March 4, 2025 | Expert Insights | Authored by Accorto Regulatory Solutions & Ward Law Office

Inventors of new medical technologies often face a myriad of decisions when beginning the process of bringing these new technologies to market. Oftentimes, one of their first objectives is to ensure their novel technologies are protected through patents, preventing competitors from infringing on their ideas, with their next goal typically focusing on achieving market clearance as quickly and cost-effectively as possible. In the medical device industry, this is typically achieved through submitting the product for FDA review via the 510(k) pathway, as this regulatory route oftentimes requires less time and resources than other regulatory routes. However, pursuing both patent protection and 510(k) clearance can create potential conflicts if not done strategically, especially with increased communication and collaboration initiatives between the FDA and USPTO in recent years.

For developers looking to bring new technologies to market, understanding the intersection of these two goals is critical for navigating the regulatory and intellectual property landscape successfully. In this article, Accorto Regulatory Solutions and Ward Law Office will explore these goals and how, when navigated correctly, innovators can position themselves for market success.

 

Patent Law and Medical Devices

Inventors often pursue U.S. patent protection as a way to secure exclusive rights to their inventions, enabling them to capitalize on their ideas and prevent others from making, using, or selling products that use their technology without permission. This legal protection allows inventors to profit from their creations by offering them a competitive advantage in the marketplace. For a device to be eligible for patent protection, it must meet several essential criteria, including utility, novelty, and nonobviousness.

Utility

Utility requires that an invention be useful and serve a practical purpose. The invention must have a real-world application and provide some beneficial use. This requirement only applies to utility patents, not design or plant patents. The utility must be specific, substantial, and credible – meaning the invention must work for its intended purpose and provide a concrete benefit.

Novelty

Novelty requires that the invention be new and not previously known or available to the public. Under 35 U.S.C. § 102, an invention fails the novelty requirement if it was publicly disclosed, sold, or made available before the patent application filing date. This includes prior patents, publications, public use, sales, or any other public disclosure. There is a limited one-year grace period in the U.S. for disclosures made by the inventor.

Nonobviousness

Nonobviousness requires that the invention be sufficiently different from prior art such that it would not have been obvious to a person having ordinary skill in the relevant field at the time of invention. Under 35 U.S.C. § 103, this is determined by considering the scope and content of prior art, differences between prior art and claimed invention, the level of ordinary skill in the field, and secondary factors like commercial success or long-felt need. The invention must demonstrate more than just a predictable combination of known elements.

 

Patent Options: Types of Patents, Timelines for Implementation, and Protections for Inventors

 

Once an innovator determines their product is eligible for patent protection, they must determine the patent type, or types, they would like to file for their product. The U.S. patent system provides different types of patents to protect various kinds of innovations. For most companies in the US medical device industry, the two primary patents used are utility patents and design patents. Utility patents cover new and useful processes, machines, or compositions of matter and follow a rigorous examination process. Design patents protect the ornamental appearance of a product and typically have a shorter, more streamlined approval process. Both patent types offer distinct benefits and protections, with varying timelines, filing requirements, and maintenance obligations. Below is a detailed breakdown of the processes for utility and design patents:

Utility Patents:

The patent process typically begins with filing a patent application with the USPTO, which can be either a provisional or non-provisional application. A provisional application provides a 12-month filing date protection but must be followed by a non-provisional application within that year. After filing a non-provisional application, the USPTO conducts an initial examination (usually 1-2 months) followed by publication at 18 months from the earliest filing date. The substantive examination process typically begins 12-36 months after filing, during which an examiner reviews the application and issues office actions that require responses within 3-6 months. This back-and-forth prosecution process can take 2-4 years. If approved, the patent issues after payment of required fees. The total process from filing to issuance typically takes 2-5 years, though some complex technologies may take longer. Patent protection lasts 20 years from the non-provisional filing date, subject to payment of maintenance fees at 3.5, 7.5, and 11.5 years after issuance.

Design Patents:

The design patent process is generally shorter and simpler than utility patents. The process begins with filing a design patent application with the USPTO, which must include detailed drawings or photographs showing the ornamental design. Unlike utility patents, there is no provisional application option for design patents. After filing, the USPTO conducts a formalities review and examination, which typically begins within 6-12 months. The examination process is usually more straightforward than utility patents since design patents have a single claim and focus solely on ornamental appearance. Office actions, if any, must be responded to within 3 months (extendable to 6 months). The total time from filing to issuance typically ranges from 12-18 months, though some applications may be approved in as little as 6-8 months through expedited examination. Once issued, design patents have a term of 15 years from the grant date and do not require maintenance fees. Publication occurs only upon issuance, unlike utility patents, which publish at 18 months from filing.

The 510(k) Process and Potential Patent Infringement Implications

The 510(k) pathway is the most common pathway for medical devices to achieve market clearance in the United States. Through this pathway, an applicant prepares and submits a premarket submission to the FDA, demonstrating that the device to be marketed is as safe and effective, that is, substantially equivalent, to another FDA-cleared, legally marketed device, also known as a predicate device (Section 513(i)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)). By leveraging the preexisting safety and performance data from the predicate device, applicants can reduce the total amount of new testing and data necessary for their application, saving both time and resources for the applicant. However, this regulatory advantage also introduces potential intellectual property (IP) risks, particularly concerning patent infringement and competitive exposure.

Patent Infringement Considerations in the 510(k) Process

A critical but often overlooked risk in the 510(k) process is the potential of patent infringement. Just as patents protect your innovations, predicate device manufacturers may hold patents covering key aspects of their devices. If substantial equivalence arguments are not carefully structured and differences in the technology are not properly discussed, applicants may inadvertently open themselves up to infringement claims. For example, the details, or lack of details, included in a 510(k) summary could be used to support allegations of direct or indirect infringement, infringement under the doctrine of equivalents, or even willful infringement. The challenge for applicants is to carefully structure their 510(k) submission to demonstrate substantial equivalence while simultaneously differentiating their device to maintain a defensible intellectual property position.

How Public Disclosure Could Impact Patent Protection

When the FDA grants clearance for a medical device, the submission details become publicly available through the FDA’s databases. This public disclosure typically includes significant technical information about the device, such as its design specifications, testing data, and intended use. This scenario particularly impacts companies that rely primarily on trade secrets rather than patents or those who haven’t filed patent applications prior to their FDA submission. Competitors can potentially develop “copy-cat” devices by using the publicly available information while making minor modifications to avoid any existing patent coverage. The situation becomes more challenging because once the information is public through FDA clearance, it cannot be patented due to the one-year statutory bar in the United States and the immediate loss of patent rights in many foreign jurisdictions that require absolute novelty.

Collaboration Between FDA and USPTO

Collaboration between the FDA and the U.S. Patent and Trademark Office (USPTO) underscores the importance of companies considering how their regulatory submissions intersect with patent filings as part of their initial IP and regulatory strategy development. Inconsistent or misleading disclosures between these agencies in filings and regulatory submissions can lead to legal challenges, as shown in past cases where selective disclosure or misaligned messaging resulted in unenforceable patents or infringement rulings.

A clear example of this can be seen in Bruno Independent Living Aids, Inc. v. Acorn Mobility Services Ltd., 286 F. Supp. 2d 1020 (W.D. Wis. 2003), in which a critical finding of the case was that an official involved in both the FDA and USPTO submissions disclosed relevant prior art to the FDA as part of their regulatory submission but withheld that same information from the USPTO in their patent filing. The court considered this selective disclosure a deliberate act of deception rather than an innocent oversight, resulting in the court ruling the complete unenforceability of Bruno’s patent of their stairway chairlift device. The case highlighted the importance of ensuring alignment between regulatory submissions and IP filings. Companies must ensure consistent disclosures across agencies to avoid accusations of bad faith. Coordinating with both regulatory and patent experts can help mitigate potential issues arising from this enhanced agency collaboration.

A more recent example of this can be seen in Belcher Pharmaceuticals, LLC, v. Hospira, Inc., 11F.4th 1345 (Fed. Cir. 2021). In this case, the primary legal issue revolved around patent infringement and the regulatory submission process for a generic drug under the FDA’s Abbreviated New Drug Application (ANDA) pathway. Similar to the 510(k) pathway for medical devices, the ANDA pathway allows for a company to seek FDA approval of a generic drug by demonstrating bioequivalence to an FDA-approved Reference Listed Drug (RLD). In this case, Belcher argued the data included in Hospira’s ANDA regulatory submission proved they infringed on the patents Belcher held on their drug’s formulation and method for use. The court ruled in favor of Belcher Pharmaceuticals, agreeing that the generic product from Hospira would infringe on Belcher’s patents. Through the protections Belcher put in place, they were able to successfully protect their IP and maintain their market advantage when faced with copy-cat technology.

In recent years, the FDA and the US Patent and Trademark Office have shown increased collaboration efforts, enhancing visibility between both offices. This increased communication could lead to greater scrutiny of applications where messaging is misaligned between regulatory submissions and patent filings and, could potentially lead to an increase in cases similar to those mentioned above. Companies should be particularly cautious about inconsistencies that may arise between substantial equivalence arguments and patent claims, as regulatory and patent examiners may be evaluating similar technical details. To mitigate risk, companies need to coordinate carefully between their patent and regulatory teams to ensure consistency and transparency between their filings and submissions.

Managing Substantial Equivalence and Patent Risks Through Strategic Collaboration

Patent attorneys and regulatory consultants often work independently, which can lead to unforeseen risks and inefficiencies in the product’s journey to market authorization. A coordinated approach between these two teams ensures that intellectual property protection and regulatory approval strategies are aligned. Strategic cooperation between these two teams is beneficial in a variety of ways:

Predicate Selection

One of the most critical considerations when developing a 510(k) application is the selection of the predicate device(s) to be used in the application. When identifying appropriate predicates, regulatory teams will be evaluating options that demonstrate strong, well-documented safety and performance data, reducing the regulatory burden and strengthening the 510(k) submission. However, a predicate that has been identified by only taking into account the regulatory perspective may not be the best choice for the client when it is also examined through the patent protection viewpoint. If the predicate device is owned by a competitor that holds active patents, the competitor may challenge the 510(k) application or initiate legal action, arguing that the new device unlawfully replicates patented features. Likewise, a predicate that meets preferred criteria from an IP perspective may have limited safety and performance data, requiring additional testing for a successful 510(k), thus delaying market entry and increasing regulatory costs. By connecting your patent attorney and regulatory consultant early in the process and bringing both teams into alignment on long-term goals, a predicate can be selected that takes both sides of the equation into account, strengthening your positioning in both areas and mitigating project risk.

Substantial Equivalence

Another important factor is how substantial equivalence is demonstrated. In the context of a 510(k) medical device regulatory submission, the term substantially equivalent does not mean the device is identical to the predicate device. Rather, the applicant must show that their device has the same intended use and either the same or similar technological characteristics as the predicate device. If there are technological differences, the applicant must provide safety and performance data and demonstrate that these differences do not raise new questions of safety or effectiveness. How this argument is framed could present either challenges or opportunities to the applicant, depending on how that argument is handled.

For example, if the application provides unnecessary information outside of the scope of safety and performance, it could unintentionally create an opportunity for a competitor to assert a patent infringement claim. However, by carefully framing technical details and structuring the application to highlight distinctions between the subject device and the patented, legally marketed predicate, the submission can be used to help support arguments against potential patent infringement allegations.

By collaborating with patent counsel, the regulatory team developing your substantial equivalence argument can ensure documents are precisely worded to minimize risk while incorporating the necessary data and technical details to strategically safeguard your product for future defense.

Timing of Filings and Submissions

Companies can enhance their market position by strategically timing patent filings and regulatory submissions. For example, filing patents before submitting a 510(k) application helps safeguard intellectual property, preventing public disclosure from compromising exclusivity.

To help mitigate risk, companies should coordinate their patent attorney and regulatory teams to ensure the successful implementation of a comprehensive intellectual property strategy. This includes properly timing filings and submissions so that all necessary patent application filings are completed prior to submitting for FDA clearance. This proactive, collaborative approach ensures that the public disclosure through FDA clearance doesn’t compromise the company’s ability to protect its innovation and maintain market exclusivity. This can also create proper safeguards to protect trade secrets from becoming public, allowing businesses to navigate the regulatory landscape without compromising their intellectual assets.

Conclusion

Properly balancing patent protection with regulatory clearance is essential for medical device innovators. By strategically coordinating patent and regulatory efforts—especially in light of increased FDA-USPTO collaboration—companies can avoid unnecessary legal risks, strengthen their market position, and accelerate commercialization. Proactive planning, cross-disciplinary collaboration, and careful management of substantial equivalence arguments will help ensure both regulatory success and strong intellectual property protection.

About Ward Law Office:

Ward Law Office LLC is a boutique law firm specializing in the practice of patent and trademark law. We are committed to providing inventors, entrepreneurs, and businesses with personal and professional services. We are flexible to meet your unique needs.

Our clients range from independent inventors and small businesses to Fortune 500 companies. The law firm has extensive experience in the preparation and prosecution of patent applications in a wide variety of technical disciplines, including mechanical, chemical, and electrical. We are also experienced in the preparation and prosecution of trademark applications.

Furthermore, Ward Law Office fosters close relationships with intellectual property law firms in many foreign countries. Through these relationships, we are able to provide clients with IP services both in the United States and worldwide.

Ward Law Office LLC was founded to provide an unparalleled level of service in intellectual property protection. It is our goal to both educate our clients on how to secure valuable patent and trademark protection, and to provide high quality services at rates affordable to independent inventors and businesses.

This article was created in collaboration between Accorto Regulatory Solutions and Ward Law Office to share industry insights. However, this collaboration does not imply a formal partnership, joint venture, or business affiliation. Both companies remain independent entities.