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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.
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.
The preceding is intended as a timely update on Canadian
intellectual property and technology law. The content is
informational only and does not constitute legal or professional
advice. To obtain such advice, please communicate with our offices
directly.
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