In Illumina, Inc. v. Ariosa Diagnostics, Inc., the court provided guidance on what makes for a natural phenomenon and how this impacts subject matter determination for patent protections. This information is important for those who work in natural sciences because inventors must often navigate subject matter eligibility to ensure the United States Patent and Trademark Office (USPTO) grants patent protections.
Why do the natural sciences face this hurdle? Because things that happen as a direct result of nature or natural phenomena are generally not eligible for patent protections.
Taking a step back: What can be patented?
In order to appreciate the nuances of this case, it is helpful to understand what patents can protect. The United States Patent and Trademark Office (USPTO) states that the appropriate subject matter eligible for patent protections include processes, machines, manufacturers and compositions of matter.
The key, according to the USPTO is to provide protections to inventors without prohibiting future innovation.
Moving on: Are protections available that involve natural phenomena?
So how do we achieve this balance while still offering protections where appropriate? It is true that a patent for a natural phenomenon itself is not available, but the mere presence of a natural phenomenon is not enough to negate patent protections. This case provides an example of the balance.
This case involved DNA work during pregnancy. Researchers were differentiating between a fraction of DNA in the mother’s blood versus the fetus’ blood. The mere presence of this difference would not qualify for patent protections, but the inventors did not stop there. They developed a process with concrete steps to determine the difference between the DNA from the mother and fetus and then invented a method to prepare a mixture enriched in fetal blood for future use. As such, the court found the process eligible for patent protection.
Conclusion: What should inventors take away from this case?
It is important to provide adequate information within the patent application to establish patent-eligible subject matter. A failure to do so could result in a denial and an inadequate explanation could result in a patent that may lose a future challenge.