Medical device companies face a unique trap at the intersection of FDA regulation and patent law. Mandatory adverse event reports submitted to the FDA become publicly accessible and can qualify as prior art that affect patent rights. Even well-intentioned compliance with FDA requirements can eliminate a patentee’s ability to patent valuable innovations if a patent application has not already been filed.
FDA Medical Device Reporting Creates Public Disclosures
Under 21 CFR Part 803, manufacturers, importers, and device user facilities must report certain device-related adverse events to the FDA. These Medical Device Reports (MDRs) enter the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, which is publicly accessible online and updated monthly.
While the FDA redacts trade secrets and confidential commercial information under the Freedom of Information Act, technical details about device design, operation, and features can remain in the public reports. For example, an adverse event report might describe how a device component failed, how two parts interact, or what materials were used—this is the type of technical disclosure that can anticipate a patent claim.
Public Databases Qualify as Printed Publications
Under 35 U.S.C. § 102(a)(1), a claimed invention is not patentable if it was “described in a printed publication” before the effective filing date. The term “printed publication” is not limited to traditional printed media, but applies to electronic databases and online materials.
Courts have held that the key question is public accessibility: whether persons of ordinary skill in the art, exercising reasonable diligence, can locate the reference. In Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, the Federal Circuit confirmed that FDA materials accessible through the Federal Register and FDA websites qualify as printed publications under § 102.
Because MAUDE (Manufacturer and User Facility Device Experience) reports are searchable, indexed, and accessible to anyone with an internet connection, they meet the standard for printed publications. Thus, the date the report becomes publicly available is its effective date as prior art.
The One-Year Grace Period Provides Limited Protection
The America Invents Act (AIA) provides a one-year grace period under 35 U.S.C. § 102(b)(1), but this grace period has significant limitations that make it unreliable for protecting against adverse event reports.
Section 102(b)(1)(A) excepts from prior art disclosures made by the inventor or obtained from the inventor within one year before filing. However, adverse event reports are often filed by user facilities, physicians, or other third parties who did not obtain the information from the inventor. These third-party reports do not fall within the inventor-originated disclosure exception.
Section 102(b)(1)(B) provides an additional exception when the subject matter “had, before such disclosure, been publicly disclosed by the inventor.” But this exception requires that the inventor made a public disclosure first, and the USPTO has interpreted this provision narrowly. The third-party disclosure must be substantially identical to the inventor’s earlier disclosure for the exception to apply. An adverse event report describing a device malfunction may contain details that differ from any prior disclosure by the inventor, making this exception unavailable.
Moreover, the duty to report adverse events sometimes falls on entities outside the company’s control. A hospital or physician may file a report before the company even learns of the adverse event. By the time the company files a patent application, the one-year grace period may have already expired.
Strategic Approaches for Medical Device Companies
Medical device companies can take several steps to avoid this trap:
File early and file often. The safest approach is to file a patent application—even a provisional application—before any public disclosure occurs. For devices already on the market, file applications covering improvements and new features before adverse events reveal those features publicly.
File before FDA clearance when possible. While this requires filing on less-developed inventions, a provisional application can establish your filing date. You can then file a nonprovisional application within twelve months with additional data and refinement.
Monitor adverse event reports. Review MDRs filed about your devices to identify technical disclosures that might affect pending applications or future filings. Adverse event reports can also reveal unpatented features that competitors might observe and claim.
Coordinate between regulatory and intellectual property teams. Your regulatory compliance team should alert your patent counsel before adverse event reports are filed. This gives patent counsel the opportunity to file applications covering features that might be disclosed in the report.
Do not rely on the grace period. The AIA grace period is too narrow and unpredictable to serve as a safety net. Independent third-party disclosures made during the grace period can still defeat your patent rights.
The Race Between Compliance and Patent Rights
The medical device industry operates under tight regulatory timelines that often prioritize safety reporting over patent strategy. But patent rights, once lost, cannot be recovered. A single adverse event report can destroy patent protection worth millions of dollars.
The solution is not to delay required safety reporting. Rather, companies must build patent filing into their product development and regulatory timelines from the start. Early engagement with patent counsel, before FDA submissions and before adverse events occur, is essential to preserving patent rights while maintaining regulatory compliance.
Medical device innovations deserve patent protection, but only if companies file their applications before public disclosure. The intersection of FDA regulation and patent law requires careful coordination to ensure that your compliance with safety requirements does not inadvertently destroy your intellectual property rights.
Justin Miller is a solo patent attorney. In 2025 he started his own law firm, Distinct Patent Law, after nearly 15 years of practice. His firm is located in Saint Petersburg Florida. He serves clients in Tampa Bay, and because patent law is federal, can file patent applications for clients all over the United States.