The Federal Court held the Minister reasonably listed Serono’s patent on the date it was found eligible, not the submission date, and dismissed the judicial review.
The Federal Court held the 868 and 917 patent claims invalid for obviousness, but upheld the 458 patent claims, found JAMP infringing those valid claims, and denied an injunction.
Obviousness
Anticipation
Patentable subject matter (methods of medical treatment)
Federal Court held that defendants in s 6(1) PM(NOC) actions may counterclaim as of right against non-asserted patent claims, subject to Rule 221 motions.
The Federal Court dismissed AbbVie’s judicial review. It held the Minister reasonably treated “another drug” under the PM(NOC) Regulations as DIN-specific and marketed in Canada.
Apotex's alleged losses resulted from the lawful operation of the Patent Act and PM(NOC) Regulations (including the statutory stay and prior court orders) and not from any unlawful conduct by Eli Lilly; the statutory regime provides the exclusive, limited remedy (s.8) for denial of early market access and therefore Apotex's statutory and common law claims had no reasonable prospect of success; the Statute of Monopolies exempts patents and Form IV listing was not a misrepresentation; the motion judge's dismissal and $700,000 partial indemnity costs award were reasonable and are affirmed.
The Federal Court of Appeal held the Federal Court did not err: the asserted claims of CA 646 were neither anticipated by AU 168 nor obvious; the inventive concept was properly identified (a sustained-release therapeutically useful dose of amphetamine that is resistant to abuse) with recourse to the specification where the bare chemical claims did not reveal inventiveness, and the prohibition order under the PM(NOC) Regulations was correctly upheld.
To obtain leave to appeal an interlocutory order under the PM(NOC) Regulations an applicant must show a fairly arguable case taking into account the applicable standard of review and must also demonstrate that the interlocutory issue is capable of directly affecting the overall success or failure of the proceeding; the motions failed this test and are dismissed with costs.
The Federal Court allowed the United States, as a patentee defendant under the PM(NOC) Regulations, to file a limited Reply and defined its pre-trial role.
The Federal Court granted Lilly leave to amend its tadalafil patent actions, but conditioned the amendment on bifurcating the new claim and trying it after existing liability issues.