For Medical Device Companies Based Outside the U.S.
The United States is the largest medical device market in the world, and among the most contested. For small and mid-sized device companies headquartered abroad, the patent portfolio that served you at home is rarely the portfolio you need here.
Entering the U.S. puts three timelines on a collision course: your patent filing deadlines, your FDA pathway, and your commercial launch. Each one is usually managed by a different advisor. The costly mistakes happen in the gaps between them.
This practice is built for that intersection. Counsel combines a medical degree, engineering training, and more than three decades of patent experience — so the clinical use, the device mechanics, the regulatory context, and the claims are considered together, by the same senior attorney, from the first conversation.
Where International Companies Get Caught Out
Patent rights are territorial. U.S. protection generally depends on filing within the Paris Convention's 12-month priority window or entering the U.S. national stage of a PCT application — typically by 30 months from the earliest priority date. Miss the window and the U.S. market may be open to competitors.
U.S. law gives inventors a limited one-year grace period for their own disclosures; much of the world, including Europe, generally does not. Relying on the U.S. rule after a trade-show demo or publication can preserve U.S. rights while forfeiting others. Filing strategy should be settled before anything goes public.
A 510(k) clearance, De Novo grant, or PMA approval says nothing about whether a device infringes someone else's U.S. patent. Freedom-to-operate review belongs on the launch plan while the design can still change.
A device manufactured abroad reaches U.S. customers by being imported. Beyond federal court, a U.S. patent owner can bring a Section 337 investigation at the U.S. International Trade Commission and seek an exclusion order barring infringing products at the border.
Some countries require government clearance before an invention made there is filed abroad — China's confidentiality examination is one example, and non-compliance can invalidate the Chinese patent. The U.S. strategy has to respect the rules where the invention was made.
For Class III devices that go through premarket approval, U.S. law allows a patent term extension to recover part of the regulatory review period. 510(k) and De Novo devices do not qualify. Knowing which patent to extend, and when to apply, is a portfolio decision made early.
Portfolio Management & Strategy Counseling
For device companies with an existing portfolio, or one still taking shape, the work typically centers on aligning what you own with what you will actually sell, and to whom, in the United States.
Discuss your U.S. strategyWho This Is For
Founders, CTOs, heads of R&D, and general counsel at medical device companies headquartered outside the United States — preparing a U.S. launch, raising from U.S. investors, negotiating with a U.S. distributor, or facing a U.S. competitor's portfolio. Engagements are handled directly by senior counsel, and consultations are scheduled by appointment across time zones.
Common Questions
Patent rights are territorial. A European or other national patent does not stop a competitor from making, selling, or importing a device in the United States. U.S. protection generally comes from a U.S. application — filed directly, through the Paris Convention within 12 months of your first filing, or by entering the U.S. national stage of a PCT application, typically by 30 months from the earliest priority date.
No. FDA clearance or approval addresses safety and effectiveness; it neither grants patent rights nor establishes freedom to operate. A cleared device can still infringe a U.S. patent owned by someone else.
Ideally while the design can still change — before design freeze and well before U.S. launch or distributor commitments. Design-arounds are far cheaper on the bench than after regulatory submissions and manufacturing are locked.
Yes. U.S. strategy is most effective when coordinated with home-country counsel so that priority claims, claim sets, and filing deadlines line up across jurisdictions.
Entering the U.S. Market?
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