Yet another intervention on this subject.
Jack Owens <owenjack@isu.edu>
------- Forwarded Message Follows -------
Date: Tue, 24 Oct 1995 09:35:56 -0700
Reply-to: H-NET List for World History <H-WORLD@MSU.EDU>
From: Ken Pomeranz <kpomeran@benfranklin.hnet.uci.edu>
Subject: Re: Patenting of person (?) -- another reply (fwd)
From: hgreely@leland.stanford.edu (henry t. greely)
Subject: Re: A note to RAFI
Papua New Guinea Patents, the Human Genome Diversity Project, and RAFI
The Rural Advancement Foundation International (RAFI) put out a press
release on Wednesday, October 4, entitled "Indigenous Person from Papua New
Guinea Claimed in US Government Patent."
As a member of the North American Committee of the Human Genome Diversity
Program, I share RAFI's concern about the patenting of a cell-line derived
from a member of the Hagahai population, or from anyone else, indigenous or
non-indigenous, who may not have given fully informed consent to such use
of his tissues or who may otherwise have been treated unfairly. But I am
also concerned that the Human Genome Diversity Project not be treated
unfairly by RAFI. Its press release contained such a host of
misrepresentations and outright lies about that Project that I am compelled
to respond.
Fact -- The Human Genome Diversity Project had nothing to do with the
collection, analysis, or patenting of the cell line from Papua New Guinea
or with the patenting of any other cell lines, indigenous or otherwise.
Fact -- The Human Genome Diversity Project is a regionally organized
project. In most of the world, including the Pacific and the Americas, it
remains entirely in the planning stage. In Europe and China, local
researchers are engaged in pilot studies that might end up being part of
the Project.
Fact -- The Human Genome Diversity Project has stated, over and over, a)
that the Project will not try to capture for itself any commercial value
that its samples or data may generate, through patenting or in any other
methods, b) but that should such value arise, the Project will seek to
ensure that the sampled population gets a fair share of any benefits.
Fact -- The North American Committee of the HGD Project has gone farther
and stated that no patenting or commercial use of samples collected by the
Project should be allowed without the express and informed agreement of the
sampled population, provided by whatever authorities are appropriate within
its culture. We expressly reject unfair and exploitative "gene hunting."
Fact -- The HGD Project has not supported the U.S. government
patent applications on cell lines from indigenous peoples. In fact, I
personally helped the Guaymi General Congress and RAFI persuade the NIH to
drop its patent application on a cell line from Panama. I discovered the
nature of the patent application, the named inventors on the application,
and the background of the patent and passed that information on to RAFI,
which didn't know any of it. I wrote to and talked with the relevant
federal officials in the efforts that led to the withdrawal of the Guaymi
claim. I also offered to help the government of the Solomon Islands in the
same manner.
Fact -- There is not, and never has been, an HGD Project list of
populations to be sampled. In October 1992, a planning workshop for the
Project created a set of tables showing examples of the kinds of
populations that would be of particular interest for studying the genetic
diversity, and hence the genetic history, of humanity. The Project gave a
draft copy of those tables to RAFI, which has proceeded for several years
to refer to them as showing "targeted populations" and now as being "a hit
list." As we have told RAFI often, these drafts were never completed and
the idea of even discussing specific populations as examples was abandoned
more than two years ago because of the way it was being misunderstood.
Fact -- When Edward Hammond of RAFI says "The thin veneer of the HGDP as an
academic, non-commercial exercise has been shattered by the US government
patenting an indigenous person from Papua New Guinea," he is, to be most
charitable, grossly misinformed. The HGD Project is NOT the United States
government. It is an international effort by scholars from around the
world to increase our understanding of our common human heritage. Although
several years ago, it received minor federal funding for planning
workshops, it has no current funding from the United States government. It
hopes to get federal funding, but even then I am sure it would not accept
funding that required the samples to be patentable without the informed
consent of the populations involved.
Fact -- All the facts stated above are known to RAFI and have been for some
time. It may well be useful for RAFI in getting publicity and funding to
have a frightening sounding "Human Genome Diversity Project" or, better
yet, "Vampire Project," to attack. But "useful" is not the same as "fair."
Or "honest." RAFI says it opposes "bio-piracy," the theft of valuable
genetic information from indigenous populations. So does the HGD Project.
The Project, in fact, sees its open, international, non-commercial and
non-governmental structure as a solution to bio-piracy. RAFI apparently
doesn't. We have areas of agreement and areas of disagreement. It is
well past time, however, for RAFI to deal honestly with both the areas of
agreement and disagreement. It is well past time for RAFI to stop lying
about the Human Genome Diversity Project.
I could, and, for the purposes of the Human Genome Diversity Project,
probably should, end here, but in investigating this situation, it has
become quite clear to me that the HGD Project was not the only party
recklessly abused by the RAFI press release. In fairness to the others
involved, I want to say a few words about them, even though I suspect they
will be posting their own responses to RAFI's false charges.
First, the N.I.H. had decided to withdraw its application to patent the
cell-line derived from blood from Papua New Guinea. The N.I.H. changed
its decision at the request of members of the Institute of Medical
Research, an agency of the government of Papua New Guinea. An Institute
scientist is listed as a co-inventor on the patent application and, by
agreement, her half of any proceeds from the patent are to go to the
Hagahai -- not to the co-inventor, the Institute, or the general government
of Papua New Guinea. (The agreement is not part of the patent because
patents do not include information on the distribution of the royalties
they produce -- they just describe the protected "invention.") The
Institute and its staff have sterling reputations for service to the
peoples of their country; this patent issued as part of their service to
the Hagahai. The Institute believed that it could best protect the
interests of the Hagahai by a patent. That may or may not have been
correct, but it certainly was not exploitation of the Hagahai -- quite the
contrary.
Second, the similar patent application for cell-lines derived from the
blood samples from the Solomon Islands was not prosecuted by the U.S.
Government. It was "continued," which means "put on the back burner," last
spring, and I am told that it has now been formally withdrawn. Dr.
Friedlaender's letter to the Ambassador from the Solomon Islands was
entirely accurate about the Solomon Islands application. It also would
have been accurate about the PNG application, except that it did not
foresee the strong request from the PNG Institute of Medical Research that
the patent application from Papua New Guinea be prosecuted.
Third, RAFI, which purports to be know something about patents, has grossly
misstated the nature of this patent. The patent was not, of course, on "a
person." Nor was it on the information contained in the person's genetic
material. Instead, the patent is on a cell-line that is infected with a
particular variant of a virus called HTLV-1 and on the possible uses of
that cell-line in developing diagnostic tests. No patent right was claimed
in the human genetic information whatsoever; that material is present in
the cell-line because it is present in human cells and the virus needs a
human cellular host.
Patents, once issued, are public documents and publicly available. This
patent, U.S. Patent no. 5,397,696, is called "Papua New Guinea human
T-lymphotropic virus" and issued on March 14, 1995, to a group of five
inventors. I have found a copy of the patent in electronic format and
would be happy to send its somewhat turgid and technical prose to anyone
who would like it. The patent included five claims, which are reproduced
below verbatim:
"What is claimed is:
1. A cell line, designated papua New Guinea-1(pNG-1) ATCC CRL 10528.
2. A viral preparation comprising the HTLV-I-variant in the cell line
ATCC CRL 10528 of claim 1.
3. A bioassay for the diagnosis of infection with PNG-1 variant
comprising the steps of:
i) fixing said cell according to claim 1 to a solid support;
ii) contacting said cell with a biological sample from a human
suspected of being infected; and
iii) detecting the presence or absence of a complex formed
between protein of said cell and antibodies specific therefor
present in said sample.
4. The bioassay according to claim 3 further comprising permeabilizing
said fixed cell prior to contacting said cell with a biological sample.
5. A bioassay for the diagnosis of infection with PNG-1 variant
comprising the steps of:
i) preparing a lysate from said cell according to claim 1;
ii) contacting said lysate with a biological sample from a
human suspected of being infected, under conditions such that
a complex is formed between protein of said lysate and
antibodies specific therefor present in said sample and
iii) detecting the presence or absence of said complex."
The patent is, thus, on the infected cell-line, preparations of pure virus
made from the cell-line, and various bioassays (tests) for detecting
infection with this virus using the cell line. No claim is made on any
human genetic material. Making people "the property of the U.S.
Government" is obviously outrageous. Patenting human genetic information
raises troubling issues. Neither happened in this case.