6 March, 2018
On December 29, 2017, the Legislative Yuan passed an amendment to the Pharmaceutical Affairs Act. The amendment introduces a patent linkage system, with the hope that the system may resolve patent infringement disputes before generic drugs are released on the market, and that generic drug companies may design around.
In the future, the holder of a new drug permit is responsible to submit the relevant patent information of the new drug within 45 days of receipt of the new drug permit or of publication of patent grant, whichever is later. The patent information which can be submitted includes those patents related to substances, compositions or formulations and medical uses. For a new drug permit issued before the amended law comes into force, the holder may submit the relevant patent information within 3 months after the amended law comes into force. In the case of a medical use invention, the claim number should also be specified.
An applicant for a generic drug permit should file a declaration concerning the listed patent(s) relating to the corresponding new drug when applying for the drug permit, certifying: (1) there is no listed patent information corresponding to such new drug; (2) the listed patent(s) relating to such new drug has expired; (3) the generic drug permit will be issued by the authority after the expiration of the listed patent(s) relating to such new drug; and (4) the listed patent(s) corresponding to such new drug should be invalidated or the generic drug applying for the permit does not infringe the listed patent(s) relating to such new drug.
The applicant of the generic drug permit who claims that the listed patent should be invalidated or is not infringed must notify the owner of the new drug permit, the patentee and exclusive licensee. The patentee or exclusive licensee may file a lawsuit to clarify the infringement issue within 45 days of receipt of such notification. The authority may continue to review the application for the generic drug permit, but should suspend the issuance of the permit for the generic drug for a period of 12 months, counted from the date of receiving such notification by the owner of the new drug permit, barring special circumstances such as a court’s finding that the patent is invalid or not infringed, settlement between the litigants, or expiration of the patent at issue. The first applicant for the generic drug permit that challenges the validity of the listed patent(s) or declares non-infringement of the listed patent(s) will be granted a 12-month period for market exclusivity after receiving the drug permit.
Finally, due to special nature of a new drug of non-new molecular entity, the new drug of non-new molecular entity is applicable not only to the provisions regarding submission of patent information for a new drug permit but also to the provisions of declaration procedure for a generic drug permit.
For further information, please contact:
Joyce I. Ho, Partner, Tsar & Tsai Law Firm
joyeho@tsartsai.com.tw
