As the U.S. imposes sweeping new tariffs on over 180 countries and territories—including a baseline 10% rate and steep increases for China (originally 145%, now reduced to 30% for 90 days) and Taiwan (32%, now reduced to 10% for 90 days)—the medical device industry finds itself at the intersection of trade policy and intellectual property enforcement. While much of the attention has focused on supply chains, manufacturing costs, and investment, the implications for patent litigation may be just as significant.
Reshoring = More U.S. Patent Infringement Claims
With companies shifting production to the U.S. to avoid tariffs, we may see a spike in domestic manufacturing activity. Increased US manufacturing would bring with it increased exposure to patent infringement under 35 U.S.C. § 271(a). More manufacturing sites would also expand the potential venues for litigation, especially in patent-friendly jurisdictions post-TC Heartland. In short, more U.S.-based activity means more opportunity, and more risk, for patent enforcement.
A Rise in Trade Secret and Contract Disputes
The urgency to replace offshore suppliers with domestic alternatives could lead to hurried onboarding of new manufacturing partners. In this scramble, disputes over technology transfer, contract terms, and confidentiality obligations are likely to grow. Expect to see more litigation around trade secrets and breach of IP clauses in supply agreements, particularly as production processes are shared or adapted in new environments.
ITC Investigations as a Strategic Weapon
Where foreign-made devices still enter the U.S., expect increased use of Section 337 proceedings at the International Trade Commission (ITC). These actions, which allow for rapid exclusion orders against infringing imports, may align well with the current trade climate. With tariffs already restricting import profitability, ITC actions could provide a strategic lever to further block competition from abroad.
Patent Filing and Enforcement Strategy Shifts
The new tariffs may also lead companies to rethink where and how they protect their inventions:
- More U.S. patent filings may be pursued to cover innovations in domestic production and new supply chain processes.
- Foreign patent activity may slow, especially in high-tariff regions where market access is reduced or uncertain.
This shift in strategy could centralize enforcement in the U.S., making it a more active and contested venue for medtech IP disputes.
Pressure on Smaller Players and Rise in IP Monetization
Tariff-related cost pressures may hit startups and mid-size medtech firms especially hard, making it more difficult to maintain margins. In response, we may see:
- Increased licensing and monetization of patent portfolios.
- Greater use of litigation funding to pursue enforcement claims as a revenue strategy.
- Distressed IP assets coming to market, potentially reshaping the competitive landscape.
Conclusion
Tariffs are often viewed as a lever of trade or manufacturing policy, but they rarely operate in isolation. For the medical device industry, the 2025 tariffs could reshape how and where IP is created, used, and enforced. From a litigation perspective, this evolving environment creates new risks and opportunities. It also underscores the need for companies to align their patent strategies with their broader operational shifts.
