Federal Court Considers the Availability of Certificates of Supplementary Protection for Vaccines

April 13, 2020
By Adam Bobker

In Glaxosmithkline Biologicals S.A. v. The Minister of Health, 2020 FC 397, Justice Barnes has issued the first Federal Court decision interpreting the “medicinal ingredient” eligibility requirements for a Certificate of Supplementary Protection (“CSP”) under amendments to the Patent Act, R.S.C. 1985, c.P-4 (the “Patent Act”) and the Certificate of Supplementary Protection Regulations, SOR/2017-165 (the “CSP Regulations”). CSP’s have the potential to be very valuable intellectual property rights. They provide up to two (2) years of additional protection for new pharmaceutical products, if it takes more than five years after a relevant patent application is filed for the drug to be approved for sale in Canada. There are other requirements to be met to be eligible for a CSP, for example, the patent owner must file its new drug submission in Canada on a certain timeline. The qualifying criteria are briefly discussed below. The criteria can be complex, so local patent attorney input is advisable. In his decision, Justice Barnes also considered the new standard of review to be applied to decisions of the Minister of Health under the Supreme Court’s recent decision in Canada (Minister of Citizenship and Immigration) v. Vavilov, 2019 SCC 65.

The case involves a patent for the SHINGRIX® vaccine, which is used to treat shingles. The patent claims an immunogenic composition comprising the antigen for the shingles virus, in combination with a particular adjuvant that facilitates a clinically desirable immune response in the body. The adjuvant is effectively a booster that would not work alone. As well, the antigen would not have a clinically desirable effect without the adjuvant. The Minister had denied a Certificate on the basis that the gE antigen is known and the adjuvants, although biologically active, are not “medicinal ingredients” eligible for supplementary protection within the meaning of the CSP regime. Applying the Vavilov case, Justice Barnes held that the Minister’s decision was unreasonable. When considering the meaning of “medicinal ingredient” in the amendments to the Patent Act, the Minister had failed to “take appropriate account” of Canada’s obligations under the Canada-European Comprehensive Economic Trade Agreement pursuant to which the CSP regime was enacted. The CSP regime contemplates protection for the “active ingredients” in vaccines. The case was sent back to the Minister for reconsideration.

Certificates of Supplementary Protection come out of Canada’s commitments when entering into the Canada-European Union Comprehensive Economic and Trade Agreement (CETA). They provide up to two years of “sui generis” protection for new pharmaceutical products that were protected by an eligible patent. The protection takes effect upon the expiry of the patent.  This can be the time during which much of the investment in a product is recouped. The CSP is intended to compensate drug companies for time spent in researching and obtaining marketing authorization for new drugs, and provide patent-like rights for up to two years after patent expiry. The CSP regime is included in Sections 104 to 134 of the Patent Act and the CSP Regulations.

– In order to be eligible for CSP protection, a patent must include:

  • a claim to a medicinal ingredient or combination of medicinal ingredients contained in a drug (product claim);
  • a claim to the medicinal ingredient or combination of medicinal ingredients as obtained by a specified process (product by process claim); or
  • a claim for a use of the medicinal ingredient or combination of medicinal ingredients (new use). CSP Regulations, Section 3(2).

– The authorization for sale of the drug must have been issued after the CSP section came into force.

– One certificate is allowed based on the first authorization for sale of a medicinal ingredient in Canada. Patent Act, Section 106(d)-(e).

– The application for a CSP must be filed within 120 days after authorization for sale is issued or the patent is granted (which ever comes first). Patent Act, Section 106(3) and CSP Regulations, Section 6(2).

– The marketing approval in Canada (application for authorization for sale) must have been filed in Canada within a prescribed period (12 months or 24 months if the application for the certificate was filed in the first year of the CETA) if a prior marketing approval had been applied for in the EU, US, Australia, Switzerland or Japan.

– A medicinal ingredient that varies from a prior authorized medicinal ingredient merely by being ester, salt, chelate, clathrate or non-covalent derivate; or an enantiomer or mixture of enantiomers, or a solvate or polymorph, or post-translational modification is considered to be the same as the original medicinal ingredient so an authorization for sale of a prescribed variation will not trigger the ability to file for another certificate of supplementary protection. Patent Act, Sections 105(3) and (4), CSP Regulations, Section 2.

– The term of protection is up to two years – from the patent filing date in Canada to the date of the authorization for sale, less 5 years, meaning supplementary protection is available if it takes more than 5 years from filing of the relevant patent to get the drug approved for sale. Patent Act, Section 116(3).

– The CSP takes effect on expiry of the patent – as long as the patent is not invalidated or voided valid before expiry. Patent Act, Section 116(1)-(3).

– An action for infringement of a CSP is akin to an action for infringement of a patent. Patent Act, Section 124(1).

– An action for impeachment of a CSP is much the same as an action for impeachment of a patent. Patent Act, Section 125(1).

Given the potential value of CSP’s relating to vaccines and other drugs, Health Canada’s further decision and/or any future appeals from Justice Barnes’ decision on whether adjuvants in vaccines are “medicinal ingredients” will have a significant impact on patent prosecution and patent litigation in Canada going forward.

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