By a decision of Justice Zinn dated April 30, 2013, the Federal
Court quashed a Board's decision on excessive pricing of
Copaxone – for the second time. In 2009, Justice Hughes
heard a judicial review application by Teva in respect of a first
Board decision which had found excessive pricing. As with the
current decision, the Court in that instance found that the
Board's decision was unreasonable in not effectively
considering each of the factors set out in section 85(1) of the
In the instant decision, the Court found the Board only paid
"lip service" in considering factors of relative price of
the medicine when compared to domestic ((1)(b)) and international
((1)(c)) therapeutic comparators. The Board found the Consumer
Price Index (CPI) factor ((1)(d)) as being determinative, despite
having found that Copaxone was the lowest priced medicine amongst
both its domestic and international comparators,
"[I]n the period following 2004, the impact of the prices
increases that were imposed upon the consumer exceeded the
protection that Parliament has provided."
In particular, the Board found excessive pricing despite
Copaxone being the lowest medicine in its therapeutic class. This
finding was based solely on increases above CPI in the years 2004
and 2005 (equalling approximately 2.8 million dollars). While
this is one of the factors to be considered, an increase above CPI
in and of itself is not determinative of excessive pricing. The
Court's decision criticizing the Board is virtually identical
to Justice Hughes' 2009 decision. Justice Zinn in
discussing the application of the CPI factor acknowledges and
accepts the Court's earlier decision:
"In short, the Board has fallen into exactly the error
suggested by Justice Hughes – it has considered the
Guidelines, and specifically, those portions dealing with CPI to be
binding. The Guidelines are not binding....
"For these reasons this decision is unreasonable and must
be set aside on terms identical to those issued by Justice Hughes
Consequently, the Board's decision was quashed and sent back
to be redetermined by a different panel of the Board.
With its decision, the Court expresses frustration with the
PMPRB, but declined to "provide the Board with further
directions in the nature of a directed verdict, specifically that
the Board redetermine the matter on the basis that the allegations
against [Teva] be dismissed", which relief Teva had
The prospect of an internal investigation raises many thorny issues. This presentation will canvass some of the potential triggering events, and discuss how to structure an investigation, retain forensic assistance and manage the inevitable ethical issues that will arise.
From the boardroom to the shop floor, effective organizations recognize the value of having a diverse workplace. This presentation will explore effective strategies to promote diversity, defeat bias and encourage a broader community outlook.
Staying local but going global presents its challenges. Gowling WLG lawyers offer an international roundtable on doing business in the U.K., France, Germany, China and Russia. This three-hour session will videoconference in lawyers from around the world to discuss business and intellectual property hurdles.
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
This appeal relates to two generic drug submissions for two different products: exemestane and infliximab. Both submissions cross-referenced the submission of another generic company that had received a Notice of Compliance.
Two recent decisions from the Supreme Court of Canada directly affect Quebec's farm businesses by confirming La Financière Agricole du Québec's discretion in the administration of the farm income stabilization program...
On October 6, 2016, the Ontario Legislature reintroduced the Patients First Act, 2016 as Bill 41. Bill 41 is very similar to its predecessor, Bill 210, which was introduced in June 2016, but makes some important changes to the previous bill.
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).