Many surgeons get great ideas about new medical devices as they solve problems in healthcare. JUNE MEDICAL Founder and Owner Angela Spang have been advising surgeons, entrepreneurs and business owners on device strategy for a long time, and have summarised her thoughts on the great question on IF AND WHEN TO PATENT the innovation.
Here is a short overview:
- 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
- Take it to market (more on this in a future post)
“If you are not prepared, able to and can fund going to court to defend your patent against say a giant healthcare company….think carefully about alternative strategies”
Founder and Owner, JUNE Medical and inventor of Galaxy II
Step 1: Decide if You Need or WANT a Patent
Patents are typically given for tangible items, whereas service marks, 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and trademarks are for artistic expressions, literary works, or other intellectual works that are either published or unpublished.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 to/could do a patent.
Patent protection is not always the right approach. It is expensive, not just to file but also to maintain, and should it be needed…..to defend.
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.
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. Always put an NDA in place, and remember….just because it is yours doesn’t mean someone else can’t file for it first (and you might lose it).
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.
Types of medical device patents:
- Utility patent: Also known as a non-provisional patent, the utility patent is the most common type of medical device patent and primarily focuses on how the device works. Accounting for 90% of patents issued by the U.S. government, the utility patent covers the invention of a new useful product, process, machine, or technology.
- Provisional patent: Patent protection is granted to those who are the first to file. With a provisional patent you can, in essence, hold your place in line before you’re ready to file for an official utility patent. A provisional medical device patent gives you a year to begin the patent application process. After the year is up, your provisional patent will convert to a non-provisional patent.
- Design patent: As the name implies, this type of medical device patent protects the exterior design or ‘look’ of your medical device. A design patent applies to an original, new, or ornamental medical device design, which could include the shape of a device, general feature appearances, user interface, and even the design of the touchscreen.
- Plant patent: Granted for any novel, nonobvious, asexually reproducible plant, a plant patent is the least common type of patent and is typically only used by research scientists and agricultural experts. As a medical device manufacturer, you will most likely not be applying for a plant patent.
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. (Or get expert help….again: NOT cheap!)
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 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.
Step 9: Decide what to do next
Sell it? Manufacture it? License it? There are so many options. A patent will often be very important if you intend to go into business and are looking to at some point take on investors or sell the company — a patent seems to work almost as a security blanket for investors.