Generic Manufacturers May Not Be Required to Address All Listed Patents

Article by Peng Fu, Eileen McMahon and Conor McCourt

The Supreme Court of Canada’s decision in AstraZeneca¹ has now been judicially interpreted by the Federal Court of Canada, for the first time. The implications are far-reaching for companies that rely on the regulatory regime established by the Patent Medicines (Notice of Compliance) Regulations that were in force before the latest amendments took effect on October 5, 2006. These implications include the following:

• Generic manufacturers may not be obligated to address all patents listed on the Patent Register.

• In certain circumstances, Health Canada may issue Notices of Compliance (NOC) for generic products when prohibition proceedings have been commenced.

• Health Canada may not necessarily alert innovator drug companies before it issues NOCs to generic manufacturers (on the basis that certain listed patents do not have to be addressed).

The case before the Federal Court comprised five separate judicial review applications, involving Ferring Inc., Sanofi-Aventis Canada Inc., Apotex Inc., Novopharm Ltd. and the Minister of Health.² The core issue to be resolved by the Federal Court was whether the Minister of Health adopted the correct analysis, in light of AstraZeneca, for determining which patents on the Patent Register a generic drug manufacturer must first address when seeking regulatory approval.

The Minister decided that Apotex and Novopharm were not required to address certain patents listed by Ferring and Sanofi-Aventis because they were added to the Patent Register after the dates on which Apotex and Novopharm purchased the comparator drugs (i.e., the innovator’s drug against which the generic manufacturer makes its comparison for approval).

The Federal Court held that the analysis adopted by the Minister was consistent with AstraZeneca and the Patent Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations), and that the Minister reached the right decision regarding each patent in dispute.

In AstraZeneca, the Supreme Court had held that under section 5 of the previous PM(NOC) Regulations, a generic manufacturer was required to address only patents listed against submissions relevant to the NOC that gave rise to the comparator drug.

As outlined by the Federal Court, the Minister sought to apply AstraZeneca by adopting a two-step analysis: (i) a generic manufacturer must address all patents listed in respect of submissions for which NOCs were issued as of the date of purchase of the comparator drug; and (ii) if a generic manufacturer has "made use" of "changes introduced to a comparator drug" in the period between its purchase of the comparator drug and the date on which it receives an NOC, it need address only those patents listed in respect of the innovator’s submissions for such changes.³

The Court further held that if the Minister determines that a generic manufacturer is not obligated to address certain listed patents and the generic manufacturer’s abbreviated new drug submission is otherwise approvable, the Minister is authorized and obligated to issue an NOC without delay. The existence of a prohibition proceeding would not prohibit the Minister from issuing an NOC in this circumstance.

Having affirmed that the Minister may issue an NOC to a generic manufacturer when deemed appropriate, the Court determined that the Minister is not obligated to advise an innovator whether a generic manufacturer is seeking an NOC. In addition, the Minister is not obligated to allow the innovator to be heard before a decision is made to issue an NOC to a generic manufacturer. The Court did not determine this lack of notice to the innovator to be either unfair or contrary to the principles of natural justice.

In addition, the Court indicated that an innovator lacks standing or status to seek a judicial review of the Minister’s decision to issue NOCs to generic manufacturers. It reasoned that the innovator would have simply lost an opportunity to commence prohibition proceedings under the PM(NOC) Regulations, which is "merely a commercial interest."

We note that Sanofi-Aventis has appealed this decision.

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