CaseTakeda Canada Inc. and Takeda GMBH v The Minister of Health and Apotex Inc., 2015 FC 570

Drug: OMNARIS® (ciclesonide)

Nature of caseProhibition proceeding under Section 6 of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations)

Successful partyApotex Inc.

Date of decisionMay 1, 2015

Summary

Takeda Canada Inc. and Takeda GMBH (Takeda) brought an application under section 6 of the PM(NOC) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. (Apotex) in respect of its generic version of OMNARIS®. OMNARIS® (ciclesonide) is a nasal spray used in the treatment of conditions such as allergic rhinitis. Apotex alleged that Canadian Patent Nos. 2,388,322 (322 Patent), 2,388,325 (325 Patent) and 2,538,419 (419 Patent) (Takeda Patents) were invalid on various grounds, including obviousness, anticipation, double-patenting, lack of utility, sufficiency and overbreadth. O’Reilly J. of the Federal Court favoured the evidence provided by Apotex’s experts on the state of the art while they remained blinded to the patent. The Court held that Takeda had failed to meet its burden on obviousness in respect of the Takeda Patents and therefore did not consider Apotex’s other allegations of invalidity. The application was dismissed.

The 322 Patent

Claim construction and inventive concept

The 322 Patent claims compositions of ciclesonide with varying osmotic pressures, ranging from 10 mOsm or less to 290 mOsm or less. The Court held that the inventive concept of the 322 Patent was an aqueous pharmaceutical composition for application to the mucosa which contains ciclesonide and a water-insoluble/water-low soluble substance which has an osmotic pressure of less than 290 mOsm and includes superior ciclesonide retentivity and permeability compared to conventional compositions.

Obviousness

Justice O’Reilly found that Takeda’s expert had not canvassed the entire state of the art and common general knowledge of the skilled person at the relevant time. Conversely, Apotex’s expert had not confined his opinion to the prior art cited in the patent and had concluded that based on the state of the art and common general knowledge the skilled person would have been led toward a formulation with low osmotic pressure.  The Court noted that Apotex’s expert had arrived at his opinion before being provided the 322 patent. As a result, the Court held that a skilled person would have arrived at the formulation in the 322 Patent by reviewing readily-available relevant publications and applying his/her knowledge.

The 325 Patent

Claim construction and inventive concept

The 325 Patent claims compositions of ciclesonide and hydroxypropylmethylcellulose (HPMC) in various compositions as well as those compositions in combination with water soluble, water insoluble and water-low soluble substances. The Court held that the inventive concept of the 325 Patent was a pharmaceutical composition containing ciclesonide and HPMC in an aqueous medium which avoids variations in ciclesonide concentration and decreases in ciclesonide recovery during production.

Obviousness

The Court accepted the opinion of Apotex’s expert who concluded that, based on the prior art and common general knowledge, a skilled formulator would have prepared a composition of ciclesonide in a stable, aqueous suspension and, in order to optimize the manufacturing process, would have selected appropriate excipients, and in particular, HPMC. Again, the Court noted that Apotex’s expert had arrived at his opinion before knowing what was claimed in the 325 Patent. Therefore, the skilled person would have arrived at the formulation set out in the 325 Patent by reviewing the relevant literature and applying his or her general knowledge.

The 419 patent

Claim construction and inventive concept

The 419 Patent claims a variety of uses for numerous ciclesonide compositions. The Court held that the inventive concept of the 419 Patent involves the use of ciclesonide in the treatment of children with chronic respiratory diseases and the reduction or avoidance of common side-effects associated with the use of other corticosteroids, including growth suppression.

Obviousness

The evidence relating to the state of the art and common general knowledge showed that the skilled person would have known that administering ciclesonide in the dosage range set out in the 419 Patent would not cause systemic side effects. Moreover, the Court accepted that the ciclesonide compositions in the 419 Patent would have been obvious to try: a routine clinical trial, as described in the 419 Patent itself, would have confirmed what the skilled person already expected.

Blinded experts preferred

The Court’s analysis expresses its clear preference for the approach taken by the blinded experts who provided their opinions before knowing what was claimed in the disputed patent.  Specifically, O’Reilly J. noted at paragraph 29 that “[T]his approach has gained favour in other cases: AstraZeneca Canada Inc. v. Apotex Inc., 2014 FC 638 at para. 321; Teva Canada Innovation v. Apotex Inc., 2014 FC 1070 at para. 94.”

Link to decision:

Takeda Canada Inc. and Takeda GMBH v The Minister of Health and Apotex Inc., 2015 FC 570