Evaluating Freedom to Operate

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This article is part three of a series that presents the three big issues in intellectual property: Do you own it? Can you protect it? Do you have freedom to practice it? The first two parts of this series appeared in the March 2014 and April 2014 editions of Endovascular Today.

The full version is published in the June 2014 edition of Endovascular Today, and is available for download here. A short teaser excerpt follows below.

In this article, we set the context and explore common issues involving that third question. You may have heard terms like freedom to operate (FTO), market clearance, right to practice, or third-party patent evaluation. All refer to the question of whether you have the freedom to practice your invention without infringing upon the patent rights of others. Without freedom to practice your invention, you could be at risk of having to pay monetary damages to a patent owner—or worse, having a court bar you from making, using, or selling your invention (known as an injunction).

A common misconception is that if you are able to patent something, you are free to practice it. This is not necessarily true. A patent gives you the right to exclude others from making, using, selling, or offering to sell your patented invention; it does not give you the right to practice your own invention. Whether you can practice the invention yourself depends on the prior patent rights of others.

For example, assume you obtain a patent on a percutaneously deliverable aortic valve with a unique leaflet geometry that leads to a clinical advantage such as superior fatigue life or coaptive characteristics. If you seek to make those valve leaflets out of a proprietary biomaterial, the patent owner of that biomaterial could block you from doing so. If you instruct cardiologists to deploy your valve via a transapical approach, the owner of a patent claiming a method of inserting a valve transapically could block you from doing so, as well. Thus, even if you can patent your technology, whether you have freedom to practice it is a separate question. You will normally need to evaluate and achieve both when bringing your medical device to market.

The remainder of the article is available here.

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