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2010 October 31

Patentability of DNA

Filed under: Uncategorized — gasstationwithoutpumps @ 10:33
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The New York Times yesterday reported on a new friends-of-the-court brief by the US Department of Justice about gene patenting.

The brief correctly asserts that merely isolating DNA does not change the DNA from being a “product of nature” and so unpatentable.

New and useful methods of identifying, isolating, extracting, or using genes and genetic information may be patented (subject to the prohibition against patenting abstract ideas), as may nearly any man-made transformation or manipulation of the raw materials of the genome, such as cDNAs. Thus, the patent laws embrace gene replacement therapies, engineered biologic drugs, methods of modifying the properties of plants or generating biofuels, and similar advanced applications of biotechnology. Crossing the threshold of section 101, however, requires something more than identifying and isolating what has always existed in nature, no matter how difficult or useful that discovery may be.

They do try to allow patenting of manipulated DNA, which is overall a valid goal.  But I think that they err in claiming that all cDNA is such a manipulated DNA, and so patentable. My belief is that DNA sequences should be patentable only if the sequence itself has been manipulated: that there has been some change from the “wildtype” sequence that occurs in nature.  Since cDNA is just a transcription of naturally occurring RNA sequences, it should not be patentable just because it has been transcribed. Otherwise we get into the silly situation where writing down a natural sequence makes a patentable object, because it is now in a different format.

Industrial and medical applications of DNA, RNA, and proteins should be patentable, even if the underlying sequence is a product of nature and not patentable.  Inventions should be patentable, but discoveries should not be.

The friend-of-the-court brief does not go quite far enough in removing the ludicrous patentability of genes that is currently practiced by the Patent and Trademark Office.  They continue to focus on the chemical nature of the gene and not its information content, thus missing the main point of DNA.  One even suspects that they were bending over backwards to retain the patents for friends of theirs (this is the interpretation of their action as being corrupt, rather than simply stupid).

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7 Comments »

  1. What about an isolated rare mutant? I generally with you in opposing patent-ability, especially as practiced currently by the Patent office, but I do worry about not thinking through the full ramifications (i.e. I haven’t, and I do think patenting inventions is useful for making innovation available).

    The recent amicae briefing (and the absence of the Patent Office in it) is very interesting, and does make one start worrying about who the Patent office thinks they’re serving. Rather than straight-out corruption, though, the problems might be a result of the “regulatory” capture problem liberationists like to talk about. I can see the reasons for capture: the people at the agency interacts with and understands and is generally a part of the social and professional network of the regulated industry, not of the “public.”

    Comment by bj — 2010 October 31 @ 10:57 | Reply

    • I think that isolating a rare mutant in a natural population counts as a discovery, not an invention. If a bacterial or yeast population is manipulated to induce an evolutionary change, and a mutant is isolated from the manipulated population, I believe that one could claim invention, rather than discovery. There is a bit of a grey area, if the mutation exists at low levels in the wild-type population.

      It is fairly easy to make patentable genes by making a few mostly irrelevant changes to a wild-type gene. Such genes are not, of course, useful for the sort of diagnostic test of human genes that triggered the particular patent case (the patents for BRCA1 and BRCA2 mutants that are associated with breast cancer).

      Comment by gasstationwithoutpumps — 2010 October 31 @ 12:45 | Reply

  2. I suspect that we are missing another point as well. Consider the case of a wildtype DNA sequence that is part of a useful mechanism that is not from the wildtype organism. This might occur as a useful binding sequence, or as a representation of some useful protein or RNA.
    Consider some useful function – say 5′ phosphorylation, or a DNA polymerase used in PCR. The DNA sequence is a useful representation of the protein sequence, which under a specifically described biotechnical application might be useful and patentable even though this is wildtype within a specific cell.

    As another example, consider an integrase protein and its associated attachment site. If this protein and attachment site are useful as a method of manipulating DNA in-vitro, shouldn’t that attachment sequence when used within the method described be itself protected when used in this mechanism?

    Yes, protection for the original sequence as a “discovery” should not enjoy patent protection. When it is used as part of an “invention”, then it should be patented.

    We should remember what the purpose of a patent is…
    “Congress shall have power . . . to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”

    The intention of Article I, section 8 of the constitution is to promote disclosure, and to thereby promote progress.

    Comment by David Bernick — 2010 November 1 @ 19:33 | Reply

  3. I agree that the use of a specific protein as a reagent for a particular purpose should be patentable, and that the sequence of the protein should be part of the description of the invention.

    Synthetic DNA genes for a protein (say optimized for expression in E. coli) should also be patentable, even though the wild-type DNA sequence would not be patentable, since the manipulation of the sequence to optimize expression would constitute an invention.

    Comment by gasstationwithoutpumps — 2010 November 1 @ 21:54 | Reply

  4. I completely concur and have been writing and blogging about this, with the same position, for a year and a half. Keep up the good work.
    David

    Comment by David Koepsell — 2010 November 3 @ 12:48 | Reply

  5. @gasstationwithoutpumps I enjoy the simplicity of your litmus test for patentability and concur with alacrity.

    Comment by Jeffrey Long — 2010 November 9 @ 18:53 | Reply

  6. [...] Patentability of DNA [...]

    Pingback by NaBloPoMo is over « Gas station without pumps — 2010 December 1 @ 00:17 | Reply


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