Are third parties free to produce Myriad’s breast cancer gene test?

In a much-anticipated decision in Association for Molecular Pathology v. Myriad Genetics, Inc., the United States Supreme Court has held that product claims directed to naturally occurring BRCA gene sequences are products of nature and are therefore not eligible for patent protection.  Thus claims to naturally occurring nucleic acids are not patentable, even if the DNA is isolated.  The case concerned DNA sequences for the BRCA1 and BRCA2 genes, which are implicated in the risk of developing breast cancer.

It is worth noting that not all Myriad’s claims were revoked.  According to the Supreme Court, product claims to non-naturally occurring nucleic acid sequences, such as cDNA sequences or sequences modified by man, may be patentable.  Also, a number of Myriad’s method claims were not challenged.

This shows that it is of huge importance to have a patent attorney involved when drafting your initial patent application to ensure your invention is suitably protected with claims in multiple claim categories.

Isabel Unwin (Ansons)