By Keith Barritt, Fish & Richardson P.C.
On average, trademarks account for about one-third of U.S. corporate value. A good brand name can boost sales, help weather negative publicity, and facilitate overseas marketing. What goes into a good name for a medical device, taking steps to protect that name, and complying with FDA regulations are all important considerations in maximizing return on investment (ROI) when developing a new medical device.
Trademarks, which are typically brand names − though they can also consist of unique colors, shapes, or other types of “trade dress” − serve to distinguish different sources of goods and services. It is not necessary that consumers know who the actual source is, as long as they recognize the trademark as indicating a single source. For example, it is not important that consumers know specifically who makes SnoreNoMore anti-snoring devices (yes, Virginia, the FDA does regulate these as medical devices under product code LRK). But, it is important that consumers are able to rely on the SnoreNoMore mark as indicating that all products bearing the mark come from a single source and can be expected to have a consistent level of quality.
What Makes A Good Medical Device Trademark?
The conceptual strength of a brand name is viewed along a continuum, which can be almost as confusing as the idea of the space-time continuum. Placing a mark in its proper place along the continuum requires placing it in one of five specific categories. Consequently, how a mark is categorized goes a long way toward how easy it will be to defend the mark against potential infringers of the same or similar marks, and trademark attorneys often battle over the proper categorization.
The strongest trademarks are terms that are invented, coined words that otherwise do not exist in the English language. Examples include UreSil catheters and myOSA, devices that treat sleep disorders. These terms are instantly recognized by the public as trademarks, since they have no other meaning, and are thus immediately protectable.
The next strongest trademark category is arbitrary marks. These trademarks consist of existing English words, but used in a manner that has no connection to the underlying product. Examples include Atomic Lift stretchers and NewMagic, devices for treating erectile dysfunction. These terms are also instantly recognized by the public as trademarks.
The third category is suggestive marks. These are existing English words that suggest or hint at the nature of the goods, but still require some imagination to make a connection between the mark and the product. Examples include CapSure fixation devices, used with hernia and soft tissue repair, and PowerCurve surgical impact devices, used to create channels and cavities in tissue. These terms are also considered to be instantly recognized as trademarks and immediately protectable, though not as strong as fanciful or arbitrary marks.
The fourth category is descriptive marks. These are existing English words that merely describe some feature of the goods. Recent trademark applications denied by the U.S. Patent and Trademark Office (USPTO) on this basis include Respiratory Oximetry devices that monitor respiratory rates, and JawLine medical devices for nonsurgical cosmetic treatments. Such marks are not instantly recognized as trademarks and are not immediately protectable upon use. Rather, trademark rights in such terms must be earned by use over time.
The USPTO typically accepts five years of continuous and substantially exclusive use of a term as a mark as evidence that a formerly descriptive term has “acquired distinctiveness” through recognition by the relevant public as a trademark, and is not merely serving a descriptive function. A recent example of such a formerly earthbound descriptive mark that reached escape velocity and was registered by the USPTO is SkinSleeves, protective fabric medical coverings used for wound prevention. By contrast, the Office denied a claim of acquired distinctiveness for Surgical Specialties Corporation, a producer of surgical knives and wound closure products.
The fifth and final category is generic terms. These terms immediately name the product for which they are used. Some proposed trademarks are “born” generic and are never eligible for any trademark protection. Other trademarks may be born as an invented or arbitrary term, but through public usage − or sloppy usage by the trademark owner − the mark loses its trademark significance and the public comes to use the term to refer to the product regardless of who makes it. Examples of medical device ersatz “trademarks” that have been deemed generic include Micropump, referring to pumps that administer drugs, and First Aid, for bandages and related items. When manufacturers market a new type of device, they should be careful to give it both a protectable trademark and a generic name that eventual competitors can use; otherwise, the trademark may become the generic name.
In short, the best trademarks for medical devices, as for any product, are fanciful terms, followed closely by arbitrary use of existing words that have nothing to do with the device or any of its features. Marks that merely hint at or suggest something about the device can also be good marks, and may facilitate marketing. Marks that merely describe something about the device, while often preferred by marketers, cannot be protected until the mark has been used enough to have acquired distinctiveness, and thus in general should be avoided.
Of course, another consideration in choosing a mark is to avoid a mark that is confusingly similar to a prior mark in the same or a related area of use. Trademark searches can help avoid any such conflicts. Recent examples of marks that were denied registration by the USPTO include Bodyguard of Athlete, bandages and braces (shot down due to a prior registration for Body Guard silicone gel pads) and Karl Storz CARDIOFIT, surgical instruments and apparatus (refused due to the prior registration of CardioFit internal and external stimulators for cardiac patients).
Registration Of Trademarks
While some limited trademark rights in the U.S. arise by use alone, registration with the USPTO provides several important benefits, including:
- Discourages others from using confusingly similar marks by making the mark easy to find in a trademark search, thereby preventing problems before they begin.
- Protects against registration of confusingly similar marks, as the USPTO has a duty to cite prior registrations against applications for confusingly similar marks and to refuse to register such marks, thereby enlisting the power of the U.S. government in helping to prevent infringement (at no additional cost to the trademark owner).
- Treats the mark as if used nationwide as of the application date, which is vital in a system in which first use wins.
- Provides nationwide notice of mark ownership as of the registration date, preventing others from claiming their subsequent adoption of the mark was in "good faith."
- Grants the right to use the ® symbol when the mark is used for the goods listed in the registration, providing marketing cachet and putting competitors on notice that you are serious about protecting your rights.
An application to register a trademark can be based either on actual use or a bona fide intent to use the mark. Foreign applicants can also rely on ownership of foreign applications or registrations. U.S. companies desiring to protect their marks overseas should be aware that, in most countries, a trademark registration is required to have rights, and no rights arise by use alone.
To obtain a U.S. trademark registration, a U.S. company must first use the mark in U.S. commerce. Typically, use begins when a medical device is first sold in interstate commerce, or to an overseas customer. While clinical trial use for pharmaceuticals has long been recognized as acceptable use, use of a mark on a medical device still under development was less clear. However, the USPTO recently agreed that delivery to the military of a Save ventilator for testing to perfect the device for battlefield use prior to FDA authorization was sufficient and legal use to establish trademark rights in the mark.
Besides registration, a trademark owner can also take proactive steps to protect its marks by signing up for trademark “watch” services, which monitor the filing of new trademark applications, Internet domain names, or other uses of a potentially confusing mark. As problems are detected, prompt action – often in the form of a “cease and desist” letter from a law firm – can prevent a more serious problem from occurring.
FDA Regulations Affecting Medical Device Trademarks
While the FDA has some regulatory jurisdiction over medical device trademarks, which form part of a device’s labeling, the FDA typically does not consider the manufacturer’s trademark when authorizing a medical device for marketing. Nonetheless, trademarks that imply a device provides a “cure,” or is otherwise more effective than it actually is, should be avoided, lest the FDA or the Federal Trade Commission (FTC) come knocking, or a competitor brings a false advertising suit. An example of a mark that was found to be false is Polysapphire for an orthodontic bracket that did not contain any sapphires.
FDA’s primary trademark regulation for medical device manufacturers is the requirement to include all “proprietary names” (i.e. trademarks) in the FDA device listing. In the past, the FDA permitted – and even instructed – manufacturers of private-label devices to simply enter “multiple” as the name of the device, especially when the private labeler didn’t want a public record of its manufacturer. Nowadays, however, each manufacturer must include all trademarks applied to the device in the FDA listing, but maintains the ability to designate marks as “confidential,” so that they do not appear on the public website. If a device is marketed without a trademark, the listing should identify the type of device and may include the model or catalog number. Device trademarks must also be entered in the FDA’s new Global Unique Device Identification Database (GUDID).
Medical device manufacturers face many hurdles in bringing their products to market, but practical steps can be taken to minimize the chance that the trademark will cause headaches. First, conduct a trademark search for a fanciful, arbitrary, or suggestive mark, and halt any desire of the marketing department to adopt a mark that is merely descriptive – or worse, generic. Once you have the requisite bona fide intent to use a mark, a U.S. trademark application should be filed. Filing early in foreign countries can be even more important, lest a manufacturer find that another company owns the rights to “its” mark. Manufacturers should also take steps to monitor competitors’ activities, so that action can be taken as soon as possible if a problem is detected. Finally, manufacturers must ensure all trademarks are properly entered in the FDA’s medical device listing database and the GUDID.
About The Author
Keith A. Barritt is a principal in the Washington, D.C., office of Fish & Richardson. His practice is primarily focused on all aspects of medical device regulation, as well as trademark law. To contact him, visit http://www.fr.com/keith-a-barritt/