Patent Decisions
The Federal Court of Appeal determines the incorrect date to assess obviousness-type double
patenting, but leaves the determination of the correct date for another day
Mylan
Pharmaceuticals ULC v. Eli Lilly Canada Inc., 2016 FCA 119
Drug: tadalafil
The Federal Court of Appeal has upheld an earlier decision (2015
FC 17) prohibiting Mylan from obtaining its Notice of Compliance until after the impugned patent
expires. Mylan had alleged that Eli Lilly's patent was invalid on the basis of obviousness-type double-patenting
and for lack of utility due to no sound prediction.
Three dates were considered as the correct date to assess obviousness-type double patenting: 1) The
priority date of the first patent; 2) The priority date of the second patent; or 3) the publication
date of the second patent. The Court of Appeal held that the third date is not appropriate. But, the
Court of Appeal further held it was not necessary to determine the question of which of these remaining
dates is the appropriate one, because on the facts of the case there was no double patenting.
Mylan's sound prediction allegation also failed, but the Court noted that even if it were successful
it would not have affected the disposition of the appeal as it would not invalidate all of the claims
in issue.
Other Decisions of Interest
Court orders Health Canada to issue a Product Licence Application for a Natural Health Product
Winning
Combination Inc. v. Canada (Health), 2016 FC 381
The Plaintiff Winning Combination sought a Product Licence Application (PLA) for its natural health
product RESOLVE, a smoking cessation aid. The Natural and Non-Prescription Health Products Directorate
and its predecessor in Health Canada was said to have made two rejections: the first was a rejection
based on safety and efficacy concerns; the second rejection a month later was made on the basis that
it was not a natural health product but rather a drug that should be regulated under the Food and
Drug Regulations.
Winning Combination alleged those denials were a result of individual and institutional bias and bad
faith in addition to the decisions being unreasonable and subject to procedural unfairness.
The Court held that the evidence showed a serious breach of procedural fairness in classifying this
product as a drug without affording an opportunity to comment, especially after three prior classification
decisions had found it was a natural health product. The subsequent removal of the active ingredient
from the Dictionary of Natural Products list of natural substances was also done without notice or
warning to the Plaintiff.
The Court also found procedural fairness concerns on the first decision relating to safety and efficacy,
as well as questions as to the reasonableness of the decision.
Although there was a reconsideration process, the Court held that an administrative decision made
in the absence of procedural fairness cannot be cured by a reconsideration process. Such a decision
is void ab initio. In any event, the reconsideration process that was taken was also found
to lack procedural fairness and showed evidence of a reasonable apprehension of bias.
In the end the Court quashed the refusals, ordered mandamus to grant a PLA within 30 days,
and awarded full indemnity costs for the application.
Other Industry News
Health Canada has published a Notice on How
Health Canada is managing safety updates when a serious health risk is identified under the Protecting
Canadians from Unsafe Drugs Act (Vanessa's Law).
Health Canada has published Notice of a Policy
on Bioequivalence Standards for Highly Variable Drug Products.
Health Canada has published a Notice
Regarding Dear Health Care Professional Letters for Notice of Compliance with Conditions.
