Trademarks Require “Use in Commerce” – But What If You Need Regulatory Approval Before Selling Your Medical Device?
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The U.S. Patent and Trademark Office (USPTO) allows for a trademark application to be filed on an “Intent to Use” basis to establish a priority date before the mark is actually “used in commerce.” However, such use in commerce must happen before the trademark application will register with the USPTO. If your company markets medical devices or related goods that require regulatory approval, the use in commerce requirement presents unique issues.
Typically, use in commerce is established when the goods affiliated with the trademark application are shipped between two states or to a foreign country, and with a label or packaging showing the trademark on the goods. For most industries, use of a trademark “in preparation” of sales will not suffice to satisfy the use in commerce requirement. Additionally, a trademark owner is only given three years to use the mark in commerce and provide evidence of such use after the USPTO determines the application is otherwise ready for registration. If the owner does not submit proof that it has used the mark by the deadline, the application is deemed abandoned. Three years seems like ample time for many trademark owners, but anyone who has needed regulatory approval for a product knows the process can stretch well beyond these three years. How does one deal with this conundrum?
You may think that you should wait to file your trademark application so that you don’t run out the three-year clock. But this may allow competitors to swoop in and file intervening trademark applications. If the USPTO believes your mark is confusingly similar to the mark in a competitors’ prior application or registration, it could prevent you from being able to register your mark.
With few exceptions, the best strategy is to file your trademark application as soon as possible. Fortunately, the law provides an accommodation for trademark registrants with goods and services that require regulatory approval. Legislators recognized the fact that “commerce” varies in different industries. For instance, while some companies can sell products as soon as they are ready for market, others must undergo testing to get a stamp of approval prior to marketing or selling their products. This latter group typically includes medical device companies. These and other devices may require pre-market approval (PMA) or a 510(k) clearance from the U.S. Food and Drug Administration (FDA), which can take many years.
Lawmakers revised the definition of “use in commerce” to state that such requirement:
be interpreted to mean commercial use which is typical in a particular industry. Additionally, the definition should be interpreted with flexibility so as to encompass various genuine, but less traditional, trademark uses, such as those made in test markets, infrequent sales of large or expensive items, or ongoing shipments of a new drug to clinical investigators by a company awaiting FDA approval (Senate Judiciary Committee Report on S. 1883, S. Rep. No. 100-515, p. 44-45 (Sept. 15, 1988))
This expanded meaning of “use in commerce” has been generally adopted by the USPTO and the courts. Therefore, shipments across a state line that include use of the mark for testing, investigation, studies, and similar efforts may satisfy the “use in commerce” requirement within industries that require regulatory approval. This may be true even if regulatory approval and sales to customers are many years down the road.
A key factor is whether the use is genuine. A token “use” just to obtain a trademark registration will not suffice for any industry. But if there are legitimate efforts being undertaken for getting a product ready for the market, and your company falls within one of these regulatory carve-outs that provide for earlier use in commerce, you should consider using your company’s mark as soon as possible in connection with all pre-approval activities. Whether such use is sufficient to constitute “use in commerce” under the law will depend on the particular facts of each situation. Even if you are unable to submit evidence of use prior to the USPTO deadline, however, you will have prevented others from registering confusingly similar trademarks during the pendency of your application. In addition, you may file a new application for the same mark prior to the expiration of the first application. This will give you additional time to begin using the mark in commerce. You should consult with legal counsel for guidance with your particular facts.
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Tom Cowan
Tom is a Partner in the San Diego office and serves clients worldwide in aerospace, mechanical, and medical technologies. He counsels clients on overall IP strategy, performs IP audits, prosecutes patents and trademarks, conducts pre-litigation enforcement of IP rights, negotiates licenses, and conducts offensive and defensive diligence such as patentability and infringement studies.
As a former aerospace engineer with experience at NASA and Northrop Grumman, and holding a master’s degree in biomedical engineering, Tom’s legal services are supplemented with his advanced technical abilities in a wide range of inventive domains.
Tom has particular experience with assisting startups from the conceptual design phase through acquisition. One recent example is Millipede, Inc., developer of a heart valve annuloplasty device. Tom prosecuted their patent portfolio and provided defensive patent diligence, resulting in investments and an acquisition by Boston Scientific totaling $540,000,000.
Other example particular technologies in Tom’s patent experience include cardiac devices, intracranial sensors, prosthetics, aircraft and rockets, robotics, unmanned aerial vehicles (drones), semiconductors, imaging and biosensors, high altitude balloons, control systems, thermal management systems, software, and more.
Additional highlights include:
Keynote Speaker, “Patent Basics for the Aerospace Industry,” at the 2019 Space Foundation Space Commerce Workshop
Former Mechanical engineer at Northrop Grumman, where he designed and tested complex structures and mechanisms for various spacecraft programs
Interned at NASA Armstrong Space Center, Aerodynamics Branch, where he analyzed data for the Quiet Supersonic Platform
Inventor of the “Inflate-A-Brake,” a system for de-orbiting small satellites to reduce space debris
Publications Coordinator for the firm’s medical device practice group, which leads the nation in medical device patent prosecution having obtained over 4,800 medical device patents since 1976 and 2,700 medical device patents since 2010
Member of the firm’s pro bono committee and coordinates with the U.S. Patent & Trademark Office’s regional patent pro bono program to assist indigent individuals and non-profit organizations
Co-Chair of the Licensing Executives Society (LES) for the San Diego Chapter
Holds a minor in Chinese and studied Chinese language and history at Shaanxi Normal University in Xian, China
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Ian Gillies
Ian Gillies advises on the procurement, management and development of patents, trademarks and copyrights for clients that range from private individuals and start-ups to large corporations. Valued for his meticulous work product and thorough analysis in identifying and resolving complex problems, Ian consistently delivers immediate likability, honed consensus building skill and a seemingly innate talent for adapting to the many audiences and viewpoints for any given matter.
A conscientious communicator and dedicated service provider, Ian protects his clients’ assets across a spectrum of transactional IP areas, and not just a single, specialized point of interest. Clients appreciate Ian’s widespread industry know-how and that he is equally well-versed in advising on patents and trademarks alike.
Ian also advises on due diligence initiatives related to IP searches, availability, acquisitions, and infringement risk. He represents clients before the U.S. Patent and Trademark Office (USPTO) and the corresponding patent and trademark appeal boards. He counsels clients on offensive and defensive IP strategies and trade secret tactics. In addition, Ian advises on the IP aspects of NDAs, material transfer agreements, assignments, and other legal instruments. He has successfully navigated the resolution of challenging IP disputes between his clients and third parties to avoid litigation or other adverse proceedings before patent and trademark boards.
Prior to his legal career, Ian worked as a mechanical engineer, inventor, and professional musician. For many years, Ian was employed as an engineer for Novellus Systems, Kimberly Clark, and General Dynamics, and as a technical salesperson for SMC. Moreover, Ian composed and performed extensively as a musician and opened for recording artists such as Pink, The Psychedelic Furs, The Lemonheads, and Air Supply.
Notably, Ian is an inventor himself and holds U.S. Pat. No. 6,648,869, as well as the author of a series of copyrights stemming from several professionally produced records. Ian’s hands-on business and entertainment experience allow him to bring a unique perspective to advocacy and a more balanced approach to representing similarly-minded creative and inventive entities.
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