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.

In contrast, as the New York Times article Consumers Slow to Embrace the Age of Genomics discusses, consumer genomic information is not actionable.

Early on during our evolution I was influenced by an interview with Meg Whitman, then CEO of eBay who said there were 5 things people want to do on the Internet: Find, Buy, Pay, Share, and be Entertained. For now, Consumer Genomics is an entertainment business.

When will it become more than entertainment? When researchers have created the association databases with enough statistical quality to make the associations meaningful.

Right now, we see a big market for providing Sequence Data Management for discovery and clinical research applications, where the results of searches is actionable, and therefore more valued by our customers. These many hundreds of thousands of researchers will lead us to millions of doctors and in the future, billions of consumers.

Additional blog posts on the NY Time article:

Gene Expression: Personal genomics is dead, long live personal genomics

Genomics Law Report: The New York Times versus Personal Genomics: Much Ado About Not Very Much