Case: Eli Lilly Canada Inc. v. Apotex Inc. (Federal Court)

DRUG:atomoxetine (STRATTERA®)

Nature of Case:NOC Regulations: Prohibition proceeding - Section 6

Successful Party:Apotex Inc.

Date of Decision: October 29, 2010  

Summary:

On October 29, 2010, the Federal Court dismissed Eli Lilly Canada Inc.'s ("Eli Lilly") 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 atomoxetine (STRATTERA®) until the expiry of Canadian Patent No. 2,209,735 ("735 Patent"). Barnes J. determined that none of the allegations of invalidity raised by Apotex were justified, but found that the proceeding was moot and dismissed the application.

The '735 Patent claims the use of atomoxetine for treating attention deficit hyperactivity disorder ("ADHD") in adults, adolescents and children. The claimed utility was based on a 7 week, double-blind, placebo-controlled, cross-over trial to investigate atomoxetine's use as an ADHD treatment (the "MGH Study"). Apotex alleged that the '735 Patent was invalid on the grounds of lack of utility, obviousness, and anticipation.

The order of evidence was reversed such that Apotex led its evidence on invalidity first, followed by Eli Lilly. In support of its allegation of inutility, Apotex argued that the patent contained insufficient information to establish sound prediction. In response, Lilly argued that the utility of the invention had been demonstrated at the filing date and was not based on a sound prediction. Apotex did not challenge the substance of Eli Lilly's evidence but argued that its evidence (the MGH Study) was inadmissible hearsay.

Barnes J. held that Apotex's allegation of inutility was not justified. The Court noted that while Apotex may have not been aware of the existence of the MGH Study when it filed its initial evidence, Apotex decided not to seek to file reply evidence or to cross-examine Eli Lilly's witnesses. Barnes J. determined that, since no evidence was put forward by Apotex as to the lack of demonstrated utility, Apotex failed to satisfy its evidentiary burden to put the inutility allegation in play.

Barnes J. also found Apotex's allegations of obviousness and anticipation were not justified. Barnes J. accepted that the evidence established a lack of understanding about the mechanism of action responsible for the treatment of ADHD. Thus, Barnes J. determined that the '735 Patent was not obvious. Apotex's allegation of anticipation was based on "a prior patent that includes thousands of compounds and where neither atomoxetine nor ADHD is specifically disclosed." Accordingly, Barnes J. found the anticipation allegation unjustified.

Although none of Apotex's allegations were justified, Barnes J. dismissed Eli Lilly's application because of an intervening decision in an impeachment action between Eli Lilly and Novopharm Limited where the Court held that the '735 Patent was invalid (2010 FC 915; September 14, 2010). This in rem decision rendered the application for a prohibition order moot and accordingly Barnes J. dismissed the application. Barnes J. made no conclusion as to the effect of this dismissal on the potential liability of Eli Lilly pursuant to Section 8 of the PM(NOC) Regulations.  

LINK TO DECISION:

http://decisions.fct-cf.gc.ca/en/2010/2010fc1065/2010fc1065.html