On May 18, 2012, the first proceeding under the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”) for a subsequent-entry biologic (“SEB”) was commenced. Amgen Canada Inc. and Amgen Inc. commenced the proceeding against Teva Pharmaceutical Industries Ltd., Teva Canada Innovation and the Minister of Health regarding Teva’s proposed filgrastim product. Filgrastim is a granulocyte colony-stimulating factor; it is a 175 amino acid protein produced by recombinant DNA technology. Amgen markets filgrastim under the brand name NEUPOGEN, which is approved for a number of indications, including to decrease the incidence of infection in cancer patients receiving myelosuppressive chemotherapy. NEUPOGEN was first approved in Canada in 1992. Amgen seeks an Order prohibiting the Minister of Health from issuing a notice of compliance (NOC) to Teva until expiry of Patent No. 1,341,537. Teva had alleged the patent is invalid. In its notice of application, Amgen asserts that Teva has indicated that it has filed a new drug submission (NDS) with the Minister. 

To put this proceeding in context, while there is no explicit pathway for the approval of SEBs under the Food and Drug Regulations, Health Canada approved the first SEB based on a reduced data package, OMNITROPE (Sandoz's somatropin), in April 2009.  Health Canada released its Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) in March 2010 but has not approved a further SEB. Health Canada’s Guidance describes SEBs as follows:

The term "subsequent entry biologic" (SEB) is used by Health Canada to describe a biologic drug that enters the market subsequent to a version previously authorized in Canada, and with demonstrated similarity to a reference biologic drug. Accordingly, an SEB will in all instances be a subsequent entrant onto the Canadian market. In consideration of supporting information generated using the reference biologic drug, an SEB approval could be granted based on a reduced amount of original non-clinical and clinical information tailored to a particular class of products or a specific case. The term, subsequent entry biologic, was chosen as an alternative to "biogeneric" or "generic biologic" in order to clearly distinguish between the regulatory process (and product characteristics) for SEBs and that which is currently used for generic pharmaceutical drugs.

Health Canada specifically contemplates certain proteins as SEBs in its Guidance, although Health Canada has not limited SEBs to only particular classes of drugs:

The demonstration of similarity depends upon detailed and comprehensive product characterization. The guidance applies to biologic drugs that contain, as their active substances, well characterized proteins derived through modern biotechnological methods such as use of recombinant DNA and/or cell culture.

The Guidance states that SEBs are subject to the PM(NOC) Regulations and data protection. 

Consistent with this (and Teva’s service of a notice of allegation regarding filgrastim), Health Canada’s Guidance Document: Patented Medicines (Notice of Compliance) Regulations states:

New drug submissions submitted in accordance with the SEB Guidance that demonstrate similarity with a biologic drug marketed in Canada, and in respect of which there are patents listed on the Patent Register, are considered to make a comparison or reference within the meaning of section 5. Sponsors of such submissions will be required to fulfill the requirements for second persons under the PM(NOC) Regulations.

The inclusion of biologics under the PM(NOC) Regulations is one of a number of key differences between the PM(NOC) Regulations and the U.S. Hatch-Waxman scheme. 

The Teva filgrastim proceeding will only determine the issue of whether the Court should prohibit the Minister of Health from granting marketing approval to Teva until expiry of the patent at issue, having regard to the issues raised by Teva in its notice of allegation. While Teva Generics GmbH received marketing authorization from the European Medicines Agency in September 2008 for its filgrastim product TEVAGRASTIM, whether Health Canada will ultimately approve Teva’s filgrastim submission remains to be seen.

Nancy P. Pei, Toronto

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