Test data protection

TRIPS requirements & TRIPS-plus provisions Carlos Correa

Test data

Preclinical and clinical trials Safety – Efficacy Empirical information obtained through the application of standard protocols

Data exclusivity During the data exclusivity period, national drug authorities cannot use or rely on test data to register generic equivalents

As long as data exclusivity lasts… Generic manufacturers must => Repeat the clinical trials => Wait until the expiry of the data exclusivity period

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.

PROTECTION OF UNDISCLOSED INFORMATION

Article 39

1. 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 with paragraph 3.

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

Countries without data exclusivity for pharmaceuticals

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

Beyond patents Patent Registration; market entry Data exclusivity Registration for new indication End patent term Data exclusivity

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