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How Design Patents Strengthen a Medical Device IP Portfolio

Wed, 11/13/2013 - 3:51pm
Eric P. Raciti, Partner; Elizabeth D. Ferrill, Associate; and Elizabeth A. Shah, Associate, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

It doesn’t have to look pretty to be worthy of design patent protection. Medical device companies often invest large amounts of time and money producing a product that is attractive to consumers or medical professionals – something ergonomic, eye-catching, or that fits with an overall product line. Utility patents protect the way an article is used or how it works, but medical device companies that strategically procure design patents can add a key layer of protection to their medical device IP portfolio. With news of large verdicts from the Apple/Samsung smartphone patent wars, design patents are gaining popularity, but not all design patents are created equal. This article will explore why and how to pursue design patent protection for medical devices and ways to maximize their breadth of coverage.

Though the recent smartphone patent wars have sparked renewed interest in design patents, they still remain a largely unexploited resource in the medical device industry. Medical device companies Karl Storz, Siemens, St. Jude Medical, and Becton Dickinson all obtained design patents in 2012. But, taking Siemens as an example, of the 960 patents received in 2012, only 25 (or 3%) were design patents. Many medical device companies focus their efforts almost exclusively on obtaining utility patents to protect the function, use, or manufacture of their devices, but as the most distinctive and easily observed aspect of a device, the design itself may impart significant value. People judge books by their covers, spend thousands more on the flashier looking ‘sports class’ car, and deliberate on which color iPhone to buy. This compulsion to inform purchasing decisions based on a product’s look doesn’t stop with the medical device market. Procuring medical device design patents can capture the value of a product’s design and erect additional roadblocks for competing products, as well as provide nuanced solutions to problems more specific to the medical industry.

Why to Pursue Design Patents
1. The Design May Impart Value not Protected by Utility Patents
When companies invest large sums of money to develop and test a device, functionality isn’t the only aspect being evaluated. Companies seek feedback and comments from users on the usability, ergonomics, layout, and compatibility of medical devices. A product’s design may determine whether it is intuitive and easy-to-use or cumbersome and unwieldy. Of the numerous possible ways to achieve these different features, the design choices that a company makes are what consumers consider when deciding between products. When it comes to influencing user satisfaction and purchasing decisions, the design of a device may increase its use and expedite a hospital’s adoption. The execution of these design features is valuable, and without a design patent, the selected design may be underprotected.

For example, a medical device company might design the handle of a surgical tool to increase comfort and to simplify operation. Actuators may be grouped in the order in which they are used, by the type of function they control, or by the frequency in which they are used. Strategically placed contours, texturing, displays, or indicators may increase ergonomics. Filing a design patent prevents competitors from benefiting from your design efforts by copying the look of your handle and incorporating the design into a competing tool.

In addition to product design, companies may carefully analyze and manipulate the design of the product packaging to promote proper use. For example, portions of modular devices may be packaged adjacent the components to which they attach or in the order in which they are used or assembled. Design patents can not only cover the overall appearance of the device and the look of the different components, but also the design of the product packaging.

Companies invest significant resources on design-oriented R&D and market research. Design patents allow medical device companies to capture and leverage the returns of that investment.

2. Graphical User Interfaces
An increasing number of medical devices include software components. Whether it’s navigating a system of menus, initiating a testing sequence, or selecting between different modes of operation, many medical devices include displays either integrated on the device or external to and in communication with the device. These user interfaces are often designed and arranged to be intuitive and easy to navigate – features that are possibly protectable, as touched upon above. Icons and information on the screen may be arranged to facilitate use during a procedure or to minimize clutter and draw a user’s attention to important patient parameters. Again, time and money is allocated to the thoughtful integration of the various interface components, all of which goes above and beyond the underlying function of the product. Design patents allow companies to protect the layout and arrangement of these graphical user interfaces.

Further, if the device or interface is the first of its kind, users may become accustomed to the layout and look of the interface, which may garner consumer loyalty, much like the arrangement of icons on the iPhone screen became the standard for cell phone technology. If competitors are unable to copy your interface design, consumers may be hesitant to switch away from the system they are comfortable with.

3. Product Distinctiveness and Identity
If you park your car in a parking lot, how do you find it again when you return? Chances are you don’t read the brand of each car or the license plate of each car to determine which one is yours. It’s more likely that you look at the shape, size, and contours of the cars to determine which brand, and even which model, is yours. In the same way, people who use medical devices day in and day out distinguish between the different brands and different models based solely on the look of the device.

It might seem trivial, but the design and look of a product, and whether that look ‘fits’ with the rest of the products, does impact brand loyalty and purchasing decisions. A design patent can prevent others from copying or creating something resembling your recognizable design resulting in an imitation that looks like it matches other products from your product line. To protect a ‘signature look’ using trademark or trade dress alone, companies must also prove other factors, e.g., that their look is distinctive and has achieved a secondary meaning, or show actual consumer confusion, in order to prove liability for copying that look. With a design patent, the question becomes simply whether, in the context of the designs of similar products, the competitor’s design appears enough like your patented design in the eyes of an ordinary observer.

4. Protect Replaceable or Disposable Components
Many medical devices include a replaceable component, such as a terminal with a consumable probe or sensor. Such devices include a more expensive, reusable portion, and a less expensive – but more frequently replaced – disposable portion. Most of the profits are derived from sales of the disposable portion, but this portion can be difficult to protect with a utility patent. The disposable portion might not necessarily have a patentably distinct utility or function separate from the reusable portion, thus not lending itself to separate utility protection. And, if the claims cover both the reusable and disposable components, then a competitor selling only the replacement part may avoid infringement.

Design patents can add an extra layer of protection to the disposable portion. They can protect the design of the disposable portion where it interfaces with the reusable component. An inhaler may include a portion that is designed to receive a disposable cartridge. Obtaining a design patent on the inhaler body, a design patent on the cartridge, a design patent on the portion of the inhaler body that receives the cartridge, and a design patent on the portion of the cartridge that interfaces with the inhaler body, may weave a tangled web for competitors looking to design around.

Mixing design patents into a patent portfolio adds a new dimension of protection by forcing competitors to switch gears and consider not only the functionality, but also the appearance of the patented article. The objective becomes both to make a disposable portion that functions properly and fits with the reusable portion while avoiding the “look and feel” that would infringe the design patent.

Further, as a last line of defense, forcing competitors to design away from the look of your disposable portion may also cause competing products to look different. While this sounds like an obvious point, it may result in competing products that look awkward -- like they don’t ‘fit’ with your reusable portion and overall product line -- even if they do physically connect.

5. Protect New Designs for Old Products
A medical device company may come up with a new design for a blood pressure cuff or other well-known technology. The technology itself might not be different, but the redesigned appearance just might be. Design patents provide a way to protect newer designs for older products, providing patent coverage for devices that are no longer eligible for utility patents. Additionally, if your company has produced several generations of the same device, each with its own design, new design patents can be filed for each design modification, even if a new utility patent isn’t warranted. While a single utility patent may broadly cover all generations, design patents can secure a closer, complimentary level of protection. Additionally, if the utility patent covering the function has since expired, a design patent can still be obtained for the newest iteration. As an added bonus, design patents can often be obtained quicker than utility patents, providing interim coverage while a utility patent is being sought.

How to Design Your Patent Portfolio
Typically, design patents are cheaper, quicker, and easier to obtain than utility patents. While that mantra is alluring, make sure that the scope of your patent is not also cheap. Not all design patents are created equal, and as you build out the design portion of your patent portfolio, make sure that proper consideration is given to the aspects of the product that are distinct or that a competitor may want to copy. Obtain design patents that cover both the overall product and focus on only those distinct components. Make sure that irrelevant details aren’t claimed in your design, such as seams, plug adaptors, or functional features common to all products of this type. Many design patents issue with trademarks or logos included in the design, but most competitors will use their own trademark rather than trying to pass off their products as your own. This may undermine the protection offered by your design patent, so make sure that the important design elements are adequately claimed and protected.

The medical device landscape is dynamic and crowded. With so many competitors, distinctive designs often set products apart from each other. Consumers are won over by the ergonomics and the user-friendliness of products. With so much prior art, utility patent claims may need to be narrowed, or patents may not be available for aspects of your medical device. By strategically procuring design patents, medical device companies can add a key level of protection to their patent portfolios and add value to their company’s bottom line.

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