TO: Concerned Readers
FROM: Pat Mooney and Edward Hammond, RAFI
RE: U.S. Patent on Hagahai Person's Cell Line
DATE: October 25, 1995
REF. M951025.318/P486
We regret that this response has been delayed due to the travel of those
RAFI staff members most directly involved. Since the discovery of the PNG
patent, Pat Mooney has been traveling extensively in Europe and North
America; Edward Hammond has been in various parts of North America en
route to Asia; and Jean Christie, who was in the Pacific at the time of
the discovery, is en route back to Canada from Australia. Meanwhile, Hope
Shand is in Guatemala. Most of RAFI's small staff are preparing to leave
for Jakarta to raise intellectual property/life patenting issues at the
second conference of the Biodiversity Convention.
Two people associated with the Human Genome Diversity Project (HGDP) have
recently reacted to RAFI's 4 October News Release regarding the patenting
of the cell line of an indigenous person from Papua New Guinea. We would
invite concerned readers to review Dr. Friedlaender's and Mr. Greely's
correspondence carefully - along with RAFI's actual news release
(http://www.charm.net/~rafi/release01.html) - this note, and the patent
itself (http://www.charm.net/~rafi/patent.txt).
The dispassionate eye - we believe - shows clearly that neither of the two
gentlemen has a sufficient grasp of the patent in question to offer useful
comment. Indeed, their correspondence continues to confuse and obscure both
the scope of the patent and the significance of the U.S. Government's
claim. Further, Dr. Friedlaender and Mr. Greely, perhaps unintentionally,
divert discussion from the role of the patent-holder (again, the U.S.
Government) to draw in individual scientists and, also, institutions in
Papua New Guinea not even mentioned by RAFI. Importantly, their defense of
the HGDP (especially Mr. Greely's) creates more questions than answers.
Readers will, of course, decide for themselves.
RAFI has always been, and still is far more concerned about trends in life
patenting, and their risk for legal precedents than we are about any
individual's motives. As a Professor of Law at Stanford University, Mr.
Greely should have a better understanding of the risks of legal precedent
with this patent than he indicates through his correspondence.
In this reply, we will avoid the dubious approach taken by Mr. Greely in
proclaiming "facts" and "comments". Most of his "facts" were "comments"
and some of the "comments" soar close to the level of "facts." We will
leave it for readers to sort truth from fiction.
First, for those expecting a retraction, there is none here. With the
single exception of identifying Dr. Friedlaender as a staff member of the
NIH (instead of NSF which, in this field, works closely with NIH and is
also US Government funded), we are perfectly content that the news release
is correct in every detail. If the NIH reference caused Friedlaender any
problem, the corrected release sent out later the same day, was probably
more of a relief to the NIH than to him.
Life Patenting:
Over the past 15 years, the USA has set world precedents in all areas of
"life patenting", including patents over microorganisms, plants, entire
plant species, and animals - including mammals. RAFI has monitored these
trends closely. The US Patent and Trademarks Office also, in the
mid-eighties, began permitting patents on human genetic material.
The current patent by the US government on a human cell line of a PNG
citizen sets yet another precedent by allowing the government of one
country to patent the genetic material of an indigenous citizen of another
country.
Two new international accords facilitate the globalization of U.S. patent
policies (especially with respect to life form claims). Both the General
Agreement of Tariffs and Trade (GATT) and the Biodiversity Convention
promote life patenting. GATT, by obligating signatories to pass
intellectual property legislation over life forms; the Biodiversity
Convention, by stipulating that such legislation must be respected.
Intellectual property clauses of the GATT agreement require states to
adopt patent laws covering microorganisms and (some form of protection
for) plants. International precedent - under the Budapest Convention -
has led to the treatment of human cell lines as nothing more than a form
of microorganism - in the same class as fungi, bacteria, or viruses.
Thus, GATT mandates the patenting of human material. There is great
danger that the Biodiversity Convention - already in favor of patenting -
will accept the GATT definition of a microorganism and also incorporate
human genetic diversity within its authority.
For 18 years, RAFI has argued (correctly) that intellectual property
precedents in the US set the pace for intellectual property practice
internationally. We continue to say so; to oppose the privatization of
living organisms; and to publicize and oppose precedent-setting cases as
they arise. We believe that current patent claims involving human cell
lines are opening the door to private monopoly control over human genetic
material.
U.S. Patent 5,397,696
Dr. Friedlaender and Mr. Greely do not seem to be aware that the U.S.
Government has filed for at least three patents on the human cell line of
a Hagahai person. Two of the patents are pending at the European Patent
Office in Munich (for patent protection in 19 countries), and one has been
granted in the United States. These three patents are not in all respects
identical. For example, the European and U.S. versions list different
sets of co-inventors. While RAFI suspects that all the patents/applications
are similar, they may vary in one or more important details which could
affect their legal consequences. Are Dr. Friedlaender and Mr. Greely aware
of these distinctions? Can they explain the differences in inventors and
other detail? If so, this would be a useful contribution.
Friedlaender and Greely argue that the patent is not on a human cell line.
Dr. Friedlaender refers to the Hagahai patent as a "gene patent
application." As RAFI's press release makes clear, US 5,397,696 is not a
patent on a gene; but rather a patent on a "human cell line." Neither is
the patent - as Dr. Friedlaender erroneously writes - on a "pooled blood
sample from about 20 Hagahai;" but rather on a cell line belonging to one
20-year old Hagahai man. Moreover, in the course of their research,
scientists drew blood from not 20; but 120 people - nearly half of the
entire Hagahai population. RAFI's information here is taken directly from
the text of the patent itself.
Whatever the inventors motives were, whatever disputes there may have been
among US policy makers, and whatever the US government now claims to be
its policy regarding the patenting of human DNA and DNA fragments - the US
government granted itself a patent on March 14, 1995, which covers a virus
and a human cell line as well as several of their uses. The patent's
title says it covers a virus. Its first claim is on a human cell line.
The cell line denotes the unique physical identity of an indigenous
person, a citizen of Papua New Guinea. It is inexcusable for Dr.
Friedlaender to make so many factual errors - once again - in describing
this patent. We urge him, probably for the first time, to read the patent
for himself before he offers further misinformation. In a further note
just received from Mr. Greely as to whether the patent is or is not on a
human cell line, we see that he has changed his position and is now
admitting that the patent does incorporate the human cell line itself,
although he is still clouding this essential point by arguing that since
no specific functions are assigned to the cell line that this is not
important. Please observe that his position has changed although he
continues to be wrong.
Biotechnology companies explicitly claim organisms containing any DNA or
cells that they have patented. Indeed, a patent lawyer and representative
of Calgene - one of the world's largest patenters of life - recently told
us, "Any organism that contains [Calgene] patented material is the
property of Calgene." (See the index of RAFI Communiques at our WWW site
for further background on these trends.).
Both gentlemen tell us that the U.S. policy on human cell line patenting
changed from the Bush to the Clinton Administration. We hope they are
right. We ask them to provide us all, immediately, with the new policy
statement - or any letter from any authorized government officer stating
government policy in this regard. If such documentation cannot be
provided, we will have to assume that the letter from Mr. Ron Brown,
Secretary of Commerce, to the Ambassador of the Solomon Islands (quoted in
our news release) remains the government attitude/policy and that the
government's actions in applying for patent rights to human cell lines in
Panama, Papua New Guinea and Solomon Islands are the best indication of
this Administration's policy. It is, to put it mildly, a stretch to
expect concerned readers to believe otherwise.
Benefits Agreement:
Friedlaender and Greely's references to a benefits sharing agreement with
the Hagahai are confusing and without either detail or verification.
A U.S. citizen, Dr. Carol Jenkins, one of the inventors named in the U.S.
patent, told RAFI that she had publicly signed a document assigning "50%
of the royalties" to the Hagahai people. We have no doubt that she did
this. We do have questions about what the agreement says, and what it
commits the various parties to do. We have not seen the document, and do
not know its legal status. As Mr. Greely notes, and as RAFI knows well,
it is not in the nature of patents to include such agreements. In this
respect, once again, Dr. Friedlaender was wrong when he stated that the
agreement was embodied in the patent itself. The patent does not include
the agreement that Dr. Jenkins signed. The institute for which Dr. Jenkins
works is not a PNG government institution (as Mr. Greely states). The IMR
is an independent institute with an independent legal status. Though
important, none of these considerations alter the fact that neither Dr.
Jenkins, nor the Hagahai, nor the PNG government own this patent. The U.S.
Government is the sole patent-holder.
Concerned readers should be given the benefits sharing agreement. In the
absence of the actual agreement, its contents are a matter of conjecture.
Several pertinent questions, however, occur to us: 1. Why, and on what
indigenous peoples' authority, is Jenkins the trustee of the Hagahai in
this matter? 2. What evidence exists that the Hagahai agreed to the
patent with full prior informed consent, including an understanding of the
patent's legal and commercial implications? 3. Does the agreement allow
for payment to the Hagahai before or after U.S. Government expenses? 4.
How will those expenses be determined? 5. What happens in the case of
licenses or the sale of the patent? 6. Is the "50%" half of the total
patent value or merely half of Jenkin's share of the total value? 7. Who
gets the rest and why? 8. How would such remuneration be transmitted and
placed at the disposal of the Hagahai? 9. Does this agreement cover the
pending patents in other jurisdictions?
Institutional Involvement:
Although Friedlaender and Greely inexplicably attempt to draw in the IMR,
the U.S. Government has no institutional partners in the patent. No
government official in Papua New Guinea has indicated to RAFI that the
patent had the PNG government's blessing. On October 2nd, RAFI's Jean
Christie was in Port Moresby, and telephoned Dr. Jenkins of the Institute
of Medical Research. They spoke for 45 minutes. At that time Jenkins
repeatedly said that the patent covered only the virus, and not a human
cell line. She insisted that the inventors "had to" patent the material
(for what reason, she did not make clear). She also acknowledged that she
had not read the patent document. In an interview with Diane Martin aired
by the Australian Broadcasting Corporation, Dr. Michael Alpers, Director
of the IMR, also claimed that the patent was only on a virus, and also
acknowledged that he had not read it.
It is tempting to suggest that only those who have actually read the
patent should comment upon it. This, however, would render the debate
one-sided. Readers can ask whatever questions, and can draw whatever
conclusions they like about the fact that, six months after it was
granted, Drs. Jenkins and Alpers had not read the patent or been correctly
appraised of its details. Clearly the U.S. Government's patent lawyers
were not keeping them informed. When RAFI learned on September 29th that
this patent had issued, we immediately notified people in PNG, including
officials in the Department of Foreign Affairs and Trade. We got an
electronic copy of the patent, and immediately sent it to government
officials and other persons in PNG. RAFI notified Dr. Alpers that it had
done this, and asked that he convey the message to Dr. Jenkins. The PNG
government officials Christie spoke to had not been made aware of the
patent.
RAFI has no indication that Jenkins, Alpers, and their coworkers at the
IMR are anything other than sound medical researchers attempting to do the
best for their patients. At no time has RAFI ascribed blame to the IMR or
Jenkins for the actions of the U.S. Government. We are perplexed by
Greely and Friedlaender's vigorous defense of the IMR when we have not
attacked that institution - or any institution or person in Papua New
Guinea. In fact, neither Jenkins nor the IMR are even mentioned in the
RAFI press release. We hope the doctor's statements in defense of the IMR
are not an attempt to deflect attention from the U.S. Government's
actions.
Solomon Islands:
What we are left with is the following:
1. At the request of the Solomon Islands Ambassador to the United Nations,
Dr. Friedlaender investigated the matter (he says this was in September
1994 - he forgot to date his letter) and advised the Government of the
Solomon Islands that both the PNG and Solomon Islands patent applications
would either be abandoned, withdrawn, or disallowed.
2. In March 1995, the Papua New Guinea patent was granted and the Solomon
Islands application remained in play.
3. Shortly after the patent was issued, Friedlaender visited Papua New
Guinea and the Solomon Islands to make arrangements to collect more human
tissue samples and did not mention - so far as RAFI has been able to
ascertain - the fact that the Papua New Guinea patent had been granted or
that the Solomon Islands claim had not been withdrawn.
Now Friedlaender and Greely inform us that the SI patent application has
been withdrawn in the U.S. RAFI, however, has not found written
confirmation that the doctors' statements are accurate. Recalling Dr.
Friedlaender's many mischaracterizations, we would prefer official
confirmation of the status of all PNG and Solomon Island claims in both
the United States and elsewhere. Unfortunately, as of this week, the NIH
Office of Technology Transfer will not confirm verbally or in writing that
the application has been withdrawn, nor - after an extensive on-line
database search - has RAFI been able to locate documentation of
abandonment at the European Patent Office. If Dr. Friedlaender and Mr.
Greely possess proof of their inside confirmation, they should make it
available. Until then, we are obliged to assume that the patent remains
pending.
Human Genome Diversity Project:
The HGDP is not simply a proposal. It is an organized group of scientists
who are actively seeking funding. Some of these scientists have initiated
HGDP-related collections of blood samples from remote populations and
indigenous people in Europe and Asia. In much of the world the HGDP is
known - with good reason - as the "Vampire Project".
Since the HGDP first ran into opposition from indigenous people in 1993,
the project has persisted in saying that it is not active. Nevertheless,
persons associated with the HGDP have been active in collecting cell lines
in a number of parallel initiatives among associated individuals, many of
whom have participated in HGDP's development, and all of whom are familiar
with the project.
In 1993 the HGDP prepared a preliminary list of over 700 groups to be
prioritized in sampling. RAFI has never suggested that it is a complete
or full list. Since the list has been disclosed, the HGDP has gone
through great pains to avoid defining who its targets are, possibly for
fear of opposition from targeted communities. RAFI nevertheless believes
that the list indicates priorities for sampling by HGDP and will continue
to make the list available to interested persons.
Mr. Greely confirms correctly that HGDP's initial funding came from the
U.S. Government and that additional funding from the U.S. Government is
being sought. Readers should note that the U.S. Government: 1) claimed
the Guaymi cells in the withdrawn application, 2) patented the cells of an
indigenous person from Papua New Guinea, 3) has claimed the cells of
Solomon Islander, 4) has scientists in its employ who have participated
in the HGDP, and 5) has funded and is expected to continue to fund the
HGDP.
There are reasons to be concerned about the credibility of the HGDP.
Initially, the group claimed that there was little chance that its work
would be of commercial interest - even after the discovery of the Guaymi
patent claim in June 1993. Yet - four months before - in February 1993,
researchers at a meeting of a U.S. HGDP committee were already openly
discussing how, in the event something commercially valuable was found,
someone could go back and collect the sample again - this time for
patenting - and that this "would not implicate the Project." In the same
conversation, which is documented in the HGDP's meeting summary, one
invited adviser discussed "the major political concern in most countries"
caused by the patenting of human genetic material might be avoided by
instead patenting the proteins associated with unique, commercially
valuable genes.
The HGDP's self-characterization has also gone through a metamorphosis,
starting life as a history project and moving on to be described as a
medical research project in its most recent incarnations. In the interest
of transparency and openness, RAFI suggests the HGDP should identify its
members in each part of the world and explain the work they are pursuing.
It should also thoroughly reveal past, current, and anticipated sources of
funding for the project. In particular, the HGDP should confirm or deny
that it is currently discussing funding support with a number of
pharmaceutical companies as has been alleged by a Norwegian journalist.
Additionally, the HGDP and its regional committees should reveal its exact
position on patenting and its interpretation of prior informed consent.
Finally, the exact location of collections being undertaken should be
revealed, along with location and cell collection deposit records of
samples that have been taken by any of its associates.
RAFI has read documents from the HGDP and its committees on ethics, prior
informed consent in the collection of tissue samples, and on DNA
patenting. We have noted ambiguity in what we have read. On the issue of
patenting, the problem we identified at the outset remains. It seems not
to be understood, or acknowledged by proponents of the HGDP. We repeat it
here:
Human tissue samples collected by the HGDP will become publicly available
for research - by HGDP associates and anyone else who cares to use them.
Researchers associated with the HGDP may agree not to patent this material
or products derived from it. Others will be under no such obligation, and
international practice is fast moving in the opposite direction. HGDP
researchers might also "re-collect" samples in "non-HGDP" research, and
file for patents. In addition to other concerns we have raised about the
HGDP, we believe - as a minimum - that its proponents, who are proposing
to collect large numbers of human tissue samples, have fundamental
responsibility to ensure that they will not be patentable by anybody,
before they collect, "immortalize", and make them publicly available.
Mr. Greely may oppose the patenting of human genetic material, but current
trends, and indications are that many scientists do not. On page 376,
Nature Magazine of Feb. 2, 1995 reports on an international conference of
leading genome scientists held in Paris. The conference concluded that
"the patent system is the 'mechanism of excellence' for commercializing
the results of the human genome project." RAFI is not fabricating facts
or trends. We are opposing them.
Medical research is, of course, appropriate, proper and should be
encouraged; but only with the full support of indigenous peoples'
organizations, communities, and the individuals involved. Despite this,
Greely and the HGDP have persistently perceived RAFI to be some kind of
filter to indigenous communities - a role that RAFI has expressly rejected.
We neither have the right - nor the competence - to address the full scope
of issues embodied in indigenous peoples' right to self- determination. This
perception necessitated the end of RAFI's direct correspondence with the
HGDP two years ago. There is no need for a filter. We believe that all of
the issues can only be addressed by indigenous peoples' organizations and
the HGDP together. RAFI will simply continue to monitor and challenge life
patenting in all its forms.
Credibility:
Both Greely and Friedlaender call into question RAFI's interest and
competence in dealing with this issue. RAFI has been involved in genetic
resources and patenting issues since 1977 and has considerably greater
expertise and experience in this field than either of the two
correspondents.
RAFI's work in crop genetic resources has led to our direct participation
in life patenting issues, which, since the early 1980s, have increasingly
included animal and human patents. As a research organization, we have
repeatedly uncovered cases concerning life forms patenting. We feel it is
our obligation to make such cases public. The Papua New Guinea patent
is not the first, and is not likely to be the last.
We particularly regret Mr. Greely's comment that he advised RAFI on the
"Guaymi" patent claim. This, put kindly, is gross misrepresentation. On
29 June 1993, RAFI informed Greely of the claim based on our research into
holdings at the ATCC. Subsequently, RAFI independently obtained more
information from our CD-ROM patent database. We did receive a reply to
our note to Greely in which Greely offered information already available
to us and which we had discovered some time before.
In September 1993, RAFI staff traveled to Panama to meet with the Guaymi
General Congress and arranged for their representatives to go to Geneva to
address the issue of the patent claim at the World Council of Churches and
the Biodiversity Convention the following month. With the agreement of
the Guaymi General Congress, RAFI requested that the U.S. Department of
Commerce withdraw its patent claims, which it did in November of that
year. If Mr. Greely's letter to the NIH was helpful in this process, we
are not aware of it; but we welcome his gesture and would suggest that he
how turn his attention (after carefully reading the patent) to convincing
the U.S. Government to drop the PNG patent.
RAFI's analysis of Dr. Friedlaender's credibility cannot be complimentary...
*Dr. Friedlaender advised the Solomon Islands that he believed the PNG and
Solomon Island patents would be dropped. He now knows he was wrong. We
must add that from June of this year (when he says he realized his error)
he did nothing to correct his mistake.
*Friedlaender says the PNG patent is on a "pooled" blood sample involving
several persons. He is wrong. The patent explicitly identifies a 20-year
old Hagahai man.
*Friedlaender says that this is a "gene patent application." He is wrong.
The patent includes a human cell line containing the entire DNA of a
Hagahai person.
*Friedlaender says the agreement to share benefits with the Hagahai is
written into the patent. He is wrong. This is an impossibility.
- Friedlaender says the Solomon Islands claim has been dropped. He gives
no evidence. He could be wrong again.
*Friedlaender says the agreement means the Hagahai will obtain half the
benefit from the patent. He gives no evidence. He could be wrong again.
*Friedlaender says U.S. policy has changed. He gives no evidence. He
could be wrong again. (Or the policy could change several more times
during the 1996 U.S. election year.)
*Friedlaender admits that he has not tried to talk to RAFI. He's right.
He has not yet admitted that he has never read the patent.
RAFI is also not impressed with Mr. Greely's authority in this field:
Mr. Greely twice stated that RAFI's news release lied about the Human
Genome Diversity Project. His exact sentences are repeated below but we
invite readers to return to his original text to confirm the context for
themselves.
"Its press release contained such a host of misrepresentations
and outright lies about that Project that I am compelled to respond."
"It is well past time for RAFI to stop lying about the Human Genome
Diversity Project."
Please note that Mr. Greely has not stated exactly how we have "lied".
The two statements are not attached to a specific complaint. Greely's
accusation represents an extremely serious charge. If he is not prepared
to substantiate his charges he should withdraw them and apologize to RAFI
and to all readers. For his penance, he should read (perhaps for the
first time) the patent and his correspondence with RAFI since 1993. We
regard his language as disgraceful and utterly without substance or merit.
Anyone wishing to see the full text of the PNG patent, or the information
publicly disclosed regarding the pending Solomon Island and PNG patents in
Europe, is welcome to contact RAFI for electronic copies. Copies of the
press release, patent, and many RAFI documents and further information
about our organization can be found on WWW at the following URL:
http://www.charm.net/~rafi/rafihome.html
We hope our extensive reply here will raise the quality of the debate.