IP and FDA Regulatory Strategies Often Go Hand-In-Hand

3 minutes

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Andrew Rapacke is a registered patent attorney and serves as Managing Partner at The Rapacke Law Group, a full service intellectual property law firm.

In the medical device industry, it is common for medical device companies to seek regulatory approval on new medical devices and innovations from the Food and Drug Administration (FDA) while simultaneously pursuing intellectual property protection. Since both processes can take years to complete, it makes business sense for a medical device company to develop parallel FDA regulatory and IP strategies.

Medical device companies often face the unique challenge of having to navigate at least two government review processes before a product can be launched to market. First, the medical device will most likely require FDA clearance, and second, it is imperative that the medical device is protected by intellectual property rights such as patents and trademarks, which are issued by the United States Patent and Trademark Office (USPTO).

While for the most part, the two processes are compatible, applicants should take care to ensure that their actions in one process do not adversely affect the other. Some areas where medical device companies can run into issues including making disclosures to either of these two government entities and coordinating timelines.

Disclosures and Timelines

Disclosures and timing are critical when it comes to obtaining both FDA approval and intellectual property rights. Without proper planning, you could be issued patent protection well before you obtain FDA approval, which means you cannot sell your device, even though you already have the exclusive patent rights. The consequence is that valuable time on your patent can run before you are able to exercise your patent rights while you apply and wait for FDA approval before you can begin selling.

Another reason medical device companies choose to implement integrated IP and FDA strategies is that certain obligations must be satisfied and disclosures must be made as part of the required FDA filings. Public disclosures can be a bar to obtaining certain intellectual property rights as is the case with patents, so once certain disclosures are made to the FDA, the company may only have 12 months to file any necessary utility or design patent applications related to those disclosures.

When filing a patent application with the USPTO, applicants must also make disclosures about their medical device invention. Applicants are also encouraged to provide evidence to the Patent Office that demonstrates that the device works as disclosed in the patent application and is thus fully enabled (a legal requirement that all patent applications must satisfy wherein the application must describe how to make and use the invention). This can include the submission of evidence that the medical device has been accepted by the FDA for clinical trials. Carefully planned parallel IP and FDA strategies will take advantage of using the same evidence concerning the medical device for both review processes.

The Actions Of One Agency Have No Bearing On The Other

It is important to note that decisions made by one agency will not serve as evidence that approval should be granted by the other agency, nor are the decisions rendered by one agency indicative of the outcome of the other agency. For instance, while the FDA may approve clinical trials for a new medical device, the FDA’s approval will have little bearing on whether a patent will be issued on the medical device by the USPTO. Similarly, while the Patent Office may issue a patent on a medical device, the FDA may deem the device is unsafe and should not be used by the public.

If you have a medical device that needs IP protection, you should reach out to the professionals at The Rapacke Law Group. We are aware that you likely have FDA regulatory concerns when it comes to your medical device innovations, and while we do not practice FDA regulatory matters, we do have an understanding of how FDA regulations can impact your company’s IP strategy. Contact us today to schedule a free initial consultation with one of our IP attorneys.

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