Taiwan Jurisdiction: A Intellectual Property Overview
Recent Developments in Patent Examination and Strategic Implications for Businesses
In Taiwan, intellectual property protection continues to play a central role in supporting business innovation and commercialisation. Over the past two years, recent developments in the patent system have introduced measures that provide greater flexibility for applicants, reflecting broader economic trends and the government’s emphasis on fostering innovation-driven growth.
A key change allows applicants to request a one-time deferral of substantive examination for invention and design patents that have not applied for accelerated examination, provided the request is made before the applicant receives the first Office Action (OA) during the substantive or re-examination stage. For invention patents, this deferral can be requested within five years of filing, while for design patents the window is two years. The measure applies to both standard and divisional applications, giving companies additional time to plan patent portfolios, prepare for commercialisation and co-ordinate international filings.
These adjustments create opportunities for businesses to align intellectual property strategies with product development and market introduction schedules. By taking advantage of the one-time deferral, companies can reduce pressure during early development, optimise patent filing strategies, and manage resources more efficiently – particularly in fast-moving innovation sectors.
At the same time, these changes pose strategic challenges. Businesses must carefully consider the timing of the deferral to ensure that patents are granted at the most advantageous stage. Effective use of this measure requires proactive portfolio planning, balancing flexibility with the need for timely protection and enforceability.
Overall, Taiwan’s evolving patent framework provides a supportive environment for innovation while requiring thoughtful management of intellectual property. Companies that navigate these changes strategically may enhance their competitive position, facilitating domestic and international commercialisation of new products and technologies.
Ophthalmic Pharmaceuticals: Licensing and Commercialisation Trends
The global ophthalmic pharmaceutical sector continues to benefit from steady growth in surgical volumes, driven by ageing populations and increasing demand for cataract and other ocular procedures. This trend has placed greater emphasis on post-operative care, where effective and patient-friendly anti-inflammatory and pain management therapies are becoming an increasingly important segment of the market.
At the same time, regulatory expectations for ophthalmic drugs remain high, particularly in major jurisdictions such as the United States. Obtaining FDA approval for new ophthalmic products is both time-consuming and costly, prompting many clinical-stage companies to adopt licensing-based commercialisation strategies. Rather than building in-house sales and distribution capabilities, developers are increasingly partnering with established pharmaceutical companies that possess existing commercial infrastructure and market access.
Recent developments illustrate how innovative ophthalmic products can leverage this model to accelerate global market entry. New steroid-based post-surgical treatments, including those utilising advanced drug delivery technologies, have successfully navigated regulatory approval processes and entered the US market after lengthy periods without comparable innovations. These approvals highlight the commercial value of differentiated formulations that combine clinical efficacy, safety and convenient dosing regimens for both physicians and patients.
From a legal and commercial perspective, cross-border licensing and supply arrangements have become central to this growth strategy. Such agreements often involve complex negotiations over exclusivity, manufacturing responsibilities, pricing and long-term supply commitments. While these structures allow developers to scale efficiently, they also present challenges, particularly where market conditions evolve after term sheets or framework agreements such as licence and supply agreements have been established.
For companies operating in this space, the key hurdles lie in balancing flexibility with certainty. Regulatory delays, shifting market dynamics and differing regional requirements can place strain on pre-agreed commercial terms. Successful participants are those that combine strong intellectual property portfolios with carefully structured licensing arrangements that allow for adaptation over time, while maintaining alignment between licensors and commercial partners. As demand for ophthalmic innovation continues to rise, these considerations are likely to remain at the forefront of industry and legal practice.
An Introduction to Intellectual Property Litigation in Taiwan
Intellectual property laws in Taiwan primarily cover patents, trade marks, copyrights, trade secrets, integrated circuit layout designs, plant varieties and seeds. To swiftly and effectively resolve intellectual property litigation disputes, Taiwan established the Intellectual Property Court on 1 July 2008. This court trials first-instance and second-instance civil cases, second-instance criminal cases, first-instance administrative litigation, and enforcement proceedings related to intellectual property matters. In the same year, a specialised procedural law – the Intellectual Property Case Adjudication Act – was enacted. This Act underwent a major revision in 2023.
The distinctive features of the Intellectual Property Case Adjudication Act are primarily reflected in the following aspects.
- Strengthening evidence preservation and trade secret protection: The “Confidentiality Order” system is introduced. When litigation materials involve trade secrets, the court may issue an order upon application or on its own initiative to prohibit or restrict parties, litigation agents or other persons involved in the proceedings from using the trade secrets for purposes outside the litigation or disclosing them to persons not covered by the order.
- Involving experts in judicial proceedings: Technical examiners are introduced to assist judges in determining technical issues and provide expert technical analysis. They may request explanations or pose questions to parties regarding factual and legal matters, directly question witnesses, expert witnesses or appraisers, present opinions to the judge on the case, and assist in evidence preservation and verification.
- Mandatory legal representation: For certain types of intellectual property civil cases, such as first-instance civil lawsuits involving patent rights, computer program copyrights or trade secrets, or where the value of the subject matter exceeds TWD1.5 million, the parties must appoint an attorney as their litigation representative.
Since Taiwan implemented its pharmaceutical patent linkage system in 2019, multiple international pharmaceutical companies have filed lawsuits against Taiwanese generic drug manufacturers for infringing on their original drug patents. Over the past five years, such lawsuits have exceeded 80 cases, indicating that original drug manufacturers frequently utilise the patent linkage system and infringement lawsuits to block generic drugs from entering the market. Generic drug manufacturers, in turn, challenge the novelty or inventiveness of the original drug patents. Therefore, such litigation often involves determinations of patent infringement and patent validity. For example: A German pharmaceutical company asserted that a generic drug infringed upon its patent related to a liver cancer medication and filed an infringement lawsuit. The Intellectual Property and Commercial Court ruled in favour of the Taiwanese generic drug manufacturer in the first instance, finding the patent lacked inventive step, revoking the patent and dismissing the original manufacturer’s infringement claims. Subsequently, the appeal of the German pharmaceutical company to the Supreme Court was dismissed in 2024.