Beginning the Patent Process

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This article is part two 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 part of this series appeared in the March 2014 issue of Endovascular Today.

In this article, we explore common issues involving the second question: Can you protect it? The full version in published in the April 2014 edition of Endovascular Today, and is available for download here. A short teaser excerpt follows below.

A lot of companies sell unpatented devices and services, relying instead on factors like marketing and price competition to maintain market share. Usually, that will not succeed in the medical device industry. The cost of product development and the cost and delay of regulatory approvals, among other challenges, are too great to attract investment capital unless the investor is confident that you have (or are likely to obtain) adequate patent protection. Unless you can attract sufficient capital, you normally have no realistic chance of taking a product to market. Making a judicious investment in building a patent portfolio is almost always a required first step.

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 a patented invention—it does not give you the right to practice your own invention. Whether or not you can practice the invention yourself depends on the previous patent rights of others. For example, assume you obtain a patent on a stent with a unique wall pattern that leads to a clinical advantage, such as superior flexibility or an improved crossing profile. If you make that stent out of a proprietary nitinol alloy, the patent owner of that alloy could block you. On the flip side, you could block the nitinol alloy patent owner from selling stents that have your unique wall pattern, regardless of the material.

Possible next steps in this situation are beyond the scope of this article, but these include legal or business options. Legal options include attacking the validity of (in other words, trying to eliminate) the problem patent; a patent that covers you can only block you if it is also valid. Business options include changing your material to a nonpatented alloy or negotiating a transaction, such as a purchase, license, or cross-license of the problem patent. The third part in this series will cover the freedom to practice an invention; for now, be aware that having your own patents is important, but it is also important to consider the patents of others.

The remainder of the article is available here. Stay tuned for part 3 of the series…

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