Effect Measure

H5N1 sequence release: patent absurdity

An interesting Commentary on the problem of releasing the flu sequences has been posted on the blog Anthropologique by its proprietor, J. F. Brinkworth. I disagree with it, but he makes some pertinent points.

Brinkworth believes WHO is not at fault for failure to release the Indonesian sequences and he provides some information of which I, and probably most others, are not aware:

Indonesia has very, very stringent nucleic sequence I.P. laws. All genetic material recovered there is their property. Their Convention of Biological Dviersity Law No.5 (1994) and Cultural Practices Law No. 12 (1992) effectively prevent all non-Indonesians from removing biological materials from the country for study (academic or commercial). If you are granted permission to remove the material, Indonesia is still the owner and licensee of that material. The WHO and CDC cannot release those sequences. It is not within their legal wherewithall. Nature and Science are aware of this – what’s eating at me is that when the story is referenced, no one ever notes that the release of these sequences would violate Indonesia law, international patent and property conventions and make research in that country much more arduous for foreign researchers.

Indonesia is what is referred to as a mega-biodiverse country. As such,they are a hotbed for pharmaceutical research. They have stringent laws governing genetic material export to ensure that they get a return on the research that is undertaken there by corporations. Given that the same patent protections are offered pharmaceutical companies in this country, I don’t have a problem with this. Everyone deserves the guarantee of a return on their investment. (Anthropologique)

The sequence issue goes beyond what WHO has or has not done or the Indonesian Intellectual Property (IP) laws. WHO has yet to ask Indonesia to release the sequences even though a high Indonesian official has stated publicly they would be inclined to authorize the release. Nor is the sequence issue just an Indonesian one. CDC is said to have thousands of sequences it has not released and the same might be true of other national laboratories and agencies. It is not likely that all of them are held hostage to Indonesian IP laws, or any IP laws for that matter. But there is a bigger issue, here, and that is these IP laws themselves.

Why is it permissible for anyone — the government of Indonesia, a pharmaceutical company, a university, and individual scientist — to patent the genetic sequence of a naturally occurring life form? They should not be patentable by anyone, period. An H5N1 sequence is not the property of the country of Indonesia, any more than it is the property of Roche or GlaxoSmithKline or anyone else. Is the Second Law of Thermodynamics someone’s property? Does quantum mechanics belong to someone? If I measure a constant of nature (e.g., the speed of light) can I patent it? These things are not property in any but the most distorted and perverted sense of that word, which unfortunately is becoming the normal use of the “property.”

Mr. Brinkworth has stated he thinks the H5N1 disease threat is overblown. I don’t know how he could know this, since those of us who follow it closely have no idea whether it is or not. But it is irrelevant. What is relevant is a point he himself makes:

Do you have any idea how many HIV sequences are held without release by pharmaceutical companies? Thousands. When people read this story do they consider how much human proteomic information relevant to TB, HIV and cancer research is being held by companies hoping to make a profit on licensing the sequences and structures? TB and HIV kill 100s and 1000s x more people annually alone than H5N1 has in the last 2 years. Again, I ask why undermine a nation and put everyone’s research and health in jeopardy? If you want the sequences, put the pressure on Indonesia and make arrangements for free academic but fee-based commercial use.

Yes, put pressure on the Government of Indonesia, on WHO, on CDC and everyone else responsible for not releasing biological information (not property) of genuine public health and scientific importance. Let’s do the same with TB and HIV information which is also not property.

Treating genetic sequences as “property” subject to patents is Beyond the Pale. What have we come to? If the law allows this (and in some cases it does), it is time for new laws.

Comments

  1. #1 Mike the Mad Biologist
    July 17, 2006

    Amen to that.

  2. #2 RPM
    July 17, 2006

    When you lag behind the human genome sequencing community in providing open access, you’re in bad shape. Alas, not every can be as open with their data as the Drosophila community.

  3. #3 crfullmoon
    July 17, 2006

    time for news laws, indeed

  4. #4 TJ
    July 17, 2006

    Everyone deserves the guarantee of a return on their investment.

    Is that in the Indonesian constitution?

  5. #5 K
    July 17, 2006

    The numbers quoted for HIV, TB, Malaria are certainly large and worth addressing. An H5N1 pandemic is uncertain but could be devastating. We can’t prepare for every possible danger in the world. However a H5N1 pandemic with even 30% infection rate and 10% lethality would be world shaking. The world is living with current diseases however uneasily. But sudden large worldwide loss of life and sickness would be extremely disabling. Comparing HIV and TB to a possible influenza pandemic is apples to oranges. They spread relatively slowly compared to the flu. So the petty arguments go on and H5N1 goes on oblivious to irrational human behavior. If H5N1 wimps out it won’t care. If humans fail to prepare you can be very sure they will care and they will be really angry at those who let them down.

  6. #6 Dan
    July 17, 2006

    Revere,

    I couldn’t agree more with your analysis of this situation. The sequences, as measurements, views, descriptions of the natural world are not property, even within the definition of ?intellectual property.”

    But I’d like to address another point you noted, a critical issue of its own: “Mr. Brinkworth has stated he thinks the H5N1 disease threat is overblown.”

    The threat is real – the probabilities, the realized severity, the number and extent of the lasting effects can only be measured in hindsight. Thus, whether or not the threat is overblown can only be known in hindsight. Either Mr. Brinkworth is claiming some form of precognition, or he is expressing the view that our reaction to the H5N1 threat is overblown.

    From a risk management perspective, for a given threat, in this case H5N1 pandemic, we attempt to combine the Probability (as a measure of our vulnerability) with the Impact (the totality of effects we can expect), to arrive at an appropriate Response (focus of our re$ources). In the case of the world experiencing another influenza pandemic, the probability is essentially unity, even if the probability of the next pandemic being caused by H5N1 is unknown. Severity in terms of morbidity and mortality are also unknown but we do have clearly indicated similarities between H5N1 and H1N1 whose severity we can now estimate in hindsight.

    A most important aspect of this equation is often overlooked. Strict probability may be unknown or at low confidence, but I believe our Vulnerability (which the probability is meant to be a measure of) can be estimated with much greater accuracy. Many may assume that the modern world (and modern medical science) is far better able to deal with a severe pandemic than the world of 1918-19. Yet article after article explains that our healthcare system has no surge capacity; our vaccine production capacity is severely limited and won?t have much impact until after the pandemic is mostly subsided. Our anti-viral drugs are also severely limited and their power to mitigate or attenuate the pandemic is unknown.

    Meanwhile we have, by design, created a global ?just-in-time? economy, driven by efficiency, which is highly reliant and dependent on the global, rapid and unencumbered transport of goods and materials. Local economies alone cannot long support the infrastructure of our large urban centers anywhere in the world. These highly integrated infrastructure systems have both enabled and promoted the unprecedented population growth and increased population densities we now have. A significant disruption of these systems is a disruption of our collective essential life support.

    In addition to the widespread transport of goods and materials required to support modern urban life, large numbers of people now move rapidly and freely all over the globe at a speed and in a quantity that has no precedent. The result is a new and significant path for a local epidemic to quickly become a pandemic. This not only increases the probability of pandemic (as has the explosive growth and density of both human and domestic animal populations), it also effects the speed of spread of any virus which is contagious prior to being symptomatic, enhancing a disease?s ability to overwhelm our healthcare and other infrastructure elements. We have in fact, created a new, modern set of interrelated vulnerabilities that render impotent any comparison to past epidemics. Understanding that kind of vulnerability in terms of global economic resilience (or lack thereof), greatly enlarges the understanding or measure of Impact which should result in suitably increased Focus.

    With this perspective, it is most difficult to understand how our current response to this very real threat could be considered overblown.

  7. #7 hank
    July 17, 2006

    Hmmm. If I catch a strain of a virus, would I be entitled to do a search for the owner and claim some kind of compensation for their failure to control their wandering property?

  8. #8 STH
    July 17, 2006

    I think the owner would sue YOU, hank, for “using” that intellectual property without the owner’s permission. Or perhaps the owner would demand a commission for all the free copies of the virus you’re making (kind of like a pirated DVD).

  9. #9 mary in hawaii
    July 17, 2006

    First..Dan, excellent! I am going to use your arguments in my science class to open discussion on this subject (with your permission.)
    As regards the intellectual property rights debate, what? If you write a book and you copyright it, that protects your compensatory rights to that IP for a given number of years. Then it can be published and read by millions without concern someone will try to use it for commercial benefit without your permission or proper compensation. Same with patents, etc. What makes the genetic sequencing thing different? If those who uncovered the sequences in H5N1 or HIV or whatever have already filed these as their IP under the equivalent of copyright laws, if someone then uses them to make a vaccine or cure, they would legally get at least a piece of the pie, wouldn’t they? In this era of specialization, I can’t imagine the guys that do the genetic sequencing are also the guys who work on inventing vaccines based on these sequences, so the only reason for withholding genetic sequences of these diseases is if they are all simply drones in some giant pharmaceutical company seeking big bucks at the expense of the public welfare.

  10. #10 Dan
    July 17, 2006

    Mary: Permission granted! On intellectual property rights, I think we can differentiate between the facts I report on in my book, from the thoughts, theories, speculation, or poetry that I add as my IP. Just because I’m the first to write about a new species of blue tree frog, doesn’t mean everyone else needs my permission to also write about that frog, but they better not claim my observations, thoughts and theories as their own. I probably also have a “right” to name the frog, but I don’t own it. If a lab comes along and learns that the frog produces a toxin that could be a cure for some cancer, I don’t own that either but I’d sure like mention (credit) for having discovered the frog.

    In the case of these sequences, the vaccine formula is IP; nature’s formula for the virus is not. The gray area we are concerned with is our discovery of nature’s formula. I can’t argue with what a country’s copyright laws are, but I can argue that on practical terms, if we can copyright all discoveries, the advancement of knowledge will quickly grind to a halt (if only under the sheer weight of beauracracy!). I agree with Revere. These things are not property.

  11. #11 K
    July 17, 2006

    Dan, great post – I was trying to think of an analogy today – for those of us who can’t get our brains around risk, probability etc. This one is not perfect but it gets in the ballpark.

    Every year many people die from the pollution in the air from coal burning electric generators – this is an important concern and needs to be addressed although it weighs less heavy on the minds of those who live far away and not down wind from such places. Nuclear power plants don’t give off airborne particles like the coal burners, yet they have the potential to melt down and spew radiation for long long distances. Unlikely perhaps, and only once in Chernobyle did the worst happen. Still it is possible and Three Mile Island gave us a warning it could happen in the US. While still monitoring coal burners we MUST prepare vigorously to prevent any Nuclear Power plant from Meltdown and to react if any should.

    I think that works passably as an illustration of why we must prepare for an ever more likely H5N1 pandemic even though folks are dying from other diseases as we speak.

    Unfortunately few realize that our modern civilization has vulnerabilities – many of which Dan mentioned. The lack of planning for emergencies in the US adds to the institutional vulnerabilties – many brought about by globalization which makes the whole world our store, but reduces local self sufficiency.

  12. #12 Jun
    July 18, 2006

    Petition to release H5N1 sequences:

    http://www.petitiononline.com/h5n12006/petition.html

  13. #13 Dr. C
    July 18, 2006

    As I understand it, individuals don’t have any rights to any therapeutic products derived from their genetic material, at least as decided by US courts.

    When clinical research subjects sign consents for anything involving their genetic materials, in effect, they sign away all rights to them. Of course, most clinical subjects don’t understand this.

    I can understand that what a company develops may rightly belong to the company, but it seems odd that the base material, if it has a therapeutic value, even if a company does nothing to it, still belongs to the developing company, and not even a percentage belongs to the research subject.

    Doesn’t make sense to me, but it must to lawyers.

  14. #14 Dr .C
    July 18, 2006

    PS. So, if my genes provide the cure for cancer, tough luck.

    Right now pharma is acquiring, banking and studying huge numbers of genetic samples from clinical subjects, for all sorts of diseases, and all they are garuanteed is anonimity.

  15. #15 Interrobang
    July 18, 2006

    Mary — Unfortunately, your analogy doesn’t work very well. It’s really quite simple. It doesn’t matter who does the sequencing, that’s still not like writing a book. If I write a book, that series of words, of ideas, of everything I put into it comes from inside my head. It isn’t just floating around out there in IdeaLand until I come along and dig it up, or something (Harlan Ellison’s quip about the idea delivery service in Schenectady notwithstanding). The people doing the sequencing aren’t coming up with the ideas, they’re just uncovering what’s already there, which comes from complex natural evolutionary processes. A better analogy for what gene sequencers do, and why it’s ludicrous to patent genetics, is cartography — you may have drawn a map of the terrain, but that doesn’t mean you own the land. Even the early New World explorers didn’t necessarily get that kind of clout.

    Since I’m a professional writer, I hate to see analogies about copyright and other forms of IP misused…

  16. #16 Ground Zero Homeboy
    July 18, 2006

    Odd, accd. to a recent NYTimes article:
    “It turned out, though, that the bucindolol trial was unique in heart disease research. Genetic material is not obtained from patients in most studies, but the researchers who conducted the bucindolol trial insisted that the participantsí DNA be collected and stored.”

    http://www.nytimes.com/2006/07/11/health/11pros.html

    The Indonesian I.P. laws are aimed at drugs derived from native plants&animals. Scanning vast numbers of compounds drops rapidly in price from technology advances. If someone makes money off this stuff, it should include a few Indonesian kleptocrats.

  17. #17 Dr.C
    July 18, 2006

    I review research in an IRB, over half of the studies now obtain genetic material from subjects, and the consent forms have a section on “Commercial Issues” where it makes clear what belongs to whom. Guess who owns nothing?

  18. #18 ugis
    July 18, 2006

    G8 commitments to infectious disease can improve global health security
    17 July 2006
    ST PETERSBURG — Today, the Group of Eight vowed to improve the ways in which the world cooperates on surveillance for infectious diseases, including improving transparency by all countries in sharing information. …
    http://www.who.int/mediacentre/news/statements/2006/s11/en/index.html

  19. #19 Henry Niman
    July 18, 2006

    This entire discussion is nonsense, About 50 sets of H5N1 avian sequences from Indopnesia have been released (as has HA and NA for the index case). There are more released after each publication (dating back to2003), and when the human data are published, the sequences will magically be “released”.

    Even sequences from India were released (and Malik Peiris was a co-author).

    http://www.recombinomics.com/News/07170601/H5N1_India_Recombination.html

    When the sequencers publish, the sequences appear.

  20. #20 mary in hawaii
    July 18, 2006

    Interrobang: just to clarify, I am a published author as well a being a teacher…although I wouldn’t call myself a “professional” as I’ve never made enough money on writing to eat. even poorly. Nonetheless, alot of writing is based on research and data from the “real world”, not just flights of fancy developed in one’s head (unless you’re HP lovecraft). Thus one extrapolates from the real world and rearranges facts intermixed with imagination to create a work of fiction. Point being, my analogy wasn’t all that far off.

  21. #21 g510
    July 19, 2006

    I’m with revere et. al.: raw nature is not IP. The whole idea that you can have IP rights over a fact of nature you happen to discover, is so far off the charts of insanity I can’t even find words for it. I’ll go further and say that the entire framework of modern IP law is strangling creativity on all fronts, shutting down progress, and slowly strangling free speech; a digital-era enclosure of the commons; and should be overturned by any available means including mass boycotts and overt nonviolent civil disobedience.

    (Speaking here as someone who at times has earned part of his living from his writing, and has friends who’ve earned theirs from their music (albums and concerts).)

    What is likely to happen: lots of people drop dead while the kleptocrats keep raking it in, until enough people cry FOUL! loudly enough to have an effect in the legislatures.

    OTOH we’re overdue for Ma Nature to clean house, so franky we deserve what we get. Meanwhile those of us who know enough to take the proper precautions (e.g. self-quarantine during each wave) will survive in larger numbers than those who don’t.

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