On June 25, 2008, the Federal Government of Canada published1 amendments to the Patented Medicines (Notice of Compliance) Regulations2 (“NOC Regulations”) meant to reverse the effects of a recent Federal Court of Appeal decision in Wyeth Canada Inc. v. Ratiopharm Inc.3 (“Wyeth”) that had established a relevance requirement between the invention claimed in a patent and the drug submission against which the patent is to be listed.   The amendments have essentially limited the Minister of Health’s authority to delete or refuse to add to the Patent Register patents submitted prior to June 17, 2006. 

The NOC Regulations provide a link between the patent protection available to drug manufacturers under the Patent Act4 and the drug approval process governed by the Food and Drug Regulations5.  Generally, they provide innovative drug companies with the possibility of listing relevant patents pertaining to their approved drugs on Health Canada’s Patent Register to ensure that such patents are addressed by generic companies who wish to rely on an innovator’s drug product to obtain marketing authorization from Health Canada (referred to as a Notice of Compliance (“NOC”)). A generic manufacturer, applying for a NOC based on a comparison with an innovator product that has patents listed on the Patent Register, must address the listed patents.  They can either await expiry of the patent(s), or allege in a Notice of Allegation that, inter alia, the relevant listed patents are invalid or that said patents will not be infringed if an NOC were issued to the generic. If the generic makes such an allegation, the innovator has the possibility of commencing legal proceedings before the Federal Court of Canada which will trigger an automatic stay of up to 24 months prohibiting Health Canada from issuing the NOC to the generic.

As reported in the MBM February 2007 Newsletter, significant amendments affecting the requirements for listing patents on the Patent Register were introduced in October 2006.  In order to avoid an increase in litigation as a result of these amendments, the government chose to “grandfather” the patents submitted for listing before June 17, 2006 such that only patents submitted after June 17, 2006 were made subject to the October 2006 amendments.  One of the key listing changes introduced in the October 2006 amendments was the introduction of a strict relevance requirement between the patent claims and the drug product being approved by Health Canada.  For example, for a patent submitted with a Supplementary New Drug Submission (“SNDS”) for a change in formulation, the patent must contain a claim to the very change in formulation approved in the SNDS.

Prior to October 2006, previous Federal Court of Appeal case law6 had refused to accept such a strict relevance requirement which resulted in a number of patents claiming unapproved formulations or uses being listed on the Patent Register.  This practice was, however, brought into question in the recent AstraZeneca7 Supreme Court of Canada decision wherein the Court commented that the pre-October 2006 NOC Regulations required a certain link between the patent sought to be listed and the drug submission against which the patent was being listed.  Shortly following the AstraZeneca decision, the Federal Court of Appeal in Wyeth reversed its previous position and, consistent with the comments made in AstraZeneca, found that relevance was required between the patent sought to be listed and the drug submission against which it was listed. The Wyeth decision essentially brought the pre-October 2006 relevance requirements for listing in line with those of the post-October 2006 requirements.  It is the effect of this recent Wyeth decision and other subsequent decisions relying on Wyeth that the government sought to reverse in its June 2008 amendments. 

The key elements of the amendments are briefly described below:

-       Section 3 of the NOC Regulations has been amended to prohibit the Minister from deleting patents submitted prior to June 17, 2006 from the Patent Register, unless the patent has expired, has been impeached, or found not to be eligible for listing following a paragraph 6(5)(a) motion8, or if the drug identification number for the drug against which the patent is listed is cancelled under the Food and Drug Regulations; 

-       Section 3 was further amended to prohibit the Minister from refusing to add to the Patent Register a patent on a patent list that was submitted prior to June 17, 2006 solely on the basis that the patent is not relevant to the submission for a notice of compliance to which the patent list relates;

-       Subsection 6(5.1) was added to prohibit the Federal Court from dismissing a Prohibition Application in whole or in part solely on the basis that a patent that was submitted before June 17, 2006 is not eligible for inclusion on the Patent Register;

-       Subsection 6(5) motions that were ongoing before April 26, 2008 (i.e. the date of publication of the amendments in Canada Gazette Part I) will not be subject to new subsection 6(5.1);

-       Finally, the amendments contain a number of transitional provisions to address situations where, following the Wyeth decision, the Minister of Health deleted from or refused to add to the Patent Register patents on the basis of relevance9.

It remains to be seen whether the above changes will, as stated in the Regulatory Impact Analysis Statement accompanying the amendments, “effectively foreclose further litigation” on these matters.  The changes certainly appear to have significantly limited the Minister of Health’s authority to delete or refuse to add pre-June 17, 2006 patents on the Patent Register and should have the desired effect of reducing the number of judicial review proceedings against the Minister of Health.  Past experience, however, has shown that new amendments such as those described above almost always give rise to new issues for the Federal Court to address, fueling further litigation regarding the interpretation of the NOC Regulations10.