Taiwan Legal And Regulatory Updates - August 2019.
Legal News & Analysis - Asia Pacific - Taiwan - Intellectual Property
26 September, 2019
TIPO announced the statistics of Patent Prosecution Highway (PPH) up to May of 2019
Through May 2019, there were 2714 patent applications filed under the Taiwan-U.S. PPH (September 2011 to May 2019), 3285 applications filed under the Taiwan-Japan PPH (May 2012 to May 2019); two application filed under the Taiwan-Spain PPH (October 2013 to May 2019), 75 applications filed under the Taiwan-Korea PPH (July 2015 to July 2019), two applications filed under the Taiwan- Canada PPH (February 2018 to May 2019) and no application was filed under the Taiwan-Poland PPH. The first office action in those matters was issued in an average time of 48.9 days. (Tony Hsieh, Patent Department)
TIPO announced statistics for the Accelerated Examination Program (AEP) on Invention Patents during the period of 2019 May
Through May 2019, there were 119 patent applications filed under the AEP, of which 52 were filed by domestic applicants and 67 were by foreign applicants. The top four foreign applicants by nationalities were: Japan (31), Germany (12), the US (12) and Cayman Islands (3). Of the applications, 70 were filed under Category 1 (i.e. the corresponding application has been approved by a foreign patent authority after substantive examination), and the first office action in those matters (including examination opinions and final decisions) was issued in an average time of 41.5 days. Five applications were filed under Category 2 (i.e. the EPO, JPO or USPTO has issued an office action during substantive examination but has yet to approve the application’s foreign counterpart), and the first office action therein was issued in an average time of 11.7 days. 40 applications were filed under Category 3 (i.e. the invention application is essential to commercial exploitation), and the first office action therein was issued in an average time of 78.7 days. 4 applications were filed under Category 4 (i.e. inventions are related to green technologies), and the first office action therein was issued in an average time of 93.6 days. (Tony Hsieh, Patent Department)
The Amendment to the Pharmaceutical Affairs Act introducing patent linkage system will take effect as of August 20, 2019
The Executive Yuan announced on August 6, 2019 that the patent linkage system in the amended Pharmaceutical Affairs Act will take effect from August 20, 2019. The amendment is summarized as follows:
New Drug Patent Listing:
Starting from August 20, 2019, the holder of a new drug permit is responsible to submit the relevant patent information of the new drug to the Health Authority (TFDA) within 45 days of receipt of the new drug permit or of publication of patent grant, whichever is later. Patentslisted in the TFDA database should contain claims related to substances, compositions or formulations or medical uses. For a new drug permit obtained before August 20, 2019, the new drug holder may submit the relevant patent information within 3 months after the amended law comes into force, i.e. by November 20, 2019.
Stay of Issuance of Generic Drug Permit and Grant of Market Exclusivity to the Generic Drug
Starting from August 20, 2019, an applicant for a generic drug permit should file a declaration concerning the listed patent(s) when applying for the drug permit, certifying: (1) there is no listed patent information corresponding to the new drug; (2) the listed patent(s) relating to the new drug has expired; (3) the generic drug permit will be issued by the authority after the expiration of the listed patent(s); or (4) the listed patent(s) corresponding to the new drug should be invalidated or the generic drug applying for the permit does not infringe the listed patent(s) relating to the new drug. The applicant of the generic drug permit who makes the above declaration (4) must notify the holder of the new drug permit, the patentee and exclusive licensee. 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, unless the patentee or exclusive licensee fails to file a patent infringement lawsuit within 45 days of receiving the notification from the applicant of the generic drug permit, the court finds that the patent at issue is invalid or not infringed, TIPO decides that the patent at issue should be invalid, the litigants settles, or the patent at issue expires. The first applicant for the generic drug permit that declares the invalidity of the listed patent(s) or non-infringement of the listed patent(s) will be granted a 12-month period for market exclusivity after receiving the drug permit. (Lucy Chuang, Patent Department)
TIPO announced the new process for “Notice for Citation of Technical Evaluation Report for Utility Model Patent” (the Notice), which came to effect on July 1, 2019
The following is a highlight of the new process:
The old process required the examiner to issue a “Notice for Citation of Technical Evaluation Report for Utility Model Patent” to the patentee for its explanation only when it was determined that all claims lack novelty or inventive step (comparison result code: 1-3). The amended process requires the examiner to issue such a Notice to the patentee as long as it is determined that any one of the claims lacks novelty or inventive step.
Under the old process, there was no need for the examiner to issue again such a Notice for the subsequent applications for Technical Evaluation Report in case the patentee had ever made explanations in response to such a Notice previously issued for the same patent, unless the basis of comparison had been changed, such as different citations found or post-grant amendment to the patent allowed. Under the amended process, in the event that the comparison result is unfavorable to certain claims, the examiner would issue such a Notice for the patentee’s explanation even though unfavorable comparison result for the same claims was previously determined in the first Technical Evaluation Report. (Charles Ma, Patent Department)
The Ministry of Health and Welfare (MOHW) promulgated the “Enforcement Rules for Patent Linkage of Western Pharmaceuticals” on July 1, 2019
The newly amended Pharmaceutical Affairs Act was promulgated by the President on January 31, 2018. The amendments are mainly directed to data exclusivity of new drugs with new indication and the establishment of patent linkage system. Although the provisions relating to patent linkage have not become effective, the MOHW published the “Enforcement Rules for Patent Linkage of Western Pharmaceuticals” on July 1, 2019 for implementing the patent linkage system. The new rules cover the following aspects of the enforcement:
The submission of patent information and the contents, alteration or deletion, recordation and publication thereof.
The declaration of the applicant for a generic drug permit, the written notice of the examination of the application, and the issuance of drug permits.
The notice by the new drug permit holder that the patentee or the exclusive licensee has filed an infringement litigation and/or has obtained a final judgment affirming the infringement.
Awarding of the marketing exclusivity period.
The provisions that the application for a generic drug permit shall be applicable mutatis mutandis to the new drugs without new ingredient and biosimilar drugs. However, Chapter 4-1 of the Act (i.e., the provisions of patent linkage) would not be applicable to those biosimilar drugs which have been granted an approval for clinical trials prior to the effectiveness of Chapter 4-1 of the Act.
The exclusion of indication, declaration and other related matters.
(Ray Hsu; Patent Department)
On June 20, 2019, the Ministry of Economic Affairs released “the Guidelines for third party’s filing a statement against a trademark application” (the “Guideline”)
According to the Guidelines, any party besides the applicant may submit a written statement (opinions) together with relevant materials/evidence to the TIPO with respect to a pending trademark application if such a party believes that the applied-for mark should not be registrable for a reason based upon the Trademark Act, such as that the applied-for mark bears no distinctiveness, that the applicant attempts to first register a prior used unregistered mark of other’s with an intent to counterfeit, that there exists a prior well-known mark similar to the applied-for mark, or that the applied-for mark is suspected for infringing upon another party’s copyright, patent or other legal right. Such a statement may be filed anonymously. The examiner should examine the statement and consider whether the content thereof is sufficiently specific and certain and whether the evidence is objective and valid, and determine whether the relevant materials should be forwarded to the applicant for response. If the applicant is not given an opportunity to respond, the content of the statement may not be adopted as the basis of rejecting the application. The examiner does not need to respond to the party submitting the statement or to notify the party of the final result of the examination. The party submitting the statement may file a separate opposition or invalidation petition if the party does not agree to the approval of the registration of the applied-for mark. (Jay You, Trademark Department)
The Administrative Judgement 108-Pan-Tze No. 250 of the Supreme Administrative Court
The appellant Nexplanar Corporation (“Nexplanar”) filed an invalidation petition against the patent No. TW528646, titled “Polishing Pads for Chemical Mechanical Planarization”, on April 27, 2012, asserting that the patent lacked novelty and an inventive step. After the patentee, Rohm and Haas Electronic Materials CMP Holdings, Inc., filed a request of post-grant amendment to the claims, TIPO ruled that “the post-grant amendment is granted; the claims 1, 2 and 5 – 7 are considered to be invalid and the patent rights concerned shall be revoked; the claims 3 and 4 are considered to be valid.” Nexplanar filed an appellate petition over the “claims 3 and 4 are considered to be valid” part of the TIPO’s ruling. The petition was dismissed by the Ministry of Economic Affairs. Nexplanar then filed an administrative action with the IP Court, contending that according to Exhibit 5 (a journal article of Irene Li et. al., published in a seminar held by Material Research Society at San Francisco, USA, in 2000) or Exhibit 6 (the slides of the presentation delivered by Irene Li et. al. in the aforementioned seminar), the amended Claim 3 of the patent should be deemed lacking of novelty. The IP Court held that the amended Claim 3 was valid because according to the final judgements of the IP Court (98-Hsing-Zuan-Su Tze No. 67) and the Supreme Administrative Court (100 Pan-Tze No. 2223) rendered on the previous invalidation petition against the same patent, Exhibits 5 and 6 had been found to be unable to corroborate with other evidences (such as the supplemental Exhibit 37 in this case showing an abstract of aforesaid journal article published in said seminar), and could not substantiate the contention that the publication date of either Exhibit 5 or 6 was earlier than the priority date of the patent in dispute. The IP Court thus dismissed Nexplanar’s lawsuit. Nexplanar appealed.
The Supreme Administrative Court reversed the original judgment and remanded the case to the IP Court. The reasons are that in the final judgement rendered on the previous invalidation petition against the patent in dispute, Exhibit 5 was used as an evidence for the invalidation action and Exhibits 6 and 37 were used as a supplemental evidence to check and corroborate the publication date of Exhibit 5; and neither Exhibit 37 nor Exhibit 6 could substantiate that Exhibit 5 was published earlier than the priority date of the patent in dispute. In this case, the IP Court failed to further investigate whether Exhibit 6 could collaborate Exhibit 37 to determine whether Exhibit 6 was published earlier than the priority date of the patent in dispute, and erred in relying upon the aforementioned final judgment to conclude that Exhibit 6 was disqualified as a prior art of the patent in dispute. The Court held that the lower court’s judgment violated the law in that the fact finding was not based upon evidence. (Ray Su, Patent Department)
The Ministry of Economic Affairs ruled that the trademark “” should not be registrable as it contains other party’s well-known nick name and and affired TIPO’s opposition decision revoking the registration
In an appellate decision rendered on May 29, 2019, the MOEA ruled that when the application to register the opposed trademark “” [Black Mamba (stylized)] was filed, “Black Mamba” had already been the well-known nick name of the famous NBA star Kobe Bryant. The petitioner (the applicant of the mark) filed for application of registration of the opposed mark containing “Black Mamba”, without Kobe Bryant’s consent, for use on sportswear, etc. violated Article 30-I-(13) of the Trademark Act, which provides that “a trademark shall not be approved for registration if it contains another person’s well-know nick name . . . and does not obtain that person’s consent for filing”. The MOEA affirmed TIPO’s opposition decision revoking the registration of the opposed mark. (Kevin Wei, Trademark Department)
For further information, please contact:
C. Y. Huang, Partner, Tsar & Tsai Law Firm