Andrea Downing Be Your Own Advocate, Beyond Awareness, BRCA, Data Sharing, ePatient

Congressional Briefing on DNA Patents (a.k.a the post about my right to interpret my genome sequence into poetry)

On March 13th I had the chance to do something I have never done before.

I attended a Congressional briefing!!  There I sat, a fly on the wall in a big drafty room on Capitol Hill full of IP lawyers, scientists, and lawmakers from around the world.  I never thought IP law and BRCA data sharing could be so exhilarating – but I have started to learn how the BRCA community is really just the tip of the iceberg in personalized medicine.

I have been meaning to write a recap of everything going on – and that’s really hard to do, given the depth of technical/legal concepts shared at this thing.  But you know what I learned?  If we don’t understand this stuff as patients, we have big problems in personalized medicine.  So, even though I was exceedingly aware that I wasn’t a scientist or lawyer, I increasingly see the need to write about these concepts from a laypersons perspective.

Here is my best shot….

What was the goal of the Congressional Briefing on DNA patents?

Last year (as you may know) the case of whether BRCA genes could be patented was heard before the Supreme Court.  Justices decided 9-0 that BRCA1 and BRCA2 were no longer eligible for patent, but cDNA is still fair game to be patented.  Since the SCOTUS ruling on DNA patents goes far beyond BRCA, this congressional briefing was organized to talk about implications of DNA patents on the industry.  This case has wide ranging implications in medical research, biotech, pharma, and beyond into the food industry and farming.  There is still debate, interpretation, and confusion around how the case can be interpreted when it comes to DNA patents.

Controversies

Since last year’s decision, many new companies have offered genetic tests that can compete with Myriad’s BRCA tests.  And Myriad is still fighting these new companies tooth and nail.  But these efforts aren’t looking so great for Myriad.  Even though the court battles continue, a federal judge denied an injunction request from Myriad as of last Monday.

A few themes emerged from the workshop….talks that I found helpful came from Bob Cook-Deegan, FORCE VP Lisa Schlager, US Court of Appeals Judge Pauline Newman, and geneticist Chris Mason.  Notes I jotted down:

The BRCA community is just the tip of the iceberg in personalized medicine.  Lisa Schlager talked about this from the perspective of someone who has been an advocate for FORCE for several years.  She explained the history of FORCE and recent developments of new options for women testing for BRCA over the past year.  We have a responsibility to make sure patient data is shared ethically.  Our community can contribute data to research in order to gain a better understanding of the risk for each of our mutations.  We also may help to inform other communities of mutations carriers how research can be done to gain a better understanding of cancer risk.

Our legal system is struggling to keep up with questions raised by gene sequencing technologies.  In diagnostics and therapeutics, gene sequencing technology is creating new challenges for government.  One of the most striking talks of the day came from Court of Appeals Judge Pauline Newman.  I wish I could quote her exactly…she basically said technology is evolving at faster pace than the legal system can keep up with.  It’s not easy for judges to decide on these things – but we have to rise to the challenge.  If there were easy answers, it’s a waste of the court’s time.  Very few people within the legal system have a strong command of both patent law and genetics.   While last year’s Supreme Court win was a big victory, the issue of patents in biotech is so complex and rapidly advancing that the government struggles to keep pace.  Another problem discussed was how the judicial system is a more passive way to handle regulation of the industry – rather than proactive legislation or regulatory bodies.  But what regulatory body is right for the task if we risk slowing the pace of innovation?  

Patients Need Data Rights.  Another theme that emerged was the need to invest in infrastructure to protect the rights and privacy of patients as  incredible amounts of genetic and phenotypic data are collected and shared.   Chris Mason, geneticist at Wiell Cornell, proposed a few during his talk:

1.  The right to look at your DNA
2.  The right to have your doctor look at your DNA
3.  The right to modify your DNA
4.  The right to PCR your genes
5.  The right to interpret your genome & all other ‘omes
And my favorite….
6.  The right to convert your genome sequence to poetry

 

….to this he added at the end – the right to extract your own DNA and learn how to make it glow in the dark and set it next to the shampoo in the shower.  Everyone laughed.  I would add a few to this list above – like the right to know how your genome is being used in research, and the right for patients to give real informed consent.

Of course, these weren’t the only themes from the workshop.  There was also a great deal of talk about how other governments were handling DNA patents, and IP issues around the world.

Here are a few papers that were presented or written by speakers from the workshop:

http://www.nejm.org/doi/full/10.1056/NEJMsa1008268

http://www.nature.com/nbt/journal/v32/n1/full/nbt.2785.html

http://www.uspto.gov/aia_implementation/gene-comment-pressman.pdf

http://www.nature.com/nbt/journal/v31/n5/abs/nbt.2568.html

My question is: what comes next?  How do we take all this brainstorming and do something with it?  I would really like to see patients genome data rights protected in tangible ways, so that the BRCA community can feel safe as we contribute data to research in new ways.  I’d also love to see insurance companies only cover genetic testing companies who contribute BRCA data to a commons, rather than create proprietary databases.