Pharmaceutical Manufacturing Education Center

What is the Status of Drug Intellectual Property (IP) in Taiwan?

Written by Bobby Sheng | Aug 20, 2020 5:30:00 PM

One of the biggest concerns about working in Asia by North American drug companies is the sanctity of their Intellectual Property (IP).  Will it be copied and then all the hard work, years of time and money invested lost?  These are valid concerns!

Taiwan, officially known as the Republic of China (ROC), is an independent state located in East Asia right next to China.  Many people wrongly assume that Taiwan is part of China, but apart from sharing a common language, their political systems are vastly different. It is interesting to note that Taiwan is one of the most populous states that is not a member of the United Nation.

Since Taiwan is not a recognized member of the UN, it cannot access the World Intellectual Property Organization treaties, especially the Patent Cooperation Treaty. However, Taiwan is dedicated to enforcing IP rights and has agreements with several IP offices in the world. Taiwan is a full member of the World Trade Organization and has fully implemented the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

The Taiwan IP Office (TIPO) has roughly the same number of employees as the Japanese and Korean Patent Offices. Taiwan pays very close attention to the needs of industry and has made major amendments to several laws including the Trademark Act, the Copyright Act, and the Patent Act. These Acts were recently strengthened to extended grace periods, extend protection to patent applicants, and update laws in response to the digital era. The TIPO has also strengthened investigation secrecy to provide better protection of trade secrets. In 2003, Taiwan established an IP police force and an Intellectual Property court in 2008.

Under the General Patent Prosecution Highway (PPH), applicants can have an accelerated examination process for application at the office of second application filing. TIPO is currently in a PPH partnership with the United States Patent and Trademark Office (USPTO).

Due to the many changes that have occurred in Taiwan over the last 10 years, Taiwan is characterized as meeting international standards. As a result, there are currently 163 pharmaceutical companies that have gained GMP approval in Taiwan, 137 of which are pharmaceutical manufacturers, and 26 of them being active pharmaceutical ingredients manufacturers.