Canada: NOA Found To Be Deficient For Failing To Plead The Facts And Law Relating To The Manufacture And Importation Of The Drug Product (Intellectual Property Weekly Abstracts Bulletin — Week of October 3)
Bayer has obtained an order of prohibition against the Minister
of Health from issuing a NOC to Fresenius for its proposed
moxifloxacin hydrochloride product.
Bayer had alleged that Fresenius infringed their patent during
the manufacturing process, at an intermediate step. Fresenius
did not challenge the validity of the patent, instead claiming it
did not infringe the patent. However, the Federal Court found
that the Notice of Allegation (NOA) was defective because it does
not contain the "detailed statement of legal and factual
basis" for the alleged non-infringement.
The NOA alleged that it did not infringe because Fresenius'
solution for injection will not contain moxifloxacin in crystalline
form. Moreover, Fresenius alleged it would not use the
monohydrate moxifloxacin specified by the patent in its
manufacturing of Fresenius-moxifloxacin or in the manufacture of
the active pharmaceutical ingredient used in the manufacture of
Fresenius-moxifloxacin. Fresenius did not disclose in its NOA
the fact that its proposed new drug is to be manufactured,
processed and packaged offshore and imported into Canada.
Bayer conceded that the imported drug for which the NOC is
sought does not contain Bayer's patented product.
However, the Court noted that Fresenius did not directly plead
non-infringement through exportation and the Saccharin Doctrine in
its NOA, instead relying on what was termed "code words"
such as "trivial and merely incidental use". Thus, the
NOA was found to be defective.
Had the Court not found the NOA defective, the Court would have
dismissed this application because Bayer failed to establish on a
balance of probabilities that the allegations of non-infringement
are not justified.
Fresenius has unsuccessfully sought to have the Court reconsider
its judgment in 2016 FC 581, summarized above. Fresenius
argued that the remedy of a prohibition order is inconsistent with
the reasons, and the reasons overlook specific concessions made by
Bayer in its argument.
The Court held that this motion was an attempt to reargue the
application, and if the decision was made in error then it is for
the Federal Court of Appeal to make such a determination on
A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).