Patenting of Pharmaceutical Products

AuthorT. Nessim Abu-Zahra/Simon Carvalho/David Edwards
Patenting of Pharmaceutical Products
e Minister of Health is not involved in the issuance of patents or in deter-
mining whether a patent has been infringed; instead, the former is the role
of the Commissioner of Patents, and the latter is the role of the courts.
Furthermore, patent law is its own area of specialized practice, with a com-
prehensive history of jurisprudence and legislation, the details of which are
outside the scope of this book.
Nonetheless, the rules relating to patents and other types of intellectual
property have an impact on the regulation of the sale of drugs by the Min-
ister of Health. As explained in Chapter , the Patented Medicines (Notice
of Compliance) Regulations create a connection — often referred to as “pat-
ent linkage” between the regulation of drugs and granted patents; one of
the conditions necessary to obtain a certicate of supplementary protection
(discussed in Chapter ) is an eligible patent relating to an approved drug;
and the jurisdiction of the Patented Medicine Prices Review Board (PMPRB,
Indeed, a number of texts have been written on Canadian patent law and practice,
such as Donald MacOdrum, Fox on the Canadian Law of Patents, th ed (Toronto:
Carswell, ) (looseleaf updated ); Stephen J Perry & T Andrew Currier,
Canadian Patent Law, th ed (Toronto: LexisNexis Canada, ); David Vaver,
Intellectual Property Law: Copyright, Patents, Trade-marks, d ed (Toronto: Irwin Law,
); Roger T Hughes, Dino P Clarizio & Neal Armstrong, Hughes & Woodley on
Patents, d ed (Markham, ON: LexisNexis Canada, ) (looseleaf).
 SOR/-.
Patenting of Pharmaceutical Products 
subject of Chapter ) relates to the sale of drugs that are protected by a
patent or a certicate of supplementary protection. In addition, although
data protection is a separate form of intellectual property that exists under
the Food and Drug Regulations (FDRs), an understanding of patent rights
provides a useful context to understanding that kind of protection.
is chapter provides a brief overview of Canada’s patent regime and
how it relates to drugs.
As stated by the Supreme Court of Canada, “there is no inherent common
law right to a patent. An inventor gets his patent according to the terms of
the Patent Act, no more and no less.” erefore, Canadian patent law is
based on the Patent Act, which is federal legislation made pursuant to Parlia-
ment’s authority to make laws in relation to patents of invention and discov-
er y. Additionally, as mentioned in Chapter , Canada’s patent law has been
shaped by the need to fulll certain international trade obligations regarding
patents, such as making patents available for all elds of technology.
A patent is a form of intangible property that grants the owner of the
patent time-limited exclusive rights in relation to their invention. Specif-
ically, an “invention— a heavily litigated term dened in section  of the
Patent Act can generally encompass both tangible and intangible subject
matter in a wide variety of technological areas. e patent document itself —
referred to in the Patent Act as the specication must explain the nature
of the invention for which protection is sought and include a set of “claims”
CRC, c .
Apotex Inc v Sano-Synthelabo Canada Inc,  SCC  at para  [Apotex Inc v Sano].
RSC , c P-.
Constitution Act,  (UK),  &  Vict, c , reprinted in RSC , Appendix II,
No , s ().
 See Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Annex
C of the Marrakesh Agreement Establishing the World Trade Organization,  April
,  UNTS , art  (non-discrimination based on eld of technology) and
art  (minimum period of protection) (entered into force  January ). More gen-
erally, see arts – of TRIPS. Canada has also taken on similar obligations in other
treaties, such as: Comprehensive and Progressive Agreement for Trans-Pacic Partnership,
 March  (entered into force  December ); Canada-United States-Mexico
Agreement,  November  and  December  (entered into force  July );
Canada-European Union Comprehensive Economic and Trade Agreement, October 
(entered into force  September ).

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