Janssen Inc. v. Apotex Inc.

Janssen Inc. v. Apotex Inc.
Court (s) Database
Federal Court Decisions
Date
2022-01-31
Neutral citation
2022 FC 107
File numbers
T-124-21
Decision Content
Date: 20220131
Docket: T-124-21
Citation: 2022 FC 107
Ottawa, Ontario, January 31, 2022
PRESENT: The Honourable Mr. Justice Manson
BETWEEN:
JANSSEN INC. and JANSSEN PHARMACEUTICA N.V.
Plaintiffs
and
APOTEX INC.
Defendant
PUBLIC JUDGMENT AND REASONS
(Confidential Judgment and Reasons issued January 31, 2022)
I. Introduction
[1] This is a motion brought by the Defendant, Apotex Inc. [Apotex], for a summary trial.
II. Background
[2] The proceeding underlying this motion is a patent infringement action brought by the Plaintiffs, Janssen Inc. and Janssen Pharmaceutica N.V. [collectively, Janssen] pursuant to subsection 6(1) of the Patent Medicine (Notice of Compliance) Regulations, SOR/93-133 [the “Regulations”] in regards to Canadian Patent No. 2,655,335 [the “335 Patent”].
[3] Janssen Inc. is a “first person” in accordance with the Regulations. Janssen Pharmaceutica N.V. is the registered owner of the 335 Patent and is a party to this action pursuant to subsection 6(2) of the Regulations.
A. The 335 Patent
[4] The 335 Patent is titled, “Prolonged-Release Injectable Suspensions of Paliperidone Palmitate and Dosage Forms and Delivery Systems Incorporating Same.”
[5] The 335 Patent issued from an application filed in Canada on December 17, 2008, claiming priority from United States Patent Application No. 61/014,918 filed on December 19, 2007. The 335 Patent was published on June 19, 2009 and issued on September 6, 2016. The 335 Patent has not expired.
[6] The 335 Patent contains 63 claims – all of which are asserted in this action. Claims 1, 2, 17, 18, 33, 34, 49, and 50 are independent claims.
[7] The 335 Patent relates to dosing regimens for long-acting injectable paliperidone palmitate formulations for the treatment of schizophrenia and related disorders. The 335 Patent teaches a dosing regimen that ensures an optimum plasma concentration-time profile for treating patients with paliperidone. The inventors targeted a plasma concentration exposure range of 7.5 ng/mL to 40 ng/mL of paliperidone after injection to ensure efficacy and minimize adverse side effects.
[8] To achieve therapeutic blood plasma concentrations rapidly, the 335 Patent teaches a “loading dose” regimen, wherein a specific dose is administered on Day 1 and a different specific dose is administered on Day 8, both in the deltoid muscle. The “loading dose” regimen is followed by a “maintenance dose” regimen of monthly doses of paliperidone palmitate administered thereafter, in either the deltoid or the gluteal muscle.
[9] The dosing regimen incorporates “dosing windows” of ± 2 days for the second loading dose, and ± 7 days for the monthly maintenance doses.
[10] The claims of the 335 Patent break down into four sets:
Claims 1 to 16 relate to prefilled syringes adapted for administration according to the claimed dosing regimens;
Claims 17 to 32 relate to a use of a “dosage form” according to the claimed dosing regimens;
Claims 33 to 48 relate to use of paliperidone as paliperidone palmitate in the manufacture/preparation of a “medicament” adapted for administration according to the claimed dosing regimen; and
Claims 49 to 63 relate to a “dosage form” adapted for administration according to the claimed dosage regimens.
[11] The claimed dosing regimen for non-renally impaired psychiatric patients in need of treatment for schizophrenia (or related disorders) is defined in claims 1, 17, and 33:
A first loading dose of 150 milligrams equivalent [mg-eq.] of paliperidone palmitate administered into the deltoid muscle on Day 1 of treatment;
A second loading dose of 100 mg-eq. of paliperidone palmitate administered into the deltoid on Day 8 ± 2 days; and
Maintenance doses of 75 mg-eq. of paliperidone palmitate administered into the deltoid or gluteal muscle monthly ± 7 days after the loading dose injection.
[12] The claimed dosing regimen for renally impaired patients, as defined in claims 2, 18, and 34, follows the same dosing schedule, dosing windows, and injection sites as set out above for non-renally impaired patients. Except with loading doses of 100 mg-eq. and 75 mg-eq., and maintenance doses of 50 mg-eq.
B. INVEGA SUSTENNA®
[13] The 335 Patent is listed on the Patent Register maintained by the Minister of Health pursuant to the Regulations in respect of Janssen’s paliperidone palmitate suspension, marketed under the brand name INVEGA SUSTENNA®, in dosage strengths of 50 mg-eq., 75 mg-eq., 100 mg-eq., and 150 mg-eq.
[14] The product monograph for INVEGA SUSTENNA® sets out dosing regimens falling within the claims of the 335 Patent.
C. Previous Litigation regarding the 335 Patent
[15] The Plaintiffs have previously asserted claims 1 to 48 of the 335 Patent against Teva Canada Limited [Teva] in Court File No. T-353-18 [Janssen Inc. v. Teva Canada Limited, 2020 FC 593 [Teva Paliperidone]].
[16] In Teva Paliperidone, I held, inter alia, that:
An essential element of claim 1 is a continuous maintenance dose of 75 mg-eq. of paliperidone injected into the deltoid or the gluteal muscle monthly ± 7 days after the second loading dose of 100 mg-eq., with the first loading dose being 150 mg-eq. [Teva Paliperidone at paragraph 145].
The essential elements of claim 2 are the same as claim 1, except that the patient in need of treatment must have renal impairment, and the claimed dose amounts are about 100 mg-eq. (first loading dose), 75 mg-eq. (second loading dose), and 50 mg-eq. (maintenance dose) [Teva Paliperidone at paragraph 146].
[17] In that decision, I concluded that Teva would directly infringe claims 1 to 16 and 33 to 48, but not claims 17 to 32, of the 335 Patent if it comes to market with its paliperidone palmitate product in accordance with its Abbreviated New Drug Submission [ANDS] [Teva Paliperidone at paragraph 35].
[18] Based on the evidence before me in Teva Paliperidone, I also held that Teva would not induce infringement of any of claims 1 to 48 of the 335 Patent because “the Teva [product monograph] recommends that the prescribing physician select the maintenance dose for patients with renal impairment based on individual patient characteristics” [Teva Paliperidone at paragraphs 35, 282, and 290].
[19] The appeal of Teva Paliperidone is currently pending.
D. Apotex’s Abbreviated New Drug Submission
[20] Apotex filed its ANDS No. 233882 on |||||||||||||||||| The ANDS seeks approval to market and sell in Canada |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| doses of its proposed APO-PALIPERIDONE INJECTION product [the “APO Product”], a generic version of Janssen’s INVEGA SUSTENNA® product.
[21] ANDS No. 233882 does not seek approval for |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| |||||| of paliperidone palmitate.
E. The Present Action
[22] On December 4, 2020, Apotex served Janssen with a Notice of Allegation in respect of the 335 Patent and ANDS No. 233882 [the “NOA”].
[23] The NOA alleged that the APO Product, that is the subject of ANDS No. 233882, would not infringe the 335 Patent. Apotex did not allege that the 335 Patent is invalid.
[24] In response to the NOA, the Plaintiffs commenced the underlying action against the Defendant pursuant to subsection 6(1) of the Regulations on January 18, 2021. The Plaintiffs are seeking:
A declaration that the making, constructing, using, or selling of the APO Product by Apotex in accordance with ANDS No. 233882 would infringe claims 1 to 63 of the 335 Patent, directly and/or indirectly;
A permanent injunction restraining Apotex (as well as its subsidiaries and affiliates) from:
Making, constructing, using, or selling the APO Product in Canada;
Offering for sale, marketing, or having the APO Product marketed in Canada;
Importing, exporting, distributing, or having the APO Product distributed in Canada; and
Otherwise infringing or inducing others to infringe the 335 Patent.
If Apotex makes, constructs, uses, or sells the APO Product before the expiry of the 335 Patent, damages or an accounting of Apotex’s profits, as the Plaintiffs may elect, resulting from Apotex’s infringing activities in respect of the 335 Patent;
The Plaintiffs’ costs of this action; and
Any other relief that this Honourable Court deems just.
[25] By Order dated February 10, 2021, the time and place for the trial of this action was set for September 26, 2022 in Toronto for ten days.
[26] On February 17, 2021, Apotex delivered a Statement of Defence denying the allegations of infringement and relying on the allegations in its NOA. Apotex advised the Plaintiffs of its intent to bring a motion for summary trial on February 19, 2021.
[27] The Plaintiffs delivered a Reply dated March 1, 2021.
III. Issues
[28] The issues to be decided on this motion are:
(1) Has Apotex established that this matter is appropriate to be decided by way of summary trial?
(2) If yes, should Janssen’s infringement action be dismissed because Apotex is not seeking approval for |||||||||||||||||| of the APO Product, or, conversely, should Janssen’s infringement action be allowed because the product monograph for the APO Product will induce infringement of the 335 Patent?
IV. Analysis
A. Has Apotex established that this matter is appropriate to be decided by way of summary trial?
[29] Motions for summary trial are directed in accordance with the Federal Courts Rules, SOR/98-106 [the “Rules”] 213 and 216.
[30] Rule 213 permits a party to bring a motion for summary trial on all or some of the issues raised in the pleadings at any time after the defendant has filed a defence but before the time and place for trial have been fixed.
[31] Summary trial need not be reserved for cases where the summary trial will result in determination of every issue. The Court has discretion to look at one or more issues and determine whether it is appropriate to deal with those issues by way of summary trial [Rule 213(1); Teva Canada Limited v. Wyeth and Pfizer Canada Inc., 2011 FC 1169 (rev’d on other grounds 2012 FCA 141) [Teva Canada] at paragraph 32].
[32] Pursuant to Rule 216(6), if the Court is satisfied that there is sufficient evidence for adjudication, regardless of the amounts involved, the complexities of the issues, and the existence of conflicting evidence, the Court may grant judgment, unless it would be unjust to do so.
[33] Furthermore, Rule 3 provides that the Rules shall be interpreted and applied so that every proceeding is determined on its merits in the just, most expeditious, and least expensive way.
[34] Ultimately, “the Court must be satisfied that the prerequisites in the Rules for summary judgment or summary trial, understood in light of Rule 3, are met and that it is able to grant summary judgment, fairly and justly, on the evidence adduced and the law” [Viiv Healthcare Company v. Gilead Sciences Canada, Inc., 2021 FCA 122 at paragraph 42].
[35] In addition to those conditions set out in Rule 216(6) above, there are a number of other factors to be considered on a motion for summary trial. These include, inter alia, the complexity and urgency of the matter; any prejudice likely to arise by delay; the cost of taking the case forward to a conventional trial in relation to the amount involved; whether credibility is a crucial factor and the deponents of the conflicting affidavits have been cross-examined; whether the summary trial involves a substantial risk of wasting time and effort, and producing unnecessary complexity; and any other matters which may arise for consideration [Wenzel Downhole Tools Ltd. v. National-Oilwell Canada Ltd., 2010 FC 966 at paragraphs 36-37].
(1) The Parties’ Positions
[36] Apotex, as the party moving for summary trial, bears the burden of demonstrating that summary trial is appropriate [Teva Canada at paragraph 35].
[37] Apotex submits that all of the factors militating in favour of granting judgment following a summary trial are present in this matter:
i. The issues are well defined and will permit the resolution of the case in its entirety. In fact, there is only one issue to be decided: whether Apotex will induce infringement of the claims of the 335 Patent despite not |||||||||| | – there are no issues of claim construction, validity, or direct infringement;
ii. There are sufficient facts and evidence to permit adjudication. In fact, there are no further facts that will come out if the Parties proceed to trial;
iii. The evidence is not controversial;
iv. There will be no issues in assessing credibility in this case because the witnesses will testify viva voce; and
v. The questions of law are straightforward and mirror those already addressed in Teva Paliperidone.
[38] Further, Apotex submits that a summary trial will be the just, most expeditious, and least expensive determination on the merits.
[39] In addition, Apotex submits that, even though this motion was brought after a time and place for trial was fixed counter to Rule 213, this Court should recognize that it acted as expeditiously as possible in bringing this motion.
[40] It is customary in actions brought pursuant to the Regulations that the time and place for trial be fixed early on. In this instance, a trial was fixed a week before Apotex had filed its Statement of Defence. Within days of filing its Defence, Apotex advised Janssen of its intention to bring this motion and sought a case management conference.
[41] As such, Apotex suggests that this is a special circumstance and this Court should, pursuant to Rule 55, dispense with compliance to the timing set out in Rule 213 and allow this motion for summary trial.
[42] Janssen’s position is that this matter is not appropriate for summary trial for the following reasons:
i. There has not yet been full discovery;
ii. There is conflicting expert evidence; and
iii. The appeal of Teva Paliperidone remains pending and its outcome may answer questions of law in respect of the test for inducing infringement.
[43] The only issue for determination on this application is whether, by not seeking approval for |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| in their ANDS and product monograph, the Defendant cannot and does not infringe any of the claims in the 355 Patent.
[44] Pursuant to Rule 216(6), I am satisfied that there are sufficient facts and evidence for the adjudication of the issue put forward by the Parties and it is an appropriate proceeding for summary trial. I also find that pursuant to Rule 55, the Court should proceed with this motion notwithstanding the timing issue with respect to Rule 213.
[45] Any disputes concerning expert and witness credibility can be addressed through the viva voce testimony provided in this matter. With respect to full discovery, it was Janssen who proposed the current timetable, which has discovery scheduled following the hearing of this motion. In addition, Janssen has not provided an indication of what information it requires at discovery that would be pertinent to this motion. That is, Janssen has not indicated what information it perceives to be missing and how this information could influence whether Apotex’s product monograph will induce infringement.
[46] It should also be noted that the evidence engaged before the Court in this matter is not the same as the evidence before the Court in the Teva Paliperidone matter.
B. Should Janssen’s infringement action be dismissed because Apotex is not seeking approval for |||||||||||||||||||||||||||| of the APO Product, or, conversely, should Janssen’s infringement action be allowed because the product monograph for the APO Product will induce infringement of the 335 Patent?
(1) Burden and Onus of Proof
[47] The preliminary issue of which party bears the burden of proof on the merits, once a matter is before the Court for determination by summary trial and the Court has determined the matter is appropriate for a summary trial, was raised in this proceeding.
[48] Apotex submits that the burden in this motion reflects that of the underlying action – Janssen bears the normal civil burden of proof with respect to their allegation of infringement, namely, to establish Apotex’s infringement of the 335 Patent on a balance of probabilities.
[49] In contrast, Janssen submits that Apotex bears the burden of proof of establishing non-infringement. Apotex is the moving party on this motion and is the party asserting the issue of non-infringement of the 335 Patent.
[50] As set out in Janssen v. Pharmascience, 2022 FC 62 at paragraphs 46 to 62, the burden for the determination of the merits of a summary trial reflects that of the underlying trial.
[51] Therefore, while on a motion for summary trial the burden is on the moving party to demonstrate that a summary trial is appropriate, once the onus of the merits of the matter, in terms of either infringement or validity, are before the Court for determination, the burden and onus of proof of the underlying action applies.
[52] Accordingly, the plaintiff asserting a claim of infringement in the underlying action bears the burden of proof on a balance of probabilities to prove that claim at the motion for a summary trial. Similarly, if the defendant asserts an affirmative validity defence in the underlying action, they bear the burden of proof on a balance of probabilities to prove that defence at the motion for summary trial.
[53] Moreover, the parties in a motion or summary judgment or summary trial are required to put their best foot forward, regardless of where the onus lies [Kobold Corporation et al. v NCS Multistage Inc., 2021, FC 1437 [Kobold] at paragraph 148].
[54] As stated above, Apotex argues that the sole issue in this motion is whether Janssen’s infringement action should be dismissed because Apotex is not seeking approval for |||||||||||||||| |||| and, thus, will not induce infringement of the 335 Patent. Janssen has the burden of proving infringement on a balance of probabilities.
[55] With Janssen’s acknowledgment that direct infringement is not at issue in this matter because Apotex is not seeking approval of |||||||||||||||||||||||| the issue is narrowed to whether, on a balance of probabilities, Janssen can satisfy the Court on a balance of probabilities that Apotex will induce infringement of the 335 Patent.
[56] At the hearing, the Parties further agreed that really the sole issue for the Court to determine is the second prong of the Corlac test for inducing infringement: whether the inducer influenced the third party to the point that the infringing act would not have occurred without the influence.
[57] Notwithstanding the question of onus with respect to Apotex’s assertion of non-infringement, the result reached below would not be different even if I were to find that the onus is on Apotex to prove infringement.
(2) The Experts and Fact Witnesses
(a) Apotex’s Experts
(i) Dr. Oloruntoba Oluboka
[58] Dr. Oluboka is a Clinical Associate Professor in the Department of Psychiatry at the University of Calgary and a practicing clinical psychiatrist in the Calgary area. His primary area of speciality is in the treatment of refractory mood and psychotic disorders, including schizophrenia.
[59] Dr. Oluboka obtained his Bachelor’s degree in Surgery and Medicine and completed his residency in psychiatry at the University of Ilorin in Nigeria. He completed a Research Fellowship in mood disorders at Western University and an additional psychiatry residency at Dalhousie University.
[60] In addition to teaching on various topics in regards to schizophrenia and related disorders, Dr. Oluboka has an active clinical psychiatry practice. He treats and oversees patients with schizophrenia and related disorders, and often prescribes INVEGA SUSTENNA® as a pharmacotherapy treatment. Dr. Oluboka is also actively involved in research and education on the use of long-acting antipsychotic therapy for schizophrenia and bipolar mood disorder.
[61] Dr. Oluboka was qualified as an expert in psychiatry with particular expertise in the diagnosis, treatment, and management of mood and psychotic disorders, including schizophrenia, schizoaffective disorder, and treatment-resistant schizophrenia, and the nature and clinical use of antipsychotic drugs, including INVEGA SUSTENNA®, for the treatment of mood and psychotic disorder, and treatment-resistant schizophrenia.
[62] On cross-examination, Dr. Oluboka stated that, while product monographs are included in the relevant literature that is reviewed by treating psychiatrists, physicians do not review the product monographs of generic drugs. This is because the generic product monographs are “carbon copies” of the product monographs for the brand name drug, which physicians are already familiar with through their many years of prescribing the brand name drug before the generic drug comes to the market.
[63] When pressed by counsel for Janssen, Dr. Oluboka agreed that some physicians might refer to generic product monographs. However, he maintained that most physicians would “more often than not” use and refer to the brand name product monographs.
[64] Dr. Oluboka also agreed that he does prescribe the claimed dosing regimen – 150 mg-eq. and 100 mg-eq. loading doses with a 75 mg-eq. maintenance dose – to some patients, as do other psychiatrists. In addition, he agreed that a |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| |||||| Dr. Oluboka stated that the choice of maintenance dose is based, in part, on the efficacy and tolerability experienced after the two loading doses. A patient’s individual characteristics are also used in the determination of the maintenance dose.
[65] Scientific papers were put before Dr. Oluboka in order to highlight the mean dose of paliperidone palmitate in the maintenance phase. One study found that the mean dose of paliperidone palmitate in the maintenance phase was 82.6 mg. Dr. Oluboka would not agree that 82.6 mg was closer to the 75 mg dose available than it was to 100 mg until repeatedly pressed by counsel for Janssen. His reluctance to agree to what was readily apparent goes to his credibility and weight to be attributed to his evidence.
(ii) Dr. Maria Zhang
[66] Dr. Zhang is a Clinician Educator and Advanced Practice Clinical Leader (Pharmacy) at the University of Toronto and the Centre for Addition and Mental Health in Toronto [CAMH].
[67] Dr. Zhang obtained her Bachelor of Pharmacy and Doctor of Pharmacy degrees from the University of Toronto.
[68] In her role at CAMH, Dr. Zhang supports and advances clinical pharmacy services for mental health patients by functioning as a resource for the pharmacists and pharmacy technicians. She also oversees educational programs delivered by the Pharmacy Department.
[69] In her role at the University of Toronto, Dr. Zhang coordinates and lectures pharmacy students of varying levels, with a focus on psychiatric disorders.
[70] Dr. Zhang was qualified as an expert in pharmacy practice and medication management, including the physician-pharmacist relationship, prescribing and drug dispensing practice, and the use of product monographs, particularly with respect to the treatment of major psychotic disorders, such as schizophrenia and schizoaffective disorder.
[71] Dr. Zhang was a credible witness. She provided evidence that the product monographs for INVEGA SUSTENNA® and the APO Product are largely identical. She also stated that, while pharmacists refer to product monographs when a product is new on the market, there is a “very low” chance that product monographs will be referred to once they are familiar with it, such as by the time the generic product is introduced.
[72] Dr. Zhang also noted that the prescribing physician will prescribe “paliperidone palmitate” and it is the pharmacists who will choose whether the brand name or generic product will be used to fulfill the prescription. She also stated that INVEGA SUSTENNA® and the APO Product would be treated as interchangeable.
[73] On cross-examination, Dr. Zhang agreed that the product monograph for the APO Product refers to |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
[74] Based on the evidence before the Court, the relevant third parties who may be sufficiently influenced by the product monograph for the APO Product to implement the claimed dosing regimen, thereby directly infringing the 335 Patent, are prescribers (such as a physician or nurse practitioner) and/or patients. Therefore, limited weight is attributed to Dr. Zhang’s evidence as a pharmacist expert.
(b) Apotex’s Fact Witnesses
(i) Mr. Nicholas Boorman
[75] Mr. Boorman is the Vice-President of Marketing and Commercial Operations for Apotex. His evidence addressed Apotex’s marketing plans for its APO Product.
[76] Mr. Boorman stated that Apotex would not market or promote the APO Product in any way to physicians or patients in Canada. However, the APO Product will be a part of its patient support program (ApoAssist) and a general communication alerting pharmacists in Canada to the launch of a new product will be delivered.
[77] On cross-examination, Mr. Boorman agreed that the product monograph for the APO Product would also be posted on the Health Canada website accessible to both physicians and patients. Furthermore, if approved, pharmacists will be provided a notice of dosage strengths available, the prices of the available products, and a contact number for pharmacists to reach an Apotex Order Desk to inquire about purchasing the products. This notice also refers to the INVEGA SUSTENNA® product as the brand name equivalent and the Apotex Order Desk is able to provide the INVEGA SUSTENNA® product monograph if requested.
(ii) Mr. Duane Terrill
[78] Mr. Terrill is the Director of Regulatory Affairs Canada and Caribbean for Apotex. His evidence outlined his knowledge of the filing of ANDS No. 233882 in regards to the APO Product.
[79] Mr. Terrill also provided information on |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Mr. Terrill noted that |||||||||||||||||||||||||||||||||||||| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
(c) Janssen’s Experts
(i) Dr. Ofer Agid
[80] Dr. Agid is a Medical Doctor with specialized training in the field of psychiatry. Dr. Agid also holds several clinical, teaching, and research positions at CAMH and the University of Toronto.
[81] Dr. Agid obtained his medical degree and completed his psychiatry residency in Israel.
[82] Dr. Agid’s psychiatry practice focusses on the diagnosis, treatment, and management of psychotic disorders, including schizophrenia and related disorders, and other complex mental disorders. He is actively involved in schizophrenia research, a large aspect of which focusses on the pharmacology of antipsychotics.
[83] Dr. Agid was qualified as an expert in the diagnosis, treatment, and management of psychotic disorders (including schizophrenia, schizoaffective disorder, schizophreniform disorder, and treatment-resistant schizophrenia) and the nature and clinical use of antipsychotic drugs, including INVEGA SUSTENNA®, for the treatment of psychotic disorders (including schizophrenia, schizoaffective disorder, schizophreniform disorder, and treatment-resistant schizophrenia).
[84] Dr. Agid stated that product monographs were an important source of information for physicians for the optimization of treatment of patients. He also stated that some physicians will consult both the brand name and generic product monographs based on their availability in the hospital formulary at that time.
[85] Dr. Agid further provided that, while physicians generally use skill, judgment, and experience when making clinical decisions for patients, they also use the product monographs. Dr. Agid disagreed with Apotex’s expert Dr. Oluboka that physicians would rely on individual characteristics, such as age, sex, weight, severity of illness, or overall physical health – other than renal impairment as set out in the product monograph.
[86] During cross-examination, counsel for Janssen objected to the use of Dr. Agid’s previous statements in Teva Paliperidone. I find that Dr. Agid’s previous statements were used for the purpose agreed upon by the Parties ahead of trial – that is, to impeach the credibility of Dr. Agid.
[87] Counsel for Janssen further argued that the Defendant’s use of prior statements in the cross-examination of Dr. Agid went against the rule set out in Browne v. Dunn, (1893) 6 R 67 (HL). The rule in Browne v. Dunn, in essence, requires that a party intending to bring evidence to impeach or contradict the testimony of a witness must present the witness with that evidence and give them an opportunity to explain or answer while on the witness stand. I find that the Defendant did correctly follow this rule. Dr. Agid was provided, and referred to, his previous expert statements filed in Teva Paliperidone, as well as the transcript of his testimony provided in Teva Paliperidone, in order to allow him to justify his evidence in this case.
[88] During cross-examination, Dr. Agid suffered from several credibility issues:
i. When Dr. Agid was referred to his previous expert reports provided for Teva Paliperidone, he insisted that he could not recall his opinion even after being referred to specific paragraphs.
ii. In contrast to his examination-in-chief, Dr. Agid agreed that when prescribing medication to patients with schizophrenia, physicians will base their prescribing decision on individual characteristics, as well as knowledge acquired from their medical training and continued education, treatment experiences, and medical literature and product monographs.
iii. Dr. Agid denied considering race in his prescribing practices. However, he was aware that patients of Asian ethnicity typically require lower doses of anti-psychotic medication and agreed that he considers this in his prescribing practices.
iv. Dr. Agid had no recollection of several peer-reviewed articles on the subject of paliperidone palmitate dosing that he was asked about (and recalled) during Teva Paliperidone, even after the Defendant provided him with both the article and a transcript of his pervious testimony in Teva Paliperidone.
(ii) Dr. Pierre Chue
[89] Dr. Chue is a Medical Doctor with specialized training in the field of psychiatry. He holds several clinical, research, and teaching positions with Alberta Health Services and the University of Alberta.
[90] Dr. Chue obtained his Bachelor of Medicine and Surgery from the Welsh National School of Medicine.
[91] Dr. Chue’s practice focuses on the treatment of adult patients with mental illness, including schizophrenia and schizoaffective disorder.
[92] As a result of his education, practical experience, and involvement in physician education, Dr. Chue claims expertise in the disorders of schizophrenia and schizoaffective disorder, including how these disorders are treated and managed by physicians. He commonly prescribes INVEGA SUSTENNA® and has been a member of advisory boards for INVEGA SUSTENNA®. He has an understanding of how paliperidone palmitate is prescribed by other Canadian clinicians.
[93] Dr. Chue was qualified as an expert in the diagnosis and treatment of schizophrenia and schizoaffective disorder. This expertise includes the clinical use of injectable depot medications, such as paliperidone palmitate, i.e. INVEGA SUSTENNA®.
[94] Dr. Chue testified that product monographs contain evidence-based information approved by Health Canada, which provides information in terms of how to safely and effectively administer medication, and they represent the baseline that clinicians follow in practice. Further, Dr. Chue stated that the review of product monographs is considered to be best clinical practice, and that many clinicians review product monographs to inform their prescribing practices, including, in some cases, the generic product monographs.
[95] Further, Dr. Chue provided that some physicians will be influenced to prescribe the claimed dosing regimen by the product monograph for the APO Product.
[96] On cross-examination, Dr. Chue agreed that treating physicians will base their prescribing decisions on their professional skill and judgment, training, experience, and individual patient characteristics – with the product monograph included in a physician’s skill and judgment, and experience. He further qualified that the choice of maintenance dose is also based on a patient’s response to the loading dose regimen.
[97] Dr. Chue further testified that, though maintenance doses and dosing windows may be adjusted, he would first reach a baseline using the claimed dosing regimen set out in the product monograph. He also agreed that his prescribing practice for paliperidone palmitate would not change if the APO Product were to be approved and enter into the market.
[98] Dr. Chue was a credible witness. Notwithstanding the evidence provided by Dr. Agid, Dr. Chue’s evidence corroborated his earlier expert statement that some physicians would be influenced by the product monograph for the APO Product to prescribe the claimed dosing regimen.
(iii) Mr. Richard Jones
[99] Mr. Jones is a Pharmacist and currently the Regional Director of Pharmacy Services at Island Health – the health authority for Vancouver Island, which provides publicly funded health care services through a network of more than 100 hospitals, clinics, health units, and long-term care locations.
[100] Mr. Jones is responsible for the safe and effective clinical and technical pharmacy operations of hospitals and health care centres under the purview of Island Health, including nine hospital pharmacies and two outpatient community pharmacies. This includes managerial oversight of over 370 pharmacists and associated pharmacy staff, such as pharmacy technicians and assistants.
[101] Mr. Jones was qualified as an expert in drug formulary management, including the process and considerations involved in listing a drug product on a hospital drug formulary, and pharmacy practice and medication management in a hospital setting, including prescribing methods, drug dispensing practices, and pharmacy clinical practice processes.
[102] Mr. Jones testified that a generic product monograph will be reviewed before a generic drug product is added to a hospital formulary. In addition, he stated that if the APO Product is added to formularies, it will be interchangeable with INVEGA SUSTENNA® – with the APO Product |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| ||||||||||||||||||||||||||||||||||
[103] On cross-examination, Mr. Jones testified that his current role is administrative and that he has not filled a prescription in approximately two decades. Mr. Jones stated that pharmacists might refer to product monographs, especially when they are verifying a prescription. Mr. Jones agreed that it is the physician that makes the prescribing decisions, including which maintenance dose within the range from 50 mg-eq. to 150 mg-eq. to prescribe for a patient.
[104] As stated above, based on the evidence before the Court, the relevant third parties who may be sufficiently influenced by the product monograph for the APO Product to implement the claimed dosing regimen, thereby directly infringing the 335 Patent, are prescribers (such as a physician or nurse practitioner) and/or patients. Therefore, limited weight is attributed to Mr. Jones’ evidence as a pharmacist expert.
(3) Claims Construction
[105] Apotex asserts that claim construction is not an issue in this matter because claims 1 to 48 have already been construed in Teva Paliperidone. Further, patent validity is not an issue because Apotex does not allege invalidity.
[106] Nevertheless, all 63 claims of the 335 Patent are alive in this motion and the applicable principles of claim construction have been summarized by the Federal Court of Appeal in Tearlab Corporation v. I-Med Pharma Inc., 2019 FCA 179 at paragraphs 30 to 34:
[30] The general principles of claim construction are now well established and were set out by the Supreme Court in three cases (Whirlpool at paras. 49-55; Free World Trust v. Électro Santé Inc., 2000 SCC 66, [2000] 2 S.C.R. 1024 at paras. 31-67 [Free World Trust]; Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., 1981 CanLII 15 (SCC), [1981] 1 S.C.R. 504 at p. 520 [Consolboard]). These principles can be summarized as follows.
[31] The Patent Act promotes adherence to the language of the claims, which in turn promotes fairness and predictability (Free World Trust at paras. 31(a), (b) and 41). The words of the claims must, however, be read in an informed and purposive way (at para. 31(c)), with a mind willing to understand (at para. 44). On a purposive construction, it will be apparent that some elements of the claimed invention are essential while others are non-essential (at para. 31(e)). The interpretative task of the court, in claim construction, is to separate and distinguish between the essential and the non-essential elements, and to give the legal protection to which the holder of a valid patent is entitled only to the essential elements (at para. 15).
[32] To identify these elements, the claim language must be read through the eyes of a POSITA, in light of the latter’s common general knowledge (Free World Trust at paras. 44-45; see also Frac Shack at para. 60; Whirlpool at para. 53). As noted in Free World Trust:
[51] …The words chosen by the inventor will be read in the sense the inventor is presumed to have intended, and in a way that is sympathetic to accomplishment of the inventor’s purpose expressed or implicit in the text of the claims. However, if the inventor has misspoken or otherwise created an unnecessary or troublesome limitation in the claims, it is a self-inflicted wound. The public is entitled to rely on the words used provided the words used are interpreted fairly and knowledgeably. [Emphasis in the original.]
[33] Claim construction requires that the disclosure and the claims be looked at as a whole “to ascertain the nature of the invention and methods of its performance, … being neither benevolent nor harsh, but rather seeking a construction which is reasonable and fair to both patentee and public” (Consolboard at p. 520; see also Teva Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60, [2012] 3 S.C.R. 625 at para. 50). Consideration can thus be given to the patent specifications to understand what was meant by the words in the claims. One must be wary, however, not to use these so as “to enlarge or contract the scope of the claim as written and … understood” (Whirlpool at para. 52; see also Free World Trust at para. 32). The Supreme Court recently emphasized that the focus of the validity analysis will be on the claims; specifications will be relevant where there is ambiguity in the claims (AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36, [2017] 1 S.C.R. 943 at para. 31; see also Ciba at paras. 74-75).
[34] Finally, it is important to stress that claim construction must be the same for the purpose of validity and for the purpose of infringement (Whirlpool at para. 49(b)).
[107] The relevant date for construing the claims is the publication date: June 19, 2009.
(4) Infringement
[108] To establish that the APO Product will directly infringe the 335 Patent, Janssen must prove, on a balance of probabilities, that the