• Patent Not Eligible for Listing: Patent Claiming One Medicinal Ingredient, but directed to a Fixed-Dose Combination of Medicines
  • November 10, 2014 | Authors: Adrian J. Howard; Beverley Moore; Chantal Saunders; Ryan Steeves
  • Law Firm: Borden Ladner Gervais LLP - Ottawa Office
  • This was an appeal from two decisions for three proceedings before Prothonotary Milczynski, in which she determined that a patent could not be listed on the Patent Register under the PM(NOC) Regulations (the “Regulations”). The issue to be decided on appeal, according to Justice Hughes, is “arcane”: “can a patent claiming but one medicinal ingredient be listed by the Minister of Health under the Regulations where the underlying Notice of Compliance (“NOC”) is directed to a fixed-dose combination (“FDC”) of two or more medicines?”

    The Applicant (ViiV Healthcare) and the Minister of Health (the “Minister”) are common in all three proceedings, while Teva is the Respondent in one (see 2014 FC 328), and Apotex is the Respondent in the others (see 2014 FC 893). The Prothonotary gave the same Order in the Apotex proceedings as she did in the Teva proceeding. These proceedings concern two of the Applicant’s drugs: KIVEXA®, a FDC tablet containing two active ingredients and TRIZIVIR®, another FDC tablet containing three active ingredients. The Applicant’s Canadian Patent No. 2,289,753 (the “ ‘753 Patent”) was listed on the Register in respect of each of KIVEXA® and TRIZIVIR®.

    Prothonotary Milczynski determined that the ‘753 Patent was not eligible for listing against KIVEXA® or TRIZIVIR®. The Prothonotary based her decision on the product specificity requirements listed at paragraphs 4(2)(a) and (b) of the Regulations (Re: claim for the medicinal ingredient and the formulation, respectively), as well as the decision of the Federal Court of Appeal in Gilead Sciences (see 2012 FCA 254). The Court undertook an extensive review of the current jurisprudence dealing with the propriety of the listing of certain patents under the Regulations as amended in 2006 (see para. 47). Based on the jurisprudence, the Court made the following notable conclusions: (i) absent precise and specific matching between what the patent claims and the product/use/ dosage forms for which the NOC has been granted to the first person, the Minister cannot properly list the patent; (ii) a claim for a formulation includes both medicinal and non-medicinal ingredients, while a claim directed to medicinal ingredients, without claims also to non-medicinal ingredients, does not qualify for listing as a formulation; and (iii) where a patent claims only one medicinal ingredient, it cannot be listed as against an NOC obtained for two (or more) medicinal ingredients. The Court rejected a number of policy arguments advanced by the Applicant in favour of listing patents containing FDCs. In addition, the Court addressed the issue of whether FDCs are unique so as to be able to be listed under the Regulations. It concluded in the negative, holding that “every medicine in the envelope [by way of analogy] must be claimed”. The Court also noted that, in this case, the evidence was ambiguous as to whether there were separate medicines functioning independently, or whether they interacted and were synergistic. However, the Court found this type of analysis useless: “[a] patent claim for only one medicinal ingredient cannot support a listing under the NOC Regulations where the underlying NOC is for a combination (synergistic or otherwise) of two or more medicinal ingredients.”

    Therefore, the Court upheld the Orders of Prothonotary Milczynski holding that the ‘753 Patent was ineligible for listing on the Register. The Applicant’s motions, by way of this appeal, were dismissed. The Court stayed its Orders in respect of the Apotex proceedings (to permit the Applicant to file an appeal, if so advised) since the orders effectively terminated those proceedings. Costs were awarded to Teva and Apotex, although Apotex was awarded half the amount since its appeals largely followed Teva’s.