Data protection and linkage

TRIPS requirements & TRIPS-plus provisions

Carlos Correa

Test data

Safety – Efficacy

Preclinical and clinical trials

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.

“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

Data exclusivity

During the data exclusivity period,

Authorities cannot use or rely on test data to register generic equivalents

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

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”.

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)

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)

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)