Comments on: Genomic Research Goes DTC

By: Maggie’s Blog » Blog Archive » Genomic Research Goes Dtc

Maggie’s Blog » Blog Archive » Genomic Research Goes Dtc — Sat, 05 Sep 2009 09:54:07 +0000

[...] In some ways this Research Revolution is genomic research meets American Idol , with the general public invited to vote by participating in the project and choosing from a list of 10 diseases to support. (Participation costs $99 for a …Page 2 [...]

By: Dan Vorhaus

Dan Vorhaus — Fri, 14 Aug 2009 02:44:08 +0000

Very belatedly I’ll add that these were excellent comments and questions, particularly with regard to the patentability of genes and the interplay between gene patents and whole genome sequencing. In fact, John Conley and I just published a new piece tackling that very topic: http://www.genomicslawreport.com/index.php/2009/08/11/whole-genome-sequencing-and-gene-patents-coexist-for-now/

By: AMac

AMac — Fri, 10 Jul 2009 11:26:41 +0000

hibob’s comment cuts to the heart of a very contentious issue that’s rapidly moving from hypothetical to real. His split is useful:

(1) issues of regulation, licensure, reliability, interpretation, and what it is that constitutes the Practice of Medicine.

(2) IP (“OPIP”).

The suit filed against Myriad and the USPTO under the auspices of the ACLU in May speaks to the second point. CAP et al. say, “genes should be unpatentable.” Beyond that, per hibob, cheap and widely available sequence information and web-based software raise questions even about methods patents.

Perhaps IP and product development trends in molecular diagnostics will follow the pattern set with software, the exemplar of an area where Information is the valuable entity, cheap or free to duplicate, disseminate, and use. As a non-lawyer, the field of software IP seems so arcane that I’m unsure what its guiding principals are, and the extent to which practical accomodations force practices to deviate from theory.

By: hibob

hibob — Fri, 10 Jul 2009 02:09:46 +0000

One issue I haven’t seen addressed when it comes to DTC genetic information: licensing of medical genetic tests. Obviously, while 23andMe and similar companies can tell you whether your eyes are blue they cannot tell you which BRCA1 & 2 alleles you possess and tell you what it means, even though the technology exists for it to be trivial for them to do so. They would have to obtain a license from Myriad, and then get certified to do medical testing.

What about companies that provide raw sequencing information for any sample submitted? Permits from the state aren’t an issue: you aren’t performing a medical test. Licensing from the holders of genetic test IP isn’t necessary: sequencing of DNA is about as obvious as it gets. I could see issues popping up when the company offers to sequence the specific gene in question – anyone could tell this is an end run around Myriad’s BRCA IP. But this isn’t the Betamax case; the information in a person’s own DNA is not intellectual property owned by someone else. it’s the process of interpreting that data w/r/t Myriad’s data that is protected.
So now you have some genetic sequences delivered to your email address. It would be trivial for someone to write software that would do the analysis, score it, interpret the results , and probably even explain them to you more effectively than many doctors could. If the software was distributed for free, it would be impossible to pursue the programmer for IP violations (as long as they had no connection to the sequencing laboratory).
I could see that doctors would not be willing to accept the results, but the future of genetic testing might be:

1.Get raw data anonymously, cheaply, conveniently.
2. Interpret it on the web.
3. If you get bad news, delete the files from your computer, buy the best insurance you can, then wait six months before paying $$$ for the licensed test.

So has anyone asked Illumina or KnowMe if the sequencing data they provide has been stripped of sequences that are relevant to other people’s IP? (OPIP?)