Some Musings on Patent Law

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In Razib’s post Patents, genes and Jews some commentators raised concerns about the patents granted, so I thought I’d expound a bit on this particular issue.

There is a long legal debate underlying the patentability of claims that many critics feel should be classified as being within the Common Heritage of Mankind. I get the sense that many objections that we’re going to see on gene patents in the coming years are going to be framed from such a perspective.

We can go back to the 1600′s and the writings of Hugo Grotius in Mare Liberum where he wrote about that the ownership of goods that were created by nature for common use should be forbidden and that common use is viable as long as the object can be used without loss to anyone else. He was at the time writing specifically about the laws of the sea, but many in the years that followed took these principles of international law to apply to to other realms, such as outer space and agriculture.


Twenty-five years ago when Diamond vs. Chakrabarty was decided it brought the issue of patents for life forms front and center into conflict with with the principle of Common Heritage. The ruling set about a flurry of debate regarding plant life and how the gene poor but industrial West was robbing the poor, but gene-rich, Third World of their genetic resources with as much as 95% of world food crops originating in the developing world. If you’re interested in the views of a defender of Indigenous Peoples who isn’t as hysteric as the persecutors of the Human Genome Diversity Project, you might find this page to be of interest. The author doesn’t begrudge the right of those scientists who add value to genetic material to profit from their work but champions the position of Indigenous Peoples so that they too may also profit from the seed material that is collected from their territory. He notes, afterall, that:

The developed countries have already realized enormous benefits from their access to Third World genetic materials. This is perhaps most clear in the case of crop plants. Few of the crops that today make the United States an agricultural power are native to North America. European colonizers found Native Americans growing maize, beans, tobacco, and squash; but these crops had been introduced from Central America and the Caribbean. A truly North American meal would consist only of sunflowers, blueberries, cranberries, pecans, and chestnuts.

Northern Europe’s original genetic poverty is only slightly less striking: oats, rye, currants, and raspberries constitute the complement of major crops indigenous to that region.The crops that one associates today with the agricultural economies of the developed nations – maize, wheat, soybeans, potatoes, alfalfa, barley, sorghum, tomatoes, cotton, tobacco – have in fact been introduced from their areas of origin in what are now the nations of the Third World. The agricultural development that has undergirded the industrialization of the rich but gene-poor North has been predicated on the collection of genetic materials from the poor but gene-rich South.

Does anyone else see the parallels to the genetic information that is being mined from Jewish, Finnish, and Icelandic peoples with most of the benefits flowing to the researchers? I wouldn’t be surprised to see the same arguments flare-up as human gene patents more frequently find their way into the marketplace.

If such a replay does come to pass, it might help to keep in mind how it played out with plant genetics. The effort to redress the situation resulted in a UN Agency, the Food and Agriculture Organization, at it’s 22nd biennial meeting in 1983 to come forth with a resolution 8/83 that stated “plant genetic resources are a heritage of mankind and consequently should be available without restriction.” This resolution, especially Article 2.1 (a) (v) in the Annex to Resolution 8/83, which read “special genetic stocks (including elite and current breeders’ lines and mutants);” put the FAO Undertaking in direct conflict with Diamond vs. Chakrabarty.

Now politics being what it is, and especially UN-centric politics, I happen to think that the FAO undertaking had more to do with advancing the dead horse of the New International Economic Order than it really did with settling the issues of intellectual property law, the prinicples of CHM and International law.

The developed nations were opposed to the FAO undertaking and its attack on IP law and property rights and their position had three main pillars:

1.) A price can’t be assigned to raw germplasm because, while there may contain useful genes, until those genes are evaluated and traits identified, the germplasm is an unknown quantity.

2.) The collection of germplasm doesn’t deprive a country of a good or benefit. If utility isn’t lost, then there is no claim for compensation.

3.) The FAO undertaking was inconsistent with Intellectual Property rights.

The FAO Undertaking would have had to overturn quite a number of patents, and and for the expired patents, their history and reasoning, such as that found in patent #141072 granted to Louis Pasteur for claiming “yeast, free from organic germs of disease, as an article of manufacture” and precedents established in cases such as Argoudelis, Feldman v. Aunstrup, and a host of other rulings.

What we’re seeing with the BRCA2 gene is the gene has existed in certain populations but there was little that could be done medically with regards to its effects until BCRA2 was evaluated and it’s traits identified, and therefore it remained an unknown quantity. Myriad Genetics has though their work in identification and evalution brought value to the identification of the gene, therefore the test for the presence of the gene is their intellectual property. The fact that it is targeted predominantly at Jewish populations who provided the “raw material” for study doesn’t unfairly target them, nor does it exploit them, for without the research performed by Myriad Genetics the presence, and identification, of BCRA2 within the population wouldn’t by itself create any value. The study of Jewish genes doesn’t deprive the community of any goods or benefits and as a community they don’t lose any utility of those genes, so it’s difficult to base a claim of exploitation when a test for BCRA2 is offered to the commmunity.

10 Comments

  1. As I understand it, there are three kinds of patents: 
     
    1. A device 
    2. A method 
    3. A breed 
     
    In this case they have probably patented the device and method, NOT the gene, since they didn’t “breed” it. That means that if someone can devise a test that doesn’t infringe on their patent (device or method), they could use it.

  2. http://wbln0018.worldbank.org/eurvp/web.nsf/Pages/Paper+by+Henry/$File/HENRY+DRAFT.PDF 
     
    I think that here is the answer :) seems that it is not impossible to patent a gene as a synthetic chemical molecule, the invention of which patent law usually reward by rights over all possible applications

  3. Surely patenting a molecule would only limit its manufacture or distribution? (Assuming you could get a patent on a naturally occurring, not synthetic, molecule, which doesn’t seem right to me.)

  4. With a good patent lawyers and consultants you could patent anything…which doesn’t seem right to me too and I still wonder if there are some limitations.

  5. 1.) A price can’t be assigned to raw germplasm because, while there may contain useful genes, until those genes are evaluated and traits identified, the germplasm is an unknown quantity. 
     
    Unknown quantities and lots are auctioned all the time. I’m thinking here of abandoned self storage lockers. You don’t know what’s in there but you have a good idea of the risk involved. (say 10 self storage lockers with nothing of value to one containing say for instance four high performance car tires and a collection of fancy rims.) 
     
    2.) The collection of germplasm doesn’t deprive a country of a good or benefit. If utility isn’t lost, then there is no claim for compensation. 
     
    Utility is lost if collection leads to a claim for exclusive use, i.e. a patent. Compensation is more about getting everyone with the power to poision the well that a “fair” aggangement has been reached.

  6. As I understand it, there are three kinds of patents: 
     
    1. A device 
    2. A method 
    3. A breed 
     
    Actually there are 3 types of patents but they are 
    1. Utility 
    2. Design 
    3. Plant 
     
    A utility patent covers your device, method and breed (unless your breed refers to plant).  
     
    35 USC 161 defines a plant patent 
    http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_161.htm 
     
    35 USC 171 defines a design patent 
    http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_171.htm 
     
    Here is an example of a gene patent 
    http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=/netahtml/search-bool.html&r=8&f=G&l=50&co1=AND&d=ptxt&s1=gene.TTL.&OS=TTL/gene&RS=TTL/gene 
     
    Surely patenting a molecule would only limit its manufacture or distribution? 
     
    Correct – a patent only gives one the right to prevent others from making, using, offering for sale, or selling the invention throughout the USA or importing the invention into the USA…. 
     
    35 USC 154 
    http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_154.htm 
     
    With a good patent lawyers and consultants you could patent anything 
     
    One doesn’t need a patent agent or patent attorney to acquire a patent and the patent can be based on virtually any subject matter. (here is a great one “Method of exercising a cat” – which is literally shining a laser and hoping the cat follows it) 
    http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=/netahtml/search-bool.html&r=19&f=G&l=50&co1=AND&d=ptxt&s1=cat.TTL.&s2=exercise&OS=TTL/cat+AND+exercise&RS=TTL/cat+AND+exercise  
     
    As stated in Chakrabarty – anything under the sun that is man made is patentable. It really is quite easy to obtain a patent (see cat exercise method above). Obtaining a patent that actually has some commercial value is a completely different story. A qualified patent agent or patent attorney is usually required for patents for the filing of patents that may have monetary value.

  7. There’s no breed patent. Statuory classes of patents are process, machine, manufacture, or composition of matter. 
     
    There’s such a thing as a plant patent, but it’s only for clones. 
     
    Incidentally, there’s also a utility requirement for a patent: You can’t just patent a molecule without claiming some use. I’d doubt if “causes breast cancer” counts as a use, but I guess “identifies a risk for breast cancer” would.  
     
    Really it’s apallingly bad reporting to do a story on a patent without giving the patent number. There are a bunch of patents that mention BRCA2, 
    5,837,492 claims “An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2.”

  8. George – I believe you are describing types of utility patents rather than separate categories of patents. The 3 types of patents are what I listed above: Utility, Design and Plant. 
     
    there’s also a utility requirement for a patent: You can’t just patent a molecule without claiming some use 
     
    Correct – which is why chemical intermediates are not patentable but a molecule such as a gene can have utility as a molecular weight marker (bp number). Utility is most often not a reason for rejection for a patent from the USPTO. If the inventors have proof (research data for example) that the gene did cause breast cancer then that can be its utility. 
     
    I must comment on the original post too. The gene poor/gene rich comments are quite silly. If the plants (insert anything here) had been in use for ages by the local populationin in the gene rich area then they are not patentable since they are not new (a USPTO requirement). No IP is being taken from the locals for the economic of others elsewhere. Even if the plants were patentable back when first introduced into a non-native environment, those patents would have run their course and the inventions would be in the public domain. At present, one has 20 years from filing for patent protection (with some adjustments available). Also of note is that in the US, patents are awarded to the first to invent not the first to file like elsewhere in the world. Thus, if a person in the gene rich area had invented something, someone in the USA would not be able to patent that invention; she/he was not the first to invent.  
     
    Cheers all

  9. observer, 
     
    re: gene poor/gene rich – That’s why I made the comment that I thought the protests at the FAO probably had more to do with reviving the NIEO than they ever did with IP and International law.

  10. Intellectual property law has been tremendously distorted over the last 20+ years by Gates and Disney. The drug companies are cashing in.  
     
    If the plants (insert anything here) had been in use for ages by the local populationin in the gene rich area then they are not patentable since they are not new (a USPTO requirement). 
     
    I don’t think that this is effectively true. I think that that rule is being muscled and jimmied too.

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