Washington Highlights: May 6, 2005
House Subcommittees
Begin Appropriations Mark-ups
Contents
Prior Issues
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The House Appropriations subcommittees on Interior and Homeland
Security approved their respective FY 2006 spending bills May 4,
signaling the beginning of what promises to be another long appropriations
cycle. The appropriations subcommittees must operate under the $843
billion overall discretionary spending ceiling established in the
FY 2006 budget resolution (H.Con.Res.
95) that Congress approved April 28 [see
Washington Highlights, April 29]. Within this total,
both the White House and Congress assume increases for defense,
homeland security and international programs, and a cut in overall
domestic discretionary spending. This funding is divided among the
10 appropriations subcommittees into what are known as 302(b) allocations.
The full House Appropriations Committee is scheduled to give formal
approval to its subcommittee allocations May 10 when it meets to
consider the Interior and Homeland Security bills. Chairman Jerry
Lewis (R-Calif.) released his tentative proposal
for the allocations on May 5.
The Labor-HHS-Education subcommittee is tentatively scheduled to
mark up its FY 2006 bill June 9, with full committee consideration
of the bill taking place the week of June 13. VA funding has been
moved to the Military Quality of Life and Veterans Affairs Subcommittee,
which is tentatively scheduled to mark up its bill May 12, with
full committee action the following week. The Science-State-Justice-Commerce
Subcommittee, which now has jurisdiction over the National Science
Foundation, reportedly will mark up its bill May 24, with full committee
action the week of June 6. All of these schedules are subject to
change.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
House Committee Passes Legislation Removing Physician
Group Limits on Patients Receiving Substance Abuse Treatment
The House Energy and Commerce Committee May 4 passed by voice vote
AAMC-endorsed legislation (H.R.
869) removing the current statutory limit on the number of substance
abuse patients that may be treated by physician group practices.
H.R. 869 was introduced by Rep. Mark Souder (R-Ind.) on Feb. 16.
The House Energy and Commerce Health Subcommittee passed the bill
on April 27 [see Washington Highlights,
April 29].
The 106th Congress passed into law the Drug Addiction Treatment
Act (DATA) 2000 to expand treatment options for patients addicted
to opiates. A limit of 30 patients per treating physician was included
in the legislation to address concerns about potential abuse or
diversion of the treatment medications. In addition to the limit
per physician, DATA also contained language that imposed a 30- patient
cap on group practices as well as
amending the Controlled Substances Act. H.R. 869 clarifies that
group practices would not be limited to 30 patients, while still
limiting each provider within the group to 30 patients seeking treatment
for their drug addictions.
Information:
Lynne Davis Boyle, Assistant Vice President
AAMC Government Relations
ldavisboyle@aamc.org
(202) 828-0526
Federal Court Hears Arguments on EST Patents
The Court of Appeals for the Federal Circuit (CAFC), which oversees
patents, May 3 heard arguments from Monsanto Corporation that its
patent application on certain Expressed Sequence Tags (ESTs) should
not have been rejected by the U.S. Patent and Trademark Office (PTO)
for not being useful. The PTO found that the ESTs claimed in the
application failed to meet a standard for "credible, substantial,
and specific" utility implemented in 2001. The PTO's own Appeals
Board later upheld the rejection, and Monsanto thus appealed to
the CAFC.
The case, In re Fisher, is a test case for the new utility
standard, which the PTO implemented at the urging of the National
Institutes of Health, the National Academies, and other research
organizations, including the AAMC. Biomedical researchers had sought
to stave off a "land rush" of intellectual property claims
to bits and pieces of human or other genes, which could entangle
later
genomic research and technology. More recently, however, the Fisher
case has also come to be seen as
a judicial referendum on the patentability of "research tools"
or technologies that are primarily used to advance other research.
Attorney Seth Waxman, representing Monsanto, argued to the three-judge
panel that the PTO had erred in supposing that the utility of ESTs
depends on knowledge of the characteristics or function of the gene
sequences to which the ESTs correspond. He offered examples of other
uses for biochemical tags not requiring a knowledge or interest
in the corresponding gene sequence. Attorney Stephen Walsh, representing
the PTO, defended the heightened standard, arguing that Monsanto's
application asserted no specific, "real world" utility
for the claimed ESTs. Chief Judge Paul Michel, Judge Randall Rader,
and Judge William Curtis Bryson questioned both attorneys at length,
particularly the PTO's Walsh, often about hypothetical applications
of the standard and the corresponding utility criteria for chemical
inventions. Judge Rader specifically asked if the PTO had not "set
the bar too high," suggesting that valuable sequence information
might go undisclosed and would be retained as trade secrets. Mr.
Walsh insisted that DNA fragments require further research and discovery
to be useful, comparing EST patent applications to "raffle
tickets."
Mr. Waxman, in his rebuttal, noted that Monsanto's claims are intended
for agricultural research. He dismissed implications for human medicine,
in part because publication of the human genome would render human
EST sequences obvious and not patentable. His argument notwithstanding,
the AAMC joined Eli Lilly Corporation and others in an amicus brief
defending the PTO standard, specifically with respect to circumstances
of biomedical research and medicine. The CAFC's decision is expected
later this year.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
Perlin Confirmed as VA Under Secretary for Health
The Senate April 28 formally approved the nomination of Jonathan
Perlin, M.D., Ph.D., as Under Secretary for Health at the Department
of Veterans Affairs. Dr. Perlin has served as Acting Under Secretary
for Health since April 2004.
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