On June 22, 2010, the Federal Court of Appeal released its decision in Sandoz Canada Inc. v. Abbott Laboratories, 2010 FCA 168. Justice Dawson for the Federal Court of Appeal held that the court will give effect to the dedication of a patent to the public even if the dedication occurs during the course of litigation. Justice Dawson's decision adds an important tool for innovators when responding to allegations of double patenting from generics. It can also assist in dealing with claims construction difficulties based on claims differentiation.
At trial, Justice Heneghan dealt with an Application brought by Abbott Laboratories and Abbott Laboratories Limited (together, "Abbott") pursuant to the PM(NOC) Regulations (the "Regulations") in respect of two patents: Patent No. 2,285,266 ('266 Patent); and Patent No. 2,358,395 ('395 Patent), with the '266 Patent being the parent application and the '395 Patent a subsequent divisional. The Application had included a second divisional, Patent No. 2,325,541 ('541 Patent), however Abbott dedicated the '541 Patent to the public two months prior to the hearing of the Application.
At trial, Justice Heneghan granted Abbott's Application for a prohibition order in respect of the '266 Patent. Justice Heneghan dismissed Abbott's Application in respect of the '395 Patent solely on the basis of double patenting over the '541 Patent. Justice Heneghan held that "had the dedication been executed prior to the service of the NOA, Sandoz would not have had a ground for alleging double patenting in respect of the '395 Patent." However, since the '541 Patent had not been dedicated as of the date Sandoz delivered its NOA, Abbott was precluded from realizing the benefit of its dedication.
Sandoz appealed Justice Heneghan's Order in respect of the '266 Patent, while Abbott cross-appealed Justice Heneghan's Order in respect of the '395 Patent. Justice Dawson for the Federal Court of Appeal dismissed Sandoz's appeal and granted Abbott's cross-appeal.
Justice Dawson held that it is correct to assess the justification of allegations contained in an NOA as of the date of the hearing, at least where assessment as of the date of the hearing will promote the purpose of the Regulations. Accordingly, Justice Heneghan erred by considering the status of the '541 Patent as of the date of the NOA, and not giving effect to the dedication. The Court of Appeal granted the prohibition order that the Federal Court ought to have granted in respect of the '395 Patent.
Of note is the fact that the '541 Patent was issued prior to the issuance of the '395 Patent, yet its dedication was effective to insulate the subsequent '395 Patent from allegations of double patenting. Also noteworthy is the Court of Appeal's confirmation of the efficacy of a dedication of part of the monopoly and not the whole. The Court of Appeal held that after dedication of claims to the public, non-dedicated claims are to be construed "without reference to the dedicated claims" and this provides an opportunity where a generic asserts an unfavourable construction based on claims differentiation.
Innovators facing allegations of double patenting (and perhaps overbreadth or construction issues) should now consider whether they can defeat such allegations by dedicating claims in a patent to the public. Unlike a disclaimer, this approach may be successful even where the dedication occurs after the litigation has been commenced and even where the statutory pre-conditions for a disclaimer are not met.
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