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...