Biotechnology and Pharmaceuticals
Summer 2007 Fasken Martineau DuMoulin LLP
Amendments to the Food and Drug Regulations Grant “Innovative Drugs” a
Period of Market Exclusivity
By Mathieu Gagné
In October 2006, important amendments were made to the Food and Drug Regulations concerning the
protection of data needed to demonstrate the safety and effectiveness of pharmaceutical products.
amendments provide “innovative drugs” with an eight-year period of market exclusivity (eight and a half
years for paediatric drugs), with the primary aim of protecting investments made to develop “innovative”
pharmaceutical products, thus giving them a competitive foothold on international markets. In addition, last
June Health Canada submitted for consultation a draft guidance document that interprets these regulatory
In fact, the obligation of data protection is set out in the North American Free Trade Agreement (NAFTA)
and the Trade Related-Aspects of Intellectual Property Rights Agreement (TRIPS) of the World Trade
Organization (WTO). Under articles 1711 (5) and (6) of NAFTA, Health Canada is obliged to protect the use
of data submitted in order to obtain approval of pharmaceutical products that utilize new chemical entities.
1) Terms of Protection
The Regulations grant a
term where the “generic product” manufacturer, seeking to copy an
innovative drug, may not apply for a notice of compliance for a new drug.
This is followed by a
no-marketing period during which the Minister will not grant a notice of compliance to that “generic
manufacturer.” The no-marketing period is extended by six months for drugs in paediatric population use in
order to encourage paediatric research.
Note that, before these amendments were made, only a single protection period of five years was provided
during which the Minister could not grant a notice of compliance to generic manufacturers.
2) Conditions of Protection
In order to benefit from this protection, a drug must meet the definition of “innovative drug”.
specifically prohibits innovators from obtaining additional protection periods simply by varying medicinal
ingredients. Furthermore, the drug must be marketed in Canada.
A manufacturer that believes its drug should qualify as an innovative drug must make a statement to that
effect in the cover letter accompanying the submission (notice of compliance) or send a letter directly to the
Office of Patented Medicines and Liaison (OPML).
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3) Register of Innovative Drugs
The “Register of Innovative Drugs” maintained by the Minister may be consulted to verify that a product is
protected. The Register includes the name of the drug, the medicinal ingredient and the termination date of
the data protection term and, where applicable, that of the paediatric extension. The Register will be
available in printed form and posted on Health Canada’s website at the following address:
4) Consent Provision
Despite this interdiction, an innovator company can allow any other manufacturer to file a licence application
during the six-year no-filing period and authorize the granting of the notice of compliance at any time during
the protection period.
5) Transitional Provision
Notwithstanding the fact that these amendments came into force October 5, 2006, they apply to drugs that
were granted a notice of compliance on or after the date of the first consultation period, June 17, 2006.
6) Court Challenges of the New Requirements
The Canadian Generic Pharmaceutical Association (CGPA) is currently challenging this eight-year
protection term awarded to innovator companies.
Specifically, the CGPA alleges that these new
requirements greatly exceed what is required of Canada to honour its international commitments and,
consequently, surpass the limits of regulation-making power. According to the CGPA, had this restriction
been in place over the last five years, the cost of prescription medication in Canada would have risen by
approximately $600 million.
A doctor of laws and partner at our firm,
Mathieu Gagné specializes in drug law and other health products
medical devices and natural health products. He has a unique grasp of all legal aspects related to drugs
and other health products, from their creation in the laboratory to their consumption. Mr. Gagné is also an
associate professor with the management and technology department at the Université du Québec à Montréal and
is active on the world scene, working as a researcher for an international drug research team.
He has contributed
to collective works, written a number of articles for trade journals, and published a work entitled “Le droit des
Mathieu Gagné can be reached by phone at 514 397 7657 or by e-mail at firstname.lastname@example.org
1) Regulations Amending the Food and Drug Regulations (Data Protection), Canada Gazette II, Vol. 140, No. 21,
October 18, 2006, SOR/2006-241. These regulations amended section C.08.004.1 of the Food and Drug Regulations,
C.R.C., c. 870 (hereinafter the “Regulations”);
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2) Health Canada, Draft Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations, Ottawa,
June 13, 2007;
3) Filing for a notice of compliance is a required step for manufacturers intending to market and sell a new drug in Canada;
4) Comparatively, it bears noting that the United States also offers an incentive program providing an additional exclusivity
period of six months for drugs on which paediatric studies were conducted and deemed acceptable by the Food and Drug
Administration; Regulatory Impact Analysis Statement – Regulations Amending the Food and Drug Regulations (Data
Protection), SOR/2006-241, October 5, 2006. In Europe, paediatric regulations provide a six-month extension for patents
(or to the supplementary protection certificate); see, for example, Regulation No. 1901/2006 of the European Parliament
and of the Council of December 12, 2006 on medicinal products for paediatric use, O. J.E.U., L378/1, Art. 36;
5) The term “innovative drug” is defined as follows: “a drug that contains a medicinal ingredient not previously approved in
a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester,
enantiomer, solvate or polymorph”; Food and Drug Regulations, op. cit. Note 1, section C.08.004.1 (1);
6) While the submission is under review, the OPML prepares a preliminary assessment as to whether it believes the drug may
qualify and provides this assessment in the form of a letter to the manufacturer. In case of a dispute, the manufacturer has
the opportunity to provide representations in writing within 30 days of receipt of the letter; Draft Guidance Document:
Data Protection under C.08.004.1 of the Food and Drug Regulations, op. cit. Note 2;
7) Canadian Generic Pharmaceutical Association v. Governor in Council (The) et al., T-1976-06, motion filed
November 14, 2006.