Biotechnology and Gene Patents
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BRCA-1 and BRCA-2:
See the CPTech Page on Myriad, which currently is involved in
patent disputes over its claim to the BRCA-1 and BRCA-2 genes,
which are used in for cancer screening.
Columbia University Cotransformation Patent
- May 10, 2004. Public Patent Foundation press release.
Patnet Office Grants PubPat Request to Reexamine Cotransformation Patent:
Order Finds "Substantial New Question" of Patentability for Entire Patent
- February 13, 2004. Susan Mayor for the Scientist.
Charity wins BRCA2 patent: Genetics researchers welcome a decision that will
make the gene freely available in Europe.
- June 26, 2000, Washington Post Editorial,
Stopping the Patent Clock
- June 23, 2000, Bureau of National Affairs,
Some Senators Cry Foul Over Inclusion
Of Patent Extension Rider in Spending Bills
- May 26, 2000, Public Citizen,
Columbia University Patent Extension Would Cost Consumers, Open Floodgates for More Special Deals
- May 18, 2000, Wired,
Columbia's Drug Patent Gift
- May 17, 2000, Bureau of National Affairs,
Major Patent Law Change
- May 12, Julie Rovner, in CongressDaily,
Columbia University amendment on patent extension
- USPTO Patent Database,
Patent Number: 4,399,216-Columbia Cotransformation Patent
The patent legend reports that "
[t]he invention described herein was made in the course of work under grants numbers CA-23767 and CA-76346 from the National Institutes of Health,
Department of Health and Human Services."
Interleukin-9 (Asthma Gene Patent)
- July 13, 2000, Mailgate archives,
San Francisco Chronicle piece and JAMA abstract on structured
intermittent therapy (SIT) and rIL-2
- March 30, 2000, Pharmalicensing,
Magainin issued patent for IL9 asthma gene
- March 29, 2000, Wired,
Company Gets Asthma Gene Patent
- November 3, 1998.
U.S. Patent #5,830,454: Method for treating cell mediated autoimmune disorders using interleukin-9.
University of Rochester Patent on Cox 2-inhibitors
- Press releases
- News Stories
- July 3, 2004. Michael Wentzel for the Rochester Democrat and Chronicle.
Appeals court rejects UR patent case.
- March 25, 2003. Ben Dobbin for the Associated Press.
School Loses Round One of Patent Fight.
- March 7, 2003. Peg Brickley for the Scientist.
Cox-2 patent case thrown out.
- March 6, 2003. Associated Press.
School to Appeal Ruling on Drug Patent.
- March 6, 2003. Andrew Pollack for the New York Times.
University's Drug Patent Is Invalidated by Judge.
- March 6, 2003. Michael Wentzel for the Rochester Democrat and
Chronicle.
UR loses first round in patent lawsuit:
Judge distinguishes between cox-2 discovery and new drug.
- May 13, 2000, Lynda Richardson, in the New York Times,
At University, Dreams of Billions and Billions
- April 12, 2000, University of Rochester Press Release,
University of Rochester Awarded Patent for New Class of Drugs Known as Cox-2 Inhibitors
- USPTO Patent Database,
Patent Number: 6,048,850-University of Rochester Patent on Cox-2 Inhibitors
The patent legend reports that "[t]his invention was made with government support under grant number DK 16177, awarded by the National Institutes of Health. The government has
certain rights in the invention.
Winter II Antibody Expression Library
Human Stem Cell
-
US Patent #6,200,806: Primate embryonic stem cells.
- NIH Press releases.
- July 31, 2002. Zachary Vasilyuk, Martha L. Carpenter and Lisa A. Haile
for the San Diego Source.
The case that has made IP for stem cells significantly clearer.
- January 10, 2002. Andrew Pollock for the New York Times.
University Resolves Dispute on Stem Cell Patent.
- January 9, 2001. January 9, 2001. Wisconsin Alumni Research
Foundation press release.
WARF and Geron Resolve Lawsuit and Sign New License Agreement
- September 10, 2001. Catherine Arnst for Business Week.
Commentary: Stem Cell Science Needs More from Uncle Sam.
- September 5, 2001. Kristen Philipkoski for Wired News.
Stem Cell Patent Issues Resolved.
- August 16, 2001. Sheryl Gay Stolberg for the New York Times.
Patent Laws May Determine Shape of Stem Cell Research.
- March 13, 2001. Geron Corporation press release.
Geron Reports Issuance of U.S. Patent for Human Embryonic Stem Cells.
Patents Held by Chiron on Hepatitis C Genes
HFE Genetic Test for Hemochromatosis
Other Biotech and Gene Patents
- June 22, 2004. Denise Gellene for the LA Times.
Chiron Relaxes Patent Licenses. (On patented genes for Hepatitis C.)
- October 6, 2003. Zina Moukheiber for Forbes.
Junkyard Dogs: A tiny Aussie firm has claimed rights to vast tracts of the
genome and is riling the biotech world.
- March 24, 2003. Andrew Pollack for the New York Times.
Advanced Cell Wins a Cloning Patent Dispute With Infigen.
- March 19, 2003. Sangamo BioSciences press release.
Sangamo BioSciences Granted U.S. Patent Covering Regulation
of Gene Expression Using Engineered Zinc Finger DNA-Binding Proteins.
- January 15, 2003. Jeffrey Kasner for the Boston Globe.
Ariad gets patent for therapy method.
- January 13, 2003. The Edmonton Journal.
Gene-patent policy review urgently needed.
- December 23, 2003. Helen Altonn for the Honolulu Star Bulletin.
UH makes gene patent history.
- October 4, 2002. Reuters.
Swede researchers apply for psoriasis gene patent.
- September 17, 2002. Joe Manning for the Milwalkee Journal-Sentinal.
Biotech firm files suit over patents: Third Wave accuses
EraGen of infringement.
- September 16, 2002. Bill Sloat for the Ohio Plain Dealer.
Ohio scientist and corporate giant in court fight over gene discovery.
- July 6, 2001. Announcement of the Department of the Defense.
Department of the Navy Notice of Intent to Grant Exclusive
Patent License.
- July, 2001. UVentures.com.
Gene Pill Platform Receives Broad Patent Coverage.
- June 26, 2001. People's Daily.
China's Largest Gene Company Gets 3,700 Patents.
- May 25, 2001. Houston Chronicle Business Wire.
Cytogenix Files Patent Application For Novel Business Structure.
This is a business method patent. For information on more business
method patents (not health-related), click
here.
Statements and Reports on Patenting of Genes
- January, 2002. Report from OECD Workshop.
Genetic Inventions, Intellectual Property Rights and Licensing
Practices: Evidence and Policies.
- May, 2001. National Organization for Rare Disorders.
Gene Patenting Policy Position.
- July 13, 2000. Jon F. Merz.
Statement on
Gene Patents and Other Genomic Inventions before the Subcommittee
on Courts and Intellectual Property of the Committee on the Judiciary,
U.S. House of Representatives.
- June 2001. Timothy B. Coan and Ron Ellis. Report for USA Specialty
Pharmaceuticals. Generic Biologics: The Next Frontier.
- February 12, 2000,
TACD Recommendation on
Patents on Genetic Diagnosis
- January 12, 1999.
Statement of Q. Todd Dickinson, Acting Assistant Secretary of Commerce and
Acting Commissioner of Patents and Trademarks before the Subcommittee on
Labor, Health and Human Services, Education and Related Agencies of the
Senate Appropriations Committee.
History of Gene Patenting
- June 16, 1980.
Diamond v. Chakrabarty. This case marked a turnaround in the patentability of
bio-engineered organisms in the U.S. In it, the Supreme Court held that a
bacterium genetically engineered to consume oil spills was patentable.
General News Stories
- July 23, 2002. Gaia Vince for the New Scientist.
Gene Patents "Inhibit Innovation."
- March 25, 2002. Tom Abate for the San Francisco Chronicle.
Do gene patents wrap research in red tape?
- September 11, 2001. Jennifer Jacobs for the Malaysia Business Times.
Biotech companies no easy set-up.
- September 5, 2001. Introgen Theraputics press release.
Introgen's p16 Cancer Therapeutic Receives Patent; Introgen Owns Exclusive
Worldwide License From The University of Texas System.
- August 24, 2001. Op-ed by Howard Markel in the New York Times.
Patents Could Block the Way to a Cure.
- August 14, 2001. Associated Press.
UW Sues Geron Over Stem Cell Deal.
- July 18, 2001. Anthony Shadid for the Boston Globe.
Battle turns fierce over biotech patents.
- May 26, 2001. China's People's Daily.
Patent Protection for China' Genetic Engineering.
- May 15, 2001. Andrew Pollack in the New York Times.
The Green Revolution Yields to the Bottom Line.
- March 8, 2001. Genomeweb.com. Interview with Leslie Misrock.
Q&A: Biotech Patent Guru Discusses Possible Proteomics Patent Wars.
- March 6, 2001. Kristen Philipkoski for Wired News.
New Quest: Mapping Gene Patents.
- February 28, 2001. Kristen Philipkoski for Wired News.
Gene Patent Healthy for Introgen.
- December 30, 2000, Justin Gillis, in the Washington Post
Gene Research Success Spurs Profit Debate
- June 28, 2000, Andrew Pollack, in the New York Times,
U.S. Hopes to Stem Rush Toward Patenting of Genes
- June 21, 2000, Greg Aharonian, in Internet Patent News Service,
Gene test patents cause debate at HHS panel meeting
- April 6, 2000, eubusiness.com,
EU 'shock' at human clone patent decision
- March 29, 2000, Upd-discuss,
RAFI: gene patent mania
- March 21, 2000, THE KCRACHANNEL.COM,
AIDS Gene Patent Contains Errors
- March 15, 2001. Andrea Knox for Knight Ridder.
Firms' gene patents worry doctors, ethicists.
- February 21, 2000, Vida Foubister, in American Medical News,
Gene patents raise concerns for researchers, clinicians
- June 4, 1998, Naomi Freundlich for Signals Magazine.
Will increasingly aggressive licensing terms
on research tool patents hurt basic
research? This story has a lot of interesting quotes.
Here is one:
At Millennium Pharmaceuticals, Inc.
in Cambridge, Mass., Chief Business
Officer Steven Holtzman says that
"We often find ourselves walking
away from licensing-in tissue
samples or other tools because the
university OTL officer is insisting
that if we ever develop a drug using
the tool we have to pay a royalty."
These royalties usually amount to
between .5 percent and 3 percent for
such tools as tissue samples,
receptors and vectors. Holtzman, who
is the one biotech participant in
the seven-member NIH Working Group,
figures that his company might
assemble five or more tools in
running differential gene expression
studies and drug development. When
promising compounds are identified,
they are usually handed off to a
pharmaceutical company in exchange
for a 5 percent to 15 percent
royalty. As the tool royalties stack
up, the biotech player could be
paying out some 25 percent to 50
percent of what they receive in
royalties from drug companies.
"We're going through the swing of
the pendulum," says Holtzman, "there
will have to be equilibrium. It may
get to the point where everyone
starts saying 'we won't sign these
darn things.' "
- May 29, 1998,
is the alliance deck becoming "anti-stacked" against innovators?
This is a very interesting report on the negotiations between
various biotechnology players over shares of royalties in inventions
with lots of inventors. From the article:
More and more "tool companies" are
filling biotechnology's ranks and filing
patents for nifty research aids like
surface receptors or useful polymorphic
markers. That's led to increasing
grousing among Big Pharma about "stacking
royalties," or the need for an eventual
developer/marketer to license so many
different technology puzzle pieces in
order to advance a given project that the
royalties reduce the eventual product's
attractiveness.
In actual fact, so-called "anti-stacking"
language has been around the
biotechnology industry since its
inception. Given the delays at the U.S.
Patent Office, companies could rarely if
ever negotiate contracts with full
confidence about exactly how broad their
intellectual property rights would be.
The major pharmaceutical company's
traditional argument for anti-stacking
language ran something like this: If Big
Pharma licenses a lead compound from
Biotech and that compound is later
blocked by another party's patent, it is
Biotech who should bear the
responsibility for that occurrence and
shoulder the burden of crediting Big
Pharma for the amount due the third
party.
It seemed a pretty compelling argument to
most biotechs developing recombinant
proteins or monoclonal antibodies
throughout the 1980s. So compelling that
biotechs adopted the same protection in
their licenses with universities - except
now the anti-stacking language was
applied to technologies as well as
compounds. In analysis done by ReCap of
university/biotech license agreements,
about 80% have anti-stacking language for
the benefit of the biotech company, and
most of this language is of the "fully
creditable to floor" variety. That means
the university's take goes from, for
example, 5% of net sales down to a floor
rate of 2.5% if the biotech player has to
pay third parties in excess of 2.5% in
royalties as well.
But a funny thing happened when biotechs
went "upstream" in the late 1980s and
began doing technology deals in which the
essence was helping big partners screen
large libraries of compounds. Major
pharmaceutical companies brought
"university style" anti-stacking language
into pharma/biotech agreements.
- May/June, 1998. MotherJones.
An Owner's Guide: Pharmaceutical companies are mining your DNA for scientific gold.
- May 1, 1998. Michael A. Heller, Rebecca S. Eisenberg for Science.
Can Patents Deter Innovation? The Anticommons in Biomedical Research.
- April 17, 1995. Franklin Hoke for the Scientist.
Gene Patenting Is On The Rise, But Scientists Are Unimpressed.
- October 26, 1992, Scott Veggeberg,
HHS Secretary Sullivan To Determine If NIH Gene Patent Quest Is Over
- June 15, 2001. Luiza Chwialkowska for the National Post.
Court to rule on patent for Harvard mouse.
- October 14, 2000, Tervil Okoko, in Panafrican News Agency,
Row Over AIDS Vaccine Patent
- October 14, 2000, M.G. Kimani, in the Daily Nation,
Science and the myth of British fair play
- October 6, 2000,
Reuters,
Setback for 'Human-Pig' Fusion Patent Bid
- April 6, 2000, eubusiness.com,
EU 'shock' at human clone patent decision
- March 19, 2000, Penny Fannin, in The Age,
Patent critics try to stophuman-gene slave trade
- February 28, 2000, Associated Press,
Genetic Face-Off
- October 18, 1999, Vida Foubister, in American Medical News,
Lapses in practice, oversight undercut genetic
testing
- June 19, 1995, AIDS Treatment News,
Religious Coalition Opposes Gene Patents
- March 1995, Joseph Kaplinsky, in Living Marxism,
Who owns your genes?
- National Institutes of Health Ethics Program,
Ethics Forms
Government sites
Non-government sites
Corrections or suggestions to Mike Palmedo
mpalmedo@cptech.org
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