United States: Intellectual Property In Medicine: Initial Considerations

Last Updated: November 28 2017
Article by Sean Solberg

Physicians are well-positioned to generate new inventions and thereby improve the treatment of their patients.  As a result, physicians have historically been some of the best and most active inventors in the United States.  One of the keys to commercial success for any inventor is a sound intellectual property (IP) strategy.

Initial considerations for your patent strategy

So, you are a physician and you have an idea.  What do you do next?  The following are the key steps and considerations for developing a strategy to protect your technology.

Disclosing your idea

Confidentiality is key.  Don't tell anyone about your idea because disclosure can create significant problems.  If you were to disclose your invention to a third party without a confidentiality agreement in place, you would technically have one year in which to file a patent application in the U.S.  In contrast, any such disclosure prevents you from pursuing patent protection in most other countries.  Plus, disclosure to a third party creates the obvious risk of that party copying your invention and pursuing development.  What constitutes disclosure?  Don't take any chances—do not disclose your invention to anyone without first consulting a patent attorney.

There are situations, such as talking to a potential business partner, in which it may be necessary to disclose your invention to a third party before you file your patent application.  If you haven't filed your patent application and you must disclose the invention, an appropriate confidentiality agreement drawn up by your patent attorney can preserve your rights to pursue a patent application.

Regardless, the best approach is to file your patent application before you disclose your invention, which eliminates the risk of public disclosure.  In fact, the recommended strategy is to use confidentiality agreements for any disclosures even after you file your patent application.  Your invention is still a trade secret after filing and until the application publishes.  A confidentiality agreement at this point can also protect against public disclosure of any additional inventions or improvements you may have developed since you filed the application.

Hiring an attorney

It is important to find a good patent attorney.  Developing an effective patent strategy is complex and not for the inexperienced.  It is critical to have an expert involved early in the invention process.  Hiring an attorney who has expertise in your technology and experience with physician-inventors is a plus.  Most important, find a patent attorney with whom you have a great connection and relationship, because trust and communication are as critical as expertise.

Who owns your invention?

As to the question of ownership, the answer depends entirely on whether you are an employee or independent contractor based on your contract with your hospital or medical clinic.  Many physicians are contractors and own any inventions they create.  Of course, ownership depends on the specific language in the contract.  If you are a contractor and your contract does not include an obligation to assign your invention rights to the hospital or clinic where you work, then you likely own your own IP rights free and clear, and can pursue patent protection.  On the other hand, if you're an employee, it is possible that your employment contract requires you to assign all of your intellectual property rights to your employer.  Regardless, the key is to have your patent attorney examine your contract to determine your rights and obligations.

Prior art

Before you go any further, you also need to consider whether your invention is actually patentable.  Your patent attorney can perform a patentability search prior to filing your application.  The attorney—or a third party search firm hired by the attorney—will search specific databases for any publications, patents, or published patent applications describing prior inventions (referred to as "prior art") similar to yours.  The attorney will then analyze those search results to determine whether your invention is novel and non-obvious in view of the prior art.  If those results are positive, then you can file your patent application.  Prior art search results also help your patent attorney (and you) to describe your invention to distinguish it from that prior art, thereby strengthening your application and chances for receiving a patent.

On the other hand, there are some reasons not to conduct a patentability analysis at this early stage.  You should understand that there is no obligation on the inventor's part to do any kind of search for prior art.  There is an obligation to disclose to the U.S. Patent and Trademark Office (the "Patent Office") any prior art of which you are aware.  While a patentability search and analysis is a good idea when money is not an issue, you can file the patent application without first paying for a patentability analysis if your budget is limited.  Alternatively, you can get a sense of the prior art in your area of technology by doing a very rough prior art search yourself on the Patent Office website—the database can be found at http://patft.uspto.gov/.

Freedom to commercialize your technology

Now that you have a better understanding of patent strategies, it's time to consider commercialization.  Many inventors think that patent strategy is focused solely on filing a patent application.  Nothing could be further from the truth.  If commercialization is the goal, a patent alone is not enough.

Before you can develop, market, and commercialize your technology, you also need to consider whether you have "freedom to operate."  In other words, you need to determine whether you are free to commercialize your technology or whether that commercialization might infringe another party's patent.

The fact that a patent does not protect against potential infringement of others' patents can seem counterintuitive to first-time inventors.  This confusion originates from a fundamental misunderstanding about what rights a patent conveys to a patentee and—just as important—what it doesn't convey.  While a patent gives the patentee the right to exclude others from making, using, or selling the invention as defined by the claims, it does not give the patentee any affirmative right to commercialize that technology.  Your patent is not a free pass to develop, market, or sell your invention.

This article series, a guide to an effective patent strategy, originally appeared in the March 2016 issue of Minnesota Physician (https://issuu.com/mppub/docs/mn_physician_mar_2016) and is reproduced here with permission.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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