How To File a Medical Device Patent: A Comprehensive Guide
Learning how to file a medical device patent is crucial for innovators in the MedTech industry, as navigating this complex path can be daunting. This article paves the…
[FREE GUIDE]MedTech and patents
The Must-Have Medical Device Patent Guide
The right IP protection can give a medical device company a real advantage over its competitors. This guide gives you a clear path to patent protecting your medical device.
[01]What's inside
Seven chapters for MedTech teams.
The Must-Have Medical Device Patent Guide, free to request with the form.
- Gain a competitive advantage
- Know the path to a patent
- Know the types of claims you should consider
- Enforce your medical device IP
- 01Guide chapter01Patenting medical devices
- 02Guide chapter02Types of claims in medical device patent applications
- 03Guide chapter03Medical device patents and kit claims
- 04Guide chapter04Software as a medical device, can it be patented?
- 05Guide chapter05Copyright protection for medical device software
- 06Guide chapter06Using trade secret protection for medical devices
- 07Guide chapter07Policing and enforcing medical device IP rights
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How do you patent a medical device?
The same way as any invention, with a few MedTech twists. Search the prior art first, file a provisional application before you present at a conference, publish a study or show the device to investors, then file the utility application within 12 months. Most devices are protected by a utility patent on how they work, and a design patent can protect how they look.
What types of claims belong in a medical device patent?
| Claim type | What it covers |
|---|---|
| Device or apparatus | The structure of the device itself |
| Method of use | How a clinician or patient uses the device to achieve a result |
| Method of manufacture | How the device is made, useful when the process is the advantage |
| System | The device working with other parts, such as sensors, software or a hub |
| Kit | The device packaged with the components and instructions sold with it |
Strong applications combine several types, so a competitor cannot design around one. See types of claims in medical device patent applications.
Can software as a medical device be patented?
Often, when it improves how the device or the diagnosis works in a technical way, rather than claiming a mental process or a mathematical formula. Eligibility rejections are common, so the application should explain the technical improvement in detail. Read when software becomes a medical device.
Patent, copyright or trade secret, which protects what?
- Patents protect how the device and its software work, against anyone who copies the function.
- Copyright protects the device software's code as written.
- Trade secrets protect what competitors cannot see in the product, such as manufacturing know-how, as long as it stays confidential.
How does FDA clearance affect patent timing?
They run on separate tracks. FDA review does not wait for your patent, and your patent term runs from the filing date whether or not the device is on the market. That is why most MedTech companies file early, then keep filing on improvements during development. Devices that go through premarket approval may qualify for a patent term extension for part of the regulatory delay. For the regulatory side, see FDA regulatory compliance.
How do you police and enforce medical device IP?
Watch competitors' product launches, published patent applications and FDA clearance filings for devices that look like yours. When you find one, a demand letter, a license or, if needed, a lawsuit enforces the patent.
When should I file a medical device patent?
Before any public disclosure, including conference talks, journal articles, trade shows and investor decks that show how the device works. A provisional application secures your date quickly.
Do I need FDA clearance before I patent a device?
No. Patents and FDA clearance are separate. Most companies file patent applications long before they submit to the FDA.
Can I patent an improvement to an existing device?
Yes, if the improvement is new and not obvious. Many medical device patents cover improvements, and an improvement patent can be valuable even when the original device is patented by someone else.
What is a kit claim?
A claim covering the device packaged with its accessories, components or instructions, the way it is actually sold. It can catch competitors who sell the same combination.
Is the guide free?
Yes. Send the short form to request it. It is general information, not legal advice.
[04]Learning Center
Read more on medical device patents.
Types of Medical Device Patents
Medical devices can be protected by utility, provisional and design patents. Here is how each type works, how long it lasts, and why design patents add value to a medical device IP portfolio.
Market Clearance Searches for Medical Device Innovations
No one needs to reinvent the wheel and you shouldn’t waste valuable time, money and resources designing a “new” medical device that already exists. Before committing too…
[05]Free resources
More free resources.
Guide
Patent Your Invention – A Step By Step Guide
A step by step walk through patenting your invention.
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The Must-Have Software Patent Guide
How the software patent process works and what protecting a key feature does.
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AI Patent Mastery for SaaS Founders
How to patent the AI features inside a SaaS product, written for founders.
Protect your device before you disclose it.
Talk through your device with a registered patent attorney. The call is free, with no obligation.