Canada: 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 (Intellectual Property Weekly Abstracts Bulletin — Week of April 25)
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
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
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
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.
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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