Companies involved in developing ground-breaking diagnostic tests received great news this week with the recent Federal Circuit decision between Ariosa and Sequenom/Illumina, upholding a patent directed to novel blood tests. A similar Illumina patent was struck down in 2015 as being un-patentable for being well-known diagnostic techniques applied to a naturally occurring phenomenon. In this new case, the Federal Circuit found the claims patentable because they are directed to a novel method of preparation.
This case highlights the importance of thoughtful claim drafting – whether in diagnostics, software, chemicals, medical devices, or others. In recent years, the judiciary has applied heightened emphasis on claiming only and specifically the improved method, structure, etc. actually invented, without encompassing well-known elements or natural phenomena. Claims must, therefore, not be unnecessarily broad, but should also avoid unnecessarily limiting details. Instead, claims should be focused on the improvement rather than the natural law or prior art undergirding it.
The latest Sequenom/Ariosa case is welcome news, especially in light of the importance of diagnostics development for COVID-19, and should encourage increased funding for innovative diagnostics firms.