On April 11, 2012, the Federal Court of Appeal dismissed an appeal from a prohibition Order of the Federal Court prohibiting the Minister of Health from issuing a notice of compliance ("NOC") to Mylan Pharmaceuticals ULC for a generic anastrozole product: Mylan Pharmaceuticals ULC v. AstraZeneca Canada Inc. et al., 2012 FCA 109.
Anastrozole (AstraZeneca's ARIMIDEX) is a drug used in the treatment of breast cancer. Justice Rennie of the Federal Court ("Applications Judge") granted the prohibition Order to AstraZeneca on August 29, 2011, finding that Mylan's allegations that Canadian Patent No. 1,337,420 ("’420 patent") was invalid for inutility and obviousness were not justified.
Mylan appealed to the FCA on the issue of utility. In particular, Mylan argued that the Applications Judge erred in finding that the ’420 patent did not promise that anastrozole has fewer side-effects than aminoglutethimide (a previously known aromatase inhibitor). Mylan further argued that, as of the filing date, the ’420 patent did not sufficiently disclose any such utility in the patent on the basis that reference to a study demonstrating the utility was required.
Mylan's argument that the ’420 patent promised fewer side-effects than aminoglutethimide relied on an "object clause" in the patent specification, which read: "It is a particular object of the present invention to provide aromatase inhibitory compounds with fewer undesirable side effects than [aminoglutethimide]."
The Applications Judge found that this object clause referred to a forward-looking aim of the invention, rather than a promise that anastrozole had achieved this aim by the filing date of the patent. Mylan argued before the FCA that the Applications Judge erred in this finding, including as a result of placing undue reliance on a dictionary definition of the word "object" and by erring in his consideration of the context of the ’420 patent as a whole, the state of scientific knowledge on the filing date of the patent and the expert evidence.
The FCA rejected each of Mylan's criticisms and ultimately found that the Applications Judge's interpretation of the object clause was correct.
The FCA agreed with the Applications Judge that "an examination of the patent as a whole supports the conclusion that … the object clause contains no more than a forward-looking aim of the invention." Further, the FCA found that the Applications Judge did not place undue reliance on a dictionary definition of the word "object" or err in his consideration of context of the patent, the state of scientific knowledge or expert evidence.
In view of the FCA's finding that the Applications Judge was correct that the ’420 patent did not promise fewer side-effects than aminoglutethimide, the FCA elected not to consider whether the ’420 patent was invalid for failing to refer to a study that demonstrated fewer side-effects, and dismissed Mylan's appeal with costs.
Daniel S. Davies, Ottawa
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