Unlike other actions, fulsome particulars of generic pharmaceutical damages claims (under section 8 of the Patented Medicines (Notice of Compliance) Regulations) have not always been thought to be necessary. It had been suggested that information in the possession of defendants might define the scope of such claims.
However, in Mylan Pharmaceuticals v Takeda Canada et al,1 the Court questioned the appropriateness of such unparticularized pleadings and clarified that they remain subject to basic pleading principles, including that they must permit defendants to intelligently reply. Specifically, with respect to claims for section 8 damages extending beyond the product at issue in the underlying NOC litigation (ie. “other products”), the Court required the generic plaintiff to provide details of that claim including, at a minimum, identifying the alleged “other products”.
This action follows NOC litigation relating to pantoprazole magnesium. In addition to claiming section 8 damages for its alleged lost sales of generic pantoprazole magnesium, the generic plaintiff claimed damages relating to, among other things, non-pantoprazole magnesium products. The defendants sought particulars of these allegations and then ultimately brought a motion after the plaintiff provided only limited additional details of its allegation.
Open-ended Claims Relating to “Other Products” Prevent Intelligent Reply
There was no dispute as to the requirements for obtaining particulars on a motion or the purpose of requiring a party to provide particulars. With respect to the latter, particulars are required, for example, to inform the other side of the nature of the case they have to meet, permit parties to reply intelligently, and limit and define the issues to be tried.
The Court noted at the outset that in the only prior decision2 specifically addressing allegations relating to “other products” the Court had required, without providing reasons, that the plaintiff specify those “other products”. However, this decision was rendered early in the development of section 8 damages jurisprudence. More recent jurisprudence had suggested that a generic plaintiff need not detail every possible claim it might assert.
The Court thus returned to first principles for motions for particulars. The Court expressed discomfort with the plaintiff’s argument that a party may plead with limited details hoping to learn further details in discovery. The Court found this improper. In particular, while accepting that the plaintiff might learn about the market for pantoprazole magnesium from the defendants during discovery, there was no evidence that the plaintiff needed this information to particularize its claim for other products.
The Court also expanded on the requirement that pleadings be sufficiently detailed so as to permit the other party to “reply intelligently”. Specifically, the Court did not agree that being able to respond with vague denials and putting the other party to the strict proof of its allegation constituted an intelligent reply. The Court cited past jurisprudence expressing concern about open-ended heads of damages which could only be vaguely denied. Such pleadings would only invite motions for particulars and would likely result in protracted and inefficient discoveries because their scope and subject matter would be inadequately defined.
The Court’s concern about the potential scope of discoveries was also apparent throughout. In particular, the Court agreed that unless the plaintiff particularized its claim for other products, discoveries could potentially extend to sales and financial information of every non-pantoprazole magnesium product that was sold or could have been sold by the plaintiff during the relevant period. A list of the other products alleged would thus narrow the scope of discovery.
Finally, the Court rejected the plaintiff’s argument that there was no evidence that it, and not the defendants, had the requested information. The Court felt compelled to assume that the plaintiff knew what it was referring to when it made its allegations and, further, found it to be apparent that the defendants did not know which other products the plaintiff had in mind in those allegations.
The Court did not address, on this preliminary motion, the merits of the plaintiff’s claim for section 8 damages relating to products other than the product at issue in the underlying NOC litigation. That issue remains open for debate. However, for now, it is clear that generic pharmaceutical manufacturers “having introduced the idea of other products… should be prepared to identify to which other products they are referring.”