Takeda Canada Inc v Canada (Minister of Health), 2015 FC 570
In this Federal Court (“FC”) decision the FC dismissed a prohibition application on the basis that the applicant failed to establish that the respondent’s allegations of obviousness were unjustified. The proceeding was brought under the Patented Medicines (Notice of Compliance) Regulations and required the FC to consider three existing patents. The FC favoured the respondent’s “blinded expert” evidence in which the experts provided their opinions before knowing what was claimed in the disputed patents.
Takeda Canada Inc. and Takeda GmbH (“Takeda”), the applicants, created Omnaris, a nasal spray used in the treatments of conditions such as allergic rhinitis. Takeda sought an order prohibiting Apotex Inc. (“Apotex”), the respondent, from marketing a generic version of Omnaris.
The active ingredient in Omnaris was ciclesonide (CS). Takeda had four patents related to CS, the first of which expired in 2011. Of the other three patents, Canadian Patent No. 2,388,322 (the “’322 Patent”) related to a pharmaceutical composition for CS, Canadian Patent No. 2,388,325 (the “’325 Patent”) related to an aqueous pharmaceutical composition for CS and Canadian Patent No. 2,538,419 (the “’419”) (collectively, “the Patents”) related to the use of CS in the treatment of respiratory diseases in children.  Apotex alleged that the three patents were invalid on the grounds of anticipation, obviousness, double-patenting, lack of utility, sufficiency and overbreadth. 
The FC dismissed Takeda’s Application. The FC found that the Patents were invalid for obviousness as there was no difference between the relevant art and the inventive concept of the Patents.
The FC was tasked with comparing the state of the art and the common general knowledge of the skilled person with the inventive concept of the Patents’ claims to determine whether the claims were obvious.
The ‘322 Patent
The ‘322 Patent claims compositions of CS with varying osmotic pressures, ranging from 10 mOsm or less, to 290 mOsm or less.  The FC found that the inventive concept of the ‘322 Patent was clear from its description, that it was “an aqueous pharmaceutical composition for application to the mucosa, which contains CS, and a water-insoluble and/or water-low soluble substance, and which has an osmotic pressure of less than 290 mOsm.” 
Looking at the evidence, the FC found that the expert used by Takeda failed to canvass the entire state of the art and the common general knowledge of the skilled person at the relevant time.  Conversely, Apotex’s expert, before even being provided with the ‘322 Patent, came to the conclusion that the only difference between the inventive concept of the ‘322 Patent on the one hand, and prior art and common general knowledge on the other, was that there was no explicit disclosure of a CS formulation with low osmotic pressure in the prior art. 
After considering the evidence, the FC held that a skilled person, in applying his or her general knowledge, would have been led to the formulation set out in the ‘322 Patent by reviewing the readily-available pertinent publications. No inventive step was taken in regard to the ‘322 Patent. The FC thus held that the ‘322 Patent was invalid for obviousness.
The ‘325 Patent
The inventive concept of the ‘325 Patent involved a pharmaceutical composition containing CS and hydroxypropylmethylcellulose in an aqueous medium, which consequently avoids variations in CS concentration and decreases in CS recovery during production. 
The FC favoured Apotex’s evidence. The FC summarized Apotex’s expert’s finding to mean that based on the prior art and common general knowledge, a “skilled formulator, using only the prior art and his or her general knowledge, would have arrived at the putative invention set out in the ‘325 patent.”  The expert came to this conclusion before knowing what was claimed in the ‘325 Patent.
The FC thus concluded that that the ‘325 Patent was invalid for obviousness as a skilled person, in applying his or her general knowledge, would have been led to the formulation set out in the ‘325 Patent by reviewing the pertinent literature.
The ‘419 Patent
The FC found that the inventive concept of the ‘419 Patent involved “the use of CS in the treatment of children with chronic respiratory diseases with reduction or avoidance of common side-effects associated with use of other corticosteroids, including growth-suppression.” 
The FC found that the weight of evidence relating to the state of the art and common general knowledge indicated that a skilled person would have known that administering CS in the dosage range set out in the ‘419 Patent would not cause systemic side effects. Furthermore, the FC found that the CS compositions in the ‘419 Patent would have been obvious to try, as a routine clinical trial described in the ‘419 Patent would have confirmed what a skilled person already expected.
One point of interest in this FC decision was that the FC preferred Apotex’s evidence that used blinded experts that provided their opinions before knowing what was claimed in the disputed patents. This approach, while not determinative of the issues, has also been favoured in other cases including AstraZeneca Canada Inc v Apotex Inc, 2014 FC 638 and Teva Canada Innovation v Apotex Inc, 2014 FC 1070.