A patent is an exclusive right to commercial use of a claimed invention.
This patent claims as its "invention" the cell-line, viral preparations
made from the cell-line, and bioassays made from the cell-line. Hammond is
certainly right that the DNA of one or more members of the Hagahai is
"part" of this patented "invention" because it is present in the cell-line.
But the DNA itself is not patented and its use is not restricted in any
way. The donors involved can continue, obviously, to use their own DNA to
run their bodies. They could also, if they chose, patent anything they
wanted to patent that was an "invention" from their DNA. If it turned out
that a version of a human gene found in this cell line was a cure for
cancer, this patent gives the U.S. government absolutely no patent or
intellectual property right in such a gene variant. The Hagahai involved
can make any use they choose of their DNA or cells EXCEPT to create their
own cell-lines that are infected with this strain of HTLV-1 and using those
cell-lines for commercial purposes.
The patent is for an invention that contains human DNA, but it is not a
patent ON that human DNA. For example, when you buy almost any animal
product -- meat, leather, hair, or bone -- the material you are buying
contains some of that animal's DNA, but you are not buying the intellectual
property rights to the DNA. If that particular chicken's blood contains a
gene that cures a disease, you wouldn't "own" the intellectual property
rights to the gene. If you bought a piece of paper that had a human blood
stain on it, that blood stain would contain some human DNA, but you
wouldn't own the rights to the information contained in the DNA, let alone
"own" the person from whom the blood came. If you patent a new kind of
electric light, based on a new type of light-producing filament, the
patented invention necessarily includes the glass or plastic bulb around
the filament, but the patent doesn't give you any intellectual property
interest in the bulb. Similarly, this patent is on an invention that
"contains" human DNA, but it is not a patent that makes any ownership
claims to that human DNA -- or to the information it contains.
I do hope this is clear. The distinction is not entirely obvious and I can
see how it could be the subject of honest confusion -- but the patent
definitely does not give the U.S. government (or anyone else) any
intellectual property rights on the DNA of any member of the Hagahai,
although it does give the patentees exclusive commercial rights (in the US)
to one particular kind of cell-line that contains some human DNA.
There are patents "on" human and non-human DNA. Such patents claim the
sole commercial right to use the information contained in that DNA to, for
example, make human insulin or human growth hormone. Whether such patents
are a good thing or not is an intensely controversial topic. The
controversy pits the pharmaceutical industry's argument that it needs some
kind of intellectual property protection to justify investing hundreds of
millions of dollars in developing new drugs that will both relieve human
suffering and make them profits against the arguments that patenting
pre-existing natural DNA sequences inappropriately "commodifies" life
itself. Personally, I think there are some good arguments on both sides.
My own personal preference would be for a non-patent form of intellectual
property protection, similar to the protection provided in the US by a
statute called the Orphan Drug Act, but I don't know how realistic that
solution would be. These are interesting issues, but they are not raised
by this patent.
On the other hand, as Gary points out, patenting cell-lines derived from
individuals does raise important ethical questions WHETHER OR NOT the
patent is on human DNA. Those questions are quite real and do arise in this
case. I have never been to Papua New Guinea, I don't know the Hagahai, and
I haven't met the scientist in PNG named as co-inventor on the patent
(though I've communicated with her by E Mail this month). From what I've
heard from her and others involved in this issue, it sounds as if this
patent was sought at the request of and for the benefit of the Hagahai,
who, if scientists were going to find a valuable virus in their blood,
wanted to get some benefits from it. I don't know from first hand
knowledge whether that's true. If it is true, it doesn't answer all the
ethical questions raised by such a patent, particularly the degree and
depth of the knowledge and consent of the Hagahai to the patent, but it
does seem to remove or at least mitigate the charge that the Hagahai were
being exploited. If, in fact, the Hagahai decided to go forward with this
patent application after full information (which I view as a big "if"),
there remains the issue whether the Hagahai, or any group, should have the
right to make such a decision.
In response to Gary's question in one of the posts, there is a Human Genome
Project as well as a Human Genome Diversity Project. The Human Genome
Project has been up and running for almost six years, at a cost, in the US
alone, of about $200 million per year currently. Its goal is to map and
sequence all 3 billion base pairs of human DNA. The human DNA being used
for the Genome Project is almost exclusively from people from Europe or
North America (as is the DNA being used in almost all research into human
genetics -- because those are the places most, though not all, of the
researchers live.
I appreciate Gary's interest in seeing the truth emerge from this dispute
and I'll be happy to answer any questions, either on the list or privately,
about the HGD Project or what I know about these indigenous patents.
And, by the way, I'm not "Dr." Greely. I'm a humble law professor with
only a law degree. My wife is an MD and if she knew I allowed people to
call me "Dr." Greely, she would be upset.