Following an earlier post, the ruling by the federal judge 0n the BRCA patents held by Myriad has created a firestorm of controversy in the blogs and in the popular media. Check this out!:
NPR: Gene Ruling Could Have Wide Implications
60 Minutes: Gene Patents
The industry blog Genetic Future has sponsored an amazing commentary from the legal and scientific community: “Jaw-dropping” verdict against Myriad in BRCA patent case.
What’s the real issue? The Myriad patent contains broad claims for not just the test for breast cancer/ovarian cancer, but all other potential tests associated with the BRCA gene on the grounds that the discovery and ability to express the gene in a diagnostic is a patentable invention. The effect is blocking other commercial testing labs from offering a competing (and possibly more cost effective) breast cancer screen. (Note: Myriad test costs $3,200 for one gene. An entire genome scan will soon be cheaper.)
Proponents of gene patenting argue that without patent protection investors will have no incentive to invest in new diagnostics research, and innovation will suffer. Opponents of gene patenting argue that the BRCA patent is blocking research into the role of BRCA in other diseases, and making breast cancer screens inaccessible to a broad market.
So, what is the future of gene patenting?
The days of broad claims on single genes are probably over, though by the time a court makes a final ruling most of them will have expired. Commercial enterprises will keep the status quo. Freedom-to-operate and patent-ability checks will continue. No one know how the courts will rule.
I also expect that the use of engineered sequences for drugs (for example molecular antibodies), treatments, and testing for disease susceptibility using complexes of interacting genes will continue to thrive and be patentable research.
Notably, the BRCA sequences are readily available in GenBank. Out of curiosity, I wondered who had dared to create IP using the human BRCA genes. If your curious, see the report generated from GenomeQuest here.
