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:
STEP 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.
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.
STEP 2 — CHECK IF YOU ARE YOU 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’ll need to seek legal advice!
STEP 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.
STEP 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
Once you know which assets are patentable, the next deciding factor is when to file. In order to get a patent, you must be able to describe how to make and use your invention so that one of skill in the art could duplicate it.
Therefore, as soon as you have a complete picture of how to make and use your invention, you are ready to proceed.
It is worth noting at this point that the more information/data you have in your Patent Application the more likely a Patent Office is to grant you a patent. So, having experimental data in your Patent Application that proves your invention works and, preferably, is better than the prior art products, will be very helpful in securing a patent.
Next, you need to decide where to file. To do this you need to know your market and plan to have patent protection in any country you plan to sell your product. You should also consider filing in any country you think your competitors might make, use, or sell your product.
If you are going to file in more than one country you can file an International Application (PCT) which streamlines the initial filing process, making it easier and, initially, cheaper to file a patent application in a large number of countries.
STEP 5 — DEFINE YOUR LONG-TERM STRATEGIES
You must continue to assess your IP needs on a regular basis. Keep notebooks or, otherwise, record evidence of any IP development.
Before you file your patent application don’t publish or disclose the “inventive” details of your idea.
However, if you do need to disclose some details with vendors or investors, make sure you always use a Non-Disclosure Agreement (NDA). It’s helpful to include in each NDA a description of the disclosure you are about to make so that parties cannot deny it later and claim it was their own invention.