training Program at the University of Toronto from 1990 to 1992. Dr. McIvor received his M.D. from Queen’s University in Belfast, Northern Ireland in 1994 and a Master of Science degree in clinical epidemiology from McMaster University in 1995. Since 2005, he has been a Staff Respirologist at the Firestone Institute for Respiratory Health (FIRH) of St. Joseph’s Healthcare Hamilton and a Professor of Medicine at McMaster University. FIRH is a referral centre for patients in the Hamilton Area with asthma and chronic respiratory disease, including patients with PAH.
[52] Dr. McIvor was qualified to testify as an expert as follows:
Dr. McIvor is a respirologist with expertise in the diagnosis, management and treatment of respiratory conditions including Pulmonary Arterial Hypertension.
[53] Dr. McIvor prepared an expert witness report dated October 12, 2021. The report sets out Dr. McIvor’s opinions on mandates related to the qualifications and knowledge of the skilled person, construction of the Asserted Claims, how PAH is treated today, how a physician would understand the instructions from the APO-MACITENTAN PM, whether the PM would result in direct infringement or induce physicians to infringe the Asserted Claims, and responses to Dr. Mielniczuk and Dr. Kapasi’s reports. Dr. McIvor’s report was taken as read.
D. Ms. Picard (Apotex’s Expert Witness)
[54] Ms. Picard is a pharmacist and President of SPharm Inc., a regulatory consulting firm that provides strategies and consultancy to pharmaceutical companies. She has a Master’s degree in hospital pharmacy and 30 years of experience in regulatory affairs.
[55] Ms. Picard prepared an expert report dated October 12, 2021. Ms. Picard was asked to provide her opinion on whether Apotex would be permitted to market or promote that APO-MACITENTAN can be used as a combination therapy with PDE5-Is, based on the APO-MACITENTAN PM provided to her. She was also provided with copies of Dr. Kapasi’s and Dr. Mielniczuk’s reports and asked to comment on those portions of their expert reports relevant to her expertise, and advise whether she agreed or disagreed.
[56] Apotex proposed the following qualifications for Ms. Picard:
Susanne Picard is a licensed pharmacist and an expert in Canadian pharmaceutical regulatory affairs, including the preparation, filing and management of new and abbreviated new drug submissions. She has particular expertise in: (a) the preparation and filing and interpretation of brand and generic Product Monographs (“PMs”); (b) the relevant regulations and guidelines for preparing PMs; (c) Health Canada’s evaluation of PMs; and (d) the regulations applicable to the marketing of approved pharmaceuticals.
[57] At trial, the plaintiffs objected to Ms. Picard’s proposed qualifications. After hearing the parties’ arguments, I revised the proposed qualifications offered by Apotex by deleting the word “particular” from the second sentence and adding a proviso. These changes were intended to make it more explicit that Ms. Picard’s opinions offer one perspective of PMs, the regulations and guidelines, and Health Canada’s evaluation of PMs, and her opinions do not go further than that perspective. The revised statement of qualifications is as follows:
Susanne Picard is a licensed pharmacist and an expert in Canadian pharmaceutical regulatory affairs, including the preparation, filing and management of new and abbreviated new drug submissions. She has particular expertise in: (a) the preparation and filing and interpretation of brand and generic Product Monographs (“PMs”); (b) the relevant regulations and guidelines for preparing PMs; and (c) Health Canada’s evaluation of PMs; and (d) the regulations applicable to the marketing of approved pharmaceuticals, provided that the expertise noted as (a), (b), (c), and (d) is within Ms. Picard’s expertise as a pharmacist or in Canadian pharmaceutical regulatory affairs.
[58] The plaintiffs also argued that most parts of Ms. Picard’s expert report (paragraphs 23, 24, 53, 55-60 and 62-80) are inadmissible. These are almost all of the paragraphs in Ms. Picard’s report that provide an opinion on the APO-MACITENTAN PM. The remaining paragraphs in the report provide information about Ms. Picard’s qualifications, or information about the regulations made under the Food and Drugs Act and other aspects of the regime that governs drug marketing in Canada.
[59] The plaintiffs do not take issue with Ms. Picard’s qualifications as an expert in the area of regulatory affairs; however, they say her expertise in this regard is irrelevant to the issues in this case and does not support most of the opinions within her expert report. The plaintiffs object to the above-noted paragraphs principally on two bases: (i) Ms. Picard provides opinions that are outside her expertise; and (ii) Ms. Picard provides opinions on domestic law, which should be excluded for that reason and also for being unnecessary.
[60] According to the plaintiffs, Ms. Picard is not a properly qualified expert whose opinion is relevant and necessary to assist the Court: White Burgess Langille Inman v Abbott and Haliburton Company Limited, 2015 SCC 23. All drafts of the PM that were submitted to Health Canada are already in evidence, Ms. Picard’s interpretation of them from the perspective of a regulatory affairs expert are not relevant to inducement, and she cannot provide the perspective of a PAH physician. Also, Ms. Picard is not a lawyer and the Court does not need her evidence to take judicial notice of the Food and Drugs Act or the regulations thereunder. The plaintiffs further note that Ms. Picard’s opinions on what Apotex can and cannot do from a regulatory perspective are not grounded in fact evidence from Apotex, and she does not know its marketing plans.
[61] The plaintiffs say the situation is analogous to Bell Helicopter Textron Canada Limitée v Eurocopter, 2013 FCA 219. In that case, the Court ruled that an expert’s opinion on the patent examination process before the Patent Office was irrelevant because the expert had no expertise on the technology in question, the patent examination history was already in evidence, a patent examiner’s perspective was irrelevant to the Court’s assessment of validity from a skilled person’s perspective, and expert opinion on domestic law was unnecessary.
[62] Apotex’s responding position was that the Court should reserve on the question of admissibility, but if the Court were inclined to rule on admissibility during the trial, Ms. Picard’s evidence met the test for admissibility as expert opinion.
[63] On the first point, Apotex argued that a determination of admissibility at trial would be premature. There was insufficient reason to rule that parts of Ms. Picard’s report should be excluded based on the threshold requirements of admissibility, and no reason to engage the Court’s discretionary gatekeeper role of balancing the potential risks and benefits of admitting her evidence. A central issue in this action relates to Apotex’s intentions as gleaned from an objective reading of the PM, and Ms. Picard’s experience allows her to opine on what can be inferred from the PM based on the purpose of a PM and the regulatory framework that applies to it. Apotex argued it would be efficient to allow Ms. Picard to testify under reserve of objection, and doing so would also promote fairness because Apotex did not have advanced notice of the challenged paragraphs and the bases for objecting to them.
[64] On the second point, Apotex argued that Ms. Picard’s evidence meets the threshold requirements for admissibility, and the plaintiffs’ objections should be considered as a matter of weight. The regulatory perspective of an expert who provides advice to pharmaceutical companies on PMs and the marketing of a drug product is helpful to assist the Court in understanding the PM. Although guided by legislation, Ms. Picard’s evidence is not a legal opinion and her evidence should not be excluded on this basis. Ms. Picard can assist the Court to navigate a complex regime that involves an interplay between legislation, standards, guidance documents, and other considerations.
[65] I agreed with Apotex that it was premature to rule on admissibility at trial. It was not clear to me that all of the impugned paragraphs should be excluded as inadmissible on the basis of relevance or necessity, and I reserved my ruling on admissibility.
[66] As noted above, as her first mandate Ms. Picard was asked to provide her opinion on whether Apotex would be permitted to market or promote that APO-MACITENTAN can be used as a combination therapy with PDE5-Is, based on the APO-MACITENTAN PM provided to her. As her second mandates she was provided with copies of Dr. Kapasi’s and Dr. Mielniczuk’s reports and asked to comment on those portions of their expert reports relevant to her expertise, and advise whether she agreed or disagreed.
[67] With respect to the second mandate, I find Ms. Picard’s expert report and testimony to be inadmissible because her opinions are outside of her expertise. For example, Ms. Picard offered opinions on whether or not the references to SERAPHIN found in the APO-MACITENTAN PM would support the use of macitentan as a monotherapy or as combination therapy. Ms. Picard is not qualified to do so as she is not a physician, she has no expertise regarding PAH, and she is not qualified to opine on whether the APO-MACITENTAN PM “omits any discussion of efficacy as it relates to the use of combination therapy”. Her opinion in this regard was based on a side-by-side comparison of words deleted from the APO-MACITENTAN PM. This is an exercise of form over substance that is potentially misleading from an expert witness with no PAH expertise.
[68] With respect to the first mandate, and to the extent that Ms. Picard’s evidence fell within the scope of her expertise as a pharmaceutical regulatory expert, I find the opinions have marginal relevance to the issues that the Court must determine in this case. For example, Ms. Picard provided a generalized opinion that generic pharmaceutical companies are not free to omit clinical and pre-clinical studies that are included in a PM for the “reference product” (the brand company’s PM) because these studies are typically conducted to establish the safety and/or efficacy of the drug in question. However, Ms. Picard has no knowledge about what Apotex was or was not required to include from SERAPHIN in particular. As another example, Ms. Picard opined that Apotex would not be permitted to market or promote that APO-MACITENTAN can be used as a combination therapy with PDE5-Is, based on the APO-MACITENTAN PM provided to her. However, the issue in this case is whether the contents of the APO-MACITENTAN PM itself would induce physicians to infringe. I accord these opinions little weight.
V. The Skilled Person and Their Common General Knowledge
[69] The notional person of skill in the art or “skilled person” is a legal construct embodying a number of concepts that inform a proper approach to resolving issues of claim construction, infringement, and validity in a patent action.
[70] The skilled person possesses a level of skill and knowledge necessary to appreciate the nature and description of the invention at a technical level: Whirlpool at para 53. This is the ordinary level skill of and knowledge of the particular art or science to which the patent relates: Free World at para 44. The skilled person embodies the “common general knowledge” (CGK) that is generally known and accepted in the field, and they are reasonably diligent in keeping up with advances: Pfizer Canada Inc v Teva Canada Limited, 2017 FC 777 at para 185.
[71] Where a patent relates to multiple scientific or technical fields, the skilled person can comprise a team of people: Amgen Inc v Pfizer Canada ULC, 2020 FC 522 at para 172. However, the skilled person is not defined on a claim-by-claim basis: Teva Canada Limited v Janssen Inc, 2018 FC 754 at para 236, aff’d 2019 FCA 273, leave to appeal to SCC refused, 39007 (7 May 2020).
[72] Expert witnesses assist the Court by opining on the qualifications, relevant experience and knowledge of the notional skilled person, and how to assess the issues in dispute from the skilled person’s frame of reference in view of the relevant experience and knowledge they would bring to bear: Tetra Tech EBA Inc v Georgetown Rail Equipment Company, 2019 FCA 203 at para 88, citing Free World at para 51.
[73] Drs. Mielniczuk and Kapasi opine that the 770 Patent focuses on the use of macitentan in combination with a PDE5-I to treat a disease where vasoconstriction is involved, particularly PH and PAH. Therefore, the skilled person would be a cardiologist, pulmonologist, or general internist who is capable of identifying and diagnosing PH and PAH, and is capable of either providing direct treatment or referring patients to the appropriate specialist. Dr. Kapasi adds that the skilled person may be part of a larger team that includes those with expertise in pre-clinical animal studies and pharmacology, and an interest in researching diseases related to the circulatory system.
[74] Dr. McIvor opines that the skilled person is a physician with experience in treating patients in diseases wherein vasoconstriction is involved, including PAH. Since severe respiratory diseases, such as PAH, are treated by specialists, the skilled person would have specialized training. The skilled person would have several years of practical clinical experience, as well as experience with or knowledge of the design of clinical trials and the interpretation of their results.
[75] While Dr. McIvor notes that parts of the 770 Patent are directed to those with experience in formulating pharmaceutical products and/or preclinical experiments, he adopted the perspective of the skilled person having the skill set of a physician.
[76] Ms. Picard did not provide an opinion on the skilled person. In these Reasons, references to “physician experts” mean Drs. Mielniczuk, Kapasi, and McIvor.
[77] In this case, the parties and the physician experts have focused on the skilled person’s qualifications as a physician who would treat PH and PAH and in this regard, they do not materially disagree on the skilled person’s qualifications. While the 770 Patent is not limited to PH or PAH, based on statements in the specification that the disease intended to be treated is “more preferably” selected from hypertension and PH, “in particular” PH, and “notably” PAH, I accept that the 770 Patent is more focused on hypertension and PH. Furthermore, I accept that treatment decisions and the management of patients with PAH are made by specialists having an understanding of PH and PAH. In my view, the skilled addressee of the 770 Patent would have knowledge and skills related to the treatment of diseases of vasoconstriction generally, but the skilled person would also have the specialized knowledge about PH or PAH and its treatments.
[78] Dr. Mielniczuk’s and Dr. Kapasi’s reports summarize the skilled person’s CGK as of 2008 regarding PH and PAH, including diagnosing and treating PAH in view of the diagnostic methods and treatments that were available at the time. Their main points are:
a) PAH is a subgroup of PH, characterized by elevated blood pressure in the pulmonary arteries due to a progressive remodeling and narrowing of the arterial walls;
b) The severity of a patient’s symptoms were graded according to a functional classification scheme developed by the World Health Organization (WHO); functional classes I-IV described progressive levels of incapacity and served to monitor disease progression and to inform the therapeutic approach;
c) PAH was rarely diagnosed early: patients often delayed seeking treatment because symptoms progress gradually; the diagnosis was often delayed because PAH symptoms can be attributed to more common cardiorespiratory diseases, and co-morbidities (particularly in older patients) can mask the disease; as a result, PAH was often diagnosed after other possibilities had been ruled out, and it was typically diagnosed in younger patients, particularly otherwise healthy young women;
d) By the time most patients began receiving treatment for PAH, their disease had progressed to WHO functional class III (fatigue, chest pain and other symptoms are experienced with less than ordinary activity) with a median survival of about five years;
e) As of 2008, there remained significant gaps in knowledge about the root causes of PAH and the efficacy and safety of potential treatments;
f) Due to the complexity of the disease, PAH patients were referred to specialized PAH clinics to initiate a therapeutic plan;
g) The therapeutic plan could include supportive medications (e.g., anticoagulants or diuretics); a small percentage of patients were treated with high-dose calcium channel blockers (calcium channel blockers were not approved for PAH i