On April 5, 2007, the Federal Court of Appeal released a decision (Pharmascience Inc v The Minister of Health et al, 2007 FCA 140) in which it addressed the question whether or not generic drug manufacturers should be permitted to submit multiple Notices of Allegation (NOAs) with respect to a patent in cases where the subsequent NOA(s) allege invalidity on ground(s) different from the previous NOA. The case was an appeal from the decision of Justice O'Keefe in Abbott Laboratories v Canada (Minister of Health), 2006 FC 341, in which he had applied the doctrine of issue estoppel to preclude Pharmascience Inc (Pharmascience) from relying on the allegations in its second NOA regarding Canadian Patent No 2,261,732 owned by Abbott Laboratories. Pharmascience had previously unsuccessfully litigated the validity of the patent on the grounds that its claims were broader than the invention it disclosed. In its subsequent NOA, Pharmascience alleged that the patent was invalid on a number of grounds, including anticipation and obviousness. The Federal Court of Appeal ruled that "generics should in most circumstances be precluded by the doctrine of issue estoppel from alleging for a second time that a patent is invalid, unless the basis relied upon for the subsequent allegation could not be determined with reasonable diligence at first instance, or some special overriding circumstance exists to warrant a judge exercising her discretion not to apply issue estoppel in the facts of the particular case". In its decision, the Federal Court of Appeal determined that Justice O'Keefe had correctly applied the doctrine of issue estoppel. The Court ruled that the issues were similar to those that had previously been litigated and were, in fact, "fundamental" to the earlier decision. The Court also upheld the statement of Justice O'Keefe that the law requires litigants to "put their best foot forward" at the first opportunity. For the full text of the decision, visit: http://decisions.fca-caf.gc.ca/en/2007/2007fca140/2007fca140.html Summary by: Heather Watts

E-TIPS® ISSUE

07 04 25

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