5 Simple Steps to Protect Your Medical Device with Patents

Yes, getting your medical device to market takes a lot of time and hard work.

The medical device industry is highly regulated and intimidating. There are numerous hurdles along the way, such as product development, finding the right people, getting funding, and navigating regulatory approval, to name only but a few.

After all your hard work, what’s to stop competitors from making, using or selling your invention?

The answer is your IP (intellectual property), and particularly your patents, so make sure you dedicate the time and money to protect your IP!

Your IP is your most valuable asset and will be a major factor in securing funding. Thus, your IP needs to be considered in all business transactions.

Here are 5 simple steps to guide you along the right path:

1 — KNOW YOUR IP

Intellectual property is an umbrella term covering trademarks, patents, copyright, design, know-how, and trade secrets. Be sure to make a list of all of your IP assets and a comprehensive plan to protect it. If you’re not sure, always seek legal counsel!

The most commonly used IP to protect medical devices are trademarks, patents, and trade secrets.

A trademark is a symbol, word, or words legally registered, or established by use, as representing a company or product. You can trademark the name of the device or any symbol or slogan used on or in connection with the device, for example, Evohaler®, EpiPEN®, BAND-AID®, and ACCU-CHEK®.

A patent, on the other hand, can provide 20 years of exclusivity for your patentable invention in the United States. A medical device can have various features that can be protected with separate patents and a strong life cycle patent portfolio will continue to protect new and improved versions and uses of your medical device.

Lastly, trade secret law protects information that derives economic value from being (you guessed it) “kept secret.” Trade secrets may include know-how, product designs, materials, and process-related inventions. One reason to keep something a trade secret would be if the likelihood of getting a patent was low.

2 — CHECK IF YOU ARE BLOCKED BY OTHER IP

The first issue to consider is if anyone else already owns your IP. That is, does someone already have patent protection which would prevent you from working in this area?

The legal term for this is Freedom-To-Operate (FTO). To determine if you have FTO you can start by searching the Patent Office websites in the countries of interest to see if there are any patents that look like they may be problematic.

To accurately determine if they are a problem you will need to seek legal advice.

3 — DETERMINE IF YOU OWN YOUR IP

The second issue to consider is to make sure your employees, contractors, and vendors do not have any rights to your IP.

Make sure all of your employees, contractors, and vendors have IP clauses in their contracts assigning all IP rights to you.

Also, look at any other agreements you use in your business to make sure they protect your IP, these include, for example, license, assignment, technology transfer, and joint venture agreements.

4 — IMPLEMENT YOUR PROTECTION PLAN

Once you know what your IP is and who owns it, you can begin to implement your plans to protect it. One of your most valuable IP assets will be your Patent Portfolio.

Remember, there are some basic legal requirements for an invention to be patentable in the USA, it must be:

• Patentable subject matter, i.e., a process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.
• Novel (i.e. at least some aspect of it must be new)
• Non-obvious
• Useful

Keep reading the full blog post to understand when you should file, where you should file, and how to determine your long-term strategy!

Also, here’s a quick guide to help you determine what type of IP is right for your medical device idea!

We are your go-to resource for all things Patent and IP! Learn how you can secure and grow your startup with instructive daily insights from our Learning Hub: https://kisspatent.com/learning-hub

Still hungry for more? There is a wealth of information in our Resource Center! Explore our ebooks, whitepapers, webinars, and more: https://kisspatent.com/resourcecenter

If you have questions regarding your particular business scenario, don’t hesitate to reach out. We’re more than happy to help! Schedule a call with our experts here: https://kisspatent.com/contact

Originally published at https://kisspatent.com on November 11, 2019.