Lilly Sues to Invalidate Patent

Lilly Canda and Lilly ICOS sued a predecessor to Pfizer Ireland Pharmaceuticals to invalidate Pfizer’s Canadian patent for the use of compounds that inhibit PDEv for the treatment of male erectile dysfunction, and Pfizer Canada and Pfizer Ireland Pharmaceuticals have sued Lilly Canada and Lilly ICOS for patent infringement.

Lilly Canada is currently selling in Canada the product CIALIS, which competes with Pfizer’s VIAGRA product. The product was launched in Canada on November 28, 2003. This litigation is part of a series of litigation cases in various countries, including the UK, where the counterpart patent was declared invalid and in Europe where, subject to an appeal, the European patent has been revoked. The issue of patentability in Europe is under appeal.

In two injunction motions, brought in the infringement action, Pfizer has argued that if the CIALIS product is sold in Canada and Pfizer later wins at trial and obtains a permanent injunction that removed CIALIS from the market, consumers and doctors would resent Pfizer’s actions and backlash against them. Pfizer also argued that the damages could not be reasonably calculated, that there would be permanent loss of market share and that the balance of convenience favoured Pfizer.

On October 28, Justice Michael Kelen of the Federal Court of Canada heard an interim injunction motion brought by the Pfizer companies seeking, quia timet, to keep Lilly Canada from bringing CIALIS to market before an interlocutory injunction could be heard. On November 3, the judge denied the injunction holding that the Pfizer companies’ allegations of resentment and backlash were not supported by clear and non-speculative evidence, and that there was no clear evidence that the loss of goodwill could not be quantified in damages.

On February 5, Justice Pierre Blais, PC, of the Federal Court of Canada heard an interlocutory injunction motion brought by the Pfizer companies to remove CIALIS from the Canadian market. On February 11, 2004, he dismissed the motion holding that he was not convinced that the plaintiffs will suffer irreparable harm by way of backlash, there being no convincing evidence to support Pfizer’s argument. The judge also held that the balance of convenience favoured Lilly as Lilly stood to lose more if the injunction was granted than Pfizer would if it was not.

Lilly Canada and Lilly ICOS were represented on the interim and interlocutory injunction motions by Ogilvy Renault in Toronto, with a team that included Don Cameron, Scott MacKendrick and Jane Caskey (patent). Pfizer Canada and Pfizer Ireland Pharmaceuticals were represented by Bereskin & Parr in Toronto, with a team that included Robert MacFarlane, Michael Charles and Andrew McIntosh at the interim injunction motion and by Robert MacFarlane and Michael Charles at the interlocutory injunction motion.