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Are Diagnostic Tests Patentable?

  • Dec 16 2020

Diagnostic testing has always been extremely important in the treatment and mitigation of illness. Never in our lifetimes has this been more apparent than it is now during the COVID-19 pandemic. These diagnostic tests have been imperative in trying to control the pandemic. 

Unfortunately, the cost of developing and confirming the validity of diagnostic tests prior to making them accessible is quite pricey. However, these expenses can be recovered if the diagnostic test is patented. By patenting a test, its developer gains access to an exclusive market for a period of time. However, patenting a diagnostic test isn’t always easy under the law.

The Patent Act

Under the Patent Act, an Inventor can’t obtain a patent if the invention they are attempting to patent would have been obvious to someone with ordinary skill in the relevant art prior to the effective date of filing.  For example, the genome of COVID-19 (SARS-CoV2) has been public knowledge and much has been shared about it. Therefore any test that works by detecting the genome could be considered “obvious.” 

The exception is if the developer can prove that there are certain unexpected benefits to targeting one protein (or the like) over another. If this is the case, the test may not be “obvious.” Examples of these benefits may include:

  • Better accuracy
  • Higher specificity
  • Easier/less steps for purification

It is important to demonstrate these benefits in the patent application itself. 

Medical Diagnosis Is Not Enough

Additionally, the Supreme Court has ruled that inventions that merely result in a diagnosis based on measurement of naturally occurring diagnostic indicators, could be “laws of nature”, which are not patentable, unless the diagnosis also includes medical treatment or other supportive measures. Therefore, there are significant hurdles that must be considered when preparing to file a medical diagnostic patent application.

Scully, Scott, Murphy & Presser Can Help Protect Your Inventions and Your Rights

If you or a loved one has an issue with a product or procedure that you wish to have protected, or if you have an existing patent that you believe is being infringed upon, it is in your best interest to consult with a knowledgeable and experienced patent attorney to determine your best options. 

At Scully, Scott, Murphy & Presser, our qualified patent attorneys can help you to navigate the patent application process or can help to defend your patent and your rights regarding any infringement. To learn more about the patent prosecution process or to schedule a free consultation, contact us today!

Posted in: Patents

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