by Tracey Stott
On January 28, 2014, Justice Harrington allowed Pfizer’s application for an Order of prohibition regarding celecoxib (Pfizer’s CELEBREX).
Mylan had alleged that the patent at issue promised celecoxib would be useful in significantly reducing harmful side effects in humans, and, although there was a sound basis for the prediction at the time of filing, this promise has not been met. The claims of the patent at issue do not refer to side effects, but the description includes references, such as the compounds of the invention have “the additional benefit of having significantly less harmful side effects” and that the selectivity of the compounds “may indicate an ability to” reduce side effects.
Justice Harrington rejected Mylan’s construction of the promise. In doing so, he cited the Court of Appeal’s distinction between potential use and an explicit promise to achieve a specific result (Sanofi-Aventis v Apotex Inc, 2013 FCA 186, reported in the August 2013 edition of Rx IP Update), and construed “may” to connote a possibility. He also held that the existence of other drugs in the field was not a consideration in this case, as it does not matter if others “were far more effective,” and relied on the lack of reference to side effects in the claims. Given his construction, he declined to decide whether celecoxib in fact has fewer side effects than other similar drugs.
Mylan also asserted that Pfizer was attempting to relitigate the patent, as Pfizer had conceded in a previous proceeding (G. D. Searle & Co v Novopharm Limited, 2007 FC 81, reported in the February 2007 edition of Rx IP Update) that the utility included reduction of unwanted side effects. Justice Harrington disagreed, and held that a “concession” made in another NOC proceeding was not binding on Pfizer. He noted that in the previous proceeding, the utility had been held to be demonstrated, a finding of fact which did not bind him as construction (a finding of law) would have. Mylan has appealed.
Pfizer Canada Inc v Mylan Pharmaceuticals ULC, January 28, 2014
Federal Court decision – 2014 FC 38
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