CASE: Pfizer Canada Inc. et al v. Apotex Inc. (Federal Court)

DRUG: XALATAN (latanoprost)  

NATURE OF CASE: NOC Regulations: Prohibition proceeding - Section 6  

SUCCESSFUL PARTY: Pfizer Canada Inc. et al  

DATE OF DECISION: April 26, 2010  

SUMMARY:  

On April 26, 2010, the Federal Court granted Pfizer Canada Inc. and Pharmacia Aktieblolag’s (“Pfizer et al”) application for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. (“Apotex”) in respect of a generic version of latanoprost, the active ingredient in XALATAN® until the expiry of Canadian Patent No. 1,339,132 (“132 patent”). This is the second successful proceeding against a manufacturer seeking to genericize XALATAN®. Ogilvy Renault LLP represented Pfizer et al. in both proceedings.

Apotex alleged that the 132 patent was invalid on the following grounds: double patenting, anticipation, obviousness, lack of utility, lack of sound prediction, overbreadth and lack of sufficiency. Apotex also alleged that its proposed generic copy of XALATAN® would not infringe certain claims on the basis of the Gillette Defence. Only claims 12, 19, 31, 37 and 38 of the 132 patent were subject to the invalidity and non-infringement allegations.  

After construing the claims, Madame Justice Heneghan considered Apotex’s non-infringement allegation and determined that Apotex’s Gillette Defence could only succeed if the allegations of anticipation and obviousness succeeded.  

Heneghan J. analyzed Apotex’s invalidity allegations and determined that each was not justified. Having found all the invalidity allegations not justified, Apotex’s Gillette Defence failed and accordingly, its non-infringement allegation was also not justified. Apotex has thirty days to appeal the decision.  

LINK TO DECISION: http://decisions.fct-cf.gc.ca/en/2010/2010fc447/2010fc447.html