Intellectual Property Protection
The Russian Patent Law passed in 1995 considerably improved the situation regarding the defense of intellectual property, including the protection of patents for pharmaceutical products. Companies with new product patents are able to register their patents in Russia and receive full protection.
However, a major problem remains as to how the Russian court system handles patent disputes or violations of registered patents. The court system remains under-qualified and unprepared to handle sophisticated patent cases, which are often concluded by extra-legal initiatives enabling them to be virtually solved before they reach the court.
An important issue which remains unclear and relatively weak in Russian patent legislation is the extent to which process patents are protected for the period prior to the passage of the new Patent Law in 1995.
Data Exclusivity - Confidentiality
The new Russian Civil Code, which was passed in 1997 contains language which appears to meet the requirements of Article 39.3 of the GATT-TRIPS. Article 139 of the Civil Code provides for serious penalties if commercial secrecy and confidentiality is violated. Further, the Patent Law provides protection for patents of new molecules and so far PhRMA members have experienced no problems in this regard. However, the weak Russian court system would have difficulty enforcing violations if they were to occur.
There is a lack of objective and verifiable criteria by which products are included on reimbursement lists. Lists and state purchases are conducted with virtually no transparency and little open or verifiable concern for the interests of quality and safety.
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.