IP: Scientific American: Molecular switches provide a route around existing gene patents

[Dave Farber <dave () farber net>]

------ Forwarded Message
From: "Robert J. Berger" <rberger () ultradevices com>
Date: Wed, 19 Jun 2002 13:32:30 -0700
To: Dave Farber IP <dave () farber net>, Dewayne Hendricks
<dewayne () warpspeed com>
Subject: Scientific American: Molecular switches provide a route around
existing gene patents


June 17, 2002
Legal Circumvention
Molecular switches provide a route around existing gene patents
http://www.sciam.com/article.cfm?articleID=000B39CC-B7DF-1D07-8E49809EC588EE
DF&catID=2
By Gary Stix


Since 1980 the U.S. Patent and Trademark Office has granted patents on more
than 20,000 genes or gene-related molecules. This thicket of intellectual
property can make it difficult to develop biotechnologies without bumping up
against patents held by others. In response, a number of companies have
devised ingenious technological means of getting around such IP hurdles.

To obtain a patent, one of the things an inventor must prove is that a
creation is truly novel. Genes, proteins, kidneys and all endogenous living
tissue in its natural form do not meet that criterion. "A basic tenet of
patent law is that you can't patent something as it is found in nature,"
says Kathleen Madden Williams, an attorney with the Boston law firm of
Palmer and Dodge. "It has to encompass something new." The genomics gold
rush revolves around genes that have been isolated and purified outside an
animal, plant or microorganism. But turning on a gene to make a protein
while the DNA is still lodged inside the body--or in the nucleus of a cell
in a laboratory dish--would allow someone to avoid infringing a patent.

A few biotechnology companies, each using a different method, have helped
partners doing research on drug candidates to switch patented genes on while
in the body or a cell. Of its 25 deals with pharmaceutical and biotechnology
companies, Sangamo BioSciences in Richmond, Calif., has made about a fourth
of them to bypass patent restrictions by using its "zinc finger protein"
transcription factors, proteins that turn genes on and off. "These
collaborations were driven largely by intellectual property," says Edward O.
Lanphier II, Sangamo's president and chief executive. Similarly, Athersys in
Cleveland has crafted about a third of its 12 collaborations to assist
partners in working around existing patents with a technique that inserts
pieces of DNA into cells to turn on genes randomly and then screen for the
protein of interest.

Endogenous gene activation is most lucrative if it does more than just let
companies do research on drug candidates and actually serves to create close
knockoffs of protein-based drugs without violating a competitor's patent.
The pitfalls of this approach were highlighted in January of last year, when
a federal district court in Boston ruled that Transkaryotic Therapies (TKT)
in neighboring Cambridge had infringed patents of Amgen in Thousand Oaks,
Calif., on an anti-anemia drug based on the protein erythropoietin (EPO).
TKT had used a type of DNA gene switch to make EPO. But to administer the
protein therapeutically, TKT would have had to purify the protein from the
cell line in which it was produced, one of the actions that were judged to
infringe Amgen patents.

Increasingly, as with Amgen's intellectual property, companies patent not
only a gene but the protein made by the gene. Again, technological fixes may
help. Sangamo's zinc finger protein switches, for instance, can be given
directly to a patient: the zinc finger can turn on a gene that expresses a
protein inside the body to alleviate a disease state--no purification step
to remove the protein from a cell is required.

As for the TKT technology, not all patent estates are as extensive as
Amgen's on EPO. Last year TKT defended itself successfully against a lawsuit
that charged it with violating a patent licensed exclusively to Genzyme,
also in Cambridge, for a method of making a drug to treat Fabry's disease, a
rare fat storage disorder. Both the Amgen and the Genzyme cases have been
appealed. But no matter what the outcome, the gene-switch companies are
proving that however dense the intellectual-property thicket becomes,
someone will find a way to crawl through it if the incentives are
sufficient.

-- 
Robert J. Berger
UltraDevices, Inc. / Internet Bandwidth Development, LLC
15550 Wildcat Ridge Saratoga, CA 95070
408-882-4755 rberger () ultradevices com / rberger () ibd com


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