Intellectual Property Protection
The Latvian patent law went into effect in 1993 and product patent protection for pharmaceutical products became available. Since it does not provide for pipeline protection, the patent law will only apply to pharmaceutical products marketed approximately in the year 2005.
The U.S. and Latvia signed an Agreement on Trade Relations and Intellectual Property Rights Protection on July 6, 1994, which provided for transitional protection for pharmaceutical products with product patents filed in U.S. between February 28, 1994, and February 28, 1991, so long as the product had not been marketed or manufactured in Latvia prior to the date on which patent protection for pharmaceutical products became effective in Latvia. Given the slow implementation of transitional protection regulations, pirate copies of products entitled to such protection are being marketed in Latvia.
Data Exclusivity - Confidentiality
As it takes 10 to 12 years to bring a new medicine to the market, the benefits of the 1993 patent act will not be felt before 2005. Until then, data exclusivity is the only type of protection which may prevent early copying.
However, current Latvian 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.
For all the aforementioned reasons, PhRMA believes that Latvia should be listed as a Watch Country under Special 301 in 1999.