Public consultation open: Proposed changes to Patent Office’s Manual of Patent Office Practice

The Canadian Intellectual Property Office (CIPO) has opened public consultations on proposed revisions to the Manual of Patent Office Practice (MOPOP). These consultations are part of the ongoing effort to modernize Canada’s intellectual property framework. The Patent Act (Act) has been amended to comply with the requirements of the Patent Law Treaty (the amendments are not yet in force) and proposed amendments to the Patent Rules (draft Patent Rules) were published in December 2018. In anticipation of the amendments to the Act and the Patent Rules coming into force (CIF) in fall 2019, the current consultation addresses administrative topics for the new Patent Rules that will be integrated into the revised MOPOP.

What you need to know

• The draft Patent Rules introduce significant changes to the Patent Office’s processes and procedures.
• The current consultations relate to 11 administrative topics to be included in the revised MOPOP. Of particular note, topics relating to substantive amendments to the Patent Rules are:
  • Due care: When seeking a restoration of rights after an application has been deemed abandoned under particular circumstances or after a patent has been deemed expired for failure to pay a maintenance fee and the late fee, applicants and patentees will be held to the standard of a reasonably prudent applicant/patentee and need to demonstrate they meet this standard. Requests for a restoration of rights made prior to the CIF date will not be held to this standard.
  • Correction of errors: It will be possible to correct certain errors in a patent application or an issued patent if done so within particular timelines.
  • Relaxed filing requirements: While the filing requirements for obtaining a filing date are being reduced under the new framework, in some instances missing information may lead to a later filing date.
• The administrative topics have been drafted based upon the current iteration of the draft Patent Rules. Further revisions to the draft Patent Rules are likely, necessitating continued revisions to the administrative topics.
• Stakeholders are encouraged to provide comments on the draft administrative topics by May 27. Comments may be submitted to CIPO by email: [email protected].¹

Draft administrative topics of the MOPOP

CIPO has published draft guidance for each of the 11 administrative topics under consultation.

1. Written communications procedures

Guidance regarding the procedures for communicating in writing with the Commissioner of Patents and the Patent Office is provided in this section. While all written communications may be physically delivered to the Patent Office (either by mail or in person), electronic submissions are only permissible under specified circumstances. These include the filing of an application, a request for PCT national phase entry, general correspondence relating to applications, maintaining the name of a patent agent, and ordering copies of a document. PCT applications may be electronically filed with CIPO’s international filing e-service. For documents submitted electronically, the draft guidance includes specific formatting requirements for submissions.

2. Time

This topic provides guidance regarding the operating hours of the Patent Office, deemed receipt dates of communications, conventions for calculating time limits, and procedures for obtaining extensions of time.

3. Representation

While inventors may prosecute their own applications, other applicants must appoint a patent agent. This draft topic provides guidance on the requirement to appoint a patent agent, how patent agents and associate patent agents are to be appointed, and the individuals authorized to take certain actions regarding an application or patent. It also outlines the procedures for appointing a common representative in respect of joint applicants or patentees. Certain actions including payment of application fees, payment of maintenance fees, submission of a request to record a transfer or record a name change may be submitted by the appointed patent agent, the common representative or any person authorized by the common representative.

For other activities, including reinstatement of an application, additions to specifications or drawings and interviewing Patent Office staff, the applicant may only be represented by the appointed patent agent or common representative. If an improper person communicates with the Patent Office, the Office will respond with a notice of disregarded communication.

4. Filing requirements

This topic provides guidance on the revised requirements for obtaining a filing date for a patent application filed directly with CIPO (i.e., an application that is not a national phase entry of a PCT application). The applicable filing date will be the latest date that information sufficient to obtain a filing date under the draft Patent Rules is received. If all information required to obtain a filing date is not included in a submission, applicants will have two months following notification to submit the outstanding documents or information, with the filing date being delayed until such date that the missing documents/information are received. If the applicant misses the two-month deadline, the application will be deemed never filed. Translations of the description from languages other than English or French must also be submitted within two months of the Commissioner requesting a translation.

To obtain a filing date, applicants may also submit a reference statement specifying a previously filed application; the guidance provides the specific requirements for permissible reference statements. Missing parts and drawings may be added to a priority application without affecting the filing date, provided the applicable time and content restrictions are met. However, for non-priority applications, later additions to the specification may result in a later filing date.

5. Compliant patent applications

Given that limited information is required to obtain a filing date, there are foreseeable situations where applicants may submit sufficient information to obtain a filing date without having submitted a patent application that fully complies with all prescribed requirements of the Act and draft Patent Rules. Applications that have successfully received a filing date, but do not meet all prescribed requirements will be considered non-compliant and receive notices of non-compliance from the Commissioner. Applicants have three months to respond in good faith to such notices before the application will be deemed abandoned. If the Office determines that the application remains non-compliant following the initial response, another notice of non-compliance will be sent and the applicant will have a further three months to respond to the notice in good faith.

Missing or incomplete information as of the filing date that may lead to a subsequent non-compliance notice include: missing sequence listings; missing drawings; incomplete inventor information; establishment of entitlement to apply for a patent; and, if applicable, establishment of authority to enter national phase in Canada.

6. Divisional applications

The draft Patent Rules replace the concept of a “division date” with a “presentation date” for divisional applications. This guidance clarifies administrative requirements that must be fulfilled to obtain a presentation date for a divisional application. The filing requirements include similar information and document requirements to what is needed to obtain a filing date for a regular application, although at least one claim must be included in the application. Additionally, the information and documents must be in English or French. If the divisional filing requirements are not fulfilled but those required for a regular application are, the applicant will receive a filing certificate for a regular application. If the relevant parent application is granted or abandoned beyond reinstatement, a divisional application cannot be filed. However, if the parent application is refused, a divisional may still be filed within the prescribed time.

7. Requests for priority

The administrative requirements for requesting priority and restoring priority covered by sections 74-78 of the draft Patent Rules are addressed. To request priority, the applicant must provide, in the petition for application, the filing date, name of country/office of filing and number for each priority application. In instances where the application number is unknown, the Patent Office will also accept a provisional application number, a copy of the request of the previously filed application including the date the application was filed, or a reference number provided in respect of the previously filed application alongside the name and address of the applicant, title of the invention and date the application was filed. Certified copies of priority applications will generally be required although exceptions are available, including for Canadian and PCT priority applications. Applicants can request restoration of the right of priority when the filing date of the pending application is within 12 to 14 months from the filing date of the previously filed application provided the failure to file within 12 months was unintentional.

8. Recording of transfers, changes of names and registration of related documents

To record a transfer or name change, a submission including the relevant request and corresponding fee may be submitted to the Patent Office. If a request to transfer is submitted by the transferee (rather than the applicant or patentee) a copy of the document effecting the transfer along with an affidavit or other signed evidence supporting the transfer must be submitted. The draft guidance provides examples of acceptable evidence and the relevant fees. No documentary evidence is required for name changes, although the name change mechanism cannot be used to change the identity of the applicant/patentee.

9. Corrections

Under the new framework, section 8 of the Act, which granted discretion to the Commissioner to correct clerical errors, is being repealed. The draft Patent Rules provide for more specific corrections, as explained in this draft guidance topic. Certain errors in the applicant or inventor name and identity, priority filing date, and priority filing country, office or number may be corrected. Errors in specifications or drawings in a patent application may be corrected if the errors are obvious. Specific time limits apply to each type of error. More limited corrections are available in respect of errors in issued patents. Corrections to errors made by the Commissioner, errors in the name of the patentee or inventor and obvious errors in the specification or drawings may be made within six months after issuance of the patent.

10. Abandonment/reinstatements of patent applications and deemed expiry/reversal of deemed expiry of patents

This draft guidance topic clarifies when applications will be deemed abandoned under section 73 of the Act and when patents will be deemed expired under subsection 46(4) of the Act. The new framework regarding availability of reinstatements or reversals is also discussed, including the due care requirement applicable to both reinstatement and reversal of expiry. Applicants will have 12 months to request reinstatement and pay the appropriate fees, following deemed abandonment of the application. Similarly, to reverse a deemed expiry of a patent, within 12 months following the six-month late maintenance fee payment period, the patentee must make the appropriate request and pay the appropriate fees to obtain a reversal.

11. The due care standard

A due care standard will be implemented under the amendments to the Act and the draft Patent Rules. This standard impacts when an applicant or patentee’s rights may be reinstated following failure to pay maintenance and late fees or the failure to request examination leading to deemed abandonment, and obtaining a reversal of deemed expiry of the term limited for the duration of the patent. The Commissioner will hold the applicant/patentee to the standard of the reasonably prudent applicant/patentee when assessing whether the reinstatement or reversal should be granted. This document provides guidance on the requisite due care standard and the supporting information that must be submitted in support of any reinstatement or reversal request. The circumstances that led to the failure, despite the exercise of due care, should be explained along with measures that were taken to avoid the failure and other justifications for the failure. An applicant requesting reinstatement of an application or reversal of the deemed expiry of a patent following a failure to pay a maintenance fee or a failure to request examination that occurred prior to the CIF date of the amended Patent Act and Rules is not subject to the due care standard.

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¹ Further details on submissions are available online: http://www.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr04574.html.

Le mois dernier, le Canada a publié sa première Stratégie industrielle de défense (la Stratégie), qui souligne l’engagement du Canada à développer une base industrielle de défense solide et à stimuler la croissance économique. Ces efforts pourraient aussi comprendre le renforcement de l’état de préparation à la biodéfense et aux contre-mesures médicales, ce qui pourrait constituer des débouchés pour le secteur canadien des sciences de la vie en raison de l’importance accordée aux capacités nationales en ce sens et de la nécessité d’atténuer les risques d’urgences sanitaires.

Développement de contre-mesures médicales au Canada

Comme indiqué dans les bulletins précédents, le quatrième pilier de la Stratégie est axé sur la « sécurisation des chaînes d’approvisionnement pour les intrants et les biens clés » par le renforcement de la production nationale et le stockage de ressources. L’accent est mis tout particulièrement sur les contre-mesures médicales, en précisant que nos « alliés ont établi un lien explicite entre l’état de préparation à la biodéfense et aux contre-mesures médicales et leur sécurité économique et nationale, en élaborant de nouvelles stratégies et de nouveaux mécanismes pour faire progresser ces travaux ». Les contre-mesures médicales désignent divers produits réglementés pouvant être utilisés pour protéger la population lors d’une situation d’urgence de grande ampleur, comme l’éclosion d’une maladie ou une attaque impliquant des armes chimiques, biologiques ou nucléaires. Il peut s’agir de vaccins, de médicaments thérapeutiques et produits biologiques, de dispositifs de tests diagnostiques, des équipements de protection individuelle ou industrielle, et d’autres dispositifs médicaux. Les contre-mesures médicales sont essentielles à la réduction et à l’atténuation des dommages lors d’une urgence de santé publique.

Exploiter les voies réglementaires mises en place lors de la pandémie de COVID-19

Pendant et après la pandémie de COVID-19, le Canada a mis en place plusieurs nouvelles voies réglementaires comme mécanismes d’accélération des approbations de produits médicaux, ce qui pourrait offrir au gouvernement des options pour déployer des contre-mesures médicales afin de faire face aux risques pour la santé publique. Au début de la pandémie, Santé Canada a émis diverses ordonnances provisoires pour permettre l’importation et la vente de médicaments et de dispositifs médicaux qui n’avaient pas eu l’approbation des voies réglementaires traditionnelles. Or, Santé Canada a plutôt fait confiance aux voies d’approbation réglementaire et de l’exemption de certaines exigences en homologation de produits des pays impliqués dans la transaction. Beaucoup de ces règles provisoires ont depuis été officiellement intégrées à la réglementation en vertu de la Loi sur les aliments et drogues et ont été appliquées bien après la COVID-19. Conformément au Règlement sur les aliments et drogues, Santé Canada tient à jour la Liste des maladies qui menacent la santé publique et utilisera une procédure d’autorisation modifiée pour les médicaments d’urgence de santé publique pouvant traiter les affections figurant sur la liste. De même, le Règlement sur les instruments médicaux a établi une liste d’instruments médicaux répondant à un besoin urgent de santé publique, ce qui permet à Santé Canada d’autoriser la commercialisation de ces instruments de manière accélérée. Ces outils réglementaires sont utilisés automatiquement quand une situation médicale présente un grand risque pour la santé publique au Canada et nécessite une action immédiate pour contrer ce risque.

Le rôle de la Stratégie dans le renforcement du régime réglementaire de la santé au Canada

La stratégie prévoit que le Canada adoptera une approche proactive en matière de planification en amont des crises sanitaires. Le gouvernement entend s’assurer que les produits médicaux sont déjà disponibles au Canada afin qu’ils puissent être distribués rapidement en cas d’urgence. D’autres modifications récentes au Règlement sur les aliments et drogues permettent de prépositionner au Canada tous les médicaments d’urgence en santé publique, ce qui signifie qu’ils peuvent être importés dans des installations d’entreposage canadiennes avant que leur mise sur le marché n’ait été autorisée. La Stratégie s’appuie sur ces fondements, en faisant référence à l’organisme existant Préparation aux crises sanitaires Canada (PCSC), un organisme opérationnel spécial au sein d’Innovation, Sciences et Développement économique Canada (ISDE), et à un nouveau Fonds des sciences de la vie, lesquels « collaborent avec des partenaires internationaux et de soutenir l’élaboration et la production de contre-mesures médicales ». PCSC supervise la Stratégie en matière de biofabrication et de sciences de la vie du Canada, qui vise à développer un secteur national des sciences de la vie fort et compétitif doté de capacités de biofabrication de pointe, en mettant l’accent sur la capacité à se préparer et à faire face aux futures priorités et crises sanitaires. Dans cette optique, il y aura des occasions pour les fabricants de nouer des collaborations de recherche et des accords commerciaux ou d’approvisionnement liés aux contre-mesures médicales financées par des programmes fédéraux.

Étroitement lié aux capacités nationales, le pilier III de la stratégie implique « Investissement ciblé pour renforcer un secteur canadien de la défense novateur », avec la promesse que le gouvernement fédéral « soutiendr[a] la recherche et le développement, protéger[a] la propriété intellectuelle, soutiendr[a] les petites et moyennes entreprises, investir[a] dans les compétences et la formation, et encourager[a] les exportations afin de créer un secteur de la défense agile et concurrentiel à l’échelle mondiale ». La nécessité de favoriser le développement de la propriété intellectuelle (PI) et la conservation des droits du Canada est mentionnée à plusieurs reprises dans la Stratégie. Par exemple, la Stratégie prévoit l’établissement de partenariats officiels avec l’industrie canadienne qui « [assureront] la propriété et le contrôle nationaux de la propriété intellectuelle (PI) et des capacités essentielles. » La Stratégie reconnaît l’immense talent des établissements canadiens et la précieuse recherche qui y est menée actuellement et qui est déjà financée par des subventions de recherche d’organismes tels que le Conseil de recherches en sciences naturelles et en génie et les Instituts de recherche en santé du Canada, et fait aussi référence à l’engagement de 1,6 milliard de dollars pour de nouveaux fonds de recherche dans le budget de 2025. Cette prise de conscience de la nécessité de promouvoir et de soutenir l’innovation au Canada laisse présager des possibilités de financement, notamment dans les domaines où le Canada accuse un retard en matière de production nationale et où des engagements d’investissement et de fabrication au Canada peuvent être pris.

Prochaines étapes

Dans les prochains mois, nous prévoyons que le gouvernement du Canada publiera d’autres directives et des mesures de suivi. L’équipe de défense des conservateurs poursuivra sa couverture de perspectives sur la défense au Canada en publiant une analyse supplémentaire pour donner des précisions sur l’incidence de la Stratégie sur de multiples secteurs.