Canadian Federal Court Dismisses Prohibition Application Regarding LYRICA® (Pregabalin)

In an 86-page judgment reviewing both Canadian and UK jurisprudence, Justice Hughes of the Federal Court (Court) on February 4, 2013 dismissed the application by Pfizer Canada Inc (Pfizer) for a prohibition order against Pharmascience Inc (Pharmascience) regarding its proposed pregabalin product and Canadian Patent No 2,255,652 (‘652 Patent). At issue was claim 3 of the ‘652 Patent which claimed the use of pregabalin and its racemate “in treating pain”. The Court construed “pain” broadly, so as to encompass virtually all forms of pain, both acute and chronic. Having done so, the Court held that Pharmascience’s allegation of overbreadth was justified on the basis that the racemate was nowhere described in the specification and that acute pain (as listed in the patent) cannot be treated with pregabalin. Similarly, the Court went on to find that the utility of the racemate to treat acute and chronic pain was not soundly predicted despite the disclosure of testing of pregabalin to treat pain in the ‘652 Patent. The Court also held that the ability of pregabalin to treat acute pain was not soundly predicted. However, the Court did reject Pharmascience’s allegation of obviousness. For the full reasons for judgement, follow this link: http://decisions.fct-cf.gc.ca/en/2013/2013fc120/2013fc120.html Summary by: Kavita Ramamoorthy