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Amgen recently started litigation against Teva over the biologic
drug filgrastim (Court File No. T-989-12). Filgrastim is a
granulocyte colony-stimulating factor analog that is used to treat
low neutrophil counts (neutropenia). It is primarily used to treat
patients with cancer. Amgen's filgrastim products have
generated billions of dollars in international sales annually.
Amgen is trying to use its patent to block Teva from getting its
marketing authorization from Health Canada (the Canadian
counterpart to the U.S. FDA)1. Amgen was able to start
the case because Teva's drug submission to Health Canada relies
on Amgen clinical data as a shortcut to approval (a drug that takes
this shortcut is called a "subsequent entry biologic" or
a "biosimilar"). This is the first time that a biosimilar
drug submission has been involved in this type of patent litigation
in Canada. When Teva filed its drug submission, it was also
required to assert that it would not infringe any valid Amgen
patent on Health Canada's Patent Register (this Patent Register
is similar to the U.S. Orange Book). This assertion was a trigger
that allowed Amgen to start the lawsuit.
The Canadian patent in the dispute (No. 1,341,537) expires in
2024. Amgen filed the case in the Federal Court on May 18, 2012,
and will have up to 2 years to get a court order blocking the
marketing authorization. Teva cannot launch its product in the
meantime, even if it meets Health Canada's safety and efficacy
requirements.
Teva's filgrastim product (Tevagrastim) has been
marketed in Europe since 2008. It has not been marketed in the
United States. Amgen and Teva settled U.S. patent litigation on the
basis that Teva could launch in the U.S. in 2013.
The Teva drug submission also raises interesting regulatory
questions. It is a biologic drug, which is a protein produced by a
genetically engineered cell. Biologics are often much larger and
more complex than conventional chemically-synthesized small
molecule pharmaceuticals. This makes the comparison of biosimilars
to their approved counterparts more difficult. Health Canada
published a guidance document in March 2009 detailing the approval
requirements for subsequent entry biologics in
Canada2.
Teva should be required to provide comparative clinical trial
data of its product tested head-to-head against the Amgen drug.
This is a much higher standard than for conventional generic
pharmaceuticals which are approved upon showing bioequivalence and
without clinical trials. However, there remains much debate as to
how high the data requirements should be set for biosimilar
biologic drugs in view of their complexity.
Footnotes
1. The litigation is under the Patented Medicines
(Notice of Compliance) Regulations.
2. Health Canada, Guidance for Sponsors: Information
and Submission Requirements for Subsequent Entry Biology
(SEBs), Mar. 5, 2010.
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