Dasatinib – Canada

Dasatinib – Canada

On March 21, 2017, The Federal Court of Canada dismissed Bristol-Myers Squibb’s prohibition application, finding that one of the patents (CA 2,366,932) had an overarching promise and lacked utility, and the other patent (CA 2,519,898) was “obvious to try.”
BMS-Canada is a Canadian pharmaceutical manufacturer that distributes and sells, among other things, the pharmaceutical SPRYCEL® (Dasatinib) tablet. Both the ‘932 and the ‘898 Patents (together the “BMS Patents”) generally relate to the compound dasatinib, and have been listed on the Patent Register with respect to SPRYCEL®.
The Respondent, Apotex Inc. (the “Respondent”), is a generic pharmaceutical manufacturer. It filed an Abbreviated New Drug Submission (“ANDS”) with the Minister of Health (the “Minister”) seeking a Notice of Compliance (“NOC”) for APO-Dasatinib, using SPRYCEL® as the Canadian reference product. It served Notices of Allegation (“NOA”) regarding the ‘932 Patent and the ‘898 Patent (the ‘932 NOA and the ‘898 NOA, respectively), on May 26, 2015.
The Applicants commenced this prohibition application on July 2, 2015, seeking orders that the Minister be prohibited from issuing a NOC to Apotex for APO-Dasatinib until after the ‘932 and the‘898 Patents expire.
At the hearing the issues were narrowed to the following specific validity issues relating to three claims being asserted by the Applicants as being valid and infringed:
1.       Is claim 27 of the ‘932 Patent invalid because it lacked promised utility
2.       Is claim 1 or claim 3 of the ‘898 Patent invalid because it was obvious to try

Finally Justice Manson dismissed BMS’s application, holding that Apotex’s allegations of inutility (against the 932 Patent) and obviousness and double patenting (against the 898 Patent) were justified.
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