Japan's Drug Intellectual "Property Not Protected"

Valuable intellectual property of Japanese pharmaceutical companies -derived from development work and submitted in drug approval applications - "is not properly protected," according to the Japan Pharmaceutical Manufacturers Association, which adds that it is concerned that the current system violates General Agreement on Tariffs and Trade/Trade-related Intellectual Property agreements requirements.

To overcome these problems and harmonize Japan's system with current European Union practice, the JPMA says the Japanese system for drug approval and data protection should be modified and notes the following problems:

- under existing regulations, major test results among all data to be submitted in application documents for new drug approval must be made public before the application is made. Due to this system of prior public disclosures, a company developing a generic equivalent drug can, after the re-examination period for an original drug, apply for approval of its drug without performing any clinical trials, attaching just a list of public literature on the original drug, and is, in effect, given a "free ride;" and