PMPRB’s Copaxone Decision Unreasonable in its Application of s. 85(1) of the Patent Act

PMPRB’s Copaxone Decision Unreasonable in its Application of s. 85(1) of the Patent Act

Teva Canada Innovation v. Canada (Attorney
, 2013 FC

Teva asked the Court to set aside a decision of the Patented Medicine
Prices Review Board (the Board), wherein the Board ordered that Teva pay Her
Majesty in Right of Canada the sum of $2,801,285 for having sold its Copaxone
Syringe in the Canadian market at an “excessive price” between 2004 and 2010,
contrary to section 83 of the Patent Act.

The Court quashed the Board’s decision, and returned the matter for
redetermination by the Board, differently constituted.

Definition of “Medicine”

The Court did not interfere with the Board’s definition of medicine.

Teva had argued that the Board placed an unreasonable interpretation on
the term “medicine” as found in the Patent Act, namely, by equating it
with the DIN. Teva had taken the position that the medicine flows from the
patent of invention, not from the delivery mechanism, and that regardless of
whether the medicine is in the vial format or the syringe, and thus carries a
different DIN, it is the same medicine. In response, the Court noted that the Board
was entitled to deference when interpreting its home statute. The court also
noted that regarding the equivalence of the vial and syringe formats, Teva had
taken a contrary position in its earlier correspondence with the Board.

Reasonableness of the Board’s Decision

The Court held that the Board’s decision is unreasonable and must be set
aside because it paid no more than lip service to the factors favouring the
conclusion that the medicine was not excessively priced, namely ss. 85(1)(b)
and (c), and treated s. 85(1)(d), i.e. the Consumer Price Index (CPI),
as a conclusive factor. 

The Court determined that, regarding s. 85(1)(b), the Board’s decision
suffers from a lack of intelligibility.

Regarding s. 85(1)(c), the Court held that what the Board appears to be
saying is that this factor is inherently unreliable and should be given little
if not no weight. The Board appears therefore to be subverting the will of
Parliament, which clearly saw this as a relevant factor to be accorded weight.

Finally, the Court emphasized that Parliament has provided protection
from “excessive” prices, stating that CPI is one of the factors to consider –
it is not the only factor, or even the determinative factor.