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

of Manufacturers, letter to Hon. Robert Kastenmeier dated October 4, 1983

866 (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...

867 (26) Lemberger, August P., Dean, of the University of Wisconsin of Madison, letter to Hon. Robert Kastenmeier dated March 18, 1983 ...

868 (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 ....

869 (28) Rainer, W. Gerald, M.D., President of the American College of Chest

Physicians, letter to Hon. Peter M. Rodino, Jr., dated July 3, 1983....... 870 (29) Engel, Ralph, President of the Chemical Specialties Manufacturers

Association, letter to Hon. Robert Kastenmeier dated July 22, 1984..... 876 (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.

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

Association of Pharmaceutical Manufacturers, letter to Michael J.
Remington dated August 22, 1983.....

879 (32) Hathaway, Janet, Staff Attorney, Drabble, Nancy, Director of the

Public Citizen, letter to Representative Robert Kastenmeier dated
July 18, 1983.

900 (33) Boyer, Dennis L., Legislative Representative of the Wisconsin

AFSCME Councils, letter to Hon. Robert Kastenmeier dated August
1, 1983 .....

903 (34) Bergen Jr., Stanley S., M.D., President, of the UMDNJ, letter to Hon. Robert W. Kastenmeier dated August 30, 1983...

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

905 (36) Fensterer, Dee, Director of the Generic Pharmaceutical Industry Association, letter to David Beier dated July 12, 1983....

914 (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 .....

916 (38) Engelberg, Alfred B., of the Amster, Rothstein & Engelberg letter to Hon. Robert W. Kastenmeier dated July 11, 1984

918 (a) Attachment-Generic Drug Testing and Approval Prior to Expiration of Patent on Brand Name Drug....

923 (b) Memorandum from Amster, Rothstein & Engelbert, Section 202 of H.R. 3605 Is Not Unconstitutional

926 (c) Constitutionality of 8 202 of Patent Extension Act

935 (39) Flug, James F., of the Law Offices of Lobel, Novins & Lamont, letter to David Beier dated July 16, 1984......

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

954 (41) Engelberg, Alfred B., of the Amster, Rothstein & Engelberg letter to David Beier dated February 15, 1984....

977 (42) Lipson, Jack of Arnold & Porter, letter to Hon. Robert W. Kastenmeier dated July 25, 1984.

979 (43) Stafford, John R. President, of the American Home Products Corporation, letter to Hon. Robert W. Kastenmeier dated June 22, 1984..... 984 (a) Drug Price Competition and Patent Term Restoration Act of

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

985 (b) Questions and Answers About Drug Price Competition/ Patent Term Extension Act

1019 (c) Memorandum of Law-Constitutional Issues Presented by

Section 202 of the Proposed Abbreviated New Drug Applica-
tion and Patent Term Restoration Act ......

1022 (d) Substantial Constitutional Questions Raised By Section 202 of

the Proposed Abbreviated New Drug Application and Patent
Term Restoration Act.

1003 (44) Fitzpatrick, James F., of Arnold & Porter, letter to Alan A. Parker, Esq., dated June 13, 1984.

1041 (45) Position Paper on the Encouragement of Patent Litigation

1043 APPENDIX 2.-ARTICLES

Page A. The New York Times, “The Half-Life Patents,” dated May 23, 1981 1134 B. The New York Times, "How Much Haven for Drug Pioneers?" dated June 25, 1984.

1138 C. Science, vol. 222, “The Push To Protect Patents on Drugs," dated November 1983.

1142 D. "Patent Preliminary Injunctive Relief,” Journal of the Patent Office Society, dated October 1978, vol. 60, No. 10.

1145 E. Sobel, “Examining the Extra Burden Imposed on a Patentee Who Seeks a Preliminary Injunction," 32 Am. Univ. L. Rev. — (1983).

1183 F. "The Decline in Effective Patent Life of New Drugs," by Martin M. Eisman and William M. Wardell, dated January 1981..

1206 G. "The Decline in Effective Patent Life of New Drugs," by Martin M. Eisman and William M. Wardell, dated March 1981.

1210 H. Estimating the Effects of Regulation on Innovation, The Journal of Law

& Economics, Volume XXI(1) April 1978, The University of Chicago
Law School.

1215 I. “Lessons from the Drug Lag,” Harvard Journal of Law and Public Policy, vol. 5, dated summer 1982

1245 J. “New Drug Development,” Clinical Pharmacology and Therapeutics, vol. 33, No. 6, dated June 1983 ..

1284 K. Engelbert, "Patent Term Extension". Health Affairs (Spring, 1982)..... 1294

APPENDIX 3.-CASES
A. U.S. District Court Eastern District of New York, Roche Products, Inc.,

plaintiff against Bolar Pharmaceuticals Co., Inc., defendant, dated Octo-
ber 11, 1983..

1307

1335

1339

1341

APPENDIX 4.-FDA DATA
A. Wetherell, Robert C., Jr., Associate Commissioner for Legislation and

Information for the Department of Health and Human Services, letter

to Hon. Robert W. Kastenmeier, dated July 30, 1984 ..... B. Wetherell, Robert C., Jr., Associate Commissioner for Legislation and

Information for the Department of Health and Human Services, letter

to Hon. Robert W. Kastenmeier, dated July 30, 1984 .. C. Wetherell, Robert C., Jr., Associate Commissioner for Legislation and

Information for the Department of Health and Human Services, letter

to Hon. Robert W. Kastenmeier, dated August 6, 1984 D. Root, Cynthia C., Deputy Assistant Secretary for Legislation for the De

partment of Health and Human Services, letter to Hon. Peter W.

Rodino, Jr., dated July 24, 1984.
E. NDA's Approved .....

APPENDIX 5.-PRIOR ART
A. Newman, Pauline, director, Patent and Licensing Department of FMC

Corp., letter to David Beier, Esq., Subcommittee on Courts, Civil Liber

ties, and the Administration of Justice, dated July 15, 1983... B. Shurn, "Is the Invention of Another Available as Prior Art?” In re Bass

to in re Clemens and Beyond, 63 J. Pat. Off. Soc'y 516 (1981). C. Wulterscheid, "The Ever Evolving Meaning of Prior Art” (pts. 1-4), 64 J.

Pat. Off. Soc'y 457, 571, 632 (1982), 65 J. Pat. Off. Soc'y 3 (1983)..

1342 1343

1435

1437

1482

APPENDIX 6.-LICENSEE ESTOPPEL

1577

1594

A. The “Decent Burial" of Patent Licensee Estoppel, 1970 Duke L.J. 375

(1970)...... B. Patent Law-Estoppel Doctrine of Licensee Estoppel Overruled; State

Protection of Unpatented Inventions Questioned: Lear, Inc. v. Adkins,

45 N.Y.U.L. Rev. 386 (1970)... C. Milgrim, "Sears to Lear to Painton: Of Whales and Other Matters,” 46 N.Y.U.L. Rev. 17 (1971)......

APPENDIX 7.-CASES A. Lear, Inc. v. Adkins, 395 U.S. 653 (1968)..........

1608

1626

Dans Coris Core 217 CSPG 314 282)

1656 varan beties Imament Ca 1. Aller :56 ESPG 372 19711.

1659 PENDIX - ACADEMIC COMMENTS ► 27 Dr. Cniversity of California Los Angeles. School of

sia's in Pobert W Kastenmeter, dated September 5,983- 1663 3 Heat, Thomas Sniversity of San Francisco School of Law, an, in Rotsert Kastenmeier, dated October 2983

1672 of mon + Marquette Caiversity Law School. etter to Hon. 2009 Katenmeer dated September 1983

1675 - 3-6 to Franklin Pierce Law Center, letter to Fon Robert W. Inanmin sate February 1984

1680 mont Surveg by the PTC Research Foundation on the Impact n. Adans decision..

1681 2 3 3 7 liam T. University of Baltimore School of Law, letter to

der har Kastenmeier, date October 17. 1983 re ER 35T: 1725 = 3-5 Bar Wiliam T, University of Baltimore School of Law, letter to dom Short W Kastenmeier, dated October 17, 1983 re the Patent and mark Office Procedures Improvement Act of 1983

1727 , agus panf Peter B University of Illinois College of Law, letter to Hon. Kakort V Kastenmeier, dates October 5, 1983

1729 postry Prof Irurence H. Cniversity of California Los Angeles, School of i etter to Hon. Robert W. Kastenmeier, dated November 14, 1983... 1735

APPENDIX 9.-EMPLOYED INVENTORS RIGHTS A Ime Dein, chairman, IEEE/USAB Intellectual Property Committee, in to Hon Robert W. Kastenmeier, dated June 1. 1984

1743 Atachment IEEE Suggested Modifications to HR 3286

1749 Attachment IEEE Comments on Harvey Manbeek's Markup of BR 5126

1754 % en fack firector. Department for Professional Employees, AFL

ib, o'n Hon Robert W. Kastenmeier, dated May 10, 1984. 1756 leurs na registant director, Department for Professional Em

ons AFC-10, etter to David W. Beier, dated June 1, 1983. 1758
Aryshment Survey Studies Inventor Award Plans in Major Com-
sar. Research Management (July, 1979).

1759
forma rowery II Comprehensive Salary and Employment Status
Porrory v American Chemical Society

1760 Aug mes enero, Memorandum to American Chemical Society Task

7*** Compensation for Employed Inventors from Kathleen
A pesma ompensation for Employed Inventors Survey

1786
Pada wannet. Sears, Roebuck & Co.: The Case of the Ludi-
t'evel, long langaton," Eur. Intell. Prop. Rev. (May 1982).

1824 % Inn **** Prir Returns Bright Idea to Inventor," 208 Science 473

1835 Mar 14lation Necessary and Coming,” address to annual meet14. American Chemical Society Corporation Associates, Novem

1837 (; Mbun (pogonisation for Employed Inventors,” 5 Chemical Tech 86 Yotent mary,

1855 H Parunth, 1% laga in Patent Law Reform,” IEEE Spectrum (March

1859 1 Orkin, the legal Rights of the Employed Inventor: New Approaches to

(18 Prekyleans" (pts. 1 and 2), 56 J. Pat. Off. Soc'y 648, 719 (1974)........... 1864 s Hipp, "Inoitus Are Seeking Bigger Share of Gains From Their Suc(," Wall St J., September 9, 1982, at 1 ....

1915 K Pages, "Award Schemes for Employee-Inventors, CIPA,” October 1975...... 1917 L. "Compensation for Employed Inventors," report of American Chemical

Society Committee on patent matters and related legislation, March
1976

1925 M Sandrock, 'The Evolution and Modern Application of the Shop Right Hule," 9 Bus, Law, 953 (1983)..

1953 N. Howell, "'Patent Ownership: An Employer's Rights to His Employee's Invention" 5 Notre Dame L. Rev. 863 (1983).

1976 Maltby, "A Government Patent Policy for Employee Invention," 21 Fed. Yar J. 121 (1961)........

2005 Page P. Manly, “Inventors, Innovators, Compensation and the Law," 21 Research Management 29 (1978).

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2027 Q. Gullette, "State Legislation Governing Ownership Rights in Inventions

Under Employee Invention Agreements,” 62 J. Pat. Off. Soc'y 732
(1980).

2031 R. Cornwell, “Employee Rights in Innovative Works,” 113 Int'l Labour Rev. 301 (1980)..

2061 S. Alam, "Employers' Obligations Regarding Employee Inventions-A New Perspective," 8 Employee Rel. L.J. 463 (1982).

2082 T. G. Doherty and J. Iandiorio, "The Law of the Employed Inventor-Time for a Change?” 57 Mass. L.Q. 27 (1972) ....

2101 U. J. Phillips and K. Mason, “Employees' Inventions and the Patents Act 1977" (1978)..

2120 V. Lieberstein, “Suing the Former Employee,” 59 J. Pat. Off. Soc'y 705 (1977).

2171 W. Leonard, "The Protected Rights of the Employee Inventor in His Invention," XLIX J. Pat. Off. Soc'y 357 (1967).

2196 X. Siekman, "Employer's and Employee's Rights in Patents Arising From the Employment,” 11 Vill. L. Rev. 823 (1966).

2213 Y. Nold, "Patents, Inventions and Inventors,” Design News 11 (November 21, 1983)

2222 Z. Morgan, "High Tech: Leaving Home,” Washington Post, May 1-6, 1983.. 2223 AA. Lourie, Alan D., vice president, SmithKline Beckman Corp., letter to editor, Harvard Business Review, dated February 17, 1984.

2270 BB. Orkin, “Rewarding Employee Invention: Time for a Change," Harvard Bus. Rev., January/February 1984....

2273 CC. Resolution 104-1 of A.B.A. Section of Patent, Trademark and Copyright

Law re Proposed Model State Law Regarding Employee Inventions.... 2276 DD. Suttle, W. Thomas, manager, Professional Programs, IEEE, letter to David W. Beier, Esq., dated September 20, 1983

2277 Attachment: J. Stedman, Congress' Jurisdiction to Enact H.R. 4732 and H.R. 6635 (July 11, 1982) (unpublished paper)..

2278 EE. Drucker, "Schumpeter and Keynes, Forbes, May 23, 1983

2287 FF. Phillips, “Patents and Incentives to Invent,” 8 Endeavour (1984)......... 2293 GG. Respess, W., "Employment of Inventors and Creators of Other Intellec

tual Property," Paper Given Before American Patent Law Association
Continuing Legal Education Institute on Business and Intellectual
Property Law, January 27-30, 1982.....

2298 HH. "Law of Employee Inventions in Foreign countries,” prepared by mem

bers of the staff of the Library of Congress Law Library, June 1983...... 2341 II. "Federal Republic of Germany,” paper prepared by Dr. Edith Palmer,

Senior Legal Specialist, European Law Division, Library of Congress
Law Library, June 1983.

2391 JJ. Calif. Codes Ann. 88 2870-2872 (West Supp. (1983)..

2398 KK. Minn. Stat. Ann. § 181.76 (West Supp. 1983)....

2401 LL. Rev. Code of Wash. Ann. § 49.44.140 (West Supp. 1982)

2403 APPENDIX 10.-GATT PROBLEMS A. Gotlieb, Allan, Ambassador, of the Canadian Embassy, letter to Hon. Robert W. Kastenmeier, dated October 4, 1984.......

..... 2408 B. Eckes, Alfred, Chairman of the U.S. International Trade Commission, letter to Hon. Peter W. Rodino, Jr., dated March 8, 1984....

2409 C. West, William K., Jr., chairman, Subcommittee B (Process Patents) of the

Cushman, Darby & Cushman, letter to Manbeck, Jr., Esq., Harry F.,
dated February 17, 1984.,

2415 D. Memorandum to Charles F. Rule, Deputy Assistant Attorney General,

Antitrust Division, from Claud Gingrich, General Counsel, dated Janu-
ary 24, 1984.

2419 E. Memorandum to Mike Remington, Chief Counsel, Subcommittee on

Courts Civil Liberties, and the Administration of Justice, from Alice
Zalik, Assistant General Counsel of the Office of the U.S. Írade Repre
sentative, dated August 14, 1984 ...

2A22 F. General Agreement on Tariffs and

Trade, Basic Instruments and Selected
Documents, vol. IV, Text of the General Agreement 1969....

2426 G. Hayhurst, William L., from Ridout & Maybee, Patent and Trade Mark Agents, letter to Michael K. Kirk, Esq., dated August 15, 1984.

2526

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