Experts Permitted to Attend Testing at Plaintiff's
Facility In the first of two similar decisions, the Federal Court has
found that Sandoz Canada is not under the jurisdiction of the PMPRB
because Sandoz does not hold any patents and no monopolies. Sandoz
is the wholly-owned subsidiary of Novartis Canada Inc., which is
itself a subsidiary of Novartis AG. Novartis AG owns patents
relating to some of the medicines that sparked the PMPRB's
concerns. The PMPRB was aware that Novartis AG authorizes Sandoz to
sell generic versions of those medicines. In the second related decision, the Federal Court has found that
Ratiopharm is not a patentee and therefore not subject to the
jurisdiction of the PMPRB. Ratiopharm sells ratio HFA, the generic
equivalent of a product manufactured by GlaxoSmithKline Inc. (GSK).
Ratiopharm sold their product to pharmacies after having purchased
it under contract from GSK. The two products competed in the
Canadian market, and GSK retained all rights to its product. The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances. and
Beverley Moore
,
Adrian Howard and
Ryan Steeves
Patent Cases
Patent Infringement Action Dismissed Since No Claims Were
Both Valid and Infringed
Vieira c. 9078-4042 Quebec inc., 2014 QCCS 2141
This was a patent infringement action, relating to an invention
that pertains to the general field of building construction.
The Court conducted a claim-by-claim analysis of the claims in
issue, and compared the device manufactured by the Defendant with
the claim in question. The Court noted that it is wrong to compare
the Defendant's device with the device manufactured by the
Plaintiff. Following the Court's analysis, the Court held that:
(i) certain claims were invalid as between the parties (and thus,
no infringement analysis was carried out), and (ii) the remaining
claims were not infringed (and thus, no validity analysis was
carried out). Since none of the claims in issue were found to be
both valid and infringed, the action failed. No costs were awarded
due to an "unexplained" lack of communication on the part
of the Defendant which, in the Court's view, might have helped
to avoid a trial.
Dow Chemical Company v. Nova Chemicals
Corporation, 2012 FC 754
This Order was issued in 2012, but just made public now. The
defendant brought a motion seeking to permit its experts to attend
testing, for samples from the testing, and to file reply affidavits
on the motion. The Court granted the motion.
In considering the reply affidavit issue, the Court held that the
affidavits met the test for seeking reply, and admitted them. All
three comment on evidence filed by the plaintiffs in response to
the defendant's motion. Cross-examinations had occurred on the
affidavits. Furthermore, the Court held that there was no
substantial or serious prejudice to the plaintiffs and the evidence
would serve the interests of justice.
The defendant produced samples of its allegedly infringing product
on the condition that its experts be permitted to attend and
monitor the tests. The plaintiff refused on the basis of safety and
privacy concerns at their facilities. The Court held that it is its
practice to allow attendance of the opposing party at testing
conducted in support of an action where the results are planned to
be used at trial. Any experts appointed to attend the testing would
be well aware of the safety issues. Furthermore, they would be
covered by the protective order, and likely a confidentiality
agreement. Thus, the privacy concerns are not warranted.PMPRB not found to have jurisdiction over two generic companies
in separate decisions
Accordingly, the PMPRB argued it had jurisdiction over Sandoz
because of sections 2 and
79(1) of the Patent Act. It was submitted that section
79(1) provides that a patentee includes any other person who is
entitled to exercise any rights in relation to that patent.
According to the PMPRB, Sandoz is effectively controlled by its
parent companies as they authorize Sandoz to enter the market,
making Sandoz a patentee.
In finding the PMPRB's decision to be unreasonable, the Court
said that the PMPRB's jurisdiction was restricted to reviewing
prices charged by patent holders to determine whether those prices
are excessive. Further, the Court found that while the federal
government can regulate patents of invention, it has no overall
jurisdiction to regulate the price of generic versions of patented
medicines because the legislation is not aimed at protecting
consumers from high drug prices generally.
The PMPRB submitted that the agreement between Ratiopharm and GSK
gave Ratiopharm the right to sell and set the prices for ratio HFA.
Without that agreement, the PMPRB argued that Ratiopharm would have
violated GSK's patent, and so in that sense, Ratiopharm was
entitled to "exercise... rights in relation to that
patent", which brought it within the definition of a
"patentee" in section 79(1) of the Patent Act. The PMPRB said that ratio HFA was
being sold at an excessive price and that Ratiopharm must pay
damages of $65.9 million.
The Federal Court followed the same reasoning as in the Sandoz decision, concluding the PMPRB did not
have jurisdiction over generic companies who do not own patents and
the governing legislation is not aimed at protecting consumers from
high prices generally.Industry News
Health Canada has released a Guidance Document: Biopharmaceutics Classification
System Based Biowaiver.
Health Canada has released an Information Sheet - Management of Drug Company
Contact and Financial Account Information.
Reports relating to Bill C-31, which amends the Trade-marks Act,
among others, were tabled by the Standing Senate Committee on National Finance
and the Standing Committee on Finance in the House of
Commons.
ARTICLE
6 June 2014
Patent Infringement Action Dismissed Since No Claims Were Both Valid And Infringed (Intellectual Property Weekly Abstracts Bulletin - Week Of June 2, 2014)
The Court conducted a claim-by-claim analysis of the claims in issue, and compared the device manufactured by the Defendant with the claim in question.