In a decision of the Patented Medicine Prices Review Board,
released June 30, 2011, the Board decided that generic drug
companies who sell patented products through agreements with a
patentee are required to report sales and pricing information. The
Board was asked to consider an application from Board Staff seeking
an order requiring generic company, ratiopharm, to provide the
Board with the information and documents required by the
Patented Medicines Regulations. These provisions require
"patentees" to provide to the Board certain information
regarding sales, pricing, revenues and research and development
The central issue in the case was whether ratiopharm could be
considered a "patentee" for products it sold under supply
agreements with other companies who were the patent-holders for the
products in question. Board Staff took the position that any
pharmaceutical distributor that has an agreement to purchase a
medicine from a patent-holder and resell it to others, and who
holds its own Notice of Compliance (NOC) for the medicine, ought to
be considered a "patentee" for the purposes of the
Act and the Regulations. Board Staff argued that,
for 14 of its products, ratiopharm fell under this definition.
ratiopharm argued that it was not entitled to exercise any
patent rights in relation to the patents at issue because the
innovative companies specifically, by agreement, retained all
patent rights. Thus, ratiopharm simply occupied a position in the
distribution chain of the medicines and could not be considered a
The Board Panel relied heavily on its decision in the
ratio-Salbutamol decision dated, May 27, 2011, a case which was
decided by the same panel. An application for judicial review of
that decision was filed in the Federal Court, on June 27, 2011.
The Board Panel concluded that it was not necessary for a
company such as ratiopharm to manufacture a medicine or hold a
patent pertaining to the medicine in order to be subject to the
jurisdiction of the Board. The Board Panel held that a person is
subject to the jurisdiction of the Board if it is entitled to
"any rights in relation to" a patent pertaining to a
medicine that is sold in Canada.
The Board Panel reasoned that, while the exercise of market
power was not a precondition to the Board's jurisdiction, the
potential for market power that arises from the monopoly conferred
by a patent is at the root of the Board's mandate. The Board
Panel held that, because a patent-holder is exercising market power
when it decides whether or not to supply ratiopharm with a
medicine, ratiopharm's right to sell that medicine is a right
to which ratiopharm is entitled "in relation to" the
The Board Panel considered it significant that ratiopharm held
its own NOCs for the medicines. Although it is possible for a
person to hold an NOC without being entitled to any rights in
relation to a patent, the Board held that a person who holds an NOC
and is entitled to rights in relation to a patent occupies the same
position with respect to the Board's mandate as the patent
The Board Panel justified its conclusion by considering the
consequences of ratiopharm's position. According to the Board
Panel, distributors in ratiopharm's position must be considered
patentees; otherwise, the Board's mandate could easily be
defeated by strategic alterations in the distribution structure for
a medicine. The Board concluded that its interpretation of the term
"patentee" was necessary to avoid "unregulated
For 12 of the medicines at issue, the Board concluded that
ratiopharm was required to file Form 1 (medicine identification
information) and Form 2 (sales and pricing information). For 2
medicines, the Board required ratiopharm to file further
information in order to allow the Board to establish whether
ratiopharm was a patentee with respect to those medicines.
The prospect of an internal investigation raises many thorny issues. This presentation will canvass some of the potential triggering events, and discuss how to structure an investigation, retain forensic assistance and manage the inevitable ethical issues that will arise.
From the boardroom to the shop floor, effective organizations recognize the value of having a diverse workplace. This presentation will explore effective strategies to promote diversity, defeat bias and encourage a broader community outlook.
Staying local but going global presents its challenges. Gowling WLG lawyers offer an international roundtable on doing business in the U.K., France, Germany, China and Russia. This three-hour session will videoconference in lawyers from around the world to discuss business and intellectual property hurdles.
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
Health Canada is proposing to change the way that it regulates non-prescription drugs, natural health products and cosmetics in Canada, which will now be referred to collectively as "self-care products."
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).