Federal Court Dismisses Prohibition Application Relating To The Drug PATADAY®

On February 14, 2014, the Federal Court dismissed an application by Alcon Canada Inc (Alcon) which sought an order prohibiting the issuance of a Notice of Compliance to Cobalt Pharmaceuticals Company (Cobalt) for its generic version of the drug PATADAY® prior to the expiry of Canadian Patent No 2,447,924 (924 Patent). Alcon had previously discontinued that part of the proceeding related to Canadian Patent No 2,195,094. (Deeth Williams Wall LLP represented Cobalt).

Cobalt alleged that the 924 Patent was invalid on several grounds including obviousness, lack of demonstrated utility/lack of sound prediction, ambiguity, overbreadth and insufficiency. Justice Gleason found that the allegations of lack of utility/sound prediction and overbreadth were justified.

After construing the claims and determining the inventive concept, Justice Gleason held that the 924 Patent promised that polyvinylpyrrolidine (PVP), at sufficient concentrations, improves the physical stability of olopatadine solutions. Specifically, claim 2 promised that PVP having an average molecular weight of 5000 to 1600K, and at sufficient concentrations, will enhance the physical stability of 0.18 - 0.22% olopatadine. The Court held that though the concentrations of PVP were not specified in Claim 2, construed in light of the disclosure, it promised effectiveness at concentrations between 0.1 – 3%. Claim 7 promised that PVP having an average molecular weight of 5000 to 1600K, and at concentrations of 1.5 – 2%, will enhance the physical stability of 0.17 – 0.62% olopatadine solutions.

Each of the claims also explicitly noted certain substances that were excluded from the claimed formulations ("excluded substances"). The Court considered whether these excluded substances were promised to not enhance physical stability. Alcon submitted that this formed part of the inventive concept but not the promise of the patent. The Court held that it was "incongruous" to argue that this element made the invention inventive, yet was not promised.

After a detailed analysis of the experimental data reported in the 924 Patent and the expert testimony, Justice Gleason held that experimental results disclosed in the '924 Patent did not demonstrate or soundly predict that the use of PVP across the whole range of molecular weights claimed would enhance the physical stability of the olopatadine solutions as promised. The Court noted the lack of evidence regarding how many points along the claimed molecular weight range need to be tested in order to demonstrate utility across the whole range. The testimony of Alcon's expert was also found wanting in that the expert provided "no discernable scientific basis for the prediction of utility across the entire claimed range." To the contrary, Alcon's expert opined that physical stability is a random and unpredictable phenomenon.

For similar reasons, the Court held that the 924 Patent was overly broad for promising more than it could demonstrate or soundly predict. As a result, the Court dismissed Alcon's application and Cobalt received its Notice of Compliance. Accordingly, no appeal lies from this decision.

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