U.S. Market Entry
A medical device company that has built a patent portfolio at home often arrives at the U.S. market with an understandable assumption: that the portfolio travels with the product. It does not. U.S. entry raises a distinct set of patent questions, several of which are governed by fixed deadlines that are difficult or impossible to recover once missed. The checklist below is general information for international device companies and their advisors; the right answer for any particular portfolio depends on its facts.
Patents are territorial. Under the Paris Convention, patents granted in different member states for the same invention are independent of one another, and a grant in one country does not oblige any other country to grant a patent. The U.S. Supreme Court has observed that the presumption that United States law governs domestically but does not rule the world applies with particular force in patent law (Microsoft Corp. v. AT&T Corp., 550 U.S. 437 (2007)).
Two consequences follow. A European, Chinese, Japanese or Korean patent confers no rights in the United States, and a U.S. patent held by someone else can be infringed by a product that is entirely lawful at home. Under 35 U.S.C. §271(a), infringement includes making, using, offering to sell or selling a patented invention in the United States, and importing it into the United States. For a foreign manufacturer, shipping product to a U.S. distributor can fall within the statute, and a manufacturer whose sales close abroad may still face claims of inducing infringement under 35 U.S.C. §271(b).
The Paris Convention allows an applicant who files a first patent application in one member state to file in other member states within 12 months and claim the earlier filing date. U.S. law implements this in 35 U.S.C. §119(a). U.S. law permits restoration of the priority right for up to two additional months where the delay was unintentional, but that is a remedy for error, not a planning tool.
The 12-month date is the first point at which a company must decide whether the United States belongs in the portfolio. It often arrives before the U.S. commercial plan is settled, which is one reason the decision is frequently deferred through an international application rather than made through a direct U.S. filing.
An international application under the Patent Cooperation Treaty defers the U.S. decision but does not eliminate it. To proceed in the United States, the applicant must meet the requirements of 35 U.S.C. §371, including payment of the basic national fee, no later than 30 months from the priority date. The USPTO's Manual of Patent Examining Procedure states that this 30-month period may not be extended. Certain later items, such as an English translation and the inventor's declaration, may follow with surcharges, but the core deadline is fixed; an application abandoned for missing it can be revived only on a petition showing the delay was unintentional.
Because 30 months frequently lands in the middle of regulatory work, national-stage entry is a natural point to reconcile the claims on file with the device actually headed for the U.S. market.
The United States offers a one-year grace period for an inventor's own disclosures. Under 35 U.S.C. §102(b)(1), a disclosure made one year or less before the effective filing date is not prior art if it was made by the inventor or a joint inventor, or by another who obtained the subject matter from them. The exception is limited to inventor-originated disclosures; it does not excuse independent work by third parties.
Many other systems are stricter. Under the European Patent Convention, the state of the art comprises everything made available to the public before the filing date, and Article 55 excuses only narrow categories of disclosure within six months, such as an evident abuse in relation to the applicant or display at an officially recognized international exhibition. A conference presentation, a published clinical abstract or a trade-show demonstration made before filing may be survivable in the United States and fatal elsewhere. The U.S. grace period is best understood as a safety net for U.S. rights, not a reason to disclose before filing.
Before any U.S. filing, it is worth confirming whether the home country restricts filing abroad. Article 19 of the Patent Law of the People's Republic of China, in the version effective June 1, 2021, requires any entity or individual intending to file abroad for an invention or utility model accomplished in China to request a confidentiality examination in advance. If a foreign application is filed in violation of that requirement, a patent will not be granted on a corresponding Chinese application. The United States has an analogous rule for inventions made domestically: 35 U.S.C. §184 prohibits filing abroad within six months of a U.S. filing without a license. Where engineering teams sit in more than one country, where the inventive work was done can determine which rule applies.
FDA describes a 510(k) as a submission demonstrating that a device is substantially equivalent to a legally marketed device, and premarket approval as a scientific and regulatory review of the safety and effectiveness of Class III devices. Neither process evaluates whether the device infringes anyone's patents. A cleared or approved device can still be the subject of an infringement action. Freedom-to-operate analysis is a separate workstream, addressed in more detail in a companion article.
Foreign manufacturers face an additional forum. Section 337 of the Tariff Act of 1930, codified at 19 U.S.C. §1337, declares unlawful the importation or sale of articles that infringe a valid and enforceable U.S. patent, where an industry in the United States relating to the patented articles exists or is being established. When the U.S. International Trade Commission finds a violation, the statute directs that the infringing articles be excluded from entry, subject to public-interest considerations, with enforcement carried out at the border. For a company whose entire U.S. supply arrives from abroad, an exclusion order can stop the business rather than merely add cost to it.
Portfolios are often drafted around the first-market version of a device. The U.S. version may differ in materials, software, form factor or labeled indications for use, sometimes as a result of FDA feedback. Claims that read on the home-market product but not on the U.S. configuration protect less than they appear to. Keeping a U.S. application pending, including through a continuation filed before the parent issues or is abandoned under 35 U.S.C. §120, can preserve the ability to pursue claims that track the product as it evolves, provided the original disclosure supports them; a continuation cannot add new matter, which is why a U.S. filing should be reviewed for U.S. written-description and enablement support rather than treated as a translation of the home-country application.
FDA's Quality Management System Regulation (QMSR), effective February 2, 2026, incorporates ISO 13485:2016 by reference, including its design and development requirements, while retaining FDA-specific requirements, so harmonization with ISO 13485 is not the same as identity. Once a design has been frozen, verified, validated and described in a submission, changing it to avoid a third-party patent can mean repeating testing and revisiting regulatory filings. A freedom-to-operate review conducted while the design is still open is generally less disruptive than one conducted afterward.
None of these items is exotic, but they sit across patent, regulatory and supply-chain functions that are often managed separately, and several run on deadlines that are narrow and costly to miss. Companies planning a U.S. entry may find it useful to review their portfolio and timeline with patent counsel before the next priority, national-stage or design-freeze date arrives.