Janssen Inc. v. Canada (Health)

Janssen Inc. v. Canada (Health)
Court (s) Database
Federal Court Decisions
Date
2023-07-17
Neutral citation
2023 FC 870
File numbers
T-2627-22
Decision Content
Date: 20230717
Docket: T-2627-22
Citation: 2023 FC 870
Ottawa, Ontario, July 17, 2023
PRESENT: The Honourable Madam Justice Aylen
BETWEEN:
JANSSEN INC.
Applicant
and
THE MINISTER OF HEALTH AND THE ATTORNEY GENERAL OF CANADA
Respondents
PUBLIC JUDGMENT AND REASONS
(Confidential version issued on June 21, 2023)
[1] The Applicant, Janssen Inc [Janssen], seeks judicial review of a decision of the Office of Submissions and Intellectual Property [OSIP] on behalf of the Minister of Health dated November 15, 2022. OSIP determined that Canadian Patent No. 3,113,837 [837 Patent] was not eligible to be added to the Patent Register against STELARA® with respect to two supplementary new drug submissions.
[2] While Janssen has raised a number of issues on this application, of central importance are the following two issues: (i) whether OSIP’s decision that a supplemental new drug submission approved for additional safety data that could provide a clinician more confidence in prescribing a drug long-term is not a “change in use of the medicinal ingredient” as prescribed by subsection 4(3) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 [PMNOC Regulations] if the approved indication never included a temporal restriction on its use was reasonable; and (ii) whether the Canadian patent filing date requirement in subsection 4(6) of the PMNOC Regulations is ultra vires the Patent Act.
[3] For the reasons that follow, I am not satisfied that Janssen has demonstrated that there is any basis for the Court’s intervention. Accordingly, the application for judicial review shall be dismissed in its entirety, with costs.
I. Background
A. Drug Approval under the Food and Drug Regulations
[4] Drug manufacturers who wish to advertise or sell a new drug in Canada must first obtain a Notice of Compliance [NOC] pursuant to the Food and Drug Regulations, CRC, c 870, by filing a drug submission with the Minister.
[5] The Food and Drug Regulations refer to several types of drug submissions, including a new drug submission [NDS] and a supplemental new drug submission [SNDS]. An NDS is typically filed by the innovator drug manufacturer in order to obtain an NOC. An NDS contains a variety of clinical, non-clinical, chemistry and manufacturing data relating to the safety, efficacy and quality of the drug. The Minister evaluates this information to determine whether the drug meets the regulatory requirements in order to initially approve the drug for sale on the Canadian market. After an NOC for an NDS is issued, a manufacturer will typically continue to file information about the drug. Significant changes made to the information or material contained in the NDS are made by filing an SNDS. An NOC is also issued by the Minister for each approved SNDS.
B. Product Monographs
[6] As part of the drug review process for an NDS or SNDS, Health Canada reviews a Product Monograph which is a factual, scientific document that describes a drug product’s properties, claims, indications, contra-indications, conditions, dosage, administration and any other relevant information that may be required for the optimal, safe and effective use of the drug. The “Indications and Clinical Use” section of a Product Monograph, among other things, lists the uses for which the drug has been approved through the issuance of an NOC.
C. The PMNOC Regulations
[7] The PMNOC Regulations, which were enacted in 1993 and have subsequently been amended on a number of occasions, were promulgated pursuant to the authority granted to the Governor in Council by subsection 55.2(4) the Patent Act, RSC 1985, c P-4, which provides:
The Governor in Council may make regulations respecting the infringement of any patent that, directly or indirectly, could result or results from the making, construction, use or sale of a patented invention in accordance with subsection (1), including regulations
(a) respecting the conditions that must be fulfilled before a document — including a notice, certificate or permit — concerning any product to which a patent may relate may be issued to any person under any Act of Parliament that regulates the manufacture, construction, use or sale of that product, in addition to any conditions provided for by or under that Act;
(b) respecting the earliest day on which such a document may be issued to a person and the earliest day on which it may take effect, and respecting the manner in which each day is to be determined;
(c) respecting the issuance, suspension or revocation of such a document in circumstances where, directly or indirectly, the document’s issuance could result or results in the infringement of a patent;
(d) respecting the prevention and resolution of disputes with respect to the day on which such a document may be issued or take effect;
(e) respecting the prevention and resolution of disputes with respect to the infringement of a patent that could result directly or indirectly from the manufacture, construction, use or sale of a product referred to in paragraph (a);
(f) respecting the resolution of disputes with respect to the infringement of a patent that results directly or indirectly from the manufacture, construction, use or sale of such a product;
(g) conferring rights of action with respect to disputes referred to in any of paragraphs (d) to (f);
(h) restricting or excluding the application of other rights of action under this Act or another Act of Parliament to disputes referred to in any of paragraphs (d) to (f);
(i) designating the court of competent jurisdiction in which a proceeding with respect to rights of action referred to in paragraph (g) is to be heard;
(j) respecting such proceedings, including the procedure of the court in the matter, the defences that may be pleaded, the remedies that may be sought, the joinder of parties and of rights of action and the consolidation of other proceedings, the decisions and orders the court may make and any appeals from those decisions and orders; and
(k) specifying who may be an interested person for the purposes of subsection 60(1) with respect to disputes referred to in paragraph (e).
Le gouverneur en conseil peut, par règlement, régir la contrefaçon de tout brevet qui résulte ou pourrait résulter, de façon directe ou autrement, de la fabrication, de la construction, de l’utilisation ou de la vente, au titre du paragraphe (1), d’une invention brevetée, et notamment :
a) régir les conditions complémentaires nécessaires à la délivrance à quiconque, relativement à un produit auquel peut se rapporter un brevet, de tout titre — avis, certificat, permis ou autre — en vertu de lois fédérales régissant la fabrication, la construction, l’utilisation ou la vente d’un tel produit;
b) régir la première date à laquelle un tel titre peut être délivré et celle à laquelle il peut prendre effet, ainsi que la manière de fixer chacune de ces dates;
c) régir la délivrance, la suspension ou la révocation d’un tel titre lorsque la délivrance de celui-ci entraîne ou pourrait entraîner, de façon directe ou autrement, la contrefaçon d’un brevet;
d) régir la prévention et le règlement de différends portant sur la date à laquelle un tel titre peut être délivré ou prendre effet;
e) régir la prévention et le règlement de différends portant sur la contrefaçon d’un brevet qui pourrait résulter, de façon directe ou autrement, de la fabrication, de la construction, de l’utilisation ou de la vente d’un produit visé à l’alinéa a);
f) régir le règlement de différends portant sur la contrefaçon d’un brevet qui résulte, de façon directe ou autrement, de la fabrication, de la construction, de l’utilisation ou de la vente d’un tel produit;
g) conférer des droits d’action concernant les différends visés à l’un ou l’autre des alinéas d) à f);
h) limiter ou interdire le recours à d’autres droits d’action prévus par toute loi fédérale concernant les différends visés à l’un ou l’autre des alinéas d) à f);
i) désigner le tribunal compétent à l’égard des procédures résultant de l’exercice des droits d’action visés à l’alinéa g);
j) régir ces procédures, notamment la procédure devant ce tribunal, les moyens de défense qui peuvent être invoqués, les conclusions qui peuvent être recherchées, la jonction de parties, la réunion de droits d’action ou d’autres procédures, les décisions et ordonnances qui peuvent être rendues ainsi que les appels de ces décisions et ordonnances;
k) préciser qui peut être un intéressé pour l’application du paragraphe 60(1) dans le cadre des différends visés à l’alinéa e).
[8] As confirmed by the Supreme Court of Canada in AstraZeneca Canada Inc v Canada (Minister of Health), 2006 SCC 49 at paragraph 12, the PMNOC Regulations lie at the intersection of two regulatory systems with sometimes conflicting objectives – (i) the law governing the approval of new drugs (Food and Drug Act) with the objective of encouraging the bringing of safe and effective medicines to market to advance the nation’s health; and (ii) patent protection provided to innovators under the Patent Act.
[9] The Regulatory Impact Analysis Statement [RIAS] related to the 2006 amendments to the PMNOC Regulations describes the balancing function as follows:
The Government’s pharmaceutical patent policy seeks to balance effective patent enforcement over new and innovative drugs with the timely market entry of their lower priced generic competitors. The current manner in which that balance is realized was established in 1993, with the enactment of Bill C-91, the Patent Act Amendment Act, 1992, S.C. 1993, c. 2.
On the one end of the balance lies subsection 55.2(1) of the Patent Act, better known as the “early-working” exception. In the pharmaceutical industry, early-working allows second and subsequent entry drug manufacturers (typically generic drug companies) to use a patented innovative drug for the purpose of seeking approval to market a competing version of that drug. Normally, conduct of this kind would constitute patent infringement but an exception has been made so that generic drug companies can complete Health Canada’s regulatory approval process while the equivalent innovative drug is still under patent, in order to be in a position to enter the market as soon as possible after patent expiry. The generic pharmaceutical industry estimates that early-working can accelerate the market entry of its products in Canada by some three to five years.
The PM(NOC) Regulations represent the other half of the balance. As explained in the original Regulatory Impact Analysis Statement (RIAS) which accompanied their passage in 1993, in creating the early-working exception, Bill C-91 removed an exclusive right otherwise available to patentees and the PM(NOC) Regulations are therefore required “…to ensure that this new exception to patent infringement is not abused by generic drug applicants seeking to sell their products during the term of the competitor’s patent…” The PM(NOC) Regulations do this by linking Health Canada’s ability to approve a generic drug to the patent status of the equivalent innovative product the generic seeks to copy. Under the current scheme, a generic drug company which compares its product directly or indirectly with a patented, innovative drug in order to establish the former’s safety and efficacy and secure marketing approval from Health Canada (which comes in the form of a “notice of compliance” or ‘NOC”) must make one of two choices. It can either agree to await patent expiry before obtaining its NOC or make an allegation justifying immediate market entry that is either accepted by the innovator or upheld by the court.
Thus, while early-working is intended to promote the timely market entry of generic drugs by allowing them to undergo the regulatory approval process in advance of patent expiry, the PM(NOC) Regulations are intended to provide effective patent enforcement by ensuring the former does not result in the actual issuance of a generic NOC until patent expiry or such earlier time as the court or innovator considers justified having regard to the generic company’s allegations. Despite their seemingly competing policy objectives, it is important that neither instrument be considered in isolation as the intended policy can only be achieved when the two operate in a balanced fashion.
D. The Patent Register
[10] The Minister maintains a Patent Register, which is a list of patents and certifications of supplementary protection associated with each approved drug. Pursuant to subsections 3(2) to 3(8) of the PMNOC Regulations, the Minister has the discretion to maintain the Patent Register, including the ability to add or delete patents in various prescribed circumstances.
[11] A “first person” who files an NDS or SNDS may, pursuant to subsection 4(1) of the PMNOC Regulations, submit to the Minister a patent for listing on the Patent Register in respect of the drug for which approval is sought. A patent will only be added to the Patent Register if the Minister is satisfied that the relevant regulatory criteria are met.
[12] In the case of an SNDS, paragraph 4(3)(c) sets out the product specificity requirements that must be met for a patent to be listed on the Patent Register:
(3) A patent on a patent list in relation to a supplement to a new drug submission is eligible to be added to the register if the supplement is for a change in formulation, a change in dosage form or a change in use of the medicinal ingredient, and
[…]
(c) in the case of a change in use of the medicinal ingredient, the patent contains a claim for the changed use of the medicinal ingredient that has been approved through the issuance of a notice of compliance in respect of the supplement.
(3) Est admissible à l’adjonction au registre tout brevet, inscrit sur une liste de brevets, qui se rattache au supplément à une présentation de drogue nouvelle visant une modification de la formulation, une modification de la forme posologique ou une modification de l’utilisation de l’ingrédient médicinal, s’il contient, selon le cas :
c) dans le cas d’une modification d’utilisation de l’ingrédient médicinal, une revendication de l’utilisation modifiée de l’ingrédient médicinal, l’utilisation ayant été approuvée par la délivrance d’un avis de conformité à l’égard du supplément.
[13] Subsection 4(4) of the PMNOC Regulations prescribe what must be included in a patent list:
A patent list shall contain the following:
(a) an identification of the new drug submission or the supplement to a new drug submission to which the list relates;
(b) the medicinal ingredient, brand name, dosage form, strength, route of administration and use set out in the new drug submission or the supplement to a new drug submission to which the list relates;
(c) for each patent on the list, the patent number, the filing date of the patent application in Canada, the date of grant of the patent and the date on which the term limited for the duration of the patent will expire under section 44 or 45 of the Patent Act;(d) for each patent on the list, a statement that the first person who filed the new drug submission or the supplement to a new drug submission to which the list relates
is the owner of the patent,
has an exclusive licence to the patent or to a certificate of supplementary protection in which that patent is set out, or
(iii) has obtained the consent of the owner of the patent to its inclusion on the list;
(e) the address in Canada for service, on the first person, of a notice of allegation referred to in paragraph 5(3)(a) or the name and address in Canada of another person on whom service may be made with the same effect as if service were made on the first person; and
(f) a certification by the first person that the information submitted under this subsection is accurate and that each patent on the list meets the eligibility requirements of subsection (2) or (3).
La liste de brevets comprend :
a) l’identification de la présentation de drogue nouvelle ou du supplément à la présentation de drogue nouvelle qui s’y rattachent;
b) l’ingrédient médicinal, la marque nominative, la forme posologique, la concentration, la voie d’administration et l’utilisation prévus à la présentation ou au supplément qui s’y rattachent;
c) à l’égard de chaque brevet qui y est inscrit, le numéro de brevet, la date de dépôt de la demande de brevet au Canada, la date de délivrance de celui-ci et la date d’expiration du brevet aux termes des articles 44 ou 45 de la Loi sur les brevets;
d) à l’égard de chaque brevet qui y est inscrit, une déclaration portant que la première personne qui a déposé la présentation de drogue nouvelle ou le supplément à une présentation de drogue nouvelle qui s’y rattache :
(i) soit en est le propriétaire,
(ii) soit en détient la licence exclusive ou détient une telle licence à l’égard d’un certificat de protection supplémentaire qui mentionne ce brevet,
(iii) soit a obtenu le consentement du propriétaire pour l’inscrire sur la liste;
e) l’adresse au Canada de la première personne aux fins de signification de l’avis d’allégation visé à l’alinéa 5(3)a) ou les nom et adresse au Canada d’une autre personne qui peut en recevoir signification comme s’il s’agissait de la première personne elle-même;
f) une attestation de la première personne portant que les renseignements fournis aux termes du présent paragraphe sont exacts et que chaque brevet qui y est inscrit est conforme aux conditions d’admissibilité prévues aux paragraphes (2) ou (3).
[14] The PMNOC Regulations also prescribe timing requirements related to patent listing, which depend on when the patent is issued. Specifically, subsections 4(5) and (6) provide:
(5) Subject to subsection (6), a first person who submits a patent list must do so at the time the person files the new drug submission or the supplement to a new drug submission to which the patent list relates.
(6) A first person may, after the date of filing of a new drug submission or a supplement to a new drug submission, and within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date in Canada that precedes the date of filing of the submission or supplement, submit a patent list, including the information referred to in subsection (4), in relation to the submission or supplement.
(5) Sous réserve du paragraphe (6), la première personne qui présente une liste de brevets doit le faire au moment du dépôt de la présentation de drogue nouvelle ou du supplément à une présentation de drogue nouvelle qui s’y rattachent.
(6) La première personne peut, après la date de dépôt de la présentation de drogue nouvelle ou du supplément à une présentation de drogue nouvelle et dans les trente jours suivant la délivrance d’un brevet faite au titre d’une demande de brevet dont la date de dépôt au Canada est antérieure à celle de la présentation ou du supplément, présenter une liste de brevets, à l’égard de cette présentation ou de ce supplément, qui contient les renseignements visés au paragraphe (4).
[15] As such, only patents that have a filing date in Canada before the filing date of an SNDS are eligible to be added to the Patent Register.
[16] For the purpose of the administration of the patent list, the Minister utilizes a form entitled “Form IV” that the Minister requires be completed by each first person. Form IV states in its header in bold to “COMPLETE ONE FORM PER PATENT PER SUBMISSION”.
[17] Having a patent listed on the Patent Register in relation to a particular drug affords significant protections to an innovator. If a second person files a drug submission that directly or indirectly compares their drug with, or makes reference to, a first person’s drug that is marketed in Canada under an NOC and which has one or more patents listed on the Patent Register, the second person must, pursuant to subsection 5(1) and (2.1) of the PMNOC Regulations, address each listed patent. One manner of addressing a listed patent is to serve on the first person a notice of allegation [NOA], pursuant to subsection 5(2.1)(c), alleging that the listed patent is invalid or would not be infringed by the second person making, constructing, using or selling their drug product. The first person then has the right, within 45 days of being served with a NOA, to bring an action against the second person pursuant to subsection 6(1) seeking a declaration that making, constructing, using or selling of the second person’s drug product in accordance with the second person’s drug submission would infringe the listed patent(s) addressed in the NOA. When such an action is brought, the Minister is prohibited from issuing a NOC to the second person for 24 months from the date of commencement of the action or such other periods of time prescribed by subsection 7(1) of the PMNOC Regulations.
[18] However, not all patents will receive the aforementioned protection afforded by the regulatory regime simply by relating to a drug for which an NOC has been issued. Only those patents that meet the product specificity and timing requirements of the PMNOC Regulations will benefit from the regime’s protections.
E. STELARA®
[19] STELARA® is a Schedule D biologic drug containing the medicinal ingredient ustekinumab [STELARA]. First approved in Canada in December of 2008 for the treatment of psoriasis, STELARA has since gained approvals for several other indications including its use to treat plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease.
[20] There are currently no patents listed on the Patent Register in respect of STELARA. Canadian Patent No. 2,418,961 was previously listed on November 17, 2009, but expired on August 9, 2021.
[21] Health Canada’s “Submissions Under Review” page shows at least one company has filed a submission for approval of a biosimilar of STELARA in January of 2023.
(1) SNDS 244739
[22] On February 15, 2019, the Applicant filed SNDS 224739 [SNDS 739] seeking approval for a new use of STELARA for the treatment of adult patients with moderately to severely active ulcerative colitis and updates to the Product Monograph. Supporting studies were submitted, including approximately one year of data (44 weeks) from a UNIFI-M maintenance study.
[23] On January 23, 2020, the Minister approved the use of STELARA for the treatment of ulcerative colitis, issuing an NOC for SNDS 739. The NOC stated, under the heading “Reasons for Supplement”:
New indication: The treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.
[24] The “Dosage and Administration” section of the approved Product Monograph included a recommended induction treatment regimen for ulcerative colitis, as well as a recommended maintenance dose regimen. No temporal limitation on the duration of treatment was included in the Product Monograph. Put differently, the NOC for SNDS 739 did not approve the use of STELARA to treat ulcerative colitis for a limited period of time.
(2) SNDS 244670
[25] On October 1, 2020, Janssen filed SNDS 244670 [SNDS 670] seeking to update the Product Monograph of STELARA with updated two-year safety and efficacy data (96 weeks) from the same on-going UNIFI-M study on its use for ulcerative colitis (which use had been previously approved with SNDS 739).
[26] The Clinical Evaluation Executive Summary notes, under the heading “Subject”, that SNDS 670 is to “update the product monograph to include results from the long-term extensions of two Phase 3 studies for the treatment of adult patients with moderately to severely active Crohn’s disease or ulcerative colitis”.
[27] Both the General Note to Reviewer and Regulatory Executive Summary notes the purpose of the submission was to provide data on safety and efficacy of STELARA through five years of treatment in subjects with Crohn’s disease and two years of treatment in subjects with ulcerative colitis, including relevant data in regard to a post-marketing adverse drug reaction for hypersensitivity vasculitis.
[28] Janssen indicated in the Product Information Regulatory Process Form for SNDS 670 that “there [were] no changes to the indication/Use/Dosage (including the maximum daily dose)”.
[29] On September 9, 2021, Health Canada issued an NOC for SNDS 670. Under the heading “Reason for Supplement”, the NOC states “Updates to the Product Monograph”. The approval resulted in two changes to the Product Monograph, as shown in bold and underlined below:
Product Monograph (SNDS 739)
Product Monograph (SNDS 670)
(1) In the “Clinical Trial Adverse Drug Reactions” section addressing adverse drug reactions reported in studies related to ulcerative colitis, on page 12:
The safety of STELARA®/STELARA® I.V. was evaluated in two randomized, double-blind, placebo-controlled studies (UNIFI-I and UNIFI-M) in 960 adult patients with moderately to severely active ulcerative colitis. The overall safety profile was similar for patients with psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
The safety of STELARA®/STELARA® I.V. was evaluated in two randomized, double-blind, placebo-controlled studies (UNIFI-I and UNIFI-M) in 960 adult patients with moderately to severely active ulcerative colitis. The overall safety profile was similar for patients with psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
The safety profile remaining generally consistent throughout the Week 96 safety analysis.
(2) In the “Study and Demographics and Trial Design” section on page 58:
The maintenance study (UNIFI-M), evaluated 523 patients who achieved clinical response at Week 8 following the administration of STELARA® I.V. in UNIFI-I. These patients were randomized to receive a subcutaneous maintenance regimen of either 90 mg of STELARA® every 8 weeks, 90 mg STELARA® every 12 weeks or placebo for 44 weeks. Randomization was stratified by clinical remission status at maintenance baseline (yes/no), oral corticosteroid use at maintenance baseline (yes/no), and induction treatment.
The primary endpoint was the proportion of patients in clinical remission at Week 44. Secondary endpoints included the proportion of patients maintaining clinical response through Week 44, the proportion of patients with improvement of endoscopic appearance of the mucosa at Week 44, the proportion of patients with corticosteroid-free clinical remission at Week 44, and the proportion of patients maintaining clinical remission through Week 44 in patients who achieved clinical remission 8 weeks after induction.
The maintenance study (UNIFI-M), evaluated 523 patients who achieved clinical response at Week 8 following the administration of STELARA® I.V. in UNIFI-I. These patients were randomized to receive a subcutaneous maintenance regimen of either 90 mg of STELARA® every 8 weeks, 90 mg STELARA® every 12 weeks or placebo for 44 weeks. Randomization was stratified by clinical remission status at maintenance baseline (yes/no), oral corticosteroid use at maintenance baseline (yes/no), and induction treatment.
The primary endpoint was the proportion of patients in clinical remission at Week 44. Secondary endpoints included the proportion of patients maintaining clinical response through Week 44, the proportion of patients with improvement of endoscopic appearance of the mucosa at Week 44, the proportion of patients with corticosteroid-free clinical remission at Week 44, and the proportion of patients maintaining clinical remission through Week 44 in patients who achieved clinical remission 8 weeks after induction. Patients who completed the maintenance study through Week 44 were eligible to continue treatment through Week 96.
(3) The 837 Patent
[30] On September 24, 2019, Janssen filed in Canada a patent application for the 837 Patent. The 837 Patent, entitled “Safe and effective method of treating ulcerative colitis with anti-IL 12/IL23 antibody”, claims priority from three U.S. provisional patents applications, the earliest one having been filed on September 24, 2018.
[31] The 837 Patent contains 68 claims generally directed toward the use of an anti-IL-12/IL-23p40 antibody (including ustekinumab) for the treatment of moderately to severely active ulcerative colitis, where the subject failed to respond to or was intolerant of at least one enumerated therapy or the subject demonstrated corticosteroid dependence and compositions for use in such treatment.
[32] The claims of the 837 Patent are directed to the treatment of ulcerative colitis, including numerous claims where the clinical response of the subject “continues at least 44 weeks after week 0”.
[33] The 837 Patent was issued on July 12, 2022.
[34] On July 25, 2022, Janssen sought to list the 837 Patent in relation to SNDS 670 by submitting three Form IVs for the 837 Patent (one for each DIN).
[35] No Form IV was ever submitted for the 837 Patent in relation to SNDS 739. The deadline by which Janssen could have submitted a patent list for SNDS 739 (as prescribed by subsection 4(6) of the PMNOC Regulations) was August 11, 2022. There is no evidence in the record as to why this was not done.
F. OSIP’s Preliminary Decision
[36] By letter dated July 29, 2022, OSIP acknowledged receipt of Janssen’s patent lists for the 837 Patent in relation to SNDS 670. OSIP advised Janssen, in detail, of the basis for its preliminary view that SNDS 670 was not approved for a change in use of the medicinal ingredient and as such, SNDS 670 did not provide a basis to list the 837 Patent. Even if SNDS was considered to be approved for a change in use of a medicinal ingredient, OSIP advised that its preliminary view was that the 837 Patent did not contain a claim to the very change sought for approval in the submission.
[37] OSIP also noted the existence of SNDS 739 and that had a patent list been submitted in respect of the 837 Patent and SNDS 739, it would not meet the timing requirements of subsection 4(6), as the filing date for SNDS 739 was February 15, 2019 and the date of filing in Canada of the 837 Patent was subsequent to that date.
[38] OSIP requested that Janssen provide representations as to the eligibility of the 837 Patent for listing on the patent register in respect of SNDS 670.
G. Janssen’s Response to the Preliminary Decision
[39] By letter dated September 14, 2022, Janssen provided detailed submissions in response to OSIP’s request. With respect to SNDS 670, Janssen asserted that the 837 Patent claims |||||||||||||||||||||||| |||||||||||||||||||||||| are a new method of use approved through SNDS 670, which is the submission against which Janssen originally sought listing on July 19, 2022. Janssen asserted that it was of the view that the 837 Patent is also listable as against SNDS 739 and that there are in fact no timing issues under subsection 4(6) as the only rational date to be used is the claim date and not the Canadian filing date. Janssen asserted that the use of the Canadian filing date in the PMNOC Regulations was illogical, arbitrary and ultra vires the scheme of the Patent Act and of the PMNOC Regulations themselves. Janssen asserted that OSIP ought to apply the intent of the PMNOC Regulations with respect to the timing of the patent and the submission under subsection 4(6) and when the claim date is properly applied, the 837 Patent is listable.
[40] In relation to Janssen’s request that the 837 Patent also be listed in relation to SNDS 739, Janssen stated at footnote 2 of its submission:
As a patent list was already submitted with respect to the ’837 Patent within the requisite 30 days of its issuance we trust that the OPML will not consider this request to be out of time under subsection 4(6) of the Regulations. Further, we understand that the OPML has already considered the listing of the ’837 Patent against SNDS 224739, as reflected in the Letter. If the OPML rejects this request, then we respectfully request that the OPML advise us of the reason and allow us an opportunity to respond.
[41] For reasons unknown to the Court, Janssen did not include a Form IV with its submission in relation to SNDS 739 and the 837 Patent.
[42] In support of its assertion that the 837 Patent claims ||||||||||||||||||||||||| ||||||||||||||||||||||||| are a new method of use approved through SNDS 670, Janssen asserted that a clinician reviewing the new Product Monograph approved with SNDS 670 would change their prescribing practices, especially a clinician who may have been otherwise hesitant to prescribe STELARA beyond 44 weeks. Janssen supported this assertion regarding a clinician’s understanding of the new additions to the Product Monograph with an expert statement from Dr. Brian Feagan and two publications.
[43] With respect to the publications, Janssen made the following submissions:
A clinician’s understanding of the additions to the Product Monograph is also reflected in publications reporting on the data collected for the treatment of patients with ustekinumab up to Week 96, including Panaccione R, et al. Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy. Aliment Pharmacol Ther. 2020; 52: 1658-1675 (“Pannaccione (2020)”; enclosed). Panaccione (2020) concluded that the “efficacy of ustekinumab in patients with [ulcerative colitis] was sustained through 92 weeks” (abstract), that “[r]ates of symptomatic remission were maintained from Week 44 through Week 92” (page 1671), and that “[t]he results reported here in patients with moderately-to-severely active [ulcerative colitis], together with both clinical trial and registry data confirm the positive long-term efficacy and safety profile of ustekinumab-treated patients” (page 1672). With respect to safety, Panaccione (2020) concluded that “[n]o new safety signals were observed” (abstract) and that “[t]he safety profile observed for ustekinumab in the second year of maintenance treatment was consistent with that reported through the first year during the maintenance study and with the established ustekinumab safety profile” (page 1672). […]
The importance of safety data for ustekinumab beyond one year was also stated in an integrated safety study, Sandborn WJ, et al. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis Results from Phase 2/3 Studies. Inflamm Bowel Dis. 2021; 27(7): 994-1007 (“Sandborn (2021)”, enclosed). Sandborn (2021) pooled data from six studies, including the UNIFI study for ulcerative colitis, through one year. The authors concluded (pages 1006-7):
Though these and previously reported findings are reassuring, longer-term longitudinal data and larger (eg, real-world observational) studies are ongoing to confirm current findings of no increased malignancy risk with IL-12/23 inhibition.
…
There are several limitations to this study. In a lifetime disease, 1 year of treatment is relatively short; longer-term data will be needed to further support these findings. This may limit comparisons, especially for long latency events like malignancies or certain infections. Although the data contained in this article are only from clinical trials, limitations on interpretation may differ from outcomes observed in real-world.
The information added to the Stelara Product Monograph via SNDS 24470 thus provided clinicians with support of the safety findings made one year after that Sandborn (2021) indicated was required.
[Emphasis in original.]
[44] With respect to the expert statement of Dr. Feagan, Dr. Feagan is a gastroenterologist at London Health Sciences Centre and a Professor of Medicine at the Schulich School of Medicine and Dentistry at Western University, with a research focus on the design, conduct and execution of large-scale randomized controlled trials in Crohn’s disease and ulcerative colitis. Dr. Feagan’s mandate was to: (i) provide brief background information on ulcerative colitis and its treatment options (including STELARA); and (ii) to advise how, if at all, a clinician’s prescribing practices would be influenced by the additions to the STELARA Product Monograph arising from the NOC for SNDS 670. Dr. Feagan provided no evidence in relation to the aforementioned publications relied upon by Janssen.
[45] While Janssen did not make specific submissions related to Dr. Feagan’s evidence (other than as detailed in paragraph 42 above), Dr. Feagan opined that community gastroenterologists (who are gastroenterologists not located in a teaching or research hospital) would “take comfort” in the additional information (as it would “alleviate fears relating to potential side effects”) and would be more willing to prescribe or be more comfortable prescribing STELARA based on the additional information contained in the Product Monograph.
II. The Decision under Review
[46] On November 15, 2022, OSIP provided Janssen with its final decision. OSIP found that SNDS 670 was not approved for a change in formulation, change in dosage form or change in use of the medicinal ingredient and did not present an opportunity to list a patent on the Patent Register in accordance with subsection 4(3) of the PMNOC Regulations. OSIP noted that SNDS 670 amended STELARA’s Product Monograph to include updated safety and efficacy data generated through an on-going study, which was the very same on-going study that had been previously included in the Product Monograph for SNDS 739. OSIP considered the text, context and purpose of subsection 4(3) of the PMNOC Regulations, the relevant jurisprudence and the submissions of Janssen, before concluding that updating the safety information in the product monograph did not result in a change in use in SNDS 670.
[47] OSIP went on to examine whether the 837 Patent would have been eligible for listing if one were to assume that SNDS 670 was in fact for a change in use. However, OSIP found that the 837 Patent did not contain a claim to the very change that Janssen alleged was approved by the NOC for SNDS 670 as required by subsection 4(3).
[48] In relation to SNDS 739, OSIP determined that Janssen had not filed a patent list to add the 837 Patent to the Patent Register against SNDS 739. The OSIP went on to find that, even if Janssen had submitted a patent list to add the 837 Patent against SNDS 739, Janssen would not have met the timing requirements in subsection 4(6) of the PMNOC Regulations, as the 837 Patent application was filed in Canada after the filing date of SNDS 739. OSIP held that to consider the claim date/priority date (as opposed to the Canadian filing date) as the appropriate date when assessing the application of subsection 4(6) as urged by Janssen would be to ignore the clear words of the PMNOC Regulations, circumvent the strict timing requirements and undo the balance struck by the PMNOC Regulations and subsection 55.2(1) of the Patent Act.
III. Issue and Standard of Review
[49] This application raises the following issues:
Whether OSIP’s decision not to add the 837 Patent to the Patent Register in relation to SNDS 670 and SNDS 739 was unreasonable and in particular:
Whether OSIP’s determination that SNDS 670 was not approved for a change in use of the medicinal ingredient was unreasonable;
Whether OSIP’s determination that the 837 Patent was not eligible to be added to the Patent Register as it did not meet the product specificity requirements of paragraph 4(3)(c) was unreasonable; and
Whether OSIP’s determination that Janssen failed to provide a patent list in relation to SNDS 739 was unreasonable.
Whether the Canadian filing date requirement in subsection 4(6) of the PMNOC Regulations is ultra vires the Patent Act.
[50] The parties agree and I concur that the first is