Last month, Taiwan became the latest economy in Asia to take a bold step to bolster life sciences innovation and to accelerate economic growth. On August 20, 2019, Taiwan’s Food and Drug Administration began implementing a patent linkage system following adoption of an amendment to the Pharmaceutical Affairs Act earlier in the summer.
The amendment is a win-win-win for patients, innovators and generic drug companies alike by enabling the orderly resolution of patent disputes before potentially-infringing products enter the market.
Taiwan’s biopharmaceutical innovators will benefit from better intellectual property (IP) enforcement, which helps drive greater investment and R&D. Meanwhile, the Taiwanese generics industry will be better positioned to determine the patent status of innovative products and enter the market without the risk and cost of post-launch litigation.
Most of all, the amendment is a win for Taiwanese patients and workers. IP protection drives greater investment and R&D, which help spurs economic growth, high-value jobs and access to breakthrough treatments and cures for patients in need – both in Taiwan and around the world.
Taiwan’s patent linkage policy also includes biologic medicines, which offer groundbreaking therapeutic hope for previously untreatable diseases. Including biologics and follow-on biosimilars in the amendment, incentivizes further investment in innovative treatments for life-threatening conditions such as cancer, multiple sclerosis and autoimmune diseases.
Taiwan’s recent actions are part of a broader trend in East Asia. Leading economies like South Korea and Singapore have already established patent linkage systems that are improving IP enforcement and boosting the global competitiveness of their life sciences industries. China is considering a linkage system, along with other bold IP reforms that would put its innovation environment on par with Europe and the United States.
While Asia is moving toward a position of global leadership in biopharmaceutical innovation, the United States – a long-time leader in producing lifesaving treatments and cures – risks sabotaging its own patent system to the detriment of American patients and the economy. For example, some U.S. policymakers have proposed radical changes that would allow for compulsory licensing – when the government breaks patent rights on innovative products – among other bad ideas that would weaken the patent system and hurt patients.
Because of a strong U.S. patent system – which allows the biopharmaceutical industry to invest more than any other industry in R&D and bring forward medical advances critical to patients – the United States has long set the pace for global progress. And as the single largest funder of business R&D in the U.S., biopharmaceutical manufacturers depend on strong IP protections to incentivize R&D and promote robust competition.
As countries like Taiwan adopt highly-encouraging pro-innovation policies and regulatory frameworks, it’s paramount that American policymakers take equal – if not greater – actions to ensure the promotion and protection of IP and innovation both here at home and abroad.
Megan Van Etten Megan Van Etten is senior director of public affairs at PhRMA. She is responsible for leading the association’s public affairs efforts on international issues, including trade, intellectual property and access to medicines. Prior to joining PhRMA, Megan was director of media and external communications at the U.S. Chamber of Commerce and communications director at the Beer Institute. She has also worked as a communications consultant for global public relations firms. When not at the office, Megan enjoys exploring new Washington, D.C. restaurants and traveling with her husband and friends.