The Federal Court (The Court) has issued a judgment granting in part an Application commenced by Alcon Canada Inc., Alcon Pharmaceuticals, Ltd. and Bayer Intellectual Property GmbH under the Patented Medicines (Notice of Compliance) Regulations relating to the drug product Vigamox. Vigamox is an ophthalmic solution containing 0.5 per cent moxifloxacin hydrochloride, an antibacterial agent belonging to the class of compounds known as quinolones.
The judgment prohibits the Minister of Health from issuing a Notice of Compliance to Cobalt Pharmaceuticals Company for its generic version of Vigamox until the expiry of Canadian Patent (CP) No. 1,340,114, Nov. 3, 2015. No order of prohibition was granted to two later-expiring patents, CP No. 2,342,211, exp. Sept. 29, 2019, and CP 2,192,418, exp. Dec. 9, 2016, which are listed on the Patent Register against Vigamox.
CP No. 1,340,114 claims a series of compounds including moxifloxacin and the antibacterial use of such compounds.
The Court rejected Cobalt's allegation that this patent lacked utility. The Court agreed with the Applicants' construction of the "promise" of the patent and held that the patentees could soundly predict the activity of moxifloxacin based on the test results for a similar molecule disclosed in the patent. The Court further dismissed Cobalt's argument that the 114 Patent was invalid for inadequate disclosure similar to the patent in the Viagra case (Teva v Pfizer, 2012 SCC 60).
The Court also dismissed Cobalt's allegation that the invention of the 114 Patent was obvious. Neither the choice of modifying the C-7 position of the quinolone ring nor the fused pyrrolidine bicycle at the C-7 position were obvious.
CP No. 2,342,211 covers pharmacological compositions for topically treating ophthalmic infections comprising 0.1 to 1.0 wt per cent moxifloxacin. Cobalt alleged that the subject matter of the patent was obvious given the microbiological data existing at the time and other quinolones had been used similarly. The Court agreed, rejecting the Applicants' arguments relating to non-obvious properties of the compositions that were not discussed or focussed upon in the patent.
CP 2,192,418 relates to a crystal form of the drug substance, moxifloxacin hydrochloride monohydrate. Since no crystals exist in Cobalt's ophthalmic solution, the issue was whether the patent would be infringed during the process to make the final product. The Court held that the Applicants failed to show on a balance of probabilities that Cobalt's process would infringe the 418 Patent.
Neil Belmore, Peter Wilcox and Marian Wolanski of Belmore Neidrauer LLP represented the Applicants.
Douglas Deeth, Heather Watts and Cheryl Cheung of Deeth Williams Wall LLP represented Colbalt.