test data protection trips requirements & trips-plus provisions carlos correa

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Test data protection TRIPS requirements & TRIPS-plus provisions Carlos Correa

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Page 1: Test data protection TRIPS requirements & TRIPS-plus provisions Carlos Correa

Test data protection

TRIPS requirements & TRIPS-plus provisions

Carlos Correa

Page 2: Test data protection TRIPS requirements & TRIPS-plus provisions Carlos Correa

Test data

Safety – Efficacy

Empirical information obtained through the application of standard protocols

Preclinical and clinical trials

Page 3: Test data protection TRIPS requirements & TRIPS-plus provisions Carlos Correa

Data exclusivity

During the data exclusivity period,

national drug authorities cannot use or rely on test data to register generic equivalents

Page 4: Test data protection TRIPS requirements & TRIPS-plus provisions Carlos Correa

As long as data exclusivity lasts…

Generic manufacturers must

=> Repeat the clinical trials

=> Wait until the expiry of the data exclusivity period

Page 5: Test data protection TRIPS requirements & TRIPS-plus provisions Carlos Correa

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.

Page 6: Test data protection TRIPS requirements & TRIPS-plus provisions Carlos Correa

PROTECTION OF UNDISCLOSED INFORMATION

Article 391. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967), Members shall protect …data submitted to governments or governmental agencies in accordance withparagraph 3.

Page 7: Test data protection TRIPS requirements & TRIPS-plus provisions Carlos Correa

USA v Argentina: WTO settlement

-Argentina kept its system based on fair competition law

- Argentina committed itself to change its law if WTO established that exclusivity was required under TRIPS

Page 8: Test data protection TRIPS requirements & TRIPS-plus provisions Carlos Correa

Countries without data exclusivity for pharmaceuticals

-Brasil- Filipinas- Ghana- India- Indonesia- Malaysia - Pakistan- Thailand- Uruguay

Page 9: Test data protection TRIPS requirements & TRIPS-plus provisions Carlos Correa

PatentRegistration; market entry End patent

term

Data exclusivity

Beyond patents

Registration for new indication

Data exclusivity

Page 10: Test data protection TRIPS requirements & TRIPS-plus provisions Carlos Correa

Colchicine : 3 years of data exclusivity

-Widely available as a generic drug for gout pain in the USA since the 19th century: second-line treatment for gout

-Tests with 185 patients, one week: shortened dosing regime :

- Lawsuits to remove any other versions ofcolchicine from the market

-Price increase by a factor of more than 50, from $0.09 perpill to $4.85 per pill.