DOH to Amend Pharmaceutical Affairs Act in Light of Wide Disputes over Diminution of New Drug Patent Right with respect to Researches And Experiments.

The provision of the fifth paragraph of Article 40-2 of the Pharmaceutical Affairs Act has been widely disputed for unduly diminishing the operability of patent right provided.  According to the said provision, which is newly introduced to the Act, new drug patent right shall not extend to the researches, teachings, or testing conducted by pharmaceutical firms prior to the application for pharmaceutical inspection and registration.  That is, a new drug patent holder may be barred from protecting his or her patent right against pre-launch pharmaceutical experiment conducted by others.  In addition, the issue remains open to questions whether anyone who, for the purpose of obtaining the pharmaceutical license, conducts the relevant research or testing prior to the relevant new drug patent term expires should be free from patent infringement claims.  The controversial new provision overlaps the provision of the first paragraph of Article 57 of the Patent Act which provides that the effect of an invention patent right shall not extend where the invention is put into practice for research, educational or experimental purposes only, with no profit-seeking acts involved therein.  The subject controversial provision, however, fails to address the balance of interests.

As the controversial provision unduly diminishes the effect of patent rights in breach of the interpretation and operation of the Patent Act, the Department of Health concurred that it is not appropriate for the Pharmaceutical Affairs Act to interfere with the operation of patent rights and that it will negotiate with the Taiwan IPO with a view to repealing the controversial provision and let the relevant issues be governed by the Patent Act as they should be.  (2005.12)

/EMA