Navigating Medical Device Regulation and IP Protection in the United States (Part 2 of 2)

Jonathan B. Roses

Nov 18, 2025 6 min read

In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and in some cases overlapping with—the frameworks for drugs and biologics. Understanding these distinctions is critical for innovators and practitioners navigating Food and Drug Administration (FDA) oversight and the IP landscape in order to protect valuable investment and bring products to market.Part one of this two-part series previously reviewed how FDA defines and classifies medical devices in the United States. This part examines the IP and exclusivity landscape for medical devices in the US, including how patents, trade secrets, and limited regulatory exclusivity can be used to protect these products, and some special considerations for combination products and diagnostics.

Regulatory Exclusivity and Patent Protection

Unlike drugs, medical devices benefit from more limited regulatory exclusivity with less practical benefit. Instead, protection is primarily from patents and trade secrets.

Patents may cover the device composition (e.g., the physical structure of the components, the formulation of a drug delivered by the device), methods of use (e.g., the use of the device to treat or diagnose a particular disease or condition, or to identify a particular patient population), manufacturing processes, and even its ornamental design.

In addition, Class III devices subject to PMA may qualify for Patent Term Extension (PTE)—a period of up to five years that can be added on to a single patent covering the approved device, its approved use, or a method of its manufacture. PTE serves to restore patent term lost during FDA review, when the patentee would otherwise be able to exploit its limited monopoly and recoup its investment in development, but is legally prohibited from doing so until it receives FDA approval. In addition to the five year cap, other limitations apply to PTE—total patent term cannot extend beyond fourteen years from FDA approval, patentee only accrues PTE for half of the time spent in the testing phase (between filing an Investigational Device Exemption and an application for PMA), and PTE term can be reduced for periods during which the sponsor did not act with due diligence during the approval process. Moreover, for a patent to be eligible for PTE based on a medical device approval, the patent claims must be directed to the aspects of the device (as opposed to the drug or biologic) or its use or manufacture.

Notwithstanding the primacy of patent protection for medical devices, it is not absolute. For example, the courts have interpreted the statutory Safe Harbor provided by Congress broadly. In particular, activities that would otherwise qualify as patent infringement are exempted if they are conducted solely for uses reasonably related to the development and submission of information to FDA. This can include both pre- and post-market activities, and even activities that do not result in submission of information to FDA. This Safe Harbor was enacted by Congress as part of the Hatch-Waxman Act of 1984 in order to spur generic competition and allow generic device makers a “runway” to prepare for commercial launch upon patent expiration (rather than having to wait to begin those activities until patent expiration to avoid infringement risk).

Other forms of exclusivity for medical devices are extremely limited. Class III devices approved via PMA receive six years of data exclusivity preventing use of clinical and safety data by FDA in approving or reclassifying another device. However, significant information regarding Class III device approvals are made public, easing the burden for follow-on device sponsors to design and run their own trials. FDA also protects trade secret and confidential commercial information submitted during the regulatory process. Combination products (discussed below) may also inherit regulatory exclusivity from the drug/biologic portion of the product.

Finally, device sponsors often rely on trade secrets to protect aspects of their products and manufacturing. Trade secrets, which are confidential information that derive independent economic value from not being generally known or readily ascertainable for which reasonable efforts are taken to maintain their secrecy, are also protected under state and federal law.

Combination Products and Diagnostics

For drug–device or biologic–device combinations, FDA regulation depends on the product’s primary mode of action (PMOA). When FDA determines that the PMOA is pharmacological or biological, the product is regulated as a drug or biologic. As a result, the device portion of the approved combination product effectively inherits any associated regulatory exclusivity granted to the drug or biologic. This includes five-year New Chemical Entity exclusivity (for an approved drug including an active moiety not previously approved by FDA), twelve-year new biologic product exclusivity (for an approved reference biological product), three-year New Clinical Investigation or New Product exclusivity (for products approved based on new clinical investigations other than bioavailability studies that were essential to approval), seven-year Orphan Drug Exclusivity (for approved drugs and biologics designated for a disease or condition generally affecting less than 200,000 persons in the US), or six-month Pediatric Exclusivity (for approved drugs or biologics that are tested in pediatric age groups, even if not actually approved for use in pediatric patients).

Patents covering combination products may also be listed in FDA’s Orange Book (OB). OB listing provides a mandatory 30-month stay of regulatory approval of a generic product for the reference listed product if the generic certifies that the listed patent is invalid or would not be infringed by the proposed manufacture, use, or sale of the generic product. While OB listing practices have varied (and been scrutinized) widely, a recent appellate court decision held that such patents are only listable in the OB if they “claim the active ingredient” or a method of its use.

Finally, it is important to note that in vitro diagnostic products face unique challenges under current patent eligibility jurisprudence in the US. In particular, the Supreme Court has held that certain diagnostic patent claims are in fact directed to laws of nature or natural correlations, and are accordingly not considered to be patent eligible subject matter. However, the Federal Circuit has since upheld patents that incorporate treatment steps applying such correlations in a specific, practical manner. These issues remain somewhat amorphous, and continue to be the subject of discussion in legal circles, including proposed legislative action that would clarify the law.

Conclusion

The regulation and protection of medical devices in the US reflects a complex and evolving landscape that is distinct from the corresponding schemes for small molecule drugs and biologics. While patent law provides the cornerstone of protection for device manufacturers, the interaction of limited data exclusivity, device classification pathways, and evolving patent issues—particularly for diagnostics and combination products—continues to shape the approaches stakeholders take to protect and advance these products to market.