While originally proposed to come into force on January 1, 2019, sweeping amendments to the Patented Medicines Regulations governing pricing criteria were still not released as of June 30. Assuming they are released, they are expected to come into force 12 months thereafter; the earliest expected in force date is therefore July 2020. Work on guidelines modernization to accompany the amendments continued through the first half of the year, including release of the Steering Committee’s final report (see latest status here).
Two Court decisions issued in June. First, the Federal Court (FC) upheld the Patented Medicine Prices Review Board’s (PMPRB) excessive pricing decision requiring a $4.2M payment regarding Alexion’s SOLIRIS (eculizumab). The Court held that the PMPRB was not unreasonable in following its Guidelines in one respect (in determining permitted increases) and in not following its Guidelines in another respect (in assessing the appropriate benchmark). Alexion has appealed.
Second, in a closely watched case, the FCA sent back to the PMPRB the question of whether the invention (in this case use of 0.3% adapalene) “pertains to” DIFFERIN (0.1% adapalene). While the determination of the invention is not an exercise of claim construction, the PMPRB must consider the patent as a whole, including the claims. In determining whether “an invention pertains to the medicine”, the phrases “rational connection or nexus” or “merest slender thread” cannot supplant the statutory language, which requires that “the invention is intended or capable of being used for the medicine.”
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.