Restriction on Term Extension for Pharmaceutical and Agrichemical Patents To Be Rescinded.

The TIPO is to lift the restriction on the patent term of pharmaceutical and agrichemicals patents as originally prescribed by the Patent Act that a patentee is not allow to apply for extension of patent term for his/her pharmaceutical or agrichemical patent where it takes less than two (2) years to obtain government approval.

It is legally required that before any pharmaceutical and agrichemical product is put on market, both a patent application and an application for registration and market approval must be filed with the TIPO and the Department of Health, respectively and simultaneously, and that the patentee thereof can implement his/her patent when and only when the pharmaceutical/agrichemical patent and a drug permit license is both issued and approved.

Pursuant to the current Patent Act, a patentee may apply for an extension of his/her patent term for a maximum of five (5) years if a prior government approval for such a patent is secured in a process exceeding two (2) years.

According to the amendment to the Patent Act, TIPO proposes to abolish the above-mentioned restriction on the patent term extension for pharmaceutical and agrichemical patents that an application for term extension is not allowed where it takes less than two (2) years to obtain government approval.  The amendment, instead, indicates that term extension is allowable to a pharmaceutical and agrichemical patent so long as the patent has been examined and granted by the TIPO before the government approval is issued, and the later approval postpones the implementation of the patent, provided however that such extension can be applied for only once for a maximum extension period of five (5) years and such patent term extension is only available to pharmaceuticals for human use but not to those with curing effects on animals.

In addition, patent term extension of a pharmaceutical patent is only limited to the scope of claims of the patent that is applied for.  For example, if a manufacture applies for the use of aspirin in the treatment of hypertension, the patent term extension is only restricted to this use but not for others.

Also, to facilitate the commercial launch of generic drugs for the purpose of national health, the 5th paragraph of Article 40-2 of the Pharmaceutical Affairs Act provides that the patent right of a new drug shall not be applicable to preparation and testing for the commercial launch of generic drugs made during the patent term of the new drug, which actually causes some practical controversies.  Moreover, relevant authorities find it more appropriate to have the issue of inapplicability of patent right subject to the administration of Patent Act.  Therefore, a proposed provision indicates that the patent right shall not be applicable to researches or testing conducted prior to the application for registration for commercial launch of generic drugs. 

[Proposed Article 62 of the Patent Act:  The effect of patent right shall not extend to the circumstance where an invention is put into practice for research and experimental purposes to obtain drug registration as required by the Pharmaceutical Affairs Act.]

Current and Amended Provisions with respect to Pharmaceutical Products of the Patent Act (Proposed on February 16, 2009)

Amendment

Current Provision

Article 55   In the case of invention patents covering pharmaceuticals, agrichemicals, or processes for preparing the same, a patentee may apply for an extension of his/her patent term for a maximum of five (5) years based on the first government approval, if, pursuant to other acts or regulations, a prior government approval must be secured to practice such patents after the publication of the patents.  Only one such extension shall be permitted based on the first government approval provided, however, that the patent term extended shall not exceed the length of time required for obtaining an approval from the central government authority in charge of end enterprises. In case the length of time required for obtaining an approval exceeds five (5) years, the term of extension shall still be limited to five (5) years. The invention patents covering pharmaceuticals as indicated in the first paragraph should not include those for animal use.  Any application for an extension of the term of a patent right must be filed with the Patent Authority by submitting a written application together with supporting evidence within three (3) months from the date of the first government approval involved provided, however, that no extension application shall be filed within six (6) months prior to the expiration of the original patent term. To determine the term of extension of a patent under the preceding Paragraph, the Competent Authority shall take into consideration the impact of the extension on the health of nationals in general and shall prescribe the approving rules in conjunction with the central government authority in charge of the end enterprises concerned.

Article 52   In the case of invention patents covering pharmaceuticals, agrichemicals, or processes for preparing the same, a patentee may apply for an extension of his/her patent term for two (2) to five (5) years, if, pursuant to other acts or regulations, a prior government approval must be secured to practice such patents, for which the processing exceeds two (2) years after the publication of the patents. Only one such extension shall be permitted provided, however, that the patent term extended shall not exceed the length of time required for obtaining an approval from the central government authority in charge of end enterprises. In case the length of time required for obtaining an approval exceeds five (5) years, the term of extension shall still be limited to five (5) years. Any application for an extension of the term of a patent right must be filed with the Patent Authority by submitting a written application together with supporting evidence within three (3) months from the date of the first government approval involved provided, however, that no extension application shall be filed within six (6) months prior to the expiration of the original patent term. To determine the term of extension of a patent under the preceding paragraph, the Competent Authority shall take into consideration the impact of the extension on the health of nationals in general and shall prescribe the approving rules in conjunction with the central government authority in charge of the end enterprises concerned.

(2009.03)
/CCS