Tuesday, March 9, 2010

What a difference a year makes

It has been one year since I commented on 23andMe's foray into clinical medicine. I was frankly blown away that such a move would be so blatant without integration of health care practitioners.

I also was blown away that Myriad wouldn't sue the ever living bejesus out of 23andMe. A year later, no lawsuit. I am still surprised about this one. Don't you have to demonstrate protection of your patent to keep it?

Maybe Google/23andMe are paying a VIG to Myriad? I don't know, but it hasn't shown up on Myriad's SEC reports yet......

Why was I so surprised? Well, a few months after 23andMe launched the service AND Myriad did not sue, MYRIAD WAS SUED.

I began to wonder if not suing Google/23andMe was a sign of weakness. I was certain Myriad would then shut down the DTC Genomics BRCA testing.

To date, they have not.

This begs the question, does Myriad think they do not have a case and would lose against Google, thus strengthening the case against them by the ACLU? If that is truly the case and we will begin to see judicial activism in patent removal, well, then we could be in for an EXPLOSION of genetic testing labs out there, each doing their own thing, their own way.

An article in Nature Medicine by Brendan Borrell, does an excellent job of discussing the potential backlash and issues related to DTC Genomics and patent holders. They took the tech line. "Should we really be charged to look in the mirror?" Well, do you have to buy a mirror to look in it? FAIL

The question is: "Will other patent holders see themselves as vulnerable by allowing DTC Genomics companies to test for THEIR patented genetic markers?"

This could prompt a huge wave of lawsuits against these fledgling DTC Genomics companies. Normally, companies sue to shake down, scare away competition and make money or at least protect patents. What we could see is lawsuits designed to crush these young companies in an attempt to scare off the ACLU et.al.

By Myriad NOT suing 23andMe, we may have opened up a new wave of patent paranoia and fear. When that happens companies often turn to the courts to scare away competitors and people hell bent on their (patent) destruction......(ACLU)

It will be interesting to see what this year holds for the Gene Patent......

The Sherpa Says: I would love to hear Dan Vorhaus or Gary Marchant's or Barbara Evans' opinions on these things.........


Andrew Y said...
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Molecular Creativity said...

Freedom to operate may be influenced by the FDA within the next few months?a

Steve Murphy MD said...
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Andrew Y said...
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Steve Murphy MD said...

I just got off the phone with someone doing precisely that right now.

keith grimaldi said...

"But what can tell you is that the guy who invented the mirror probably worked his A$$ off and should be rewarded for such"

A lot of IP is owned by universities. Research group, publicly funded, all paid salaries to do a job (research) - no risk. They make a discovery and patent it, now that (publicly funded) discovery cannot be used until lawyers have worked out a deal and a licence fee is paid. So they get rewarded twice. It's different when discoveries are made with private funds and real risks but publicly funded research should not be patentable.

Steve Murphy MD said...


I tend to agree with you. But I do have a more nuanced view. We need to classify, what part of public funding is required for the trigger of patent denial?

That is something that needs to be addressed. If serendipity leads you somewhere that the grant did not, is that discovery non-patentable?

I have a big problem just giving a statement like that full play.

So yes, I agree. If taxpayers paid for the discovery, the taxpayer should benefit.

But I am not certain to what extent that has been really thought out.

keith grimaldi said...

Thought about it quite a bit. Also lived it many times over many years in both university and industry. I think that there are some IP lawyers who could work out a reasonable IP policy when there is both private and public funding involved, after all, I hear that some of then are as smart as doctors.

Serendipity is not an issue. A serendipitous discovery doesn't all of a sudden yield a patent. Decisions need to be made and those should decide the IP outcome. I'm working in my public lab with my public salary - I discover that some fungus kills bacteria and think, hmmm, I could make a killing here as well. To take it further someone needs to take some risks, to pay for the research needed, pay the lawyers, etc, before any IP can be claimed. If I want to make money I should take the risk, along with others, or I take the easy option and keep my tenure, I shouldn't have it both ways, and nor should my employers.

Cesar Milstein did not patent monoclonal antibodies, Cambridge University and the MRC lost out on billions but the rest of the world benefited, inlcuding the 50 million british taxpayers. Cetus patented taq and PCR, caused a lot of legal fuss but fine, seems fair.

Currently there are a lot of gene variant associations tied up in IP that cannot really be used in tests (useful or not). To create a reasonable panel you have to battle with several university "tech transfer" offices (in quotes because they are often so inept and/or greedy that the transfer hardly ever happens - leaving everyone unhappy, including, usually especially, the scientist(s) who just want their research to be used for something useful.

Obviously it's not all black and white, would be ridiculous to suggest so. A grey area (that I have been in) is working in a university with a group funded by a charity - here there is a case for exploiting any patentable discoveries since the charity would benefit and the funds go back into research. But both have a duty to be reasonable, not be greedy and obstructive (whereas a fully private venture can be as unreasonable as it wants). It's an ideal world that will never happen of course, but I would be nice to have some movement at least in that direction. It's becoming a mess. I understand the opposite arguments in favour of universities and patents, there are some reasonable points but overall I disagree. Since the landmark Cohen-Boyer patents which arguably sowed the seeds I think we have overgrowth that needs some pruning back.

Steve Murphy MD said...

I appreciate your experience and understanding and would love to chat over a beer about it.

Thanks for your points. I think in some places there are too many, where in others there are not enough....


keith grimaldi said...

Damn - there I was thinking you would just roll over and agree with me...

I'll take you up on the beer, or some nive vino rosso if you happen to come over to Italy