Federal Court Sets Aside PMPRB Board Decision re Teva’s COPAXONE Syringe Product

On April 30, 2013, the Federal Court granted Teva’s application challenging a decision of the Patented Medicines Price Review Board (PMPRB) regarding Teva’s copaxone syringe product. This is the second successful challenge Teva has made against the PMPRB regarding its copaxone product. In 2009, the PMPRB held that Teva had excessively priced its copaxone syringes in Canada and ordered Teva to pay close to $2.5 million to the Crown. Teva challenged that decision by way of judicial review and on November 12, 2009, Justice Hughes granted Teva’s application. Justice Hughes held that the PMPRB had improperly limited its review to only one of the four factors that must be considered under subsection 85(1) of the Patent Act. Specifically, he held that the Board improperly focused on section 85(1)(d) which pertains to the Consumer Price Index (CPI) and that the Board paid “lip service” to the other enumerated factors. Justice Hughes ordered the matter be returned to the PMPRB for redetermination and required the matter to be considered using all the factors listed in section 85(1) to provide “intelligible, clear reasons as to the consideration and weight given to each factor.” By its decision dated February 23, 2012, the PMPRB once again found Teva’s pricing of copaxone syringes excessive and ordered a payment of over $2.8 million. Despite finding that Teva’s copaxone syringes were the lowest priced medicine in its class relative to the nearest competitors since 2004 and that it was priced lower in Canada than in other countries between 2004 and 2010, the Board discounted the importance of these factors including stating that pricing in other countries might be affected by “exogenous factors”. The Board, instead, placed heavy weight on the CPI and in two paragraphs provided the reasoning for its findings of excessive pricing. In reasons dated April 30, 2013, Justice Zinn allowed the application. He held that the PMPRB had “paid no more than lip service to the factors favouring the conclusion that the medicine was not excessively priced, namely paragraphs 85(1)(b) and (c) and again treated paragraph 85(1)(d), as a conclusive factor.” He went on to find that the Board had committed a “fundamental legal error” in its interpretation of section 85(1) generally. The Board incorrectly believed that section 85(1) provides “limits” on pricing. Rather, section 85(1) provides a list of factors that are relevant to determine whether a medicine is excessively priced. No one factor provides any protection or limit in pricing. The matter has been sent back to the PMPRB for redetermination in accordance with the Court’s reasons. The full reasons for judgment can be found here: http://decisions.fct-cf.gc.ca/en/2013/2013fc448/2013fc448.html Summary by: Kavita Ramamoorthy