Intellectual Property Protection
The Estonian patent law took effect in 1994 at which time product patent protection for pharmaceutical products became available. Since the law does not provide for pipeline protection, pharmaceutical products will benefit from the law approximately in the year 2006. "Pipeline" protection for marketed pharmaceutical products in Estonia is needed.
Data Exclusivity - Confidentiality
As it takes 10 to 12 years to bring a new medicine to the market, the benefits of the 1994 patent act will not be felt before 2006. Until then, data exclusivity is the only type of protection which may prevent early copying.
Although the protection of undisclosed information is regulated by the Competition Act, which prohibits the misuse of confidential information, there is no provision in Estonian law corresponding directly to Estonia's WTO TRIPS obligations in the area of data exclusivity. Current Estonian Patent law does not include any provisions meeting the requirements of Art. 39.3 of WTO-TRIPS on the use of a previous applicant's documents, and, in particular, does not provide that, in order to refer to documents submitted by a previous applicant, the second applicant has to obtain the consent of the previous applicant. There is therefore a high probability that health authorities in Estonia may provide marketing approval to a product relying on confidential test data of another patented product without approval of the right holder.
Potential Exports/Foreign Sales
PhRMA is not able at this time to provide any reliable estimates of the increase in our industry's sales that would accompany the removal of the aforementioned trade barriers.