Who owns your genes and body parts

[James Love <love@cptech.org>]

Subject: PATNEWS: Who owns your genes and body parts ??????
     Date: Tue, 20 Jan 1998 01:55:43 -0500
     From: srctran@world.std.com (Gregory Aharonian)
 Reply-To: patent-news@world.std.com

!19980120  Who owns your genes and body parts??????

    An issue of increasing controversy is the ownership of part's of
people bodies, in particular their genes and cells with unusual
properties.  Much like finding the location of "X" on the map, such
genes and cells can be worth billions.   But to who?  The person whose
body they came from, the end result of genetic mixing of his/her
ancestors?  The scientist who determined the importance of such cells? 
The company that exploited the discovery and commercialized the
results?  Large companies because they deserve everything? (a dig at one
of my readers :-)  The issue has yet to be resolved.

    Two articles recently appeared that are worth reading.  The first is
titled "Whose body is it anyway? Disputes over body tissue in a
biotechnology age", appearing in the January 3, 1998 issue of the UK
medical journal Lancet.  Written by Prof. Lori Andrews (Chicago-Kent
College of Law), and Prof. Dorothy Nelkin (NYU), it discusses the
sociological, psychological, scientific, and political aspects of these
issues.  Nice bibliography.

    The second article is titled "Who owns the code?", and appeared in
the Autumn 1997 issue of Science and Public Affairs, the quarterly
science issues magazine of the Royal Society and the British Association
for the Advancement of Science.  The article is written by Dr. Thomas
Caskey and Jack Tribble of Merck & Company (a pharmaceutical company
that is also a nice stock to trade if you are a technical analyst). 
Their article  focuses on the intellectual property aspects of the human
genome, in particular, reiterating the confusion everyone in the US
feels (led by the NIH/NAS/HUGO) over the refusal of the PTO to clearly
explain its EST patenting policies, after Lehman and Goffney made the
somewhat conflicting and somewhat loophole-ish comments last year -
".... that broad claims on ESTs won't be allowed, except."   They talk
about the patenting of both genes/gene fragments, as well as entire
genomes.  Nice article as well.

    A recent press release illustrates the growing complexity of such
issues:

          LANDMARK BIOTECH PATENT RECOGNIZES FRAGMENT OF A GENE 

    In November, Elanex Pharmaceuticals (Bothell, WA) won the rights to
    patent a fragment of a gene, erythropoietin, which not only gives a
    boost to kidney, anemia and chemotherapy patients, but promotes
    competition in a billion dollar biotech market.  Elanex has
succeeded
    where many other companies failed in obtaining this patent. 
According
    to Dr. Ybet Villacorta, patent attorney with the law firm Lowe Price
    Leblanc & Becker (San Jose, CA) who worked on behalf of Elanex,
"This 
    is the first time that we're aware that the U.S. Patent and
Trademark
    Office allowed us to slice and dice a gene and obtain patent
protection
    for a fragment of that gene."


Such sentiments typically lead to lawsuits, for example, along the lines
of the ongoing BRCA1/BRCA2 squabble.  The December 12th issue of Science
has a well written review article on the lawsuits involving these two
breast cancer genes.  Myriad Genetics (Salt Lake City, UT) has patents
both on BRCA1 and BRCA2.  Oncormed (Gaithersburg, MD) has a patent on
BRCA1 and has licensed a BRCA2 patent from the UK Institute of Cancer
Research.  History of each companies discoveries aside, the fundamental
problem here is that the PTO pretty much allowed two patents for what
appears to be the same use of BRCA1.  "Geneticist Ray White of the Univ.
of Utah, Salt Lake City, says he can't understand why the PTO would
grant two patents on two slightly different versions of BRCA1.  If every
newly discovered allele can be secured by a separate patent, he says,
'that would destroy the entire point of patenting'".  Or from PTO
management's point of view, patenting each allele means more maintenance
fee streams, quality once again losing out to quality.  With regards to
BRCA2, the question is priority of invention, with ICR/Oncormed already
having received a UK patent.  Lawsuits are flying back and forth.

    But my biotech kudos of the season go to a fellow troublemaking
physicist, Dr. Richard Seed, who is causing turmoil in little minds
by announcing his intention to raise money and start R&D efforts to
clone humans.  Personally, I think cloning one's self is idiotic (with
efforts to retrodifferentiate stem cells to an embryonic stem cell form
eliminating the need for cloning for body parts - give me a jar of ES
stem cell paste - the ultimate human plaster of Paris).  Logistically,
just as idiotic (when you think of the high failure rate with the sheep
eggs). The ethics controversy of his pronouncements is much to due to
the one hypocrisy that both science and religion fear to address.  He
wasn't the first, he won't be the last, each one feeding the hypocrisy.

    Finally, many of us as kids got either the Invisible Man or
Invisible Woman dolls as educational Christmas gifts (which should be an
oxymoron), or played around with the equivalents in high school biology
labs, like the human heart or brain rubber models.  Large scale
models/dolls of our body parts is nothing new.  Yet consider the
following patent awarded last September.  What's unobvious about a big
sperm doll?

    Human pre-natal development dolls
    5672058

    1.  A set of dolls for play or educational purposes, comprising a
    plurality of dolls comprising at least one doll for portraying a
    human gamete or at least one doll for portraying a human zygote,
    and at least one doll for portraying a human embryo, each of said
    plurality of dolls having a different exterior appearance from
    others of said plurality of dolls, having different exterior
    appearances sufficient to portray a human pre-natal development
    sequence from gamete stage prior to fertilization through
    progressively different states of development during human
    pregnancy at a set of points prior to full term.

Sperm dolls?  No wonder the PTO is having trouble with the BRCA genes.
Barbie and Ken, take notes.


Greg Aharonian
Internet Patent News Service