On July 3, 2018 generic manufacturer, Pro Doc Ltée (Pro Doc), commenced a judicial review application (the Application) in connection with the Minister of Health’s decision to release patent hold letters and Drug Identification Number (DIN) assignment dates in response to a request made under the Access to Information Act.

The Application has significant implications for the innovative industry not only because of the relevance of patent hold letters to section 8 damages actions, but because of the breadth of the relief sought by Pro Doc. That relief includes an order restraining the Minister from disclosing the records and Pro Doc’s confidential information, as well as “an order directing the Minister to issue a policy relating to the disclosure of confidential information from drug submissions filed with Health Canada”.

The Application relates to a request from an unidentified person or entity under the Access to Information Act.  The request was for records reflecting the date on which Health Canada (a) assigned DINs to certain (but undisclosed) Pro Doc products; and (b) certified that the examination of the Pro Doc products was complete.  Pro Doc alleges that the Minister initially refused the request only to initiate a new consultation process and which resulted in the Minister’s decision to release the information sought.  Pro Doc alleges that the records at issue contain confidential information supplied to Health Canada and are valuable commercial, scientific or technical information.

Patent hold letters (also called “certification letters”) are provided by Health Canada to advise a generic manufacturer of the date when Health Canada completed its review and approval of that manufacturer’s abbreviated new drug submission such that a Notice of Compliance would have issued but for the Patented Medicines (Notice of Compliance) Regulations) (the Regulations).

These letters play a central role in damages actions commenced by generic manufacturers under section 8 of the Regulations.

Subsection 8(2) of the Regulations provides that the presumptive start date for an innovators’ liability is the later of the date that the generic served a notice of allegation addressing relevant patents, and the day, as certified by the Minister, on which a notice of compliance would have been issued in the absence of the Regulations. In a typical section 8 damages action, the Court will need to understand the patent hold dates of not only the section 8 claimant, but other generic manufacturers who would have competed in the hypothetical generic market. Despite being expressly referenced in the Regulations, innovators have been forced to obtain these administrative documents through Access to Information requests and non-party production motions.

Pro Doc alleges that the information contained in the records is not public and reveals information originating from Pro Doc.  According to Pro Doc, the company would be harmed if this information were to be disclosed.

Pro Doc will have to overcome clear judicial authority which has held that the Access to Information Act is not intended to exempt from disclosure knowledge of how the regulatory process works, including information about timelines related to specific drug submissions, which is exactly the kind of information sought from a patent hold letter.  Pro Doc’s allegations regarding the confidentiality of patent hold letters is also inconsistent with the treatment of patent hold dates by generic manufacturers and courts alike. Section 8 claimants routinely plead their patent hold dates in their statement of claims and to-date, no Court has redacted a patent hold date in any section 8 decision.

The Minister of Health has filed a Notice of Appearance. It is unclear whether the person or entity seeking the release of Pro Doc’s patent hold letters will be added as a party to the application or whether any industry associations will seek leave to intervene.

Links:

Notice of Application