In 2017, the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) came into force. CETA covers virtually all sectors and aspects of trade and aims to increase bilateral trade and investment between Canada and the EU. In order to comply with this agreement, Canada enacted the CETA Implementation Act (CIA) which provided for, among other things, the introduction of the Certificate of Supplementary Protection (CSP) to the Patent Act. CSPs offer up to two years of additional protection to patentees for the medicinal ingredient or the combination of medicinal ingredients in a drug and is meant to compensate for time spent researching and obtaining regulatory approvals. In order to receive a CSP, the drug must be approved by Health Canada via a Notice of Compliance (NOC).
On July 10, 2020, the Federal Court issued a decision in a judicial review on the Minister of Health’s (the “Minister”) refusal to issue a CSP to ViiV Healthcare ULC (“ViiV”) in respect of Canadian Patent No. 2,606,282 (the “282 patent”) and the drug JULUCA®. JULUCA® is a combination drug containing medicinal ingredients dolutegravir and rilpivirine. The 282 patent is listed on the Patent register with respect to JULUCA®. The 282 patent, has claims directed only to dolutegravir, but does not have claims directed at the combination of dolutegravir and rilpivirine.
At issue in this judicial review, was whether the Minister had reasonably interpreted the Patent Act and the CSP Regulations (CSPR) in a manner that was consistent with CETA. The Minister was of the position that a CSP could not be granted because the 282 Patent does not pertain to the combination of the medicinal ingredients contained in JULUCA®. In taking this position, the Minister relied primarily on the Regulatory Impact Analysis Statement (RIAS) for the CSPR and the CSP’s Guidance Document. ViiV took the position that CETA’s intellectual property provisions were intended to provide protection for single medicinal ingredients or combinations of medicinal ingredients in new drug products. In addition, ViiV contended that the Minister’s interpretation would incentivize drug manufacturer’s to continue to make separate products instead of innovating fixed-dose combination therapies. The Court held that the Minister had unreasonably considered ViiV’s submission since the CIA required that the CSP legislation be interpreted in a manner that was consistent with CETA and that the sole reliance of the Minister on the CSPR RIAS and associated Guidance Document was not adequate, as neither CSPR RIAS nor the Guidance document has legislative force. As such, the Court granted the judicial review and remitted the matter to the Minister for redetermination.
In conclusion, this decision, if not appealed by the Minister would expand the scope of combination drugs eligible for CSP protection. In addition, this decision exemplifies the importance of harmonious interpretation of Canada’s international obligations and the statutory language with respect to IP protection in Canada.
For more information please contact:
Poonam Tauh, Ph.D., Senior Patent Agent
Carl Farah, Summer Student