A disquieting blend of genes and patents

Patents and genes

The Legal Genealogist loves genetics. I am a self-confessed DNA junkie and never met a DNA test I wouldn’t take. And The Legal Genealogist loves patents. Not only are they wonderful tools for genealogists to use in adding depth and breadth to our family histories, but there’s just something cool about the very notion of inventions — even the word with its implication of technological progress seems a wonderful and wondrous thing.

But The Legal Genealogist confesses to being totally, thoroughly, absolutely discombobulated by the notion of combining genetics and patents. It strikes me as being just plain wrong in a very fundamental way that there is such a rush to patent genes and genetic tests and genetic results and…

And so The Legal Genealogist casts a distinctly jaundiced eye on the recent announcements of genetic genealogy testing company 23andMe that it has secured a patent, U.S. Patent No. 8,187,811, “Polymorphisms associated with Parkinson’s disease” and that it has acquired CureTogether, Inc., a company that allows persons with health conditions to share information about health issues and connect with others suffering the same ailments.

It’s not that my genes and my responses to 23andMe’s health questionnaires were used (or at least could have been used) in isolating genes that create a predisposition to Parkinson’s Disease or that may be protective against the disease. I gave permission for their use in research when I signed the consent form to be tested with 23andMe: “Giving consent by checking the appropriate box below means that you agree to let 23andMe investigators use your Genetic & Self-Reported Information for 23andWe research.”

It’s not that 23andMe didn’t tell me, and others, that it wouldn’t pay me for any use it made of my information. The consent form says that “If 23andMe develops intellectual property and/or commercializes products or services, directly or indirectly, based on the results of this study, you will not receive any compensation.”

No, what gets me is what exactly 23andMe has patented. The patent was issued for:

a method for screening a human subject for susceptibility to Parkinson’s Disease (PD) … comprising:
• obtaining a nucleic acid sample from the human subject;
• determining whether (a particular marker) is present in the sample at (a particular location); and
• identifying the human subject as having an increased risk of developing PD if the subject has (that marker at that location).

In other words, this patent is being issued for this “invention”: if person A has marker B at place C in his or her DNA, then the person’s chance of developing Parkinson’s is D.

There’s nothing about the patented “method for screening” that changes A’s condition from before the screening to after the screening. This won’t put the marker there if the person doesn’t have it or take it away if the person does have it. And there’s nothing about this method that changes the fact that people with marker B at place C in their DNA have a D risk of developing Parkinson’s.

In my book, this isn’t an invention, it’s a discovery — a discovery of a purely natural phenomenon. And this patent is like giving Einstein a patent for discovering that E=mc2.

Now, some truth in advertising: I am a breast cancer survivor. I was faced a few years ago with the question of whether to have a genetic test for the BRAC1 and BRAC2 genes that greatly enhance a woman’s chances of developing breast and/or ovarian cancer. Because of a lack of family history and the specific kind of cancer I had, my insurance company was unwilling to pay for the test.

One hitch: Myriad Genetics holds the patent on the BRAC1 and BRAC2 genes. Just exactly like the situation in this 23andMe patent, Myriad Genetics didn’t create the gene, or change the person’s status or condition, or change the fact that people with BRAC1 or BRAC2 have an elevated risk of cancer. All it did was patent the connection and say nobody else could test for BRAC1 and BRAC 2.

And because of Myriad’s patent — a patent that’s been challenged in the courts for years without final resolution — I couldn’t shop around. I had one choice for the test — Myriad — and the cost would have been more than $4,000.

After consulting with a genetic counsellor, I opted not to have the test. But at least, for me, it was an option. If my life had been on the line, I could have found the $4,000. For many women, coming up with that much cash is out of the question, especially in light of all the other costs of cancer treatment.

Now 23andMe says “23andMe will not prevent others from accessing their genetic data or its interpretation specific to our patents. Other entities can present information about the genetic associations covered in our patents without licensing fees.” That sounds like a pledge not to limit this testing method to a single company with fees running into the thousands of dollars the way Myriad Genetics charges for its test.

But 23andMe then goes right on to say: “Patents give organizations researching and developing new drugs confidence that their significant investments will be commercially viable. Developing new drugs and treatments costs time and money. A lot of time and money. Often the only way a company will even think about pursuing a drug lead is if they have assurance that they can recoup their investment. Having patent protection over the entire line of discovery gives a company confidence to invest in this resource-intensive process.”

It’s awfully hard not to read that as a warning that somebody is going to need to charge for this test the kind of money Myriad Genetics charges for its test in order for pharmaceutical companies to develop drugs for Parkinson’s and similar ailments.

My problem, and that of others who’ve commented on the 23andMe patent is that the patent doesn’t say a thing about treating Parkinson’s. It only covers a method of detecting a predisposition to the disease — in other words, like the BRAC1/BRAC2 test, this is for diagnosis, not treatment. Blogger Stuart Hogart at genevalues asks bluntly:

1) If your intent was only to support therapeutic R&D then why does the patent cover diagnostic applications?
2) Will you try to prevent other companies selling Parkinson’s Disease tests for these (markers), or, will you seek license fees from other companies selling Parkinson’s Disease tests for these (markers)?

There aren’t any clear answers yet. And the picture isn’t made any clearer by 23andMe’s purchase this past week of CureTogether, another crowd-sourced health-information-exchange system. What it will do with that data, what it intends to do, is very much an open issue but spending hard cold cash on what has been a free resource surely suggests some intent to find a way to get hard cold cash in return.

At this point, I can only hope that this turns out to be a tempest in a teapot. 23andMe may donate its patent to a non-profit corporation. Or, ultimately, the courts may well rule you just can’t patent genes, genetic markers or genetic tests. In March of this year, the U.S. Supreme Court ruled, in Mayo Medical Labs. v. Prometheus Labs., that phenomena of nature can’t be patented. And it’s hard to see how the patent claims here (if person A has marker B in place C, then the likelihood of Parkinson’s is D) are any different from the claims struck down in that case.

But in the interim… well… let me just say … I’m not answering any more health surveys from 23andMe.

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14 Responses to A disquieting blend of genes and patents

  1. CeCe Moore says:

    Nice coverage of this issue, Judy. It certainly gives us all a lot to think about. Thank you.

  2. While this doesn’t surprise me, it disappoints me that our Court System didn’t turn down the first request of this nature. As you point out this is a discovery, not an invention. The fact that women (and men) may not be able to afford a test to rule out a disease because there’s only one source simply infuriates me.

    I was fortunate to be able to take a 23andme DNA test through a grant OpenSNP received. I was excited about the prospect of having my DNA captured as I’m the last person in my direct genetic line, and I have a rare blood disorder. The idea that 23andMe has the potential to make a test to determine if someone has this disorder available in only one place, or so cost prohibitive that only a few can afford it, makes me think of the SciFi movies of old. Control access to information and you control everything. It’s a little scary imho…

    • Judy G. Russell says:

      The notion of a patent on this sort of thing is distressing, indeed, Laura. Let’s hope the courts respond appropriately.

  3. Dave Dowell says:

    For better or worse our forefathers included “discoveries” in Article 1, Section 8 of the U.S Constitution: “Congress shall have the power to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their writings and discoveries.”

    • Judy G. Russell says:

      The mere discovery of a natural phenomenon has been expressly held by the US Supreme Court NOT to be patentable.

  4. Martha Forsyth says:

    End of the 4th paragraph, “Giving consent by checking the appropriate box below means that you agree to let 23andMe investigators use your Genetic & Self-Reported Information for 23andWe research.” – should that next-to-last “word” read “23andMe” – or is there a subtlety going on here?

  5. Judy,

    Interesting post, as always. I have a few thoughts I wanted to share. While I always try to remain unbiased and professional, I should note that I am an intellectual property attorney. Some will probably discredit my opinion because of this (or because I’m an attorney to begin with!), but I thought I could at least present my views on some aspects of the debate.

    You say that “There’s nothing about the patented ‘method for screening’ that changes A’s condition from before the screening to after the screening.” I disagree completely; as a result of the ‘method for screening’ A now knows her genotype for that SNP and has some additional information about her risk for Parkinson’s (the actual value of this additional information is another debate that shouldn’t be confused with this one). Prior to the screening, A had no knowledge of the Parkinson’s information. And before the association was discovered by 23andMe, A couldn’t have known the Parkinson’s information, even though the risk existed in her body.

    Regarding the diagnostic v. therapeutic aspect, a patent can only be directed to something you’ve invented. For example, I can’t apply for a patent for drug X claiming that it cures cancer, because I haven’t invented a drug X that cures cancer (part of the exchange for being granted a patent monopoly is that you describe the invention in the text of the patent so well that you actually ENABLE the public to make it or practice it themselves). 23andMe can’t apply for a patent for a therapeutic unless they discover a therapeutic, and I haven’t seen anything indicating that a therapeutic has been discovered.

    Further, in my opinion the claim in the 23andMe patent is very different from the claims in either Mayo (which didn’t involve DNA), or Myriad (in which the disputed claims are simply directed to either isolating the BRCA gene, or to comparing a patient’s BRCA sequence to the “normal” sequence to identify the presence of 1 or more mutations). The claims are so different that even if all the Myriad claims are eventually invalidated, that would have no effect on the 23andMe patent.

    Lastly, the most controversial comment, and one on which we likely won’t agree. In my opinion, the natural phenomenon here is that the presence of a “T” at rs10513789 results in an increased risk of Parkinson’s; in other words, there is some process in the body that involves Parkinson’s and rs10513789. But as I note above, 23andMe has not patented that natural process; they have instead patented a method for identifying a person’s individual risk for Parkinson’s based on their genotype at rs10513789; information that the person did not – and could not – have previously had regardless of whether the natural phenomenon was operating within him. If Einstein had invented a tool that allowed him to identify the natural phenomena of E=mc2, we wouldn’t have a problem with him patenting the tool. But that wouldn’t grant him a patent on the underlying phenomena of E=mc2.

    Just a few thoughts, looking forward to yours. Blaine

    • Judy G. Russell says:

      I definitely appreciate your take on this, Blaine, since we’re surely coming at this from different viewpoints. And I confess that I can’t quite bridge the gap between the discovery and the need to fund the discovery process without some sort of intellectual property protection or what have you. I suppose my bottom line here is that these sorts of discoveries inevitably call into question the moral underpinnings of unconstrained capitalism in personal health cases. The people who could be most benefited by the discovery end up paying… and paying… and paying… far beyond the reasonable costs of the discovery itself (particularly in a case like this where the crowdsourcing so greatly reduces the costs of research).

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