and
Graham Ragan 
In this issue:
- PMPRB Reporting Guidelines Updated and Changes Proposed to the
Compendium of Policies, Guidelines and Procedures
PMPRB Reporting Guidelines Updated and Changes Proposed to the Compendium of Policies, Guidelines and Procedures
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:
http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1049&mp=146
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 :
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=1616&mp=1617
Footnotes
1. See PMPRB-08-D3-ratio-Salbutamol HFA – Merits, May 27, 2011 (online: http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1500&mp=254) and PMPRB-08-D3-ratiopharm – Merits, June 30, 2011 (online: http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1518&mp=254)
2. 2011 SCC 1.
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