By letter dated November 8, 2002 to the main trade associations, the Therapeutic Products Directorate (TPD) of Health Canada requested representations on an issue relating to the eligibility of patents for listing on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations ("Regulations").
The letter from TPD notes that in January 2002 it filed a Reference with the Federal Court of Canada (File No. T-139-02) with respect to patent eligibility, but that the Reference was dismissed by the Court on preliminary grounds, prior to the parties advancing substantive submissions on the question posed. TPD notes that in order to study the matter further, it is inviting representations on the following questions:
Question 1
- A first person files a new drug submission for Drug A, containing the medicinal ingredient compound x, on January 1, 2000, and then files an application for a patent on February 1, 2000.
- The patent is granted on March 1, 2002 (the '000 patent). The '000 patent claims the medicine itself (compound x).
- On September 1, 2000, the first person files a supplemental new drug submission, seeking to change the formulation of Drug A from formulation 1 to formulation 2. Along with this supplemental new drug submission, the first person includes a Form IV, seeking to list the '000 patent on the Patent Register.
Is the '000 patent eligible for listing on the Patent Register for Drug A pursuant to the requirements of the Patented Medicines (Notice of Compliance) Regulations?
Question 2
- The same circumstances as in Question 1 apply, except that patent, (now the '001 patent), contains a claim for the medicine itself or a claim for the use of the medicine, and claims formulation 2.
Is the '001 patent eligible for listing on the Patent Register for Drug A pursuant to the requirements of the Patented Medicines (Notice of Compliance) Regulations?
TPD has stipulated that written representations will be limited to twenty pages and must have been filed with TPD by November 25, 2002. All written representations received by TPD are to be posted on a designated website. In addition, TPD will be holding a one-day meeting on December 2, 2002, according a total of two hours each for first and second person representatives under the Regulations, with a further half hour each for reply. Those wishing to be present during the December 2, 2002, hearing were to advise TPD by November 22, 2002.
The questions posed by TPD are of considerable interest and of great potential importance to both pharmaceutical patentees and generic companies. Presumably, TPD will be guided by the submissions made to the questions posed, in formulating a policy for the future administration of the Regulations, and in particular, patent eligibility.
We will report on further developments in future issues of Rx IP Update.