The Committee acknowledges the government’s continued efforts to engage in productive dialogue and enhance cross-agency cooperation for the protection of intellectual property (IP) rights. These efforts are essential in addressing persistent challenges related to copyright and patent law, helping to strengthen Taiwan’s position in the global innovation ecosystem.

However, in light of rapid technological advancements, particularly those related to artificial intelligence (AI), additional steps are needed to ensure Taiwan’s IP framework remains both resilient and responsive. At the same time, longstanding issues such as the extension of copyright terms and streamlining of patent term extension (PTE) procedures still require further attention. To this end, the Committee presents several recommendations aimed at strengthening IP protection, supporting innovation, and ensuring consistency with international practices.

First, we urge the government to align Taiwan’s copyright term with international standards. The current term of 50 years after the death of the author is shorter than that of many major trading partners, including the United States, the European Union, and Japan. Extending the copyright term to 70 years post-mortem would not only support creators’ rights but also strengthen Taiwan’s position in international trade negotiations.

Second, we recommend clarifying the legal status of copyrighted materials used for training generative AI models. As the use of AI in content generation grows, it is vital that the Taiwan Intellectual Property Office (TIPO) under the Ministry of Economic Affairs and other relevant agencies establish clear guidelines in consultation with creators, developers, and industry stakeholders. A balanced approach that respects copyright while enabling responsible AI development is vital to ensuring legal certainty and continued innovation.

Finally, the Committee recommends improving the efficiency and transparency of the PTE process for pharmaceutical patents. Delays and inconsistencies in the review process create uncertainty for applicants and can discourage investment. Establishing clearer timelines and communication protocols would help streamline the process and improve predictability.

The Committee looks forward to continued collaboration with the relevant authorities to modernize Taiwan’s IP system in line with global standards and support sustainable innovation.

Suggestion 1: Amend the Copyright Act to extend protection and address generative AI.

1. Extend the copyright protection term to strengthen global competitiveness. The Committee reiterates its longstanding recommendation that Taiwan extend the duration of copyright protection to align with global standards. While a defined copyright term is essential to incentivize creative expression and protect creators’ rights, this must be balanced against public interest considerations, including the eventual availability of works in the public domain. Whereas Taiwan offers protection for only 50 years, more than 80 jurisdictions, including the United States, the EU, Australia, Japan, Singapore, and South Korea, offer copyright protection for at least 70 years after the creator’s death.
   Taiwan’s cultural and creative sector plays a significant role in the national economy. According to the Taiwan Creative Content Agency’s 2022 Taiwan Cultural Content Industries Survey Report, the industry generated around NT$1.6 trillion (US$51 billion) in revenue in 2022, amounting to 4.81% of GDP. Export revenues alone totaled NT$112.7 billion (US$3.8 billion), with particularly high export contributions from product design, digital audiovisual content, and crafts.
   With the rapid growth of cross-border digital distribution, Taiwan’s creative works are increasingly subject to the “Rule of the Shorter Term,” under which countries that offer longer copyright protection may apply only the shorter duration of a foreign country’s law, meaning Taiwanese works may enter the public domain sooner overseas. The absence of term parity could thus disadvantage Taiwan’s music, film, and audiovisual exports in global markets.
   Despite these considerations, opposition from a small segment of book importers has hindered legislative progress for many years, citing increased licensing costs. However, prioritizing such concerns at the expense of international competitiveness undermines Taiwan’s broader economic and cultural interests. The Committee urges the government to recognize copyright term extension as a necessary economic and trade policy and to amend the Copyright Act without further delay.
2. Introduce AI-specific copyright regulations to ensure responsible use. The emergence of generative AI presents new opportunities for creative innovation but also introduces pressing legal and ethical concerns, particularly around the unauthorized use of copyrighted content in AI training datasets. Many AI systems are developed using large volumes of copyrighted material such as musical compositions, sound recordings, and visual works without permission, posing a significant threat to creators’ livelihoods.
   To address this issue, the Committee recommends that Taiwan amend the Copyright Act to provide a clear and enforceable framework for AI-related copyright issues. Specific suggestions include:
   a.)    Prohibiting the development or training of AI systems using copyrighted content without prior authorization. Rights holders must be allowed to publicly declare in advance that their works may not be used for AI training.
   b.)    Requiring separate authorization for AI systems to reproduce the voice, image, name, and likeness of performers.
   c.)    Stipulating that if exceptions are introduced for AI-related uses, they must adhere strictly to the three-step test under the Berne Convention, the World Intellectual Property Organization Copyright Treaty, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
   d.)    Allowing rights holders to withdraw previously granted consent for the use of their works in AI training.
   e.)    Requiring AI developers, providers, and operators to maintain transparent records detailing the use of copyrighted material in training datasets.
   f.)     Mandating clear labeling of AI-generated content, along with verifiable methods of identification.
   g.)    Clarifying that works generated solely by AI, without human creative input, are ineligible for copyright protection.

   These reforms would promote responsible AI development while safeguarding the rights and contributions of Taiwan’s creative community. By modernizing the Copyright Act to reflect these emerging challenges, Taiwan can support innovation without compromising the rights of artists, creators, and cultural stakeholders.

Suggestion 2: Strengthen PTE and linkage systems through centralized oversight and international alignment.

1. Designate TIPO as the sole authority for PTE and patent linkage oversight. PTE is a legal mechanism that allows pharmaceutical patent holders to regain time lost during regulatory review (typically up to five years) by extending the life of their patent. Meanwhile, patent linkage is a system that connects drug marketing approval with patent status, preventing the approval of generic drugs that would infringe valid patents still in force. Inaccurate linkage records can result in premature market entry of generics, undermining patent protections and deterring innovation.
   The Committee recommends that Taiwan assign exclusive jurisdiction over pharmaceutical PTE and the Patent Linkage System to TIPO. While the Taiwan Food and Drug Administration under the Ministry of Health and Welfare currently serves as the competent authority for patent linkage, both patent linkage and PTE involve complex legal interpretations and intellectual property determinations that are best handled by TIPO, which possesses the relevant expertise and procedural infrastructure. Assigning sole authority to TIPO would ensure greater consistency, legal clarity, and alignment with international best practices.
2. Recognize the Clinical Study Report date as the end of foreign clinical trials. Under Article 53 of the Patent Act and its associated regulations, patentees of pharmaceutical or agrichemical products may apply for a patent term extension of up to five years to account for regulatory delays. However, the absence of a uniform definition for the “end date” of foreign clinical trials creates inconsistencies in how PTE is calculated. While Taiwan’s Patent Examination Guidelines refer to the “study completion date,” Supreme Court of Taiwan rulings in 2017 and 2018, as well as subsequent administrative court decisions in 2022, suggest that the “date on which trial results are presented” should be used.
   This approach is impractical, as trial conclusions typically require a period of data analysis, statistical processing, and internal validation following the completion of the trial. These steps are documented in the Clinical Study Report (CSR), which is finalized once results are confirmed by the principal investigator.
   Consequently, the Committee recommends formally adopting the “clinical study report date” as the trial end date for PTE calculations. This interpretation reflects regulatory realities, enhances predictability, and aligns with the intent to compensate patentees for time lost during the regulatory review process. Using the CSR date as the trial completion point ensures companies are fully compensated for regulatory delays, encouraging continued investment in R&D.
3. Amend the Patent Examination Guidelines to reinstate harmonization with U.S. and Japanese practice. The current Patent Examination Guidelines (Chapter 11, Part 2, Section 4.3) restrict PTE eligibility to cases in which the active ingredient in the first market approval matches the exact substance claim. An example added in 2018 (Example 5) disqualifies PTE if the approved product is a hydrate of a compound but the patent claims only the base compound.
   Prior to 2018, Taiwan’s practice was consistent with both the United States and Japan, which allow PTE in such cases as long as there is a clear relationship between the approved product and the claimed compound. The 2018 amendment diverged from this established norm, undermining the legislative intent of PTE, which is to compensate for regulatory delays that prevent the commercial use of patented inventions. Moreover, disqualifying hydrates from PTE eligibility creates arbitrary barriers to protection, discouraging drug makers from launching products in Taiwan.
   The Committee urges TIPO to remove Example 5 from the Guidelines to restore alignment with international norms and Taiwan’s historical practice. This change would re-establish consistency in interpretation and ensure that patentees are not penalized due to overly narrow or contradictory administrative standards.
4. Update the patent linkage system to accurately reflect extension applications. Article 54 of the Patent Act provides that if a PTE application is filed before the expiration of the patent term, the patent remains in force during the review period of the extension and is protected under the law. TIPO has further clarified that the public should be notified of such pending extensions through an official announcement. However, Taiwan’s Patent Linkage System does not explicitly account for this interim protection. As a result, under Article 48-9, Paragraph 2 of the Pharmaceutical Affairs Act, generic drug applicants may still declare that a patent has expired, potentially leading to premature approvals despite a pending PTE.
   To close this gap, the Committee recommends the following updates to the New Drug Patent Information Submission and Third-Party Response Submission forms:

   ．Add a field titled “Extension Application Date” under the section “Extension of Patent Term.”
   ．Include start and end dates for the presumed extension period during which the patent remains effective.
   ．Restrict drug license applicants from selecting the Article 48-9, Paragraph 2 declaration (claiming patent expiration) when an extension application has been recorded in the system.

   These adjustments would ensure accurate representation of patent legal status and prevent procedural misuse that could undermine patent rights and regulatory certainty.
   By consolidating authority for both PTE and patent linkage under TIPO and aligning administrative practices with international standards, Taiwan can reinforce legal clarity, protect patent holders’ rights, and promote a more competitive and innovation-friendly pharmaceutical sector.