Data Protection

• Author: T. Nessim Abu-Zahra/Simon Carvalho/David Edwards
• Pages: 244-264



FIFTEEN

Data Protection

A. INTRODUCTION

In addition to the intellectual property protection available to pharmaceut-

ical products under the Patent Act (i.e., patents and certicates of supple-

mentary protection (CSP)), the Food and Drugs Regulations (FDRs) provide

an additional form of intellectual property protection for pharmaceutical

products, commonly referred to as “data protection.”

As described in Chapter , a brand-name manufacturer wishing to intro-

duce a new drug to the Canadian market will typically seek a notice of com-

pliance (NOC) by ling a new drug submission (NDS) relying on data from

Phase III clinical trials in which the drug in question was given to patients

suering from the disease or condition the new drug is said to be eective

in treating. At the same time, Chapter  explains that it is possible for a

manufacturer — such as a generic or biosimilar manufacturer — to obtain an

NOC on the basis of a comparison to a previously approved drug for which

the safety and ecacy has already been established.

With this in mind, C... of the FDRs serves to protect the data

that brand-name manufacturers submit to obtain approval of drugs con-

taining medicinal ingredients that were never previously approved. Drugs

eligible for data protection are referred to as “innovative drugs” and the

protection is achieved by prohibiting a generic or biosimilar manufacturer

 RSC , c P-.

 CRC, c .

Data Protection 

(i.e., someone ling a comparative submission) from obtaining approval for

its own version of the innovative drug for eight years following the initial

approval of the “innovative drug.”

Data protection is dierent in many important respects from intellectual

property arising under the Patent Act. However, data protection is similar in

that — like both patents and CSP (via inclusion in the Patented Medicines

(Notice of Compliance) Regulations (PM(NOC) Regulations)) — the data

protection scheme operates to prevent the Minister from issuing a notice

of compliance (NOC) to a generic or biosimilar manufacturer for a period

of time due to the intellectual property status of the brand-name drug the

generic or biosimilar manufacturer seeks to copy. Further, like the protec-

tion conferred by a CSP, data protection is a form of protection specic

to pharmaceutical products that Canada is required by international trade

treaties to provide. Data protection can overlap with Patent Act protections,

but nonetheless serves as an additional, independent source of intellectual

property (IP) protection for qualifying drugs.

B. TREATY OBLIGATIONS WITH RESPECT TO

DATAPROTECTION

With the conclusion of the North American Free Trade Agreement (NAFTA)

in  and Agreement on Trade-Related Aspects of Intellectual Property Rights

(TRIPS) soon thereafter, Canada became obliged to provide a form of pro-

tection against “unfair commercial use” of the “undisclosed test or other data

necessary to determine whether the use of ” a pharmaceutical product making

use of a “new chemical entity” is safe and eective. ese treaty obligations

 Treaties also require data protection to be provided in relation to agricultural products.

Canada fullls these treaty obligations by way of a scheme set out in the Pest Control

Products Act, SC , c .

 North American Free Trade Agreement between the Government of Canada, the Government

of Mexico and the Government of the United States,  December , CanTS 

No , Article () (entered into force  January ). Also note that art()

provided an obligation in instances where a country permits approval of drugs con-

taining new chemical entities based on evidence of foreign marketing approval.

 TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights,  April ,

Marrakesh Agreement Establishing the World Trade Organization,  UNTS ,

 ILM  () Article ..