This document discusses data protection and linkage requirements under TRIPS and related provisions. It explains that TRIPS Article 39.3 requires protection of undisclosed test data submitted for marketing approval of pharmaceuticals and agrichemicals against unfair commercial use and disclosure. Data exclusivity prevents authorities from relying on such data for a period of time, requiring generic companies to conduct their own trials. It also outlines limitations on data exclusivity, such as only applying to new chemical entities, and exceptions for compulsory licenses. Linkage refers to procedures that link drug approval to patent status.

1. Data protection and linkage
TRIPS requirements & TRIPS-plus provisions
Carlos Correa

2. Test data
Safety – Efficacy
Preclinical and clinical trials

3. TRIPS Article 39.3
Members, when requiring, as a condition of
approving the marketing of pharmaceutical or of
agricultural chemical products which utilize new
chemical entities, the submission of undisclosed
test or other data, the origination of which
involves a considerable effort, shall protect such
data against unfair commercial use. In addition,
Members shall protect such data against
disclosure, except where necessary to protect
the public, or unless steps are taken to ensure
that the data are protected against unfair
commercial use.

4. “Unfair commercial use”
-The Drug Regulatory Authority
(DRA) may not request the data
(approval by reference)
- Even if the DRA does use the data,
it is not commercial use

5. Data exclusivity
During the data exclusivity period,
Authorities cannot use or rely on test
data to register generic equivalents

6. As long as data exclusivity lasts:
Generic manufacturers will have to
submit their own data to prove safety
and efficacy
=> They will have to repeat the
clinical trials and other tests
Alternatively, they can only enter the
market after expiry of the data
exclusivity period

7. Ukraine: Article 9-Law on Pharmaceutical
Products
 “If the pharmaceutical product is registered
in Ukraine, it is prohibited, for five years
after the date of such registration
(regardless of the validity of any patent
which concerns the medical product), to
use the registration information for filing an
application for state registration of another
pharmaceutical product, except for cases
when the right to refer or use such
information is received in a due manner”.

8. Limitations to data exclusivity
 Test data required for marketing approval
 New chemical entity (active moiety)
 Significant effort
 Term counted from the 1st approval in the
world
 Use of test data in case of compulsory
licenses
 Exceptions/revocation (e.g. abuses, high
prices)

9. Limitations to data exclusivity
 Test data required for approval
 New chemical entity (active moiety)
 Significant effort
 Term counted from the 1st approval
in the world
 Use of test data in case of
compulsory licenses
 Revocation (e.g. abuses, high
prices)

10. Linkage
 Administrative v. judicial
(information or notification to right
holder v. direct refusal of
application)
 Mandatory registration of patents
(e.g. ‘Orange Book’)
 Patents on active ingredients only
 Damages in case of abuses (payable
to companies and the government)