[Congressional Record Volume 148, Number 127 (Wednesday, October 2, 2002)]
[House]
[Pages H6955-H6957]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PRIVILEGES OF THE HOUSE--INTEGRITY OF PROCEEDINGS AS PRESCRIBED BY THE
CONSTITUTION
Mr. BROWN of Ohio. Mr. Speaker, I rise to a question of the
privileges of the House, and I offer a privileged resolution, that I
noticed yesterday pursuant to rule IX, and ask for its immediate
consideration.
The SPEAKER pro tempore (Mr. Thornberry). The Clerk will report the
resolution.
The Clerk read as follows:
Whereas Article I, Section VIII, of the Constitution states
Congress shall have Power to promote the progress of Science
and the useful Arts, by securing for limited Times to Authors
and Inventors the exclusive Right to their respective
Writings and Discoveries;
Whereas such protections on Writings and Discoveries have
been promulgated by patent, copyright, and other laws,
including Public Law 98-417, affording Authors and Inventors
the exclusive Right to their respective Writings and
Discoveries for a limited period of time;
Whereas Public Law 98-417 breaches this constitutional
requirement by failing to impose such limitation on the
protection of certain medical inventions;
Whereas provisions of Public Law 98-417 imbue the Food and
Drug Administration with the authority to secure for limited
time for Inventors the exclusive Right to their respective
Medical Inventions;
Whereas public Laws 98-417 fails to provide the Food and
Drug Administariton the authority to refrain form securing
this exclusive right for inventors if the conditions for such
exclusivity are not met;
Whereas due to the failure of Congress to provide the Food
and Drug Administration with the proper authority to fulfill
obligations under the Act, certain medical inventions have
received the exclusive Right to their respective Inventions
without limitation;
Whereas the unlimited exercise of exclusivity by
prescription drug manufacturers subjects healthcare consumers
and third party payers to no-competitive prices and results
in significantly higher prescription drug costs for
purchasers;
Whereas health care costs increased by 5% in 2001, 3.7
times faster than overall inflation rate;
Whereas prescription drug cost spending is the fastest
growing component of heath care costs, and rose 17% in 2001;
Whereas health insurance premiums rose by 11% in 2001,
driven largely by the increased cost of prescription drugs;
Whereas state Medicaid spending increased by 11% in Fiscal
year 2002, driven primarily by increased prescription drug
spending and enrollment growth;
[[Page H6956]]
Whereas the number of individuals with health insurance
declined by 1.4 million in 2001, a function of the faltering
economy, rapid health inflation, and a growing number of
states in which public insurance programs are outpacing
budgets;
Whereas prescription drugs are prescribed by licensed
healthcare professionals to consumers as a non-discretionary
purchase essential to their welfare;
Whereas it is in the public interest to grant a limited
period of exclusivity to inventors of prescription drugs, but
extending that exclusivity places an inappropriate fiscal
burden on consumers, insurers, and public sector payers;
Whereas generic drugs are sold as alternatives to medical
inventions for which exclusivity is no longer available;
Whereas generic drugs have the same dosage, safety,
strength, quality, and performance as the medical inventions
for which they serve as substitutes, according to the Food
and Drug Administration;
Whereas limitations on exclusivity have allowed
prescription drug prices to drop 40-80 percent when generic
drugs enter the market;
Whereas limitations allowing generic drugs to enter the
market saved consumers $8-$10 billion in 1994 alone,
according to the Congressional Budget Office;
Whereas the failure to apply limitations to the Exclusive
rights granted under Public Law 98-622 has afforded widely
used medicines, including Prilosec and Paxil, an indefinite
period of exclusivity;
Whereas Prilosec and Pxil were among the 50 medicines
seniors used most in 2001;
Whereas the Senate has passed S. 812, which amends Public
Law 98-417 to restore constitutionally mandated limitation on
medical inventions;
Whereas the House has not considered Legislation to amend
Public Law 98-417 to restore constitutionally mandated
limitations in medical inventions;
Whereas it is the obligation of the House to consider such
legislation in keeping with its constitutionally mandated
obligations to secure for Limited Times to Authors and
inventors the right to their writings and Inventions;
Whereas the failure of the House to restore limitations on
the exclusivity afforded to the inventors of prescription
drugs, if not remedied, will cost consumers and other
purchasers $60 billion over the next ten years, according to
the Congressional Budget Office;
Whereas the failure of the House to restore limitations on
the exclusivity afforded to the inventors of prescription
drugs, if not remedied, will leave more seniors and other
Americans without access to needed medicines;
Resolved, that it is the sense of the House of
Representatives that the house should consider pending
legislation to amend Public Law 98-417 to restore
constitutionally mandated limitations on medical inventions
on behalf of American consumers, including seniors, American
businesses, and tax-funded federal and state health insurance
programs.
{time} 1530
Point of Order
Mr. BURR of North Carolina. Mr. Speaker, I rise on a point of order.
The gentleman has not presented to the House a question of privilege
under rule IX of the rules of the House. As the House Practice Manual
clearly states, and I quote, ``Rule IX is concerned not with the
privileges of the Congress as a legislative branch but only with the
privileges of the House itself.'' The mere enumeration of the
legislative powers in article 1, section 8 of the U.S. Constitution,
which the gentleman cites in his resolution, do not give rise to a
question of privilege of the House itself. The precedents of the House
are clear on this point.
Mr. Speaker, I therefore insist on the point of order.
The SPEAKER pro tempore (Mr. Thornberry). The Chair will hear from
the gentleman from Ohio on the point of order as to whether his
resolution constitutes a question of privileges of the House under rule
IX.
Mr. BROWN of Ohio. Mr. Speaker, this resolution goes to the question
of the integrity of the House and its proceedings, and failure to act
impugns the integrity of the House.
Under article 1, section 8 of the Constitution, Congress has two
obligations in regard to intellectual property protection: to provide
authors and inventors a period of exclusivity, and to place a defined
limit on that exclusivity. Both obligations are crucial because they
accommodate a delicate balance between promoting new innovation and
promoting broad scale access to that new innovation.
In the case of prescription drugs, the balance is especially crucial.
It is in the public interest to promote the development of new
medicines. Every day, however, that competition in the drug market is
delayed means fewer Americans with access to that medicine. The only
thing more tragic than a life-threatening or debilitating illness is
knowing that one cannot afford the medicine that would cure that
illness.
In accordance with its obligations under the Constitution, Congress
has enacted a number of laws intended to provide inventors and authors
limited intellectual property protection: the Patent Act, the Copyright
Act, the Bayh-Dole Act, the Hatch-Waxman Act, and licensing laws for
atomic energy and anti-pollution devices. Unfortunately, Hatch-Waxman
confers intellectual property protection without limit. This was
clearly not the intention of the authors, and Congress has impugned its
integrity by failing to address this constitutional breach.
Under Hatch-Waxman, drug makers can trigger an automatic 30-month
period of exclusivity for their products above and beyond the 14 to 17
years of patent protection they already receive by taking two simple
steps: first, the drugmaker notifies FDA that it possesses an
additional patent that claims the drug, meaning that it covers an
essential aspect of the drug as approved by FDA. This typically occurs
at just about the time when the drugmaker's original patents on the
drug are about to expire. Then, if any generic drug companies have
filed on application with FDA to market a generic version of that drug,
the brand-name company then sues the generic for patent infringement.
Under those circumstances, FDA is obligated to place a 2\1/2\-year
stay on the approval of the generic drug application regardless of the
merit of the patent, regardless of whether the drugmaker's new patent
actually claims the drug. In fact, FDA has no authority under Hatch-
Waxman to assess whether a patent is actually in any way relevant to
the underlying drug patent. The agency must take the drug industry's
word for it and award the drugmaker an additional 30 months of
exclusivity.
While the Judicial Branch tries to step into the breach, the courts
have repeatedly curtailed the 30-month exclusivity by ruling that a
drug company's patent does not claim a drug, the courts cannot prevent
drug companies from repeating this process over and over again, filing
new patents with FDA, triggering 30 months of exclusivity, then
enjoying that exclusivity until the courts rule against them.
The SPEAKER pro tempore. The Chair requests the gentleman confine his
remarks to the question of whether the resolution constitutes a
question of privileges of the House.
Mr. BROWN of Ohio. Mr. Speaker, this goes to the question of the
integrity of the House and its proceedings; and by building this case,
it will be clear to all Members how this in fact has happened.
The Patent and Trademark Office cannot prevent drugmakers from
securing indefinite periods of exclusivity under Hatch-Waxman. It only
determines whether a drugmaker should receive a patent, not whether
this patent claims an existing prescription drug product. Under Hatch-
Waxman, neither FDA nor any agency or branch of government can prevent
intellectual property protection from being conferred over and over
again, in other words, indefinitely for the same product, a violation
of the Constitution.
This problem is not theoretical; it is real. Neurontin, a $1.1
billion-a-year drug, is a prescription drug for seizures. Its two main
patents, one on the drug's ingredients, one on the use of the drug,
expired in 1994 and 6 years later, respectively. Right before the
second patent expired, the company listed two new patents, one of which
was an unapproved use to treat Parkinson's. The drugmaker did not ask
FDA to approve the drug for Parkinson's patients. The drugmakers did
not do any research to assert whether the drug actually is effective
for Parkinson's patients, but the generic drugmaker still had to go to
court to argue that its product is not intended for Parkinson's
patients.
When the generic and brand-name company go to court, FDA is
automatically required to withhold approval of the generic for 30
months, or 2\1/2\ years. That is why this goes to the integrity of the
House and its proceedings. After those 30 months, the industry filed a
new patent, forcing the generic industry to go back to court, starting
the 30-
[[Page H6957]]
month clock again. The two delays, equal to 5 years, delayed generic
entry and additional patent protection illegally and
unconstitutionally, costing consumers a million and a half days in
potential savings.
It is our responsibility, Mr. Speaker, to restore the original intent
of Hatch-Waxman and meet our constitutional obligation to limit
intellectual property protection afforded to drugmakers. Our failure to
act on pending legislation impugns the integrity of this House and
impugns the integrity of Congress. In failing to act, we play a
complicit role in a looming health care crisis. We know what that is:
rising prescription drug costs fuel double-digit increases in health
insurance premiums, they put State budgets in the red, and they force
seniors to choose between medicine and food.
My question of privilege, Mr. Speaker, regards the integrity of our
proceedings as a House as prescribed by the Constitution. The
Constitution conveys upon this body the power to secure for limited,
underscore limited, times to authors and inventors the exclusive rights
to their writings and discoveries. Hatch-Waxman confers intellectual
property protection without limit, and therefore it is our obligation
to remedy this constitutional breach.
The other body has passed legislation already that fulfills this
obligation bipartisanly and overwhelmingly. This House has three pieces
of legislation before it, H.R. 1862, 5272, and 5311, with several
sponsors from both parties, that would enable the House to meet its
constitutional obligation. This resolution urges the House to take up
one of these measures in keeping with our constitutional obligations
and to restore the integrity of our proceedings.
I ask the Speaker to recognize any Member wishing to speak on the
resolution.
The SPEAKER pro tempore. The Chair is prepared to rule.
As the Chair ruled earlier today, a resolution expressing the
sentiment that Congress should act on a specified measure does not
constitute a question of privileges of the House under rule IX.
The mere invocation of legislative powers provided in the
Constitution coupled with a desired policy end does not meet the
requirements of rule IX and is really a matter properly initiated
through introduction in the hopper under clause 7 of rule XII.
Accordingly, the resolution offered by the gentleman from Ohio does
not constitute a question of the privileges of the House under rule IX,
and the point of order raised by the gentleman from North Carolina is
sustained.
Mr. BROWN of Ohio. Mr. Speaker, I appeal the ruling of the Chair and
ask to be heard on the ruling.
The SPEAKER pro tempore. The question is, Shall the decision of the
Chair stand as the judgment of the House?
Motion to Table Offered by Mr. Burr of North Carolina
Mr. BURR of North Carolina. Mr. Speaker, I move to lay the appeal on
the table.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from North Carolina (Mr. Burr) to lay on the table the appeal
of the ruling of the Chair.
The question was taken; and the Speaker pro tempore announced that
the ayes appeared to have it.
Mr. BROWN of Ohio. Mr. Speaker, I object to the vote on the ground
that a quorum is not present and make the point of order that a quorum
is not present.
The SPEAKER pro tempore. Evidently a quorum is not present.
The Sergeant at Arms will notify absent Members.
The vote was taken by electronic device, and there were--yeas 212,
nays 204, not voting 15, as follows:
[Roll No. 434]
YEAS--212
Aderholt
Akin
Armey
Bachus
Baker
Ballenger
Bartlett
Barton
Bass
Bereuter
Biggert
Bilirakis
Blunt
Boehlert
Boehner
Bonilla
Bono
Boozman
Brady (TX)
Brown (SC)
Bryant
Burr
Burton
Buyer
Callahan
Calvert
Camp
Cannon
Cantor
Capito
Castle
Chabot
Chambliss
Coble
Collins
Combest
Cooksey
Cox
Crane
Crenshaw
Cubin
Culberson
Cunningham
Davis, Jo Ann
Davis, Tom
DeLay
DeMint
Diaz-Balart
Doolittle
Dreier
Duncan
Dunn
Ehlers
Emerson
English
Everett
Ferguson
Flake
Fletcher
Foley
Forbes
Fossella
Frelinghuysen
Gallegly
Gekas
Gibbons
Gilchrest
Gillmor
Gilman
Goode
Goodlatte
Goss
Graham
Granger
Graves
Green (WI)
Greenwood
Grucci
Gutknecht
Hansen
Hart
Hastings (WA)
Hayes
Hayworth
Hefley
Herger
Hobson
Hoekstra
Horn
Hostettler
Houghton
Hulshof
Hunter
Hyde
Isakson
Issa
Istook
Jenkins
Johnson (CT)
Johnson (IL)
Johnson, Sam
Jones (NC)
Keller
Kelly
Kennedy (MN)
Kerns
King (NY)
Kingston
Kirk
Knollenberg
Kolbe
LaHood
Latham
LaTourette
Leach
Lewis (CA)
Lewis (KY)
Linder
LoBiondo
Lucas (OK)
Manzullo
McCrery
McHugh
McInnis
McKeon
Mica
Miller, Dan
Miller, Gary
Miller, Jeff
Moran (KS)
Myrick
Nethercutt
Ney
Norwood
Nussle
Osborne
Ose
Otter
Oxley
Paul
Pence
Peterson (PA)
Petri
Pickering
Platts
Pombo
Portman
Pryce (OH)
Putnam
Quinn
Radanovich
Ramstad
Regula
Rehberg
Reynolds
Riley
Rogers (KY)
Rogers (MI)
Rohrabacher
Ros-Lehtinen
Royce
Ryan (WI)
Ryun (KS)
Saxton
Schaffer
Schrock
Sensenbrenner
Sessions
Shadegg
Shaw
Shays
Sherwood
Shimkus
Shuster
Simmons
Simpson
Skeen
Smith (MI)
Smith (NJ)
Smith (TX)
Souder
Stearns
Sullivan
Sununu
Sweeney
Tancredo
Tauzin
Taylor (NC)
Terry
Thomas
Thornberry
Thune
Tiahrt
Tiberi
Toomey
Upton
Vitter
Walden
Walsh
Wamp
Watkins (OK)
Watts (OK)
Weldon (FL)
Weldon (PA)
Weller
Whitfield
Wicker
Wilson (NM)
Wilson (SC)
Wolf
Young (AK)
Young (FL)
NAYS--204
Abercrombie
Ackerman
Allen
Andrews
Baca
Baird
Baldacci
Baldwin
Barcia
Barrett
Becerra
Bentsen
Berkley
Berman
Berry
Bishop
Blagojevich
Blumenauer
Bonior
Borski
Boswell
Boucher
Boyd
Brady (PA)
Brown (FL)
Brown (OH)
Capps
Capuano
Cardin
Carson (IN)
Carson (OK)
Clay
Clayton
Clement
Clyburn
Condit
Conyers
Costello
Coyne
Cramer
Crowley
Cummings
Davis (CA)
Davis (FL)
Davis (IL)
DeFazio
DeGette
Delahunt
DeLauro
Deutsch
Dicks
Dingell
Doggett
Dooley
Doyle
Edwards
Engel
Eshoo
Etheridge
Evans
Farr
Fattah
Filner
Ford
Frank
Frost
Gephardt
Gonzalez
Gordon
Green (TX)
Gutierrez
Hall (TX)
Harman
Hill
Hilliard
Hinchey
Hinojosa
Hoeffel
Holden
Holt
Honda
Hooley
Hoyer
Inslee
Israel
Jackson (IL)
Jackson-Lee (TX)
Jefferson
John
Johnson, E. B.
Jones (OH)
Kanjorski
Kaptur
Kennedy (RI)
Kildee
Kilpatrick
Kind (WI)
Kleczka
Kucinich
LaFalce
Langevin
Lantos
Larsen (WA)
Larson (CT)
Lee
Levin
Lewis (GA)
Lipinski
Lofgren
Lowey
Lucas (KY)
Luther
Lynch
Maloney (CT)
Maloney (NY)
Markey
Matheson
Matsui
McCarthy (MO)
McCarthy (NY)
McCollum
McDermott
McGovern
McIntyre
McNulty
Meehan
Meek (FL)
Meeks (NY)
Menendez
Millender-McDonald
Miller, George
Mollohan
Moore
Moran (VA)
Morella
Murtha
Nadler
Napolitano
Neal
Northup
Oberstar
Obey
Olver
Ortiz
Owens
Pallone
Pascrell
Pastor
Payne
Pelosi
Peterson (MN)
Phelps
Pomeroy
Price (NC)
Rahall
Rangel
Reyes
Rivers
Rodriguez
Roemer
Ross
Rothman
Roybal-Allard
Rush
Sabo
Sanders
Sandlin
Sawyer
Schakowsky
Schiff
Scott
Serrano
Sherman
Shows
Slaughter
Smith (WA)
Snyder
Solis
Spratt
Stark
Stenholm
Strickland
Stupak
Tauscher
Taylor (MS)
Thompson (CA)
Thompson (MS)
Thurman
Tierney
Towns
Turner
Udall (CO)
Udall (NM)
Velazquez
Visclosky
Waters
Watson (CA)
Watt (NC)
Waxman
Weiner
Wexler
Woolsey
Wu
Wynn
NOT VOTING--15
Barr
Deal
Ehrlich
Ganske
Hastings (FL)
Hilleary
Lampson
Mascara
McKinney
Pitts
Roukema
Sanchez
Skelton
Stump
Tanner
{time} 1604
Mrs. NORTHUP changed her vote from ``yea'' to ``nay.''
So the motion to table was agreed to.
The result of the vote was announced as above recorded.
A motion to reconsider was laid on the table.
____________________