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Failure to address all art cited in NOA sinks ciclesonide prohibition application

On May 1, 2015, Justice O’Reilly dismissed a prohibition application brought by  Takeda against Apotex involving the  drug ciclesonide. The application involved three patents listed against Takeda’s OMNARIS nasal spray. While Apotex had raised a number of allegations against the patents in issue, Justice O’Reilly dismissed the application solely on the basis that Takeda had failed to establish that Apotex’ allegations of obviousness were unjustified.

Canadian Patent 2,388,322

The 322 Patent is generally directed to a high mucosal permeability formulation of ciclesonide having a low osmotic pressure and a water insoluble and/or low water solubility. The increased permeability is disclosed to allow the administration of lower doses, thereby reducing side effects.

Justice O’Reilly, following the obviousness framework in Sanofi-Synelabo, held that the inventive concept included superior ciclesonide retentivity and permeability compared to conventional compositions. In assessing the state of the art, Justice O’Reilly preferred the evidence of Apotex’ expert, Dr. Mumper, over Takeda’s expert, Dr. Bodmeier, in part because the latter did not consider all of the prior art cited in Apotex’ Notice of Allegation:

I note that Dr Bodmeier relied only on three of the prior art references contained in Apotex’s NOA and cited by Dr Mumper. Dr Bodmeier did not address all of the relevant prior art, and never referred to the standard text sources mentioned in the NOA and cited by Dr Mumper. I find, therefore, that on the subject of the state of the art and the common general knowledge, Dr Mumper’s opinion is more helpful.

Justice O’Reilly also noted that Dr. Mumper’s evidence was helpful in that his opinion was provided before knowing what was claimed in the patent. Based on the state of the art and common general knowledge, Justice O’Reilly held:

The preponderance of the evidence shows that a skilled person would have arrived at the formulation set out in the ‘322 patent simply by reviewing readily-available relevant publications and applying his or her general knowledge. The inventive concept of the ‘322 patent and the relevant art, taken as a whole, are coextensive. There was no gap to bridge; no inventive step was taken.

Canadian Patent 2,388,325

The 325 Patent was generally directed to a formulation of ciclesonide and hydroxypropylmethylcellulose. Justice O’Reilly held that the inventive concept included avoiding variations in ciclesonide concentration and decreases in ciclesonide recovery during production.

Justice O’Reilly  preferred the evidence of Apotex’ expert because Dr. Bodmeier again did not address all of the references cited in the NOA and Apotex expert’s opinion was given before knowing what was claimed in the patent in dispute. Justice O’Reilly concluded that there was no difference between the inventive concept and the relevant art such that the skilled person could arrive at the claimed formulation by reviewing the relevant literature and applying his or her common general knowledge.

Canadian Patent 2,538,419

The 419 Patent is generally directed to a new method of using ciclesonide to treat respiratory diseases, especially in children.

Justice O’Reilly agreed with Apotex’ experts that the inventive concept of the 419 Patent includes the reduction of side effects associated with other corticosteroids, particularly growth suppression in children upon long term exposure. Justice O’Reilly accepted Apotex’ expert evidence, again provided prior to knowing what was claimed in the patent in dispute, that the skilled person would begin by conducting a literature search and would find the art cited in Apotex’ NOA. Based on this prior art and the skilled person’s common general knowledge, Justice O’Reilly concluded that the invention described in the 419 Patent conformed to what a skilled person would have expected, specifically that 20 to 200 μg of intranasal ciclesonide would be effective and would not affect children’s growth.

A copy of Justice O’Reilly’s Judgment and Reasons may be found here.