[Congressional Record (Bound Edition), Volume 148 (2002), Part 14]
[House]
[Pages 18934-18936]
[From the U.S. 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;
       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.

[[Page 18935]]



                              {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- 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

[[Page 18936]]

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.

                          ____________________