Validity Term of Pharmaceutical Patents, Agricultural Drug Patents Proposed to Be Extendible for 2 - 5 Years.

　To practice a pharmaceutical or agrochemical patent, the patent holder must obtain the approval from the Department of Health or the Council of Agriculture.  Due to the lengthy approval process, the duration in which the patent holder may practice his/her patent is substantially cut short.  Therefore, TIPO is proposing to revise the criteria for grant of a 2-5 years’ extension of the patent term.  Once enacted, the extension will apply to and only to valid patents issued on pharmaceuticals, agrichemicals (including the method of using the patent), and the process for preparing the same.

　According to Article 52 of the Patent Ac, in the case of invention patents covering pharmaceuticals, agrichemicals, or processes for preparing the same, the patent holder may apply for extension of the patent term for 2 to 5 years, if, pursuant to other acts or regulations, a prior government approval must be secured to practice such patents, for which the procedure takes two (2) years after the publication of the patents.  This patent term extension regime is to mend the lapse of the patent term due to the time lapsed waiting for the approval; as such, the patent term may be extended once and only once on request.

　Under the proposed revision, the subject matter of a request for patent term extension must be an active ingredient or the purpose thereof as indicated in the approval license or, in the case of agrichemicals, (a) the active ingredient, (b) the ingredient to achieve the purpose of the agrichemical, (c) the purpose of the agrochemical, or (d) the method of preparing the patented agrochemical.  That is, the patent right enforceable during the extension granted will be that in and only in the special subject matter of the invention patent which cannot be practiced without the approval of the end business competent authority.

TIPO said that the inevitable lapse of the patent term of patented pharmaceuticals or agrochemicals for the time lag for the launch approval could lead to diminished interest and investment in the R&D of new drugs and allowing extension of the patent term is a reasonable step to take and  welcomed by the trade.  (2008.10)

/EMA