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CONTENTS

OPENING STATEMENT

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

108

516

Prepared statement

2, 385

Prepared statement.........

20, 392

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

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Prepared statement

523

APPENDIXES

APPENDIX 1.-BILLS.-ADDITIONAL HEARING MATERIALS

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

B. Mossinghoff, Gerald J., Commissioner of Patents and Trademarks, letter
to Hon. Robert W. Kastenmeier dated July 20, 1984.

Page

600

650

C. Patent Term Extension-Flowchart of Processing under 35 U.S.C. 156
(Supplied by the Patent, Trademark Office)...

660

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).....

674

676

691

700

713

I. Lipson, Jack of the Arnold & Porter, letter to David W. Beier III, dated
June 28, 1984.......

720

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

721

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.......

739

741

754

764

O. Mica, Daniel A., of the Congress of the United States, letter to Hon.
Robert Kastenmeier dated July 6, 1984

766

P. Statement of the Honorable Daniel A. Mica, M.C., A Representative in
Congress From the State of Florida.........

769

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.............

771

1. Wegner, Harold C., of Wegner & Bretschneider, letter to Robert W.
Kastenmeier dated July 6, 1984.....

779

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

796

809

4. Sweeney, John J., Seiu International President, Western Union Mail-
gram to Hon. Robert W. Kastenmeier dated June 5, 1984

810

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.....

811

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.........

812

(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.

864

865

(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.............

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APPENDIX 2.-ARTICLES

Page

APPENDIX 4.-FDA DATA

APPENDIX 5.-PRIOR ART

1577

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