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The PMPRB has updated its "Patentee's Guide to
Reporting", a guide intended to help patentees complete the
forms required by the PMPRB for the reporting of sales and pricing,
with information that the PMPRB then uses to assess product
pricing.
The majority of the changes are cosmetic and are designed to
make the text read more smoothly, but do not introduce any
substantive differences. There are two changes of note, however.
First, the definitions of "patentee" and "former
patentee" have been changed to explicitly reference not only
the patent owner, but any other person who is entitled to the
benefit of a patent. This change seems to be in response to the
recent PMPRB decisions regarding generic
manufacturers.1
The second noteworthy change deals with the Special Access
Program (SAP) and other situations where no marketing approval has
been issued for a product, yet there have been sales. The reference
to the SAP program reflects the Supreme Court's decision in
Celgene Corp v. Canada (Attorney General)2 that
determined that the Board's jurisdiction extends to sales which
do not originate in Canada but products are sold into Canada to
customers who live in Canada.
The Board's updated reporting guidelines can be found
at:
The PMPRB has also proposed two changes to the Compendium of
Policies, Guidelines and Procedures (the Guidelines) by way of a
recently released Notice and Comment. These proposed changes would
affect products whose prices are near the Non-Excessive Average
Price (NEAP). The first change would reduce the number of
investigations which are triggered by the National Average
Transaction Price (N-ATP).
Currently, the Guidelines require Board Staff to commence an
investigation when the N-ATP of a product exceeds the NEAP by 5%.
This provision has the potential to trigger an excessive number of
investigations.
The proposed changes would remove this trigger. An investigation
would still be triggered if excessive revenues for a product are
greater than $50,000, if a product's introductory price exceeds
the maximum average potential price by 5% or if the PMPRB receives
a complaint.
The second proposed change would affect the way small amounts of
excess revenues are offset. Currently, excess revenues which are
below the threshold for an investigation must either be offset
under a Voluntary Compliance Undertaking (VCU) or a Board hearing.
This is often an inefficient proposition.
The proposed changes would simply require patentees to offset
excessive revenue "in a timely manner", without further
prescription.
Comments on the changes are due by May 14, 20102. The
Notice and Comment can be found on the PMPRB website at :
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