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Although methods of medical treatment per se are not patentable in Europe, the use of agents or products in the preparation of medicaments for such treatments are. The drawbacks of such limited protection is clear. The European Patent Office is becoming ever more stringent in their requirements for the presence of experimental data in support of the medical use to be present in the application on filing. Whether Europe will ever harmonize with the US in allowing the protection of medical methods is not clear. Until then the burden on inventors to obtain patent protection for medical-use-type inventions is significant and the return is far from adequate.
Tipranavir (Aptivus; Boehringer Ingelheim) was given accelerated approval by the FDA for the treatment of HIV-1 infection in combination with other antiretroviral agents in June 2005. It is the first in a new class of non-peptidic HIV-1 protease inhibitors, and is active against HIV-1 strains that are resistant to other protease inhibitors.
