Intellectual Property Protection
Lithuania's patent law took effect on February 1, 1994, and product patent protection for pharmaceutical products became available. The Agreement between the United States and Lithuania on Trade Relations and Intellectual Property Rights Protection was signed on April 26, 1994. According to Article VII, paragraph 5, a contracting party shall provide a transitional protection for pharmaceutical products for which product patents were not available prior to February 1, 1994, if the following conditions are satisfied:
- the U.S. patent has been issued for the product based on application filed 12 months or more before February 1, 1994, but not before February 1, 1984,
- the product has not been marketed in the territory of the Contracting Party providing such transitional protection.
However the Lithuanian government did not ratify this Agreement because of strong opposition of local pharmaceutical companies. Consequently, the products that could qualify for "pipeline" protection have now lost this benefit and now must compete against pirate copies. "Pipeline" protection for marketed pharmaceutical products in Lithuania 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 because its "pipeline" provisions are ineffective. Until then, data exclusivity is the only type of protection which may prevent early copying.
However, current Lithuanian 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 said previous applicant.
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.