Medical devices are useful and non-obvious—the criteria that must be met before considering an application for a U.S. patent. However, a patent is only reviewed to those who can prove their medical device invention is new and useful, or improves upon a process or object in new and useful ways.
The process may seem daunting, and it most definitely is time-consuming, but for the majority of novel medical devices, the effort of applying for a U.S. patent is worth the reward.
Medical Device Patents Explained
Patents, trademarks, servicemarks, and copyrights can sometimes seem confusing. It is important to understand what a patent is, before attempting to apply for one.
A patent for an invention is the grant of a property right to the inventor, issued by the United States Patent and Trademark Office. Patents are typically issued for twenty years from an application’s submission date and are only abiding to U.S. patent grants within the United States.
The right conferred by the patent grant is, in the language of the statute and of the grant itself, “the right to exclude others from making, using, offering for sale, or selling” the invention in the United States or “importing” the invention into the United States.
Steps to Patent A Medical Device
There are eight steps to an application for a U.S. patent that the United States Patent and Trademark Office require of a medical device inventor. This process is described in full detail on the USPTO website.
The Eight Steps Involved in a Patent Process
- Decide if You Need a Patent
- Decide if You Can Patent
- Pick the Type of Patent You Need
- Prepare to Apply
- Submit Application
- Work With an Examiner
- Get Approval
- Maintain Your Patent Protection
Step 1: Decide if You Need a Patent
Patents are typically given for tangible items, whereas servicemarks, copyrights, and trademarks are for artistic expressions, literary works, or other intellectual works that are either published or unpublished. If your medical device is ‘novel’, you probably need a patent.
Step 2: Decide if You Can Patent
Many inventors attempt to make their own search of the prior patents and publications before applying for a patent. This may be done in the Public Search Facility of the USPTO, and in libraries located throughout the United States that have been designated as Patent and Trademark Resource Centers (PTRCs).
To be considered novel (or new), your invention cannot have appeared in prior art, such as advertisements, a different patent, or trade brochures. For this reason, it’s a good idea not to talk to anyone outside your organization about your invention until your patent application is filed.
Step 3: Pick the Type of Patent You Need
There are three types of patents available for submission: utility patents, design patents and plant patents. Utility, or non-provisional patents are the most common and are designated for inventions and discoveries of new and useful processes, machines, articles of manufacture, compositions of matter, or any new, useful matter involving these areas. If you are seeking to patent a new invention, technique or technology, like a medical device, a utility patent is what you need.
Step 4: Prepare to Apply
Application preparation includes following the proper procedures, paying the required fees, and submitting a complete application. There are some quirky rules associated with acceptable forms—including using only one of three accepted fonts—so make sure to read the fine print. For a list of the types of U.S. patent applications and proceedings, click here.
Step 5: Submit Application
Submitting an application can be a bit tricky. In the minimum, a written document of explanations and descriptions, drawings (if applicable), an oath, and filing, search and examination fees are requirements.
Different parts of the application need to be filed together and fees need to be paid. The application itself is not terribly expensive if you do it yourself, though you may want to consider retaining the services of a patent attorney, which can substantially increase the cost.
Step 6: Work With an Examiner
Once your patent application is submitted, it will be assigned to an examiner who will work with you to determine if your application meets the requirements for U.S. patent approval consideration.
Step 7: Get Approval
You are not going to get away without paying more fees, but if your examiner gives you a stamp of approval, you will receive a Notice of Allowance. The Notice of Allowance will list the issue fee and the publication fee that you will have to pay prior to having the patent issued to you.
Step 8: Maintain Your Patent Protection
Once you have it, make sure you protect it. Maintenance fees are required to protect your patent, so don’t forget to pay or your patent will expire. If you retained the services of a patent attorney early in the process, they can help with this. The more complex the device you are intending to patent, the more expensive it is likely to be to receive, maintain, and secure your patent, but the rewards can be considerable.
Patenting a Medical Device: Difficult but Worthwhile
If you have a novel idea, it makes sense to protect it. Even though the process is not a sprint, reading the fine print on the USPTO website will ensure a complete application and better chances of acceptance. No matter how you look at it though, a patent is truly rewarding in the long run. So, go for it!