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CONTENTS

HEARINGS HELD

OPENING STATEMENT

Hon. Robert W. Kastenmeier, a U.S. Representative in Congress from the

State of Wisconsin.........

TEXT OF BILLS

H.R. 3286.

H.R. 3605..

Banner, Donald W., president, Intellectual Property Owners, Inc

108

Prepared statement

118

Bryson, president, Elanco Products Co., a division of Eli Lilly & Co.......... 185

Prepared statement

188

Cape, Ronald E., chairman, Cetus Corp., Emeryville, CA..

548

Prepared statement

553

Dorsen, Norman, professor of law, New York University School of Law

423

Prepared statement.

516

Haddad, William F., president and chief executive officer of the Generic

Industry Association..

405

Prepared statement

415

Lewis, Robert J., representing the Pharmaceutical Manufacturing Association 405

Prepared statement on behalf of Lewis A. Engman, president, Pharma-

ceutical Manufacturers Association.........

408

Manbeck, Harry F., Jr., general patent counsel, General Electric Co

61

Prepared statement

70

Maurer, John, general consulting attorney, Monsanto Co

185

Mossinghoff, Gerald, J., Assistant Secretary of Commerce and Commissioner

of Patents and Trademarks ..

2, 385

Prepared statement ....

20, 392

Orkin, Neal, an attorney at law and an adjunct assistant professor of legal
studies at Drexel University in Philadelphia

166
Prepared statement.

169

Saegebarth, Dr. Klaus A., director of research and development, Du Pont Co... 185

Schuyler, William E., Jr., former Commissioner of the Patent and Trademark

Office

423

Prepared statement

523

Schwartz, Herbert, lecturer in law, University of Pennsylvania School of Law. 146
Prepared statement

150
Stafford, John R., president, American Home Products

423
Prepared statement .....

427

APPENDLXES

741

A. H.R. 3605.........

B. Mossinghoff, Gerald J., Commissioner of Patents and Trademarks, letter

to Hon. Robert W. Kastenmeier dated July 20, 1984.

C. Patent Term Extension-Flowchart of Processing under 35 U.S.C. 156

(Supplied by the Patent, Trademark Office)

D. Statement by the American Federation of Labor and Congress of Indus-

trial Organizations to the House Subcommittee on Courts, Civil Liber-

ties, and the Administration on Justice, Committee on the Judiciary on

H.R. 3605, Generic Drug-Patent Term Restoration dated June 27, 1984

E. Fitzpatrick, James F., Arnold & Porter, letter to Hon. Robert W. Kasten-

meier dated July 23, 1984 (on behalf of the "Research Coalition").

F. Engman, Lewis A., President of the Pharmaceutical Manufacturers,

letter to Hon. Robert W. Kastenmeier dated July 20, 1984

G. Schuyler, William E., Jr., prepared statement (on behalf of the "Research

Coalition”)....

H. Lipson, Jack of the Arnold & Porter, memorandum dated July 5, 1984

(accompanied by a letter from Norman Dorsen to Robert W. Kasten-

meier, dated July 3, 1984).

I. Lipson, Jack of the Arnold & Porter, letter to David W. Beier III, dated

June 28, 1984 ....

J. Statement of Henry Paul Monaghan, Thomas M. Macioce Professor of

Law, Columbia University.

K. Lipson, Jack, of the Arnold & Porter, letter to Peter W. Rodino, Jr. dated

August 7, 1984 ......

L. Memorandum of Laurence H. Tribe Regarding the Constitutional Issues

Posed by Section 202 of the Patent Extension Provisions of H.R. 3605

and S. 2748...
M. Testimony of U.S. Representative Lawrence Coughlin, Patent Law

Reform Submitted to the Subcommittee on Courts, Civil Liberties, and

the Administration of Justice, dated June 26, 1984.....

N. Kostmayer, Peter H., Coughlin, Lawrence, McDade, Joseph M., of the

Congress of the United States, letter to Peter W. Rodino, Jr. dated July

23, 1984..

0. Mica, Daniel A., of the Congress of the United States, letter to Hon.

Robert Kastenmeier dated July 6, 1984

P. Statement of the Honorable Daniel A. Mica, M.C., A Representative in

Congress From the State of Florida...

Q. Letter from Ester Petersen, Special Assistant for Consumer Affairs to

President Carter, the White House-Washington-To Hon. Robert W.

Kastenmeier dated June 19, 1980..

1. Wegner, Harold C., of Wegner & Bretschneider, letter to Robert W.

Kastenmeier dated July 6, 1984.........

2. Kokulis, Paul N. Attorney-At-Law of the Cushman, Darby & Cushman,

letter to Hon. Robert W. Kastenmeier dated July 9, 1984.

3. American Bar Association, Patent, Trademark and Copyright Law,

June 12, 1984

4. Sweeney, John J., Seiu International President, Western Union Mail-

gram to Hon. Robert W. Kastenmeier dated June 5, 1984...

5. Welsh, William B., Director of Legislation of the American Federation

of State, County and Municipal Employees, Employees letter to Rep-

resentative Kastenmeier dated June 26, 1984 ..

6. Stockman, David A., Director of the Executive Office of the President,

Office of Management and Budget, letter to Madigan, Edward R.

dated August 9, 1984.

7. Sokal, Allen M., of Finnegan, Henderson, Farabow, Garrett & Dunner,

letter to David Beier, Assistant Counsel on the Subcommittee on

Courts, Civil Liberties, and the Administration of Justice, dated July

31, 1984...

A. (1) Statement on Behalf of Division 14 Patent, Trademark and Copyright

Law, District of Columbia Bar, Regarding the Patent Term Restoration

Bill-Prepared by Charles L. Gholz, Barry L. Grossman, Helen M.

McCarthy, Joseph M. Potenza, Edward M. Prince, Watson T. Scott,

Robert G. Weilacher

(2) Western Union Mailgram to Peter W. Rodino, dated June 15, 1984

(3) Western Union Mailgram to Peter W. Rodino, dated June 15, 1984.

(4) Law Offices of Synnestverdt & Lechner from Elliott Jr., William H.,

to Hon. Peter W. Rodino, Jr. dated July 19, 1984..

(5) Pravel, B. R. President of the American Intellectual Property Law

Association, letter to Hon. Robert W. Kastenmeier dated July 11,

1984

(6) Goodman, Alfred N., Chairman of the Patent, Trademark and Copy-

right Law Section, letter to Hon. Robert W. Kastenmeier dated July

16, 1984.

(7) Lipson, Jack of the Arnold & Porter, letter to David Beier, Esq.,

Counsel, dated July 19, 1984......

(8) Bremer, Howard W., Patent Counsel of the Wisconsin Alumni Re-

search Foundation, letter to Hon. Robert W. Kastenmeier dated July

16, 1984..

(9) Oddis, Joseph A., Executive Vice President, of the American Society

of Hospital Pharmacists, letter to Hon. Peter Rodino dated July 6,

1984.

(10) Ruggieri, Nicholas L., Manager, Washington Affairs of the Johnson

& Johnson, letter to Hon. Peter W. Rodino, Jr., dated July 30, 1984....

(11) Hughes, Peter W., Legislative Counsel of the American Association

of Retired Persons of 26 years of service, letter to Hon. Peter W.

Rodino, Jr., dated June 26, 1984..

(12) Denison, Ray, Director of the Department of egislation, letter to

Hon. Peter Rodino, Jr., dated June 14, 1984.

(13) Goodwin, Thomas G., Director of Government Affairs of the National

Association of Pharmaceutical Manufacturers, letter to David Beier

dated May 8, 1984.

(14) Oddis, Joseph A., Executive Vice President of the American Society

of Hospital Pharmacists, letter to Hon. Peter Rodino, dated July 6,

1984.

(15) Clayman, Jacob, President, of the National Council of Senior Citi-

zens, letter to Hon. Peter Rodino, Jr., dated June 20, 1984

(16) Warden, Dick, Legislative Director of the International Union,

United Automobile Aerospace & Agricultural Implement Workers of

America-UAW, dated August 2, 1984 ......

(17) Welsh, William B., Director of Legislation of the American Federa-

tion of State, County and Municipal Employees, letter to Representa-

tive Kastenmeier dated August 2, 1984....

(18) Hughes, Peter W., Legislative Counsel of the American Association

of Retired Persons, letter to Hon. Robert W. Kastenmeier dated

August 2, 1984..

(19) Brickfield, Cyril F., of the American Association of Retired Persons,

letter to Hon. Robert W. Kastenmeier, dated August 3, 1984.

(20) Marcy, Willard, of The American Institute of Chemists, Inc., letter to

Hon. Robert W. Kastenmeier dated September 14, 1984.

(21) Boyle, J. Patrick, Government Affairs Counsel of the United Fresh

Fruit and Vegetable Association, letter to Hon. Robert W. Kasten-

meier dated September 20, 1983...

(22) Barreto, Hector, President of The United States Hispanic Chamber

of Commerce, letter to Hon. Peter W. Rodino, Jr., dated August 6,

1983
(23) Lord, Edward A.R., M.D., Chairman of the Board of Trustees, letter

to Robert W. Kastenmeier, dated October 15, 1983 ..

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(24) Seibert, H. Richard, Jr., Vice President of the National Association

of Manufacturers, letter to Hon. Robert Kastenmeier dated October

4, 1983 (25) Levine, Laura E., Director, Office of Governmental Affairs of the

American Association of Colleges of Osteopathic Medicine letter to

Hon. Robert W. Kastenmeier, dated November 21, 1983.... (26) Lemberger, August P., Dean, of the University of Wisconsin of Madi

son, letter to Hon. Robert Kastenmeier dated March 18, 1983 ..... (27) Seibert, H. Richard, Jr., Vice President Resources and Technology

Department of the National Association of Manufacturers, letter to

Hon. Peter W. Rodino, dated October 4, 1983 ...... (28) Rainer, W. Gerald, M.D., President of the American College of Chest

Physicians, letter to Hon. Peter M. Rodino, Jr., dated July 5, 1983....... (29) Engel, Ralph, President of the Chemical Specialties Manufacturers

Association, letter to Hon. Robert Kastenmeier dated July 22, 1984..... (30) Renson, James E., Executive Director of the National Association of

Printing Ink Manufacturers, Inc., letter to Hon. Robert W. Kasten

meier dated August 8, 1983. (31) Goodwin, Thomas G., Government Affairs Director of the National

Association of Pharmaceutical Manufacturers, letter to Michael J.

Remington dated August 22, 1983....... (32) Hathaway, Janet, Staff Attorney, Drabble, Nancy, Director of the

Public Citizen, letter to Representative Robert Kastenmeier dated

July 18, 1983... (33) Boyer, Dennis L., Legislative Representative of the Wisconsin

AFSCME Councils, letter to Hon. Robert Kastenmeier dated August

1, 1983 (34) Bergen Jr., Stanley S., M.D., President, of the UMDNJ, letter to

Hon. Robert W. Kastenmeier dated August 30, 1983 (35) Fensterer, Dee, Director of the Generic Pharmaceutical Industry

Association, letter to David Beier dated July 26, 1983... (36) Fensterer, Dee, Director of the Generic Pharmaceutical Industry

Association, letter to David Beier dated July 12, 1983... (37) Kennedy, Donald, President of Stanford University to the Law Of.

fices of Lobel, Novins & Lamont, letter to Flug, Esq., James F., dated

March 9, 1982 ....
(38) Engelberg, Alfred B., of the Amster, Rothstein & Engelberg letter to
Hon. Robert W. Kastenmeier dated July 11, 1984..
(a) Attachment-Generic Drug Testing and Approval Prior to

Expiration of Patent on Brand Name Drug...
(b) Memorandum from Amster, Rothstein & Engelbert, Section

202 of H.R. 3605 Is Not Unconstitutional.

(c) Constitutionality of $ 202 of Patent Extension Act. (39) Flug, James F., of the Law Offices of Lobel, Novins & Lamont, letter

to David Beier dated July 16, 1984...... (40) Engelberg, Alfred B., of the Amster, Rothstein & Engelberg letter to

Hon. Robert W. Kastenmeier dated July 20, 1984 .. (41) Engelberg, Alfred B., of the Amster, Rothstein & Engelberg letter to

David Beier dated February 15, 1984... (42) Lipson, Jack of Arnold & Porter, letter to Hon. Robert W. Kasten

meier dated July 25, 1984 (43) Stafford, John R. President, of the American Home Products Corporation, letter to Hon. Robert W. Kastenmeier dated June 22, 1984... (a) Drug Price Competition and Patent Term Restoration Act of

1984, Position Paper on S. 2748 and H.R. 3605 dated June 16,

1984.
(b) Questions and Answers About Drug Price Competition/

Patent Term Extension Act.
(c) Memorandum of Law-Constitutional Issues Presented by

Section 202 of the Proposed Abbreviated New Drug Applica

tion and Patent Term Restoration Act..
(d) Substantial Constitutional Questions Raised By Section 202 of

the Proposed Abbreviated New Drug Application and Patent

Term Restoration Act.. (44) Fitzpatrick, James F., of Arnold & Porter, letter to Alan A. Parker,

Esq., dated June 13, 1984 .. (45) Position Paper on the Encouragement of Patent Litigation

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