This is an exciting time to be a part of the medical device technology sector. Innovations that improve the quality of patient care, particularly in the field of orthopaedics, are entering the market, and competition is fierce. Not only is innovation in orthopaedics taking place across market segments, but this particular area of medicine is teetering on the edge of a significant patient population increase due to the aging Baby Boomer generation. It’s an important time to think about patent protection.
Careful and creative thought often goes into developing a new orthopaedic implant or surgical device. Since successful products and designs could translate to thousands, if not millions, of dollars in potential sales, it is important to protect the underlying intellectual property (IP) associated with any new and innovative orthopaedic medical devices. Considering that modern medical innovations are often rooted in a combination of other technologies, one medical device invention could be the bases for multiple IP rights, such as multiple patents. Therefore, a smart legal strategy is to develop a comprehensive IP portfolio of the various diverse—but related—IP rights associated with the inventive device.
Overview of the Differences Between Utility Patents and Design Patents
Patents are IP rights granted by the United States Patent and Trademark Office (USPTO) exclusively for inventions. There are different types of patents, and the two most common types are utility patents and design patents. Understanding the differences between utility patents and design patents is key to determining the value that each type of patent protection offers in the medical device realm.
Utility patents are granted for novel and non-obvious inventions, such as a medical device or implant, and patents may be granted for the way the device or implant is manufactured or the way it is used (e.g., a medical procedure that includes the use of the inventive medical device or implant). A utility patent gives the patent holder the right to exclude others from making, using, selling or importing the invention claimed in the patent for a period of twenty years. Applying for a utility patent involves preparing a detailed description and set of drawings for the invention, along with a set of claims that define the scope of the invention and filing the application with the USPTO.
On the other hand, when the invention is directed to a novel and non-obvious design included as part of an article of manufacture, inventors can apply to the USPTO for a design patent. A design patent protects the claimed ornamental appearance, and provides the right to exclude others from making, using, selling or importing items that include the protected design for a period of 15 years, i.e., others are prohibited from copying the protected design. A design patent application consists of a number of drawings depicting the design incorporated as part of an article of manufacture.
Why Does Design Matter?
Design is often critical to the commercial success of a product and a multitude of factors contribute to the overall design of a product, such as an implant or a medical device. Some of the most common considerations for design choices include:
- Enhancing usability. Intuitive designs are easier for both healthcare professionals and patients to use. Similarly, design can convey to a user that the device is “fit” for its intended purpose, which boosts the user’s confidence in the device. Another example of improved usability would be designing a device to be used with one hand, which is useful for practitioners who are using the device as part of a medical or surgical procedure.
- Ergonomics and/or user comfort. The shape, texture, contours, and placement of displays and buttons all factor into ergonomic designs of medical devices. Design can also be utilized to reduce a patient’s sense of fear or apprehension about using a medical device. For instance, many medical devices that are made for pediatric patients are designed to reduce a child’s sense of anxiety or fear.
- Promoting proper use of the device. Medical devices can be challenging to use for those who are unfamiliar with them. Thoughtful design can go a long way towards helping patients and practitioners easily understand how to use the device properly.
- Overall fit with the rest of a product line. Uniformity of design in a product line is often desirable for marketability.
- Branding and an easily recognized product. A specific design can become associated with a particular brand over time, which can translate into users developing a sense of trust in the product or can encourage brand loyalty among users. When the design is easily recognizable, users learn to associate the design with a brand and will immediately recognize the source of the product.
Protecting Designs in Orthopaedics
In the field of orthopaedics, countless aspects of innovations are eligible for design patent protection. The design of an implant (e.g., the spinal implant design of U.S. Design Patent No. D810,942 assigned to Spinal Elements, Inc.), a new surgical instrument (e.g., U.S. Design Patent No. D696,399 assigned to Kleiner Intellectual Property, LLC), ancillary tools (e.g., the implant sizing device of U.S. Design Patent No. D799,042 assigned to BioMedical Enterprises, Inc.), and the arrangement of buttons on an instrumentation panel for a medical device can all be protected. But design patents are not just limited to the tangible and physical design aspects of orthopaedic hardware.
Many aspects of software used in medical applications are protectable with design patents as well. For instance, the appearance of a graphical user interface (e.g., U.S. Design Patent No. D766,285), the transition or progression of images used to display information to a user (e.g., U.S. Design Patent No. D734,773 assigned to Aerocrine AB), and the appearance of icons or digital buttons are all designs of digital features of medical device hardware that are eligible for design patent protection when incorporated into a display or screen (i.e., an article of manufacture).
Redesigning old instruments may also rise to the level of design patent eligibility, even if the underlying device may not be eligible for utility patent protection. Utility patents are granted for novel and non-obvious inventions. Therefore, something that is old and well-known would not be eligible for utility patent protection. However, redesigned old and well-known medical devices may be eligible for design patent protection under the right circumstances.
By way of example, goniometers are an old and well-known measuring device in orthopaedics for assessing joint range of motion, but an innovative ornamental design for a goniometer could be eligible for design patent protection. Several real-world examples of goniometer designs include U.S. Design Patent No. D766,446 assigned to Leppert Level LLC, U.S. Design Patent No. D689,383 assigned to Neshiwat Designs, LLC, and U.S. Design Patent No. D337,955 assigned to Greenleaf Medical Systems, Inc.
Design Patents Contribute Undeniable Value to An IP Portfolio
To be clear, design patents make up only a small fraction of all patents that are issued by the USPTO each year. By way of comparison, in 2017 there were 322,224 issued utility patents, while only 30,899 design patents issued. However, medical devices are one of the leading technology areas for design patent filings. According to the most recent data collected by the USPTO from 2015, nearly 1,300 design patent applications were filed for medical devices in 2015. The number of design patent filings for medical devices as a whole classification of technology is comparable to the number of design patent applications that are filed in other highly design-focused industries like fashion, automobiles or building architecture.
Design plays a significant role in adoption and market acceptance of new medical devices and orthopaedic implants. Therefore, the role that design patents play in a strategic planned IP portfolio is important. First, design patents are often easier to obtain than utility patents, and design patents are often granted substantially faster than utility patent applications. This means that inventors can secure at least some protection on their innovations sooner rather than later. Design patent applicants also have the benefit of being able to use the “patent pending” label on products and in advertising. Furthermore, if a utility patent is later issued for the invention, the earlier-obtained design patent serves as supplemental legal coverage to the utility patent.
The addition of design patents to an IP portfolio fortifies and helps protect the investment of time, money and resources that went into developing and designing a new and useful medical device. Design patents discourage infringement and copying of the protected medical device design and appearance and the grant of a design patent comes with a special statutory damages provision (35 U.S.C. § 289), which requires infringers to pay their total profits from any “article of manufacture” that includes the protected design when infringement is found in a court of law.
Design patents are ideal for final product designs that are to be marketed for sale. Since design patents are effectively picture patents, meaning that what is protected is specifically pictured in the design patent application, a design patent offers the most benefit when the patent is for the product design that is actually being sold. Counterfeits often emulate products that are already on the market, and copycats will be discouraged from copying product designs that have design patent protection.
Design patent protection is often an overlooked IP right because few inventors and medical device makers are aware that design patent rights exist. While the protection offered by design patents is limited to what is shown in the design patent application, there are a number of useful benefits that can be obtained by seeking and securing design patent protection on a medical device or orthopaedic implant. Design patents have their place and purpose in intellectual property strategy, and with the right marketing plan, orthopaedic medical device makers can capitalize on the hidden value that design patents have to offer.
This article has been written for information purposes only and should not be considered or interpreted as legal advice. Please contact an experienced, licensed patent attorney to discuss any specific questions you may have about utility or design patent protections. This information is not intended to create an attorney-client or similar relationship. Determining whether you need legal services and choosing the lawyer that is right for you are important decisions and should be made based on criteria beyond these informational materials.
Andrew Rapacke is a registered patent attorney and managing partner at the boutique intellectual property law firm The Rapacke Law Group, P.A. Before attending law school, Mr. Rapacke attended the United States Naval Academy, and has a Master of Science in electrical and electronics engineering. Mr. Rapacke has worked with orthopaedic doctors and medical device companies to obtain IP protections on valuable business assets. Mr. Rapacke has experience working in a number of industries, including medical devices, electrical systems, computers, software and mobile apps. He can be reached by email.