Trade Secrets In Molecular Diagnostics

The US Supreme Court's decisions in the Mayo¹ and Myriad² cases have cast unfortunate doubt on the patentability of some diagnostic products and methods. In the face of this uncertainty, some companies are giving more strategic consideration to protecting their diagnostic innovations as trade secrets, either as a primary strategy or as an adjunct to patent filings. 

Any diagnostic-related product, process or information that confers an economic benefit, is difficult to replicate/reverse engineer, and requires technical know-how, has trade secret potential. Diagnostics that incorporate laboratory developed tests (LDTs)³, are particularly good candidates since there is very little requirement for the testing process or reagents to be publicly disclosed in order to obtain regulatory approval and market the diagnostic test.⁴ Thus, a trade secret could encompass the overall LDT, or the individual constituent steps in the test.