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If you go through the rigors of designing and developing a medical device, it only makes sense that you’d want to protect your intellectual property from any late-comers who would like to profit off your work.
For a physical product, that entails getting a patent from the federal government. And generally speaking, in the medical device industry, there are two types of patents companies generally pursue: utility patents and design patents.
Now, before we dive into these patents and the potential uses for each of them, know that your best bet is talking to a patent attorney. This article cannot replace their expertise and should not be taken to constitute any sort of legal advice.
With that said, if you’re simply curious about the patent options that are available for your medical device, when you might use them, and the possible advantages of doing so, then read on.
The difference between a design patent and utility patent comes down to the separation of form and function. Broadly speaking, a utility patent covers what a device does or how it does it, while a design patent protects the appearance of a device.
It’s important to note that this isn’t an either-or situation; you can hold both utility and design patents on the same device if you need to protect both its function and form.
A utility patent is the type of patent most people are familiar with—it’s the patent you get when you invent a device that does something new or performs an old task in a new way. A utility patent protects the functional aspects of your device, such as the way it operates or is used.
Some key points to remember about a utility patent:
On average, it takes roughly two years from the date of application to obtain a utility patent, but it may take much longer than that—sometimes up to five years depending on the device and your application.
A utility patent is valid for 20 years from the date the patent was filed. However, you’ll need to pay maintenance fees three times over the course of the patent’s lifetime.
To obtain a utility patent, you must prove that your device is novel, non-obvious, and useful.
Design patents are used less often than utility patents. However, they can still be tremendously useful. A design patent protects the “visual ornamental characteristics” of your device, which include the shape, configuration, or surface ornamentation you use.
For instance, while many thermometers use the same mechanism for providing you with a reading of your internal body temperature, there are many varying designs of thermometers available on the market. Even if the method for obtaining your temperature is the same, the design of the thermometer can be (and likely is) patented.
Some key points to remember about design patents:
Of the two, utility patents tend to be more difficult to obtain than design patents, with rates of rejection for initial applications hovering just under 90%, according to one analysis.
The reason for this comes down to the fact that a design is mostly visual and thus the scope of the application is naturally limited. A utility patent application, on the other hand, while it may include visual representations, is a broader, text-based description of the invention and the claims you’re making about it.
You should consider a utility patent if you believe the function of your device is “novel, non-obvious, and useful.” However, just because you believe your device to be novel, that doesn’t make it so.
To make sure a similar device hasn’t already been patented, you’ll want to have a patent search performed by a registered patent professional.
If you want to move forward with a utility patent, you have two options: a provisional application or a nonprovisional application.
If you file a provisional application, you are not required to have a formal patent claim or include any information disclosure statement as part of your submission. The provisional application is simply meant to establish an earlier effective filing date. That’s important because the effective filing date is used to resolve patent disputes.
Keep in mind, the provisional application only lasts 12 months and cannot be extended. So you must file a nonprovisional application for your patent during those 12 months.
A nonprovisional application is simply the normal application process for a utility patent. If you’re curious about what it entails, you can read the US Patent and Trademark Office’s application filing guide or speak with a patent attorney.
Design patents are used all the time in the world of consumer goods, where competitors are incentivized to copy a great design. The phone or computer you’re reading this on almost certainly has its design protected by a design patent.
Design patents can also be quite useful in the medical device industry for a variety of reasons:
Protecting value that isn’t covered by a utility patent. For instance, the design and ornamentation of a medical device might make it slightly easier to use than a comparable device, perhaps due to a change in the ergonomics of the product design. Or the design may simply be more aesthetically appealing—giving your device a distinct identity that users prefer. A design patent may be able to protect you in both cases, preventing competitors from copying your design or creating an imitation that closely resembles it.
Protecting graphical interfaces. You may not initially consider your display or the manner in which a user navigates it to be worth patenting, but a design patent may be useful in this case, as well. Many medical devices have graphical interfaces that are designed to be intuitive and easily navigable, and you may be able to protect those aspects with a design patent.
Protecting a device using old technology. The technology behind a blood pressure cuff or a stethoscope has been around long enough that it can no longer be protected by a utility patent. However, that doesn’t mean that a redesign of that product can’t be protected. If your device is a new design built on existing technology that can’t be covered by a utility patent, a design patent can offer you protection against competitors.
Applying for and obtaining a patent—whether utility or design—can be a time-consuming process, especially for a smaller medical device company where everyone is already wearing multiple hats.
At Greenlight Guru, we designed our Medical Device Success Platform (MDSP) specifically to meet the needs of medical device companies like yours. Our industry-specific software is purpose-built to help you bring safer products to market faster, while reducing risk and lowering costs.
We can’t help you get your product patented, but we can help you get it into the hands of the patients and providers it was built to help. Get your free demo of Greenlight Guru today!
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Wade Schroeder is a Medical Device Guru at Greenlight Guru with a noticeable enjoyment of medical device product development processes. As an electrical engineer by trade, he began his career developing medical exam procedure chairs and later designing IVD devices. He has been a risk management enthusiast since the...