In a recent decision, the Federal Court dismissed a motion by Apotex seeking particulars from (or to strike paragraphs from) Allergan's pleading relating to the prior art, inventive concept, promised utility and sound prediction of utility of the patents at issue.

In this case, Allergan Inc. ("Allergan") brought an infringement action against Apotex and AA Pharma in respect of two patents relating to Allergan's drug ALPHAGAN P. Apotex filed a statement of defence and counterclaim, seeking to impeach Allergan's patents. In its defence to counterclaim, Allergan denied Apotex's invalidity allegations.

Prothonotary Milczynski paraphrased Apotex's demands for particulars in respect of Allergan's pleading as follows:

  • "why is every piece of prior cited by Apotex impermissible";
  • "what is the promise and inventive concept disclosed by the patent";
  • "what is the utility of the inventive concept"; and
  • "how was that utility demonstrated".

Prothonotary Milczynski dismissed Apotex's motion in its entirety. In so doing, Prothonotary Milczynski held that:

  • Apotex bears the burden of proving invalidity of the patents at issue.
  • The particular sought are not material facts but would require Allergan to plead evidence, expert opinion, legal conclusions and claim constructions.
  • Allergan's denials of Apotex's allegations of invalidity, though stated in the affirmative, are traverses.
  • Allergan's "wide and undefined" pleadings are not in substance "pregnant negatives" and do not require particulars.
  • Apotex filed no evidence to establish that they need the requested particulars to prepare its responding pleading.

Notably, Prothonotary Milczynski's order was in full agreement with an earlier decision of Prothonotary Aalto. The earlier decision also involved Allergan and Apotex and arose in the context of a patent impeachment action where Apotex was seeking essentially the same particulars from Allergan.

These decisions of Prothonotary Milczynski and Prothonotary Aalto are significant for innovative pharmaceutical companies, and patentees in general, who have been asked to "particularize" the inventive concept(s) or promise(s) of utility (if any) at the pleadings stage. Such requests put the cart before the horse by requiring that constructions be pleaded even before experts are retained and consulted. Furthermore, such requests ignore the fact that these demands are not for material facts and that they effectively reverse the burden which lies on challengers to impeach patents that are presumed to be valid.

Federal Court Dismisses Motion For Particulars Of The Patent's Inventive Concept And Promise Of Utility

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