The Federal Court Of Appeal Further Clarifies The Test For Obviousness: That Something Is "Worth Trying" Does Not Mean That It Was Obvious To Try

• Published date: 17 March 2021
• Subject Matter: Intellectual Property, Litigation, Mediation & Arbitration, Food, Drugs, Healthcare, Life Sciences, Patent, Trials & Appeals & Compensation, Food and Drugs Law
• Law Firm: Bereskin & Parr LLP
• Author: Ms Melanie Szweras and R. Scott MacKendrick

In the recent Federal Court of Appeal decision in Janssen et al. v. The Minister of Health (2021 FCA 45), Justice Locke, writing for the Court, provided further clarity on the test to be applied for a finding that an invention is obvious to try. In particular, Justice Locke elaborates on his previous comments in the Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research decision [Hospira] (2020 FCA 30) decision, which some worried could open the door to a more lenient "worth a try" test.

An appeal on a patent since found invalid

The present case relates to an appeal of a Federal Court decision under the old Patented Medicine (Notice of Compliance) ((PM)NOC) Regulations granting Janssen et al.'s application to prohibit the Minister of Health from granting to Apotex a notice of compliance (NOC). The product at issue was a generic version of abiraterone, marketed by Janssen as ZYTIGA. Apotex argued before the Federal Court that the 422 Patent, which it was required to address since it was on the Patent Register, was invalid for obviousness and patentable subject matter. The 422 Patent concerns the use of therapeutically effective amounts of abiraterone acetate (AA) and prednisone (PN) in the treatment of castration resistant prostate cancer. The same patent was recently invalidated in a separate decision under the current PM(NOC) regime (see Federal Court Invalidates Janssen ZYTIGA Patent) and although arguably moot, this appeal proceeded as it could have an impact on an Apotex section 8 damages claim.

The appeal proceeded regardless of the invalidity finding

On appeal, Apotex argued that the Federal Court required a finding that the person of skill in the art know the results of certain solutions with certainty in order for the claimed combination to be obvious. For example, the Federal Court supported its finding that there was no predictability of an anti-cancer effect when it stated "[a] POS would not know that the two drugs would not, for example, cancel each other's effectiveness." Justice Locke was not prepared to infer from this finding that the Federal Court applied a certainty requirement. Apotex also argued that the Federal Court's acknowledgement that a skilled person would be wary of side effects was also indicative of the Federal Court's conclusion that the uncertainty about the side effects rendered the combination nonobvious. However, Justice Locke disagreed finding that a skilled person's concern about side effects "could...