Newsletter
EXAMINATION GUIDELINES FOR PATENT TERM EXTENSION UNDER CONSIDERATION
The ROC, for the first time, adopted the patent term extension (PTE) system on 23 January 1994. In order to fully implement the PTE system, on 1 January 1997, the Intellectual Property Office (IPO) coordinated with the Department of Health and the Council of Agriculture, and announced the Regulations Governing Patent Term Extension. In order to standardize the handling of PTE cases, the IPO is currently drafting the Examination Guidelines for Patent Term Extensions (Guidelines). The IPO held public hearings on 16 June and 7 July 1999 to solicit comments on the draft Guidelines. The following is a summary of the draft Guidelines and conclusions of the public hearings:
Applications for Patent Term Extension
Applicant qualifications
The applicant for a PTE application must be the patentee. If the patent is jointly owned, the application must be filed by all the joint owners. In addition, if the patentee is a foreign national, his or her own country must have a treaty or agreement with the ROC for reciprocal protection. Currently, only the United States and Australia have established such reciprocity with the ROC.
Patents allowed for PTE
Patents allowed for PTE are limited to those covering inventions related to pharmaceuticals, agrichemicals, or their manufacturing processes, for which the patentees must secure governmental approvals to practice such patents according to the Law of Pharmaceutical Affairs or the Management Measures for Pesticides, and for which the processes for obtaining the government approvals exceed two years after the publication of the patents. PTE for a Patent-of-Addition should not be independently filed.
Timing for filing PTE applications
A PTE application must be filed within three months from the date when the first government approval is obtained and six months prior to the expiration of the original patent term.
Application documents
To apply for PTE, a written application must be submitted. The application should clearly cite the patent number, the title of invention, name of patentee and his places of domicile and residence (in the case of a legal person, its name, office, and name of agent), grounds and time period for extension as well as the date on which the first government approval was obtained. The application must also include a copy of the government approval serving as the basis for PTE.
IPO's handling of PTE applications
Upon receipt of a PTE application, the IPO will publish the contents of the application in the Patent Gazette and designate an examiner to examine the application.
The government approval serving as the basis for PTE must be obtained by the patentee or his assignee or licensee as recorded with the IPO according to Article 59 of the Patent Law.
The claims of the patent under PTE application must cover the active ingredient and/or their uses identified in the government approval. In other words, the claims of a product patent which does not specify its use(s) must cover the active ingredient identified in the government approval. The claims of a use patent must cover the active ingredient and their use identified in the government approval. As for a manufacturing process patent, the product manufactured from the process must cover the active ingredient identified in the government approval. The fact how the active ingredient identified in the government approval is actually produced is not relevant.
Only one PTE is allowed for one single patent. After a PTE application is approved, the patentee should not apply for another PTE for the same patent based on another government approval.
The length of time subject to PTE is the sum of foreign testing period, domestic testing period and domestic regulatory review period recognized by the competent authority. However, the following period of time must be deducted: the time period during which the patentee did not act properly for obtaining the government approval, the overlap between the foreign testing period and the domestic testing period, and the overlap between the testing periods and the regulatory review period. The total length of time calculated in accordance with the above must exceed two years, and the extended term should not exceed five years.
The commencement date of domestic testing for a pharmaceutical is the date on which the competent authority approves the domestic clinical testing. The date of conclusion of the testing is the date on which the competent authority approves the clinical testing report. For testing conducted at multiple centers, the commencement date should be the first date on which the competent authority approves the testing. If there are two or more identical testings, the conclusion date shall be the date on which the competent authority approves the first testing report. If, however, the multiple centers conduct different testings, the conclusion date should be the date on which the competent authority approves all the testing reports.
The commencement date of domestic testing for agrichemicals is the date of the competent authority's letter agreeing to commission an entrusted field testing. The conclusion date is the date on which the competent authority issues a notice approving the testing data.
After the IPO receives a PTE application, the applicant may, during the examination stage, file an application to amend and/or correct mistakes or unclear portions in the written application and/or supporting documents. However, a PTE application should not be amended after it is approved and published.
PTE applications should be treated same as re-examination applications. If the IPO plans to reject a PTE application, or plans to allow an extension period which is different from that sought by the PTE applicant, the IPO should issue a notification, advising the applicant of the proposed rejection or proposed extension term and requesting a response from the applicant within a specified time limit.
Approval of PTE
When a PTE application is approved, the IPO should publish the PTE allowance in the Patent Gazette and endorse the extension period on the original patent certificate. The subject matters protected during the extended patent term are limited to the active ingredient and/or their uses identified in the government approval. Other portion of the patent which is not identified in the government approval cannot receive protection during the extended patent term.
Cancellation and revocation actions
Any person may file a cancellation action against an approved PTE. The IPO may also ex officio revoke an approved PTE.
Cancellation actions can be filed by any person at any time during the effective extended patent term. However, only a person who has a retroactive legal interest due to the cancellation of a PTE may file a cancellation action after the extinguishment of the extended term.
The subject matter of a cancellation action against an approved PTE is the patent right receiving the extended term.
Grounds for cancellation actions include:
1.it is not necessary to obtain a government permit to practice the patented invention;
2.the patentee, assignee, or his licensee did not obtain a government permit;
3.the approved term of extension exceeds the length of time during which the patented invention cannot be practiced;
4.the PTE application is filed by a person other than the patentee or his assignee;
5.the patent right is jointly owned by two or more persons, but the PTE application is not filed in the name of all co-owners;
6.the PTE is sought based on the time period for testing conducted in a foreign country, and the extended term exceeds the duration recognized by the government agency of such foreign country; or
7.the time required for obtaining the permit is less than two years.
If a cancellation action is irrevocably sustained, the extended patent term originally granted becomes non-existing ab initio. However, if such cancellation action was irrevocably sustained based on grounds 3 or 6 mentioned above, the excess term of extension should be deemed non-existing.
Articles 42 through 44 of the Patent Law regarding the defense by the patentee, designation of examiner, issuance and service of examination decisions, and actions which may be taken during examination apply mutatis mutandis to cancellation actions against granted PTE.
The IPO plans to soon finalize the drafting of the Guidelines. We will closely monitor the developments and keep our readers informed.