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Entirety Of The Patent Must Be Considered When Determining If A Patent Pertains To A Medicine

Galderma had two patents for Differin which contained 0.1% adapalene (Canadian patent nos. 1,266,646 and 1,312,075 (expired 2007 and 2009, respectively). In 2009, Galderma obtained Canadian patent no. 2,478,237 for Differin XP which contained 0.3% adapalene. Representative claim 7 of the 237 Patent provides:

  1. A pharmaceutical composition comprising, in a physiologically acceptable medium, 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid or one of its pharmaceutically acceptable salts, characterized in that it is a gel or a cream comprising 0.3% by weight of said 6-[3-(1-adamantyl)-4-methoxyphenyl]- 2-naphthanoic acid or its salt relative to the total weight of the composition.

In December 2016, the Board concluded that the 237 Patent pertained to Differin (0.1% adapalene) and ordered that Galderma file the prescribed information for the period January 1, 2010 to March 14, 2016. Galderma sought judicial review of the Board’s decision.

The Judicial Appeal

The parties agreed that the question was whether the invention claimed and described in the 237 Patent “pertained” to Differin (0.1% adapalene). Justice Phelan concluded that there are a number of problems with the decision that individually and cumulatively are sufficiently serious as to warrant that the decision be quashed. Throughout the Board’s decision, it appeared to use the words “patent” and “invention” interchangeably. Justice Phelan concluded that the interchangeable use of these words was not simply a form of short hand, and that the Board did not determine what was the invention in the 237 Patent.

Section 79(2) requires the Board to focus on the invention before it determines whether the invention is intended or capable of being used for the “medicine”. A key question was whether the invention of the 237 Patent was intended or capable of being used for Differin (0.1% adapalene).

[41] The Board focused its attention on the commonality of the active ingredient adapalene in both medicines and never determined whether the 0.3% Differin XP medicine was intended or capable of being used for the 0.1% Differin medicine. There was no evidence that it was so capable. It appears that the Board assumed that one merely had to dilute the 0.3% medicine to arrive at the 0.1% medicine capable of performing the same function. However, the evidence was that there were two separate medicines and there was no evidence that the 0.3% invention could be used to create a 0.1% medicine or that it was capable of doing so.

[42] The Board focused on the issue of whether the 237 Patent could be used for 0.1 Differin not, as it should, whether the 0.3 Differin XP medicine was intended or capable of being used for 0.1 Differin medicine.

While the Board was not to engage in claims construction, the Board did not refer to claims, description or scope of the invention in coming to its decision. Instead, the Board referred to the abstract and an introductory paragraph of the 237 Patent to conclude that one of the objects of the 237 Patent was 0.3% adapalene to argue that the patent did not pertain exclusively to 0.3% adapalene. Justice Phelan, following the decision of the Supreme Court of Canada in Whirlpool that the whole of the patent must be considered and the maxim that “what is not claimed is considered disclaimed”, concluded that the Board had erred in ignoring critical parts of the 237 Patent.

Justice Phelan concluded that it was unreasonable (and irrelevant) to conclude that, on the face of the 237 Patent, it pertained to Differin (0.1% adapalene) because the patent is capable of being used for that, noting that the Board failed to explain how the 237 Patent could be used for a medicine with 0.1% adapalene. Justice Phelan accordingly granted the judicial review and quashed the decision of the Board.

A copy of the Judgment and Reasons by Justice Phelan can be found here.