Some New Jersey medical researchers may be affected by a federal appellate court decision on Feb. 6 regarding diagnostic test patenting. Rather than providing clarification about this type of patenting, the decision instead increased the pressure on Congress to provide guidance.
The Athena unit of Quest Diagnostics, Inc., filed a lawsuit against the Mayo Clinic in 2015 regarding a diagnostic method for neurological disorders that involves the detection of certain antibodies. The company argued that the Mayo Clinic owed it royalties, but the case was dismissed. The argument was that the diagnostic test could not be patented because it only dealt with a correlation between the presence of antibodies and the condition. Therefore, it was a matter of "natural law".
The argument by the Mayo Clinic was based on a 2012 Supreme Court decision. The majority decision by the appeals court pointed out that the application of natural laws could be patented but not a series of conventional steps to make the diagnosis. The dissenting opinion said that patients were at risk since the decision provided no incentive to develop new diagnostic tests. Some experts say Congress must act since the judicial system cannot provide the needed clarification.
Companies or individuals who have created a new design or formula may need to patent it, and an attorney may be able to assist in the process. An attorney may also be helpful if a person or company believe another party has violated its patent. As this case demonstrates, in certain industries and situations, patent law and determining whether something can be patented can be complex. Furthermore, the status of certain types of diagnostic patents may change if Congress does choose to address the issue.
Source: Bloomberg, "Court Rules Medical Diagnostic Can't Be Patented, Leaving Biotech in 'Legal Mess'", Susan Decker and Malathi Nayak, Feb. 6, 2019