Myriad loses granted gene patents

On March the 29^th 2010 Judge Robert Sweet, of the federal court in New York City, declared 7 out of 23 controversial gene patents invalid. Note, these were granted patents that Judge Sweet ruled to be improperly granted.

The particular patents covered the breast cancer susceptibility genes BRCA1 and BRCA2 and were licensed by Myriad from, amongst others, the University of Utah.

Based on these patents, Myriad invested time and money to commercialise and develop test services. These test services identify mutations in the genes of patients, indicating an increased risk for cancer. Judge Sweet decided that the 7, now invalid, gene patents circumvented a prohibition against patenting human DNA. In practical terms, the 7 patents would reduce the access of patients to tests, validation of these tests and inhibit development of downstream technologies.

The ruling, if maintained, will provide opportunities for other businesses to develop their own tests for BRCA1 and BRCA2 mutations. Myriad still has the advantage of extensive know-how in this testing area, and maintained its “method of use” patents on the specific DNA sequences for assessing cancer susceptibility. It is likely that Myriad will file an appeal.

How will gene patenting in general be affected? It is going to take some time before we can estimate the effect of the ruling for future gene patenting processes. The patent law concerning DNA is not yet stabilized regarding what can be patented and what cannot. However, it is likely that several other gene patents, claiming DNA sequences as an invention per se rather than as part of a process, will be invalidated in the US as well.

Gene patents that claim modified or engineered gene sequences or processes for using specific genes are not affected by the US District Court ruling.

If you have a patent portfolio in this field, keep your eyes on this case!

What is a gene patent?

A gene patent claims the rights to a specific gene sequence, the specific chemical composition, methods to obtain or use the gene, or a combination of these. It is controversial to patent naturally-occurring genes, because these genes are discovered, not invented.

Biotechnology companies have used the argument that the moment they isolate and purify the naturally occurring DNA, these sequences are “man-made” and not anymore “naturally-occurring”. The Intellectual Property is therefore attached to the “man-made” sequences. However, the man-made and the naturally-occurring sequences are identical and cannot be distinguished from each other.