Listing
Patent not Eligible for Listing on the Patent
Register
Novartis Pharmaceuticals Canada Inc. v. Canada
(Attorney General)
Drug: TOBI® PODHALER (Tobramycin)
This is a case relating to the refusal by the Minister of Health
(the "Minister") to list a patent on the Patent Register.
The Court dismissed the application.
The Court described the product in question: "Tobi Podhaler
consists of a medicinal and a non medicinal component: the
medicinal component consists of a capsule dosage form providing a
dry powder formulation which contains the active ingredient
tobramycin (an amino-glycoside antibiotic), intended for oral
inhalation with the help of the Podhaler inhalation device (the non
medicinal component)." The Court described the patent in
question: "Of importance to the matter at bar, the '819
patent includes claims for the use of a bioactive agent in the
manufacture of a medicament for pulmonary delivery, comprising a
plurality of perforated microstructures and administered by an
inhalation device (claims 1 to 11) and claims for a perforated
microstructure powder comprising a bioactive agent (claims 41 to 50
and 59 to 68), as well as claims of an inhalation system for
pulmonary administration of a bioactive agent to the patient
(claims 51 to 58)."
The sole issue to be determined by the Court was whether the
Minister erred in requiring the patent claims to explicitly mention
the medicinal ingredient in order to be eligible for listing. The
Court found the Minister's construction of the relevant claims
of the patent and the relevant provisions of the NOC Regulations to
be correct in law.
The Court construed the claims to dosage forms in the patent to be
generally directed to an improved delivery system. The approved
dosage form was found to be the inhalation delivery system as a
whole, and not the individual parts. Finally, the Court found that
a "rather high threshold of specificity in the formulation
claims is required for a patent to be eligible for listing".
The Court ultimately found that the Minister was correct in finding
that none of the claims of the patent contain the approved
medicinal ingredient tobramycin.
Copyright
Providing Hyperlink to Applicant's Website is
Authorized Communication for Purposes of Copyright
Warman v. Fournier
This application alleged copyright infringement in respect of
three works. The Respondents operate a website providing a forum
for online political discussions.
With respect to the first work, the Warren Work, the Court found
that the Applicant was time-barred as he did not bring the
application within the limitation period in section 41(1) of the
Copyright Act. With respect to the second work, the Kay Work, the
Court found that the Respondents did not reproduce a substantial
part of the Work, and in the alternative, the reproduction
represented fair dealing for the purposes of news reporting. The
Applicant posted a copy of the third work, the Barrera Work, on his
own website, and the Respondents provided a hyperlink to this
website. The Court found that the Applicant authorized
communication of this Work by posting it on his website.
Accordingly there was no infringement.
The Court indicated that the defence of abuse of process was not
available to the Respondents as the application was not frivolous
or vexatious; instead, the Respondents were arguing the tort of
abuse of process, which must be brought by separate action. The
Court also refused to award costs on the highest scale as there was
no evidence of the Applicant's conduct that would justify
higher costs.
Other Industry News
Health Canada has released: Notice : Implementation of International
Conference on Harmonisation of Technical Requirements for the
Registration of Pharmaceuticals for Human Use (ICH) Guidance: E2F:
Development Safety Update Report (DSUR).
The PMPRB published an important reminder regarding Form 2
filings.
The Natural Health Products Directorate has published its Calendar of Activities.
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