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Strong intellectual property protections sustain biotechnology innovation by enabling the investment needed to develop new medical breakthroughs.
In comments submitted for the 2026 U.S. Trade Representative (USTR) Special 301 Report, the Biotechnology Innovation Organization (BIO) underscores the need to strengthen and enforce IP protections globally. In markets where protections fall short, biotech companies face significant barriers to entry.
“This directly harms their ability to innovate, invest, and create jobs in the United States,” according to BIO’s comments. “BIO, therefore, strongly urges USTR to take appropriate and proportionate actions including enforcement of existing trade agreements and U.S. trade laws to efficiently remedy IP issues with key trading partners.”
The Special 301 report, produced annually by the USTR, provides a review of IP protection and enforcement worldwide. “The United States uses the review and resulting Report to focus our engagement on these issues,” in discussions with trading partners, according to the USTR.
The report is typically released around the end of April, and BIO submitted its comments to inform the 2026 report earlier this year.
Why biotech and IP matter
BIO’s comments explain the importance of biotech to the U.S. economy.
“According to the TEConomy/CSBA/BIO 2024 Report on the Bioscience Economy, the U.S. bioscience industry directly employs nearly 2.29 million people across nearly 150,000 U.S. business establishments,” BIO says. “Our sector’s economic impact on the U.S. economy totaled $3.2 trillion in 2023, as measured by overall output.”
Of course, biotech advances have an impact beyond the economy. New treatments help us live longer, healthier lives. But we need market incentives to fund these treatments, BIO explains.
“Without strong and predictable patent protection, investors will shy away from investing in biotech innovation and will simply put their money into projects or products that are less risky—without regard to the great value that biotechnology offers society,” BIO’s comments say.
BIO cites a University of California Berkeley survey in which 73% of the biotechnology entrepreneurs reported that potential funders, “indicated patents were one of the most important factors in their investment decisions.”
Given that many of BIO’s members are small and medium-sized enterprises with no products on the market, they “rely heavily on the strength and scope of their IP to generate investments needed to develop and commercialize their technologies,” BiO says. These businesses need global IP protections to be able to expand beyond American markets.
Actions that weaken IP globally
The comments note that some U.S. trade partners employ various practices that interfere with the IP protections biotech needs.
For instance, drugmakers are often pressured to give up their licensing rights and localize their technology in exchange for access to a country’s market.
“Efforts by governments and activists, including in Colombia, Russia, and Brazil, to normalize the use of routine, non-emergency compulsory licenses undermine the legal and economic property rights framework that enables the world-leading U.S. investment in biopharmaceutical technology innovation,” BIO says.
There have also been efforts taken within multilateral institutions, such as the World Trade Organization and the World Health Organization, that treat IP as a barrier to spreading innovation, according to BIO.
It is essential that USTR oppose these attempts to weaken IP, BIO says.
“Accordingly, we strongly encourage USTR to play an active role in IP discussions with key trading partners and within multilateral fora to defend U.S. interests by protecting the IP of U.S. companies,” BIO says.
The need to protect trade secrets
BIO’s comments put a particular focus on the challenge of protecting trade secrets. In some countries, inadequate legal protections enable commercial competitors to obtain trade secrets from regulators or other sources. In other cases, governments make concerted efforts to gain access to trade secrets, even from third countries.
“Economic espionage targeting the U.S. biopharmaceutical sector has become a strategic priority for countries such as China and Russia,” the comments explain. “These countries leverage their economic, political, and intelligence relationships with many countries around the world, to gain advantages that include acquisition of U.S. intellectual property.”
Any firm operating directly within China and Russia faces further threats to their trade secrets.
“China’s Biosecurity Law and Human Genetics Regulation require foreign firms to partner with Chinese entities and share records, data, and other information as part of doing business in China,” BIO says. Russia has decreed that Russian businesses may freely use Western intellectual property “with the aim of reducing Russian reliance on U.S. companies and further countering the effects of sanctions.”
To protect trade secrets and other IP, BIO recommends that the USTR:
- pursue strong trade secret commitments in bilateral and multilateral trade agreements;
- develop coordinated responses with allies to address nation state-sponsored trade secret theft;
- enhance information sharing between government and industry regarding specific threats to biopharmaceutical intellectual property.
“BIO urges USTR to prioritize these issues in its engagement with trading partners, recognizing that the protection of trade secrets is fundamental to maintaining U.S. leadership in biopharmaceutical innovation and ensuring continued investment in developing life-saving medicines for patients worldwide,” BIO concludes.
