For Chinese companies to launch medical device products in the United States market, the secret to safeguarding product intellectual property lies in a good understanding of all available options.
Choosing which type of intellectual property (IP) protection is the most suited for your medical device is not always easy, especially when a device is eligible for more than one type of protection. This article discusses the types of IP protection that are generally applicable to medical devices in the United States. Knowing which types are available, appropriate, and most beneficial—as well as knowing the timing and method of making the right choices—is crucial to understanding how to protect your devices. We explore these issues through the following questions:
• What types of IP protection may be available for medical devices?
• What are the general advantages and disadvantages of each type?
• Which types of IP protection can be used together, either successively or simultaneously, and which may be mutually exclusive?
Types of IP Protection
The following section explains the five different forms of IP protection and their application to a medical device. Medical devices can be of various types, such as imaging devices, sensors, analytical systems, clinical treatment devices, implantable products, and prostheses, to name a few. In each of these categories it is important to achieve optimum protection as well as the type of protection best suited for different categories of devices.
Protection by Trademark
A trademark is any word, symbol, design, smell, or sound, or any combination thereof, that identifies the source of a product or service. Registrability should be seen as a hierarchy, with "inherently distinctive" marks at one end, "generic" marks at the other end, and "descriptive" marks with acquired distinctiveness somewhere in the middle. The more distinctive a mark is, the greater the scope of protection it will receive.
Trademarks can apply to medical devices in several ways. First, the name of the device, as well as any symbol or slogan used on or in connection with the product that identifies the source of the product, may be protectable. Second, the “look and feel,” or aesthetic design of the device, may be protectable as a particular type of trademark called “trade dress.” In the United States, unlike in China where registration is generally required, trademark rights arise out of mere use of the trademark in commerce. Additional benefits accrue through registration of a trademark with the United States Patent and Trademark Office.
Example: The “brand name” for a device may be entitled to immediate trademark protection if it identifies the source of the product and is not a generic or descriptive term. Similarly, if the device bears a symbol or logo that accompanies the name, that symbol or logo may also be protectable as a trademark.
Using trademark law as a form of IP protection presents several advantages. For instance, trademark rights may exist perpetually so long as the trademark is being used properly, is licensed only under appropriate quality controls, is enforced against infringers, and is monitored for misuse. This is the case even if the product design changes over time, which can be a key difference from patent, copyright, or even trade dress protection. In addition, the costs of obtaining trademark protection may be low relative to other forms of IP protection, such as utility patents. However, there are some disadvantages to be aware of. For instance, it may take substantial time and investment to gain recognition of your name, slogan, or symbol to acquire sufficient source-identifying power. Under the use-based system in the United States, in order to perfect those rights, the trademark must be properly used and “attached” to the goods.
Protection by Trade Dress: While trade dress is often perceived as a unique form of IP protection, trade dress is really a form of trademark protection. Trade dress has been defined as “the total image of a product, including such features as ‘size, shape, color, or color combinations, texture, graphics, or even particular sales techniques. ’” As with trademarks, trade dress must have sufficient source-identifying power to be protected. Additionally, trade dress protection is only granted for nonfunctional aspects of the design.
Example: If the shape or color of a device does not serve a utilitarian or functional purpose and is purely aesthetic, such features may be protectable as trade dress.
As with word and logo marks, trade dress protection may last indefinitely. Further, deciding to change the external, visible product design may limit or even extinguish trade dress protection by altering the distinctive appearance that consumers use to identify the source. In addition, care must be given when licensing trade dress rights to third parties, alone or bundled with other rights (such as patents), so as to not limit, or even extinguish the trade dress rights.
Protection by Patents/Utility Patents/Design Patents
In the United States, utility patents and design are protected as patent rights, and are both applicable to medical devices.
Utility Patents: A utility patent may be sought on any “new and useful process, machine, manufacture, or composition of matter. ” An invention may be protected with a utility patent if it is novel, non-obvious, and useful. Subject to some exceptions, the term of a utility patent in the United States is 20 years from the earliest U.S. filing date of any nonprovisional patent application to which the patent application claims priority. While obtaining a utility patent can be expensive, the benefits of filing are numerous. Issued patents enjoy a presumption of validity in legal proceedings and patents can be a major source of income, as the rights to use the technology may be licensed to competitors or be kept for competitive advantage.
Design Patents: Design patents protect the novel ornamental features of a patented design. Like a utility patent, a design patent allows the patentee to exclude others from using the patented aspect of the product. While the utility patent term is 20 years from the filing date, the term for a design patent is 14 years from the date of issue.
Example: A medical imaging device may have various features and design aspects that can be protected with patents. Utility patents may protect the new features provided by the software and hardware design. Design patents may protect the user interface and the exterior configuration.
Protection by Copyright
Although many people think of copyright law only as a tool for protecting artistic works such as paintings, songs, and books, copyright protection can be sought for a wider range of intellectual property. Copyright protection may be granted to “original works of authorship fixed in any tangible medium of expression. ” Thus, so long as a work is original, is fixed in a tangible medium (“sufficiently permanent or stable to permit it to be perceived, reproduced, or otherwise communicated”), and consists of copyrightable subject matter, it should be eligible for copyright protection. A copyright only protects the expression or embodiment of an idea rather than the idea itself.
Example: A medical imaging device may have several aspects that may be protected under copyright law. Such aspects include the software used to run the device, artistic designs applied to the exterior housing, and the look and feel of the user interface.
There is a fine line, however, between “applied arts,” which are copyrightable, and useful “industrial design,” which is not copyrightable. Courts have held that the design of a useful article, like a medical device, can be protected by copyright only to the extent that its artistic features can be identified separately from and exist independently of the useful aspects of the item. This idea is also best explained by means of an illustration:
Example: If an implantable medical device were designed with curves configured to secure the device in place in the body, and the same curves were also artistically attractive, such features may not qualify for copyright protection. The reasoning here is that the design aspects for which copyright protection is sought, i.e., the curves of the device, serve a useful function. These artistic features cannot be separately identified or exist independently of the useful aspects of the item.
If all of the criteria for copyright protection are met, copyrights confer some important protections on their owners. First, the owner of a copyright possesses the exclusive right to reproduce, distribute, and perform or display the copyrighted work, as well as create derivative works based on the copyrighted work. Second, U.S. copyright protection lasts for the life of the author, plus 70 years in the case of a single author.
Trade Secret Protection
As the name suggests, trade secret law protects information that derives economic value from being “kept secret.” Under the Uniform Trade Secrets Act, trade secrets are different from trademarks, patents, and other forms of IP in that, by their very nature, they are not disclosed to the public. Trade secrets may include source code, business plans, customer lists, marketing strategies, and process-related inventions.
Examples: The maker of a device could keep as a trade secret the method for creating a particular alloy that is used in an implantable device. The manufacturer could also keep the list of doctor and hospital clients as a trade secret.
Trade secrets can exist indefinitely, so long as the information remains secret. One difficulty with relying on trade secrets, however, is that they can be difficult to monitor for improper use. Further, there is no recourse if the trade secret is lawfully reverse-engineered. Moreover, owners of trade secrets who suspect that their trade secrets have been misused or misappropriated may be reluctant to pursue litigation out of fear of having the secret information divulged. Unlike a patent or trademark registration, which carries a presumption of validity, a prima facie case of trade secret theft requires the plaintiff to demonstrate that it possessed confidential information and made reasonable efforts to retain its secrecy.
It is possible that the different features of a product could meet the requirements for several, or perhaps all, of the types of IP protection discussed above. The question then becomes which form or forms will be most advantageous to protect the assets in question.
The good news: courts have consistently held that “a product’s different qualities can be protected simultaneously, or successively, by more than one of the statutory means for protection of intellectual property.” This means that upholding trademark protection on product configuration is not necessarily equivalent to improperly granting perpetual patent protection to the configuration.
For example, in a case involving Mogen David Wine Corp., the court held that trademark rights can extend after the patent term expires because the two forms of protection “exist independently. . . under different law and for different reasons.” In the Yardley case, the court held that a design patent and copyright could apply simultaneously because “Congress has not provided that an author-inventor must elect between securing a copyright or securing a design patent. ” Thus, it is possible, and perhaps advisable, to attempt to secure different forms of protection for the same asset. Table I compares the different types of IP protection.
[Table 1] Comparison Chart
Type of Protection
What Does It Protect?
Varying degrees of protection based on distinctiveness
May only exclude other marks that create consumer confusion
Nonfunctional features that are distinctive
Varying degrees of protection based on distinctiveness
May only exclude other trade dress that creates consumer confusion
Not utility patents (for same features)
New and non-obvious (and useful, for utility patents)
Presumption of validity
Not trade dress (for same features)
Not trade secret
Original, tangible expression
Lasts over 70 years
Difficult to obtain copyright protection for useful articles
Expression of the idea is protected, not the idea itself
“Secret” information that provides economic value
Perpetual protection if kept secret
Low to no cost
Once discovered by legitimate means, protection is lost
Licensing negates secrecy
Not utility patents (for same feature)
As the preceding chart highlights, many types of IP protection may be used together without conflict if applied to different aspects of a medical device. For example, a utility patent could cover the invention itself while trademark law could be used to protect the name of the product. The more interesting question is: when can two or more different IP protections be simultaneously or successively sought? For instance:
Trade dress may be incompatible with utility patents. An expired utility patent may be evidence that the feature is functional and therefore not eligible for trade dress protection. Choosing to include ornamental aspects of product design in a utility patent may foreclose potentially perpetual trade dress protection.
Design patent and trade dress protection may often be pursued for the same feature. One strategy to leverage both forms of protection is to secure a design patent and then use the period of exclusivity to build a record of consumer recognition in support of trade dress protection.
Utility patent and trade secret protection for the same feature are incompatible. Deciding which to pursue can be a critical business determination. For instance, if a third party discovers your unpatented secret through legitimate means and patents it, you could lose your rights to use the technology you developed. However, if the invention is not easily reverse-engineered, then trade secret protection may be more appropriate.
Advice: Carefully Consider Your IP Goals
Ultimately, the question of which type of IP protection is best for your device cannot be determined by simply looking at the pros and cons of each type. Careful, strategic consideration, in view of near- and long-term goals, should be given to factors such as available capital, the value of the device and its intended longevity, foreseeable design changes, and even the intention to license the device or the underlying IP. For example, if the device is in a field where technology changes rapidly and brand recognition provides competitive advantages, then trademark protection for the name and logo may be advisable. If a competitive advantage is derived from the device’s technology, then a utility patent should be considered. If the device incorporates a technological process that is not easily reverse-engineered and can be kept secret, then trade secret protection may suffice. If the device has a unique and recognizable appearance, then its design may be important to protect through trade dress, copyright, and design patent protection.
Choosing one form of IP protection does not necessarily preclude using another form of protection concurrently or successively. In order to optimize protection of medical devices, a layered approach may be appropriate, such as seeking a strong protection in the short to middle term from patents while seeking longer term protection through copyrights and trademarks.
 15 U.S.C. § 1127.2.; see Abercrombie & Fitch v. Hunting World, Inc., 537 F.2d 4 (2d Cir. 1976).
 See Kohler Co. v. Moen, Inc., 12 F.3d 632, 637 (7th Cir. 1993).
 Roulo v. Russ Berrie & Co., 886 F.2d 931, 935 (7th Cir. 1989) (internal citation omitted).
 Wal-Mart Stores, Inc. v. Samara Bros., Inc., 529 U.S. 205 (2000).
 35 U.S.C. § 101.
 35 U.S.C. §§ 101-103.
 35 U.S.C. § 154(a)(2).
 35 U.S.C. § 173.
 17 U.S.C. § 102(a).
 See Williams Elecs., Inc. v. Artic Int’l, Inc., 685 F.2d 870, 874 (3d Cir. 1982).
 17 U.S.C. § 101.
 Brandir Int’l, Inc. v. Cascade Pac. Lumber Co., 834 F.2d 1142 (2d Cir. 1987).
 17 U.S.C. § 106.
 Learning Curve Toys, Inc. v. Playwood Toys, Inc., 342 F.3d 714 (7th Cir. 2003).
 Kohler , 12 F.3d at 638.
 In re Mogen David Wine Corp., 328 F.2d 925, 930 (C.C.P.A. 1964).
 In re Yardley, 493 F.2d 1389, 1394 (C.C.P.A. 1974).
Jeffrey H. Greene from Foley & Lardner LLP