Can a generic pharmaceutical manufacturer who engages Canada's pharmaceutical linkage regime (the PM(NOC) Regulations) make a claim for treble damages or the patent holder's profits in respect of alleged market entry delays caused by the statutory scheme? The answer, as confirmed by the Ontario Court of Appeal in Apotex Inc. v Eli Lilly Canada Inc., is no.

In March of last year, we reported on a decision by Schabas J. of the Ontario Superior Court of Justice (the "Schabas Decision") dismissing, via summary judgment, claims brought by Apotex for treble damages under the Statute of Monopolies, damages or an accounting of Eli Lilly's profits under the Trademarks Act, and damages pursuant to the tort of conspiracy.

The Ontario Court of Appeal has dismissed Apotex's appeal from the Schabas Decision. This was the first appellate decision in a series of similar actions currently pending before the Ontario and Quebec Superior Courts.

Writing for a unanimous Court, Roberts JA confirmed that Apotex's claims were meritless on multiple separate grounds:

  1. There is a "complete code" for the purposes of determining whether damages are available to a generic manufacturer outside of the patent regulatory scheme. In particular, s. 8 of the PM(NOC) Regulations provides the only potential remedy for generics that successfully challenge a patent under the PM(NOC) Regulations;
  2. Any alleged harm to Apotex was caused by the operation of the statutory regime of the Patent Act and the PM(NOC) Regulations. Eli Lilly is not liable for actions that it was authorized by law to take, and for alleged harms that were caused by the statutory regime (which Apotex voluntarily invoked and benefitted from);
  3. The Statutes of Monopolies explicitly excludes patents of invention from liability. The purpose of the Statutes of Monopolies was to attempt to limit abuses by the Crown in granting letters patent, not patents of invention;
  4. Eli Lilly did not make any misrepresentation in filling out a government mandated form – a "Form IV" – in seeking to list its patent on Canada's Patent Register; and
  5. A claim brought by Apotex under the tort of conspiracy was not supported by any evidence. In any event, procuring and enforcing a patent were lawful acts that Eli Lilly had the right to do.

Gowling WLG's Marc Richard, Alex Gloor and Rebecca Johnston represented Eli Lilly in this matter.