The Top Line
The Patented Medicines Pricing Review Board does not have jurisdiction to regulate unpatented (or formerly patented) medicines, the FCA ruled again. In this case, the PMRPB was not permitted to seek pricing information for DIFFERIN beyond a limited period after patent expiry. To rule otherwise would reach beyond the constitutional powers of the federal government.
In a long-running dispute between the Patented Medicines Pricing Review Board (PMPRB) relating to DIFFERIN (0.1% adapalene), the FCA recently ruled (in 2024 FCA 208) that the PMPRB “crashed through the constitutional, statutory and jurisprudential guardrails” by demanding production of pricing information from Galderma.
A condensed history of PMPRB’s requests
The PMPRB had sought pricing information on DIFFERIN for 2010 to 2016, despite the fact that the relevant patent expired in December 2009. The PMPRB’s request was unusual in that they sought information six years after expiry, despite the fact that s. 80(3) of the Patent Act states that the obligation to provide information does not apply to a person who “has not been entitled to the benefit of the patent or to exercise any rights in relation to the patent for a period of three or more years”
, and because the PMPRB was using Galderma’s patent for DIFFERIN XP (0.3% adapalene) as a basis for jurisdiction over DIFFERIN.
Galderma has consistently fought against this order, which was the subject of previous court decisions including 2019 FCA 196, where the FCA held that the PMPRB acted unreasonably in determining that the second Galderma patent, claiming 0.3% adapalene, “pertained” to DIFFERIN, which contains only 0.1% adapalene.
The FCA rejects the PMPRB’s position
After the 2019 FCA decision, the PMPRB continued to seek the documents from Galderma. The PMPRB asserted in this case that it had jurisdiction over the unpatented DIFFERIN on the basis that: (1) Galderma is and was a patentee of a patented medicine, (2) that the DIFFERIN XP patent (for the higher concentration) had the same active ingredient as DIFFERIN, and (3) that patients often use the two products interchangeably.
The FCA categorically rejected each of these arguments. The Court noted that after 2009, Galderma no longer benefited from patent protection for 0.1% adapalene, and therefore was no longer a “patentee” for the purpose of s. 79(1) of the Patent Act for DIFFERIN. In other words, from the expiry date forward DIFFERIN was an “unpatented medicine”.
Further, the ‘237 Patent at issue claimed the “use” of 0.3% adapalene, not the active ingredient itself. The Court held that 0.3% adapalene “cannot” be “intended or capable of being used” for 0.1% adapalene. This latter statement appears to be more definitive than the FCA’s 2019 decision, where it held that there was only “one reasonable interpretation” of the ‘237 Patent.
Finally, reiterating a consistent line of case law since the 1980s, the FCA repeated that the PMPRB does not have jurisdiction to generally review or regulate unpatented medicines. The Patent Act cannot be read to provide such jurisdiction as it would exceed the constitutional power of the federal government, which is limited to regulation of intellectual property and not the regulation of pricing in general.
In the result, the FCA set aside the judgment of the Federal Court below (which originally affirmed the PMPRB), and the order of the PMPRB itself.
Takeaways
This decision further affirms a long line of cases limiting the PMPRB’s jurisdiction to patented medicines as a matter of both constitutional and administrative law. While this may not yet be the final chapter of the PMPRB’s efforts, the FCA’s comments seem likely to inform the presently-ongoing development of new PMPRB Guidelines, which are undergoing revisions based on stakeholder feedback and expected to be released in 2025.