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Davis Brown Intellectual Property Law Blog 


Intellectual property in Medicine: Patent Law Basics - August 15, 2016

This article originally appeared in the March 2016 issue of Minnesota Physician and is reproduced here with permission.


For physicians considering patents, there are some initial issues to address and then a comprehensive patent strategy to develop  before going down the path toward filing an application. Once your patent strategy is in place, you can turn your attention to your patent application.  As discussed earlier, you can file either a provisional (and then a non-provisional within a year) or a non-provisional application in the U.S.  Regardless of the approach, you will ultimately need to file the non-provisional in order to pursue a patent.

 

Once you have filed your application, what happens next? 

Many first-time inventors assume that once a non-provisional application is filed, the hard work is done and a patent is on its way.  That, however, is not the case.  Drafting and filing the application is just the first step.  Once the non-provisional application is filed, it is eventually assigned to a patent examiner who will review the application, analyze the claims (which define the invention and are the focus of the prosecution of the application), perform a prior art search based on the claims, and then issue an office action to the applicant.  In the office action, the examiner takes a position as to the patentability of the claims, among other things.  Typically, in the first office action, the examiner will “reject” the claims based on one or more prior art references identified in the prior art search or based on other statutory requirements for the claims.


Upon receipt of the office action, you will want to consult with your patent attorney and come up with a response strategy.  Generally, your main options in responding to the office action are to:

  1. argue that the claim rejections are incorrect and provide a reasoned explanation regarding why the rejections are incorrect and the claims are patentable, 
  2. amend the claims to overcome the rejections
  3. both argue and amend the claims.  Once you’ve come up with a satisfactory response strategy, your patent attorney will draft and file the response.

This process can repeat itself several times, and it is not unusual to have multiple rounds of office actions and responses for any given patent application.  As of December 2015, the average number of office actions per application was almost 2.5, but I have seen applications that received more than eight office actions.  Ultimately, the goal is to present successful arguments and/or amendments that result in the issuance of a patent.

 

Foreign patent protection

Of course, while you’re preparing your strategy for your U.S. non-provisional application, you must also consider whether you want to pursue foreign patent protection.  To this point, we have been discussing patent protection mainly in the context of the U.S. Patent Office, but it is equally important to consider your patent strategy outside the United States.  If you are planning to pursue foreign patent protection in two or more foreign countries, the simplest, most cost-effective approach is a PCT application, which is an international patent application created by the Patent Cooperation Treaty that was signed in 1970. 


This treaty created a unified application and procedure for pursuing a patent application in foreign countries under which an applicant in the U.S. can file the PCT application within a year of the applicant’s first filing (usually the provisional application).  Subsequently you have 30 months from the original filing to enter any foreign jurisdictions that are party to the treaty with the same patent application and preserve the original filing date thereof.

 

Conclusion

The road from invention to an issued patent is not easy or simple—it is a complex process that requires determination, effort, and a good patent attorney.  But if you take the appropriate steps, the patent process gives you an opportunity to protect your ideas and hopefully improve the well-being of your patients.