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Myriad Genetics face a judicial ruling against their patent of the BRAC1 and BRAC2 genes.

Solution structure ensemble of BRCA1/BARD1 RING domain heterodimer. Brzovic, Rajagopal, Hoyt, King and Klevit Nat. Struct. Biol. 8:833 (2001) (Source: PDB.)

Solution structure ensemble of BRCA1/BARD1 RING domain heterodimer. Brzovic, Rajagopal, Hoyt, King and Klevit Nat. Struct. Biol. 8:833 (2001) (Source: PDB.)

Judge Sweet presented this as to centre around the issue,

Are isolated human genes and the comparison of their sequences patentable?

(Isolated here means ‘extracted in pure form’.)

His ruling goes on to say,

It is concluded that DNA’s existence in an “isolated” form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issues directed to “isolated DNA” containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. §101.

The full ruling is available on-line as a PDF file. (165 pages.)

To my hurried reading, the Judge Sweet has indicated, no, isolated DNA sequences may not be patented just because have been isolated. Read widely this may have implications, not just for Myriad’s patents on the BRAC1 and BRAC2 genes, but for many other applications.

Chromosomal location of BRCA1. (Source wikipedia.)

Chromosomal location of BRCA1. (Source wikipedia.)

I haven’t time to explore this in detail unfortunately–the ruling runs to 156 pages!–so I welcome comments elaborating on my rushed presentation of this news. The ruling mentions a “partial grant”, so I would guess there’s details to be considered too. (Interested readers find Google News a useful source for further stories on this.)

Patently of gene sequences has been deplored by biologists and many others. It would be excellent to think that this might be the beginning of the end of what many see as legal nonsense. (The judicial ruling outlines how the use of ’isolated’ is used in what others perceive as a ’lawyer’s trick’ to get around ’the prohibitions on DNA patenting of the DNA in our bodies’ in the introduction.)

An interesting take on the patent posted earlier this month, points to a paper by Kepler et al who point out that read literally this patent would cover most genes, never mind just the BRCA1 gene. (The patent claims for ’at least 15 nucleotides’ of the BRCA1 gene; most genes would contain 15 nucleotides that matched.)

HT: Many people via twitter.