[Ip-health] RE: NIH Limiting Scope on Foreign Patents

[Jackie Wootton]

George,
Thanks for pointing this out.  This is of concern to any of us whose work
and concerns involve protection of intellectual property rights.  The
HerbMed database has many uses and audiences but one important one is to
provide Prior Art information.
Jackie

Jackie Wootton, M.Ed.
Director, HerbMed
PO Box 60016
Potomac, MD 20859-0016, USA
http://www.herbmed.org

-----Original Message-----
From: George M. Carter [mailto:gmc0@ix.netcom.com]
Sent: Thursday, July 18, 2002 10:53 AM
To: ip-health@lists.essential.org
Cc: healthgap@CritPath.Org; ATAC-USA
Subject: NIH Limiting Scope on Foreign Patents


The article below is of serious concern to FIAR
(http://aidsinfonyc.org/fiar).

FIAR hopes to conduct both domestic and international studies of
interventions which it is to be reasonably hoped may have some benefit in
slowing HIV or chronic hepatitis disease progression. In order to undertake
ethically sound studies in resource poor regions such as parts of Africa,
India and so forth, FIAR will address a number of issues, including clear
informed consent (even for illiterate participants).

FIAR will also seek to assure that intellectual property rights (IP) are
addressed prior to a study commencing. Such agreements will rely on the
concepts of FAIR TRADE (as opposed to free trade). This is predicated on a
positive outcome to any such clinical study and the need for IP issues to
be addressed.

In order for FIAR to conduct such studies, we shall be seeking funding from
a variety of sources. NIH and, specifically, the National Center for
Complementary and Alternative Medicine, seemed to be two reasonable sources
for such funds for specific projects. However, the policy change below is a
serious concern. Advice, input and thought on this issue is solicited.

(Note the article was scanned and I've reviewed it; any errors are mine.)

George M. Carter
Director, FIAR
http://aidsinfonyc.org/fiar

****
NIH To Limit Scope of Foreign Patents
Science, 2002 Jun 28;296:2316

More than 20 years ago, the U.S. National Institutes of Health (Nlli) began
supporting Australian researchers who discovered two cytokines that can
boost the immune system of cancer patients. These drugs, marketed by
companies such as Amgen and Schering-Plough, have saved lives and chalked
up more than $1.5 billion a year in U.S. sales. Yet NIH now wants to revise
the policy that allowed the Australian scientists' institutions to patent
and license one of the drugs on the Australian scientists the grounds that
it could put U.S. companies at a "disadvantage." The move has sparked an
uproar in Australia and even left U.S. university officials wondering how
it might affect collaborations.

A notice on NIH's Web site says that the planned change, to go into effect
by the end of the year, is in "the best interests of U.S. citizens" by
making sure that they benefit fully from all NIH-funded research. Posted 14
March, the notice explains how NIH plans to limit the future patent rights
of all foreign recipients of grants and contracts to the awardee's own
country and have NIH retain the rights elsewhere. Institutions could ask
for exceptions on a case-by-case basis.

George Stone of NIH's Extramural Inventions and Technology Resources Branch
says that the new rule is intended to address the concerns of some members
of Congress and the public but that it was not triggered by any particular
incident. "There has just been a heightened awareness," he says. "We want
to be proactive."

Few patents will likely be affected, Stone says. Only 13 of roughly 6000
inventions reported to NIH in the past 3 years included patent holders from
other countries, he says, and in just two cases were the foreign grantees
the only patent holders. The new policy would not have applied to the 11
joint inventorships, he says. An upcoming fact sheet will clarify the new
policy, he adds.

Some foreign research institutions are quite concerned about NIH's plans.
Alan Pettigrew, CEO of Australia's National Health and Medical Research
Council, has complained to Stone, as have Donald Metcalf and Nicos Nicola
of the Walter and Eliza Hall Institute of Medical Research in Melbourne,
whose discoveries led to the cancer drugs. Discoveries are less likely to
be commercialized if NIH holds the patent rights, they suggest, which "will
actually decrease the health and economic returns to U.S. citizens."
Canadian officials "are very much aware of" the NIH policy and are mulling
over their response, says Janet Scholz, senior manager of the University
Industry Liaison Office at the University of Manitoba in Winnipeg.

Scholz, who is also chair of the U.S.-based Association of University
Technology Managers (AUTM), says that U.S. universities are concerned that
the rule will discourage international collaborations by complicating
patent filings and removing commercial incentives for the foreign partners.
"To some extent, there isn't a border in science," says Scholz. The AUTM
board plans to take up the matter this week.

Scholz says AUTM members are annoyed that NIH cannot cite examples of why
the new policy is needed. "I just don't understand why they think that
whatever they have now doesn't work," she says. -JOCELYN KAISER