ROSG's patent strategy taken towards the USPTO is working alright as few of its patents were issued and allowed. Courts on the other hand are a different story. The genetic patent landscape is evolving: judge Sweet has recently invalidated both MYGN's patents on BRCA1/2 genes, the composition claims and the method claims under 35 USC 101. For the composition claims, he found that the claimed isolated DNA is not “markedly different” from native DNA. I believe it should be identical for RNA, although no judge has said so. However, isolated sequences are not easy to obtain and higher court might reverse it. If not, ROSG's IP protection may not be as strong as they think i.e. claims covering miRNAs sequences may be vulnerable and the patent protection will relay on claims covering uses of miRNAs as diagnostic biomarkers and therapeutic targets.
