FW: [Upd-discuss] patenting genes

[Moy Carl]

-----Original Message-----
From: Moy Carl 
Sent: Thursday, March 16, 2000 1:42 PM
To: 'upd-board@lists.essential.org'
Subject: FW: [Upd-discuss] patenting genes




-----Original Message-----
From: Moy Carl 
Sent: Thursday, March 16, 2000 1:37 PM
To: 'Robert Weissman'
Subject: RE: [Upd-discuss] patenting genes


Rob:

The process of becoming a specialist to some degree that of learning more
and more about less and less.  It is therefore perhaps unfortunate that I
can, at this stage of my career, answer your question in excruciating
detail.

You are right that attempts to the human genome, or portions of it, are
vulnerable to being blocked by the fact that the genome is itself
pre-existing.  Patent law has long contained the restriction that one cannot
patent a pre-existing apparatus (or other structure) simply because one has
discovered the apparatus has a previously unknown property.  The typical
admonition is that such a person must be content with patent protection over
any new method of using the apparatus that may have been developed.

Patent practitioners are skilled in avoiding this barrier, however.  The
most common technique, in the case of an newly isolated, but naturally
occuring chemical, is to claim the chemical in a purity that comfortably
exceeds what would have existed naturally.  Industrial use of the chemical
will typically require access to the purified form.  The claim is therefore
still commercially viable.  Because the chemical has never existed in the
purified state, moreovern the claimed invention is not anticipated by the
art.  In addition, since the chemical was previously unknown the purified
form is also unobvious, a fortiori.

This is main technique by which the companies seeking to patent genomic
material expect to establish that their work is patentable over the art.

The other hurdle of substantive patent law that is problematic for these
companies is that of the so-called "utility" requirement.  The statute, 35
U.S.C. 101, limits patenting to inventions that are "useful."  This
inherently raises the question of "how useful?" and, specifically, what the
threshhold utility of an invention must be before the system will allow
patenting of it to be considered.  Patent law has traditionally (i.e., since
a case in 1817) held the view that the invention need only be "minimally
useful for its intended purpose," and that, as a result, the disclosure of
virtually any non-trivial use for the claimed invention will be sufficient.
This very low threshhold is justified with the argument that, since the
economic harm of patenting depends on the invention actually being demanded
by consumers, inventions with comparatively little utiility will impose a
corresponding injury on the marketplace.  The result is a "no-harm, no-foul"
rule that relies heavily on Adam Smith's invisible hand.

Application of the this traditional rule would probably result in the human
genome being considered to have adequate utility.  Dr. Ventor, for example,
alleged at least two utilities for the claimed parts of the genome, i.e.,
forensics and marking, that would meet the test.  Thus, the expectation of
many in the patent community is that patent protection for the genome will
be available to the person who first isolates it.

This having been said, however, there are some indications that the utility
requirement does not have the simole structure that some in the patent
community assume.  For example, at times in the past it was fashionable to
assert that there was, as a practical matter, simply no utility requirement
for chemical compounds whatsoever.  This was based on the reasoning that
every compound, once made, was inherently useful for at the purpose of
further inquiry.  Thus, no compound could be rejected for lack of utility.

This question went to the Supreme Court in a test case in the 1960's and, to
the patent community's surprise, the Court there disagreed.  The facts of
that case were roughly as follows.  The applicant/inventor had synthesized a
chemical that had no known use itself, but which was strucurally similar to
another chemical that was known to have anti-cancer properties.  The attempt
was made to claim the new chemical per se, with the only assertion of
utility being that the new chemical could be used in further research, and
that might have anti-cancer properties itself.

The holding of the Court in the case has been difficult for the patent
community to grasp.  Basically, the patent community sees the case as
requiring that inventions possess a "practical" utility before they can be
patented, and the usefulness as the subject of further research is not
practical.  Thus, the community sees the question for the genome as being
whether forensics and marking are sufficiently practical.  They conclude
that the uses likely are.

A careful reading of the Supreme Court case, however, suggests that the
genome applications may run into trouble.  Basically the Court was
addressing the problem that patenting perversely slows future research into
as-yet undiscovered technologies whose use will be covered by the patent
rights being given.  This is particularly troublesome for chemical
compounds, whose control via initial patent rights inherently blocks the
right to use all methods of making and using.  This call for denying patent
rights on the chemical compound in some cases, to keep the field open for
future research.  (Germany, for instance, did not grant any chemical-product
patents at all for time during the 20th Century.)

Read correctly, I believe, the Court's discussion of practical utility was
directed to this latter problem.  Even where the claimed invention in not
currently in commercial demand, its control is costly to society if there
are significant future uses that remain to be discovered.  The case is
therefore is best viewed as having held that patent rights to the compound
will not issue unless the applicant has provided a teaching of a substantial
part of the overall uses to which we expect the compound to be put.  Under
this view the attempts to patent the genome are in real trouble.  Forensics
and marking are clearly only a miniscule part of the valuable uses we expect
to be able to make of the genome in this generation.

While it is not clear at this point, I feel this more restrictive view of
the utility requirement, or at least some proto-form of it, will be applied
to the genome applications.  I expect the attempt to patent them to fail.

I hope this long explanation has been at least a net benefit.

Carl Moy



-----Original Message-----
From: Robert Weissman [mailto:rob@essential.org]
Sent: Thursday, March 16, 2000 12:20 PM
To: upd-discuss@venice.essential.org
Subject: [Upd-discuss] patenting genes


As many may know, the issue of the patenting of the human genome is now
very hot (see cover of today's Wall Street Journal).

I remain unclear on how it is that patents are granted for genes. Why is
not the discovery of a gene a non-patentable discovery rather than a
patentable invention?

The patent office is now making a distinction between finding genes and
being able to explain what a particular gene does, with a tendency to give
patents only the latter case. But why does this cross the invention
threshold?

This is not to ask for a moral critique of life or human patents, or even
necessarily a legal critique of the patents. I'm just trying to understand
the basic rationale for granting patents in these cases.

Robert Weissman
Essential Information			|   Internet:	rob@essential.org



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