The Federal Court of Appeal (FCA) upheld a recent infringement
decision finding a patent to be invalid due to inutility (decision
here). The Federal Court held that the patent promised its
compounds would provide improved pharmacokinetic and metabolic
properties which would give an improved therapeutic profile.
However, this promise was held to be neither demonstrated nor
soundly predicted. The FCA held that the Federal Court had not made
any errors in its findings.
The FCA held that inutility must be assessed on a claim by claim
basis, it is settled law that some promises can be construed to
impose requirements across each of a patent's claims while
other promises may only touch a subset of the claims.
The FCA rejected the Appellants' assertion that because a
claim must receive one interpretation for all purposes, there must
be a unitary understanding of the essential elements of the claim,
inventive concept, and utility. The Court was not shown any
jurisprudence to support the submission that the promise of utility
must be virtually coterminous with the inventive concept.
OTHER CASES OF INTEREST
Stay Granted Preventing Issuance of NOC Pending Judicial Review
Application for Data Protection
This is a motion by Horizon for an Order staying the issuance of
a Notice of Compliance (NOC) to Horizon for its drug, pursuant to
sections 18(1), 18.1 and 18.2 of the Federal Courts Act.
Horizon was seeking the stay pending judicial review of the
decision of the Minister of Health (Minister) refusing data
protection for RAVICTI. The motion was granted, with the Court
finding a serious issue to be tried, irreparable harm to the
applicant if the stay is not granted, and a balance of convenience
favouring the stay.
In the course of considering Horizon's New Drug Submission
(NDS), the Minister initially refused data protection to RAVICTI.
However, after negotiations with Horizon, the Minister agreed that
RAVICTI was eligible subject to a final review of NOC issues. As a
result of regulatory issues, approval of Horizon's NDS was
delayed and prior to the issuance of Horizon's NOC, a NOC was
issued to a generic company for its drug. The Minister then refused
data protection to RAVICTI because it was considered an ester
variation of the generic company's drug. As a result, it could
no longer be considered an "innovative drug" for the
purposes of data protection. Horizon commenced a judicial review of
this decision by the Minister.
The Court found that the judicial review proceeding raised
serious issues of potential errors by the Minister, and thus the
first step for a stay was met. In terms of irreparable harm,
Horizon submitted evidence that it will withdraw the NDS if data
protection is not provided. The evidence showed that the patent
relating to the product expires shortly and Horizon will not be
able to recoup sufficient investment in the absence of data
protection. The Court found the second part of the test for a stay
is met as "the applicant could not recoup its investment and
would have no recourse or means to be compensate [sic] in respect
of lost sales". The Court found that it was not necessary to
consider whether irreparable harm to third parties, in this case,
patients, could be considered for the purposes of the second part
of the test but instead considered it as part of determining the
balance of convenience. The Court found a compelling public
interest in granting the stay, namely access by Canadian patients
to this drug. Further, the respondents took no position on the
motion for a stay, further supporting the finding by the Court.
The Federal Court dismissed a motion by Apotex seeking particulars from Allergan's pleading relating to the prior art, inventive concept, promised utility and sound prediction of utility of the patents at issue.
Last year we saw the Canadian Courts release trademark decisions that granted a rare interlocutory injunction, issued jailed sentences for failure to comply with injunctive relief, grappled with trademark and internet issues...
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