Medical devices are a crucial part of healthcare, and many inventors strive to create unique, groundbreaking inventions. To make sure these inventions are protected and marketed, it’s important to understand the patenting process.
A medical device patent prevents someone else from exploiting or using your invention without permission. Generally, medical devices qualify for utility patent protection if they’re novel, meaning the device is new and different from prior inventions, and non-obvious, meaning that someone of ordinary skill in a relevant field can’t easily make the invention. In addition, medical devices may be eligible for a design patent, which protects the device’s ornamental design, such as its configuration and shape.
If you want to patent a medical device, there’s also an option to file a provisional patent, which is a low-cost way to gain protection for up to 12 months before the filing date of a full patent. Provisional patents also give you time to test and perfect your invention before filing for a full patent, which is called a non-provisional patent. After receiving a provisional patent, your medical device will be considered patent pending. However, provisional patents can only be issued on utility patents, not design patents.
Medical device companies are uniquely positioned to take advantage of the cutting-edge technology available in the modern world. However, to be successful, these companies must be aware of the complex interplay between the FDA regulatory system and patent law.
The FDA regulatory system is complex and ever-evolving, requiring medical device manufacturers to make certain disclosures to obtain device approval. Similarly, patent law is also complex and equipped with many potential pitfalls that can lead to a company losing their ability to capitalize on their inventions.
When sending in your 510(k) submission and filing a medical device patent, it’s important to ensure that your FDA and patent counsels are aware of each other’s strategies and medical device submissions. By coordinating the timing and content of disclosures, you can avoid patent risks and maximize opportunities in the healthcare industry.
Below are the steps to take to apply for a patent that protects your medical device:
To obtain a utility patent for a medical device in the U.S., your device must meet certain criteria, falling within one of the statutory classes:
Your invention must also be non-obvious, work the way you claim it does, and be clearly useful for a specific purpose. For a design patent, the device must be an “article of manufacture,” meaning it’s a tangible object made by man.
Before you apply for a patent, conduct a preliminary search of US patents and published applications to ensure that your medical device isn’t already patented. The Patent and Trademark Resource Centers (PTRCs) provides online access to the PatFT (Patents Full-Text and Image) and AppFT (Applications Full-Text and Image) databases. By using keywords that describe your device based on its purpose, composition, and use, you can search through the database to ensure that your invention isn’t already patented. Be sure to search the database before submitting an application to avoid wasting time and effort.
The patent application process may seem daunting, but with a few simple steps, you can ensure your application is filed correctly and quickly.
First, make sure you have all the necessary forms and documents to submit your application, including a completed patent application, a Declaration, Power of Attorney form, and fee payment. Gather all of the required documents and double check that they’re accurate before submitting your application.
Once everything is in order, it’s time to file. Medical device patent applications must be filed electronically via the Electronic Filing System (EFS). You’ll also need to pay the necessary fees associated with your application at the time of filing, taking note that fees may vary depending on the type of patent you are applying for.
After submitting your application, keep track of its status. You can monitor the progress of your application with the USPTO’s Public PAIR system, which provides access to patent-related documents and information about the prosecution of patent applications. You can also contact the USPTO if you have any questions or need assistance.
Once you’ve applied, the USPTO assigns an examiner to your case. Working with the examiner is an essential part of the patent application process. Examiners are patent attorneys or agents who’ve been trained in USPTO law and procedures to review your application and ensure it meets the criteria for patent approval. To make a decision, the examiners thoroughly review technical aspects of your invention and research the prior art to ensure it’s novel and non-obvious. During the process, your examiner may suggest revisions or modifications that can help improve the chances of success for your application.
Once your medical device patent application is approved, you’ll be issued a Notice of Allowance. The Notice of Allowance lists the issue and publication fees required to be paid to finalize the patent process. Paying these fees secures your patent.
After all the hard work of researching, submitting, and waiting, it’s finally time to reap the benefits of your intellectual property rights. But don’t forget that the protection granted with a patent requires continuous maintenance and renewal to keep it in effect. Utility patents generally last for 20 years from the filing date. During this time, make sure to pay the required maintenance fees or your patent will be considered abandoned. Design patents last for 15 years from the date of grant and are also associated with fees to keep your patent active.
At Remington Medical, we’re experts in the FDA medical device submission process, ensuring that your device is properly logged into the FDA portal. We understand that any product audit may raise questions about the manufacturing process, and as your manufacturer of record, we’re prepared to answer any questions and provide the right documentation to ensure compliance. Contact us today to learn more about how we can help you manufacture and patent your FDA-approved device.
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