Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: Intellectual property
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- Intellectual property
- Data protection
- Patented Medicines (Notice of Compliance) Regulations
- Certificate of supplementary protection
As a consequence of the review, authorization and oversight of COVID-19 drugs under the Regulations, manufacturers may benefit from intellectual property protections that are available in respect of a submission that results in an NOC. These protections include:
- data protection under section C.08.004.1 of the Food and Drug Regulations
- protection under the Patented Medicines (Notice of Compliance) Regulations (PM (NOC) Regulations)
- protection under the Certificate of Supplementary Protection regime
The amendments contain one interpretive provision clarifying the impact of an authorization under the ISAD IO on data protection eligibility, but do not alter these protections.
Subsection C.08.004.1(1) of the Food and Drug Regulations provides that an “innovative drug” is one that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient. The amendments introduce language to explain that, for the purpose of the definition of “innovative drug” in subsection C.08.004.1(1) of the Regulations, a medicinal ingredient is not considered to be approved in a drug by reason of an authorization under the ISAD IO. This provision is not intended to change the scope or current interpretation of “approved” under the existing definition. Rather, it explains the intended application of that definition where a medicinal ingredient was used in a drug authorized under the ISAD IO.
The interpretation of “innovative drug” ensures that an authorization granted under the ISAD IO does not preclude data protection eligibility under the Regulations.
Data protection will be assessed in accordance with the existing process, as described in the Guidance document on data protection under C.08.004.1 of the Food and Drug Regulations.
Patented Medicines (Notice of Compliance) Regulations
The amendments to the Food and Drug Regulations do not disturb the operation of the Patent Act or the Patented Medicines (Notice of Compliance ) Regulations (PM (NOC) Regulations). Patent lists may be added to the Patent Register at the time the submission or supplement is approved under the Regulations, provided the requirements of the PM(NOC) Regulations are met, including that a patent list be submitted in accordance with subsections 4(5) and 4(6), as applicable.
For a rolling submission, data or information provided after the filing date will not change the filing date of the submission. As with other submissions, patent lists provided after the filing date of the submission must meet the timing requirements of subsection 4(6) of the PM(NOC) Regulations to be considered for inclusion on the Patent Register.
The PM(NOC) Regulations will continue to be administered in accordance with existing processes. These are described in the:
Certificate of supplementary protection
The amendments to the Food and Drug Regulations do not disturb the operation of the Patent Act or the Certificate of Supplementary Protection Regulations (CSP Regulations). Therefore, a certificate of supplementary protection may be issued in respect of a patent to a drug approved under the Regulations, provided the requirements of the CSP Regulations and Patent Act have been met.
Though not introduced for this purpose, the provisions contained in these amendments allow an earlier filing of an NDS, making it easier for manufacturers to file their NDS within the time period specified in paragraph 106(1)(f) under the Patent Act and 6(1)(b) established under the CSP Regulations to be eligible to obtain a certificate of supplementary protection.
The certificate of supplementary protection scheme will continue to be administered in accordance with existing laws and the process described in the Guidance document on certificates of supplementary protection. Section 2.2.2 of this document outlines Health Canada’s continued interpretation of an “application for a marketing approval equivalent to an authorization for sale” for the purpose of the timely submission requirements in paragraph 106(1)(f) of the Patent Act and paragraph 6(1)(b) of the CSP Regulations. Such an application is considered equivalent to an NDS rather than equivalent to an ISAD IO application. Similarly, the definition of “authorization for sale” explicitly excludes an authorization issued pursuant to an interim order made under section 30.1 of the Food and Drugs Act. Therefore, if a manufacturer submits an application in a prescribed foreign country that’s equivalent to an NDS, in order to meet the timely submission requirements, the manufacturer must file an application for the authorization for sale of the same drug with the Minister before the end of 1 year from the date of the foreign application.
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