In August 2019, Allergan commenced an action under section 6(1) of the PM(NOC) Regulations against Apotex and HRA Pharma in which it seeks a declaration of infringement in respect of Canadian Patent No. 2,723,254. Apotex filed a Statement of Defence in which it argued that the 254 Patent was invalid.
The United States, the co-owner of the 254 Patent, was named as a Defendant to the proceeding under section 6(2) of the PM(NOC) Regulations and it brought a motion seeking solely to reply to Apotex’s allegations of invalidity. In adjudicating the motion, Prothonotary Furlanetto considered three specific issues:
- Is the United States permitted to file a responding pleading to Apotex’s Statement of Defence, and if so, what should that pleading be called?
- Should paragraph 6 of the United States proposed pleading, which alleged that Apotex must establish the Commissioner of Patents acted unreasonably in granting the 254 Patent be struck?
- What role can the United States play in the proceeding during the pre-trial steps and at trial?
On the first issue, Prothonotary Furlanetto allowed the United States to file a responding pleading, holding:
 Following further discussions between the parties, there no longer appears to be a dispute that the USA should be entitled to file some form of responding pleading provided that appropriate safeguards are in place; I agree. It would be inconsistent with section 6(2) of the PM(NOC) Regulations which specifically provides that a patent owner must be named as a party to the proceeding to then interpret the same regulations as then saying that a patentee can only play a role in the proceeding if they are a party Plaintiff. This Court has long held that a patent owner should be before the Court when its patent is under consideration (Pfizer Canada Inc. v. Canada (Minister of Health), 2007 FC 167 at para 15; aff’d 2008 FCA 15). If the owner is not a Plaintiff it is appropriate to name the patentee as a Defendant.
On the second issue, Prothonotary Furlanetto held that the United States “should be permitted to participate separately and raise its own arguments in response” and that it was not clear that the assertion contained in paragraph 6 was without merit.
On the final issue, Prothonotary Furlanetto held that as long as Allergan’s and the United States interests remained aligned, they “would not examine each other’s representatives or trial witnesses and would not seek to take an adverse role on motions” If there came a time where their interests diverged, leave would need to be sought from the Court to depart from this approach.
For these reasons, Prothonotary Furlanetto granted leave to the United States to serve and file its proposed Reply by January 7, 2020.
A copy of the judgement and reasons may be found here.