Design Protection for Medical Devices
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Design patent protection maybe granted for the ornamental design of a functional item, such as a medical device, so long as the design is novel and non-obvious. Not only can design patent protection be sought for the overall appearance of a medical device, but protection can also be sought for individual components of a medical device, including graphical user interface icons. Similarly, replacement or consumable components that are designed to be used with a specific medical device could also be protected by design patents. Design patent protection is not unique to the United States. Other parts of the world also allow for unique designs that are used in industry to be legally protected, but by different means than a patent.
10.1 Design Patents for Medical Devices
In the United States, a design patent can be granted for the ornamental design of a functional item. 35 U.S. Code § 171 is the statue focused on design patents, which states that “[w]hoever invents any new, original and ornamental design for an article of manufacture may obtain a patent.”
Notice how similar the above statute is to 35 U.S. Code § 101 for utility patents, previously discussed in Chap. 6, which states “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.”
Both statutes require that the invention be new (i.e., novel) and original (i.e., non-obvious), and each specifically identify what the invention can be. 35 US Code § 101 requires that the invention must be directed to a process, machine, manufacture, or composition of matter; while 35 U.S. Code § 171 requires that the ornamental design must be incorporated into an article of manufacture. Since a medical device invention can have utility and can have an ornamental design, in many cases both a design patent and a utility patent can be obtained for different aspects of the same invention.
The United States Patent and Trademark Office recognizes thirty-five (35) classes of articles of manufacture under the Nice Agreement concerning the International Classification of Goods and Services. Designs related to medical devices are often classed in D24: Medical and Laboratory Equipment.
10.1.1 Requirements for Design Patents
Although different in scope and duration (which is described in detail below), design patents share many of the same filing requirements as utility patent applications. For instance, design patent applications, just like utility patent applications, must be directed to an inventive design that is novel under 35 U.S.C. §102 (see Chap. 6) and non-obviousness under 35 U.S.C. §103 (see Chap. 6), and must include a written description as required by 35 U.S.C. §112 (see Chap. 6). The written description, however, is a little different for a design patent application because the specification and claims are largely directed to the drawings included in the application, which depict the claimed design.
In the case of design patents, it is difficult to capture the nuisances of an ornamental design with words  and therefore the drawings are critically important. In fact, in 1886 the Supreme Court concluded that a design is better represented by a photographic illustration than it could ever be by description using words, and even if a description were provided, it would probably not make much sense without a corresponding illustration . Consequently, the drawings of the design patent are relied upon to provide the description of the invention . The drawings included in design patent applications are critically important.
Design patent protection can be secured for individual elements of a medical device invention, or for the overall design of a medical device that is produced from a combination of individual design elements. For instance, in the Federal Circuit case of Ethicon Endo-Surgery, Inc. v. Covidien, Inc., several U.S. design patents related to ornamental features of a surgical instrument (ultrasonic surgical shears) used to cut tissue and blood vessels were involved in an infringement dispute . The ornamental design features of the surgical instrument included several different aspects:
To determine the validity of the design patents, the Ethicon court considered whether the a claimed design was primarily functional, but cautioned that “the function of the article itself must not be confused with ‘functionality’ of the design of the article” , p. 1328. As a result, the Ethicon court instructed that “the utility of each of the various elements that comprise the design is not the relevant inquiry with respect to a design patent because whether a design is primarily functional or primarily ornamental requires viewing the claimed design in its entirety” , p. 1329. Accordingly, the court held that “the underlying ultrasonic shears could still function in the same manner with a differently-shaped open trigger, activation button, and torque knob, and different relative locations of the trigger, button, and torque knob” and thus the design, when viewed as a whole, constituted protectable ornamental design elements , p. 1331.
Ethicon illustrates that a design patent can cover the ornamental design when several parts (e.g., the trigger and knob) are combined to form the ornamental design of a surgical device. However, design patents can also cover the design of the individual parts themselves.
10.1.2 Protection Afforded by Design Patents
The scope of a design patent, compared to a utility patent, is quite different. A design patent only covers how the article of manufacture looks. More precisely, “[i]f the particular design is essential to the use of the article, it cannot be the subject of a design patent , p. 1123. To determine whether a design is essential to use of the article, alternative designs to obtain the same function are considered and “if other designs could produce the same or similar functional capabilities, the design of the article in question is likely ornamental [and] not functional” , p. 1378. Accordingly, “where a design contains both functional and non-functional elements, the scope of the claim must be construed in order to identify the non-functional aspects of the design as shown in the patent” , p. 1405.
In addition, the duration of protection afforded to a design patent is different than a utility patent. Design patents are granted for a term of 15 years from the date of grant, for design patent applications filed on or after May 13, 2015 . For design patent applications filed prior to May 31, 2015, the term of the patent is 14 years from the grant date. The change in duration was implemented in December 18, 2012 by the Patent Law Treaties Implementation Act of 2012 to harmonize the US patent laws with the Hague Agreement concerning the International Registration of Industrial Designs (the Hague Agreement is discussed in more detail below in Sect. 10.2.3).
10.1.2.1 Priority Claims for Design Patents
A design application can be filed as a continuing application of a utility application provided that the utility application shows the ornamental designs in sufficient detail. Consequently, a design patent application may claim the benefit of a utility patent application’s filing date, yet the term of the design patent is not limited by the priority date. This potentially allows the design patent to be enforceable for several years after the term of the utility patent has expired since the term of the design application is calculated from the grant date and not the effective filing date.
10.1.3 Design Patent Disputes
10.1.3.1 Apple v. Samsung
At the lower court, a jury had awarded Apple $399 million dollars in damages after concluding that Samsung infringed on Apple-owned design patents; however, those damages were calculated based on Samsung’s sales of each phone it sold bearing the Apple-infringed designs , as a whole unit. The case ultimately ended up at the Supreme Court because Apple only had design patent protection for a few aspects of the phone’s appearance, so why should Apple be entitled to the entire profit that Samsung made from selling phones having only a few design aspects that infringed on Apple’s patents? To say this another way, if Apple owned design patents on discrete components of a phone design (such as a rounded corner of the phone housing, or a particular design of the graphical user interface), why should Apple be awarded damages for Samsung’s sales of each phone Samsung sold as a whole?
The Supreme Court held that when “several articles of manufacture of peculiar shape which when combined produce a machine or structure having movable parts … each [part may] separately be patented as a design , p. 435”. To say this plainly, a design patent can cover both the ornamental overall design of the complete product (e.g., a design patent for the overall look of a phone) as well as the ornamental design of individual components of the product (e.g., a design patent protection only the rounded corner design feature of a phone housing).
10.2 International Design Protection
10.2.1 Design Protection in Europe
In the European Union (EU), which is not be confused with the thirty-eight (38) contracting countries and three (3) extension countries of European Patent Convention (EPC), “the appearance of the whole or a part of a product resulting from the features of, in particular, the lines, contours, colours, shape, texture and/or materials of the product itself and/or its ornamentation” may be protected by a Community Design Right , Art. 3(a).
However, a design is only protectable “to the extent that it is new and has individual character , Art. 4.1.” A design is considered to be “new” if “no identical design has been made available to the public , Art. 5.1.” In addition, a design is to have “individual character” when “the overall impression it produces on the informed user differs from overall impression produced on such a user by any design which has been made available to the public , Art. 6.1.” If a design meets these two requirements, then the design may qualify for two different types of design rights that are available in the EU: Unregistered Community Designs (UCD) protection and Registered Community Designs (RCD) protection.
A UCD, like a copyright under US law (see Chap. 9), does not need to be registered, and infringement requires actual copying. The UCD right arises as soon as the design is first disclosed to the public within the territory of the EU. The right then lasts for a non-extendable period of 3 years from the date on which the design was first made available to the public within the territory of the EU. The date of disclosure can be demonstrated in a number of different ways, such as by a printed review bearing a date or mass publicity of the design. The date of disclosure could also be evidenced by publication of the design in a national IP Office Bulletin, display of the design at an international exhibition or by a dated mailing containing the design to all trade associations belonging to given industrial sector. Once a UCD has been established, there is a 1 year grace period to obtain a RCD.
A RCD offers similar protections to those offered by a U.S. Design patent. The RCD provides protection against similar designs even when the similar design was not the result of physical, direct copying. The term of the RCD is 5 years from the date of filing of the application and can be renewed every 5 years up to a maximum of 25 years.
While the use of UCD and RCD is useful in protecting many designs in the EU, the use of UCD and RCD to protect replacement parts is potentially problematic in Europe. Like in the US, European Design regulations prohibit the protection of designs that “subsist in features of appearance of a product which are solely dictated by its technical function , Art. 8.1.” However, the European design law also provides a “Must-Fit” exception. The “Must-Fit” exception prohibits designs from being registered for the design of a product “which must necessarily be reproduced in their exact form and dimensions in order to permit the product in which the design is incorporated or to which it is applied to be mechanically connected to or placed in, around or against another product so that either product may perform its function , Art. 8.2.” Accordingly, a registered design for something like a surgical cassette may not be as readily available in the EU as it would be in the U.S., since the cassette must fit into its matting receptacle in order to function.
In addition, European Design protections offered for replacement parts are further limited to designs that remain visible during normal use of the replacement part , Art. 4.2(a). Normal use is very narrowly construed to mean use someone who is the end user, whereas use by someone for the purposes of maintenance, servicing or repair work is not considered normal use , Art. 4.3. Therefore, European UCD and RCD offer similar protections as a US design patent; however, these protections are afforded to a more limited set of goods.
10.2.2 Design Protection in Asian Countries
China grants design patents for a term of 10 years from the filing date of the Chinese design patent. In China, a design patent can be granted for “the shape, pattern, or combination thereof, or the combination of the color with shape and pattern which are rich in an aesthetic appeal and are fit for industrial application , Art. 2(4).”
Japan allows for designs to be registered for “the shape, patterns or colors, or any combination thereof, of an article (including a part of an article, the same shall apply hereinafter except in Article 8), which creates an aesthetic impression through the eye , Art. 2(1).” The term of an Industrial Design patent, in Japan an Industrial Design patent has a patent term of 20 years from the date of registration, provided that annual maintenance fees on the patent are paid.
South Korea (Republic of Korea) registers industrial designs for “the shape, pattern, color or combination of these in an article that produces an aesthetic impression on the sense of sight” for objects that are “movable properties which are independent and definitive , Art. 2(1).” The industrial design registration in South Korea is valid for 20 years from the date of filing.
The industrial design patent in India is valid for up to 15 years from the date of registration provided that a 5 year extension and the corresponding fee is paid before the expiration of the initial 10 year term.
10.2.3 The Hague Agreement
The Hague Agreement Concerning the International Deposit of Industrial Design (“the Hague Agreement”) is an agreement among sixty eight (68 nations) that allows applicants to register an industrial design by filing a single application with the World Intellectual Property Organization (WIPO) in order to protect their designs with minimum formalities in multiple countries or regions.1 This allows the applicant to file a single international design application (IDA) and potentially receive design registration protection (e.g., a design patent or registered industrial design) in each of the nations or regions participating in the Hague Agreement the applicant designates in the IDA. When the IDA is registered in a particular country, the same protections are afforded to the design as if the application had been originally filed locally in the respective patent office. For example, an IDA that designates the U.S., once granted, will be treated under U.S. law as a design patent, even if the IDA was filed in the EU.
In many ways, the IDA under the Hague Agreement is similar to a PCT Application filed under the Patent Cooperation Treaty (PCT) (see Chap. 6). As with a PCT patent application , the IDA can be either filed directly with the International Bureau (IB) or with the applicant’s home patent office (e.g., the USPTO, the European Patent Office, the Japan Patent Office, etc.). However, unlike the process for a PCT, regardless of where the IDA is filed, the application will be filed with the IB for examination.
Unlike in the case of a PCT, the IB does not perform a substantive review of the IDA. Instead, the IB conducts a review of the design filing to confirm that formal requirements are satisfied. For instance, the IB ensures that the application is filed in English, French, or Spanish. The IB further confirms that the applicant has identified the Contracting Parties where the applicant seeks protection, and has paid the basic filing fee, the publication fee, and a fee for each designated contracting party.
Be a national of a Contracting Party;
Be a national of a member state of an intergovernmental organization that is a Contracting Party (e.g., European Union);
Be domiciled in a Contracting Party's territory; or
Have a real and effective industrial or commercial establishment in a Contracting Party’s territory.
Once the IB confirms that the formal requirements of the IDA are satisfied and the formal, preliminary examination phase of the IDA is completed, the IB then publishes the IDA. Next, substantive examination of the IDA before the patent offices of the countries or regions that applicant has designated commences.
The substantive examination of the IDA is performed in accordance with the local design laws of the particular patent office examining the IDA. However, the particular patent office has 6 months (if the local laws permit opposition) to issue a refusal. If the local patent office issues a refusal, the patent prosecution process begins according to the local patent laws and will likely require the applicant to obtain local counsel.
Renewal fees must be paid on the IDA. Renewal fees must be paid to the IB every 5 years for up to a total of 15 years. The amount of the renewal fee is based on the particular member states that have agreed to grant a design right protection for the IDA. This allows the applicant to pay one renewal fee directly to the IB instead of having to pay individual renewal fees to each individual country where protection has been obtained.
10.3 Importance of Protecting Medical Device Designs
Medical devices are often designed in particular ways and decisions about the ornamental design of a medical device or component of a medical device are often chosen for a reason. Similarly, one medical device can be distinguished from another through the use of unique icons. The placement of buttons or interactive components might be located in a certain place on the medical device so that the user can have easy access, the shape of a component might be chosen because it is most suitable for a particular use, or a medical device design might be tailored for user comfort during use (e.g., for ergonomics). Design could be important to encouraging market adoption of the medical device, ensuring that users use the device properly or to conveying to the user the brand of the medical device product.
Since design is so important in the medical device field, it is not surprising that medical device ornamental designs serve as one of the leading technology categories for design patent filings and grants. Design protection is sought for various aspects of medical devices. The overall design of the medical device could be patentable, as well as the design of individual components of a medical device or unique icons used on the medical device or display screen.
10.3.1 Graphical User Interfaces and Icon Designs
There are many computer-based medical device technologies available in the healthcare field. It is typical for computerized medical devices allow for user interaction with the device through a graphical user interface. Many features of a graphical user interface (GUI) , such as unique icons , and animations of how icons transition from one state to another can be protected by a design patent.
10.3.2 Replacement/Consumable Parts
Medical devices often require a large number of consumable replacement parts in order to maintain the sterility of the device. Similarly, many medical device components need to be replaced once they wear out. Design patents may be utilized to protect these consumable replacement parts.
By employing design patents, both Gillette and Abbott Medical Optics are able to protect the replaceable consumables used in their respective medical device systems.
The contracting parties to the Hague Agreement Concerning the International Deposit of Industrial Design include: the African Intellectual Property Organization (OAPI), Albania, Armenia, Azerbaijan, Belgium, Belize, Benin, Bosnia and Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Cambodia, Croatia, Côte d’Ivoire, Democratic People’s Republic of Korea, Denmark, Egypt, Estonia, the European Union (EU), Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Holy See, Hungary, Iceland, Italy, Japan, Kyrgyzstan, Latvia, Liechtenstein, Lithuania, Luxembourg, Mali, Monaco, Mongolia, Montenegro, Morocco, Namibia, Netherlands, Niger, Norway, Oman, Poland, Portugal, Republic of Korea, Republic of Moldova, Romania, Russian Federation, Rwanda, Sao Tome and Principe, Senegal, Serbia, Singapore, Slovenia, Spain, Suriname, Switzerland, Syrian Arab Republic, Tajikistan, Tunisia, Turkey, Turkmenistan, Ukraine, United Kingdom, United States of America, and the former Yugoslav Republic of Macedonia.
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