Ten things you need to know about Canada’s new patent rules

The Government of Canada has proposed amendments to the Patent Rules (draft Patent Rules), which are expected to be promulgated in final form in mid-2019 and come into force in late-2019 (the CIF date). Assuming the current draft of the amended Rules will be maintained, these new Patent Rules will create a number of changes to the patent regime in Canada.

1. Shortened prosecution timelines

Applicants will face shorter time limits during prosecution. In particular, applicants will be required to:

• request examination four years after the filing date of an application, instead of five years;
• respond to an office action within four months instead of six months; and
• respond to a notice of allowance within four months instead of six months.

Additionally, when filing a divisional application, applicants will need to request examination before the later of: (i) four years after the filing date of the original application; and (ii) three months after the presentation date of the divisional application.¹

Although the time limit for responding to an office action will be shortened from six months to four months, applicants will be able to request a two-month extension of time. To obtain an extension, applicants will need to make a request before the expiry of the original time limit, describe why an extension is justified and pay a prescribed fee. The draft Patent Rules do not specify what circumstances will justify an extension. Despite the availability of a potential extension, if an original time limit is missed, then it will no longer be possible to request or continue with advanced examination.

2. Modified framework for correcting errors

The current “clerical errors correction” provision in section 8 of the Patent Act is being repealed and replaced with specific provisions governing the correction of errors.

Specific procedures will be provided to correct certain errors for pending applications such as the identity or name of the inventor or applicant, errors in priority claims, and “obvious” errors in the specification or drawings after receipt of the Notice of Allowance. Deadlines will vary according to the type of error and in some cases are quite short; therefore, it will be important to verify filing documents.

Errors in issued patents may be corrected within six months of the issue date. The applicant may request correction of (a) the name of the patentee or inventor, if the correction does not change their identity, or (b) an “obvious” error in the specification or drawings. Given the limited time period to correct errors, patents should be carefully reviewed upon issue.

Notably, the standard for correctable errors will change from “clerical” to “obvious.”² According to the Regulatory Impact Analysis Statement accompanying the draft Patent Rules, “[t]his change is intended to provide more flexibility to applicants and patentees, as ‘clerical error’ has been interpreted fairly narrowly by the courts, and to align with corresponding provisions for trademarks and industrial designs.”

3. New notice-and-late-fee regime

Currently, applicants and patentees are not notified of a missed deadline to request examination or pay a maintenance fee. Under the draft Patent Rules, a new notice-and-late-fee regime will be introduced, which is to help avoid the inadvertent loss of rights if the following deadlines are missed.

• Request for examination: The Canadian Intellectual Property Office (CIPO) will notify the applicant of the missed deadline, and the applicant will be given a grace period of two months from the date of the notice to request examination and pay a late fee before the application is deemed to be abandoned.
• Maintenance fee payment: CIPO will notify applicants and patentees who have missed a deadline to pay a maintenance fee, and will provide a grace period to allow the applicant or patentee to pay the maintenance fee and a late fee before the application is deemed to be abandoned or the patent is deemed to have expired. The grace period will be the of the later of: (i) six months after the missed deadline; and (ii) two months after the date of CIPO’s notice.

4. Introduction of due care and third party rights

Due care

Under the draft Patent Rules, the time limit to request reinstatement for an abandoned application will continue to be 12 months from the date of abandonment. However, in certain circumstances, applicants will not be able to reinstate an application as of right. Instead, the applicant will need to show that the application became abandoned in spite of “due care” having been taken. The draft Patent Rules do not specify the types of circumstances that will meet the “due care” standard.³

The due care requirement will apply in the following circumstances.

1. To reinstate an application that was abandoned for failure to pay a maintenance fee.
2. To reinstate an application that was abandoned for failure to request examination, if the request for reinstatement is filed more than six months after the deadline to request examination.
3. To reverse the expiry of a patent where it was deemed to be expired for failure to pay a maintenance fee.

Third party rights

The draft Patent Rules will also afford rights to third parties during certain periods of abandonment. In particular, third parties who take actions in good faith to use or prepare to use an invention may be insulated from an infringement action during certain periods in limited circumstances.

Given the introduction of due care and third party rights, extra care should be taken with maintenance fee and examination deadlines. Applicants who have previously relied on the reinstatement as of right regime to control the timing of prosecution, such as coordination of prosecution of related applications, are encouraged to speak to their agents early in the prosecution process regarding alternative strategies.

5. Streamlined amendment after allowance procedure

The draft Patent Rules will make it easier for applicants to make more complex amendments to applications after allowance.

Currently, applicants may only make amendments to allowed applications that do not require the examiner to conduct a further search. To make any other amendments, applicants must wait for the application to become abandoned for failure to pay the final fee and then reinstate the application to re-open prosecution.

Under the draft Patent Rules, applicants will be able to request that a notice of allowance be withdrawn, causing the application to immediately re-enter examination. This new procedure will apply to any amendment made after receiving a notice of allowance, with the exception of the correction of an “obvious error,” which may still be corrected without re-opening prosecution.

6. Simplified filing requirements

Non-PCT applications

The requirements to obtain a filing date in Canada for non-PCT applications will be significantly reduced. Applicants will only need to file a description, indicate a patent is being sought, provide information regarding their identity and their contact information to obtain a filing date. No claims or application fee are required at the time of filing and the documents submitted may be in a language other than French or English. Additionally, a filing date can be obtained by filing a reference statement to a previously filed application, provided that a copy of the specification and drawings are submitted to CIPO within two months. Applicants will also be able to add missing parts to the specification or drawings within a prescribed period, without affecting the filing date, provided that the missing parts are completely contained in a priority document, and certain other criteria are met.

CIPO will notify applicants of any missing content required to complete the application, which will need to be submitted within two months of notification.

PCT applications

The simplified requirements being implemented for non-PCT applications do not apply to PCT applications. Therefore, an English or French translation of the international application and the applicable application fee will continue be required at the time of national phase entry to Canada.

The most significant change is that the as-of-right time period for national phase entry is being shortened from 42 months to 30 months. Applicants may still enter national phase in Canada up to 42 months after the priority date, if they can demonstrate the delay is “unintentional.”⁴

7. Amended framework for priority claims

There are also a handful of changes to the priority system under the draft Patent Rules. Restoration of priority will be available in certain circumstances. The process for correcting errors in priority claims will change following the repeal of section 8 of the Patent Act and certified copies of priority applications will need to be filed or made available via one of the digital libraries acceptable to the Patent Office, in certain circumstances.

See “Canadian patents and priority claims: Learning to play by the new patent rules,” for an in-depth discussion of these changes and their implications.

8. Cost savings for sequence listings

Excess page fees for sequence listings filed online will no longer be charged. As such, for applications with lengthy sequence listings, delaying the notice of allowance until after the CIF date of the draft Patent Rules may lead to substantial cost savings.

9. Simplified transfer requirements

The evidence and documentation required to record most transfers or name changes is being reduced. Name changes may be made on request of the applicant or patentee without any supporting documentation. A transfer may be recorded on request of the applicant or patentee without any supporting documentation, although transferees (who are not the currently recognized applicant or patentee) making the request will still need to provide documentation.

10. Transitional provisions and Category 3 applications

The draft Patent Rules include a complex set of transitional provisions, particularly for applications filed between October 1, 1996, and the CIF date. The transitional provisions refer to these as Category 3 applications. Category 3 applications will be treated differently from applications filed after the CIF date in a number of respects, including in relation to the deadlines to request priority and examination and the abandonment and reinstatement framework.

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¹ The presentation date of a divisional application means the date on which CIPO has received all of the following documents and information: (i) an indication that a divisional application is being sought; (ii) information establishing the identity of the applicant; (iii) contact information for the applicant; and (iv) a document that, on its face, appears to be a description.

² The draft Patent Rules states that an error is obvious if “it is obvious both that something other than what appears in the patent, specification or drawings was intended, and that nothing other than the correction could have been intended.”

³ A definition for “due care” is provided in the draft amendments to the The Manual of Patent Office Practice (MOPOP), which has been published for consultation. According to this definition, when assessing whether “due care” has been exercised, the Commissioner will assess “all measures that a reasonably prudent applicant / patentee would have taken—given the particular set of circumstances.” The definition further states that measures taken after the failure occurred will not be taken into consideration. This definition is still subject to change and does not have the force of law, but provides an indication of CIPO’s expected practice. For further details regarding the consultation on changes to MOPOP, see “Proposed changes to manual of patent office practice.”

⁴ Under the draft Patent Rules, the “unintentional” standard is set forth for delays in national entry, as opposed to the “due care” standard that applies to reinstatement, as discussed above. The draft Patent Rules do not, however, specify the types of circumstances that will meet the “unintentional” standard.

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.