INNOVATION AND PATENT LAW REFORM HEARINGS BEFORE THE SUBCOMMITTEE ON COURTS, CIVIL LIBERTIES, OF THE COMMITTEE ON THE JUDICIARY NINETY-EIGHTH CONGRESS SECOND SESSION ON H.R. 3285, H.R. 3286, and H.R. 3605 INNOVATION AND PATENT LAW REFORM 45-024 O MARCH 28, APRIL 26, AND JUNE 6, 27, 1984 Part 2 Serial No. 105 Printed for the use of the Committee on the Judiciary U.S. GOVERNMENT PRINTING OFFICE WASHINGTON: 1985 32 452ST XL 1 10/96 53-005, 115 APPENDIXES APPENDIX 1.-BILLS.-ADDITIONAL HEARING MATERIALS 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 H. Lipson, Jack of the Arnold & Porter, memorandum dated July 5, 1984 (accompanied by a letter from Norman Dorsen to Robert W. Kasten- Page K. Lipson, Jack, of the Arnold & Porter, letter to Peter W. Rodino, Jr. dated J. Statement of Henry Paul Monaghan, Thomas M. Macioce Professor of Law, Columbia University L. Memorandum of Laurence H. Tribe Regarding the Constitutional Issues Posed by Section 202 of the Patent Extension Provisions of H.R. 3605 M. Testimony of U.S. Representative Lawrence Coughlin, Patent Law 754 764 766 O. Mica, Daniel A., of the Congress of the United States, letter to Hon. P. Statement of the Honorable Daniel A. Mica, M.C., A Representative in 769 Q. Letter from Ester Petersen, Special Assistant for Consumer Affairs to 771 1. Wegner, Harold C., of Wegner & Bretschneider, letter to Robert W. 779 2. Kokulis, Paul N. Attorney-At-Law of the Cushman, Darby & Cushman, 3. American Bar Association, Patent, Trademark and Copyright Law, 796 4. Sweeney, John J., Seiu International President, Western Union Mail- 810 811 V 7. Sokal, Allen M., of Finnegan, Henderson, Farabow, Garrett & Dunner, A. (1) Statement on Behalf of Division 14 Patent, Trademark and Copyright (2) Western Union Mailgram to Peter W. Rodino, dated June 15, 1984. (6) Goodman, Alfred N., Chairman of the Patent, Trademark and Copy- (7) Lipson, Jack of the Arnold & Porter, letter to David Beier, Esq., (8) Bremer, Howard W., Patent Counsel of the Wisconsin Alumni Re- (9) Oddis, Joseph A., Executive Vice President, of the American Society (10) Ruggieri, Nicholas L., Manager, Washington Affairs of the Johnson Page 813 814 819 820 822 824 830 844 845 847 848 851 (12) Denison, Ray, Director of the Department of Legislation, letter to 852 854 (14) Oddis, Joseph A., Executive Vice President of the American Society 855 (15) Clayman, Jacob, President, of the National Council of Senior Citi- (17) Welsh, William B., Director of Legislation of the American Federa- (18) Hughes, Peter W., Legislative Counsel of the American Association 856 857 858 859 (19) Brickfield, Cyril F., of the American Association of Retired Persons, 860 861 (22) Barreto, Hector, President of The United States Hispanic Chamber (23) Lord, Edward A.R., M.D., Chairman of the Board of Trustees, letter 862 864 865 (24) Seibert, H. Richard, Jr., Vice President of the National Association of Manufacturers, letter to Hon. Robert Kastenmeier dated October (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- (31) Goodwin, Thomas G., Government Affairs Director of the National Association of Pharmaceutical Manufacturers, letter to Michael J. (32) Hathaway, Janet, Staff Attorney, Drabble, Nancy, Director of the Public Citizen, letter to Representative Robert Kastenmeier dated (33) Boyer, Dennis L., Legislative Representative of the Wisconsin AFSCME Councils, letter to Hon. Robert Kastenmeier dated August (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 (38) Engelberg, Alfred B., of the Amster, Rothstein & Engelberg letter to 918 (a) Attachment-Generic Drug Testing and Approval Prior to 923 (b) Memorandum from Amster, Rothstein & Engelbert, Section 926 (c) Constitutionality of § 202 of Patent Extension Act. 935 (43) Stafford, John R. President, of the American Home Products Corpo- ration, 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, (c) Memorandum of Law-Constitutional Issues Presented by (d) Substantial Constitutional Questions Raised By Section 202 of APPENDIX 2.-ARTICLES Page A. The New York Times, "The Half-Life Patents," dated May 23, 1981. B. The New York Times, "How Much Haven for Drug Pioneers?" dated E. Sobel, "Examining the Extra Burden Imposed on a Patentee Who Seeks a Preliminary Injunction," 32 Am. Univ. L. Rev. · (1983).. F. "The Decline in Effective Patent Life of New Drugs," by Martin M. Eisman and William M. Wardell, dated January 1981. G. "The Decline in Effective Patent Life of New Drugs," by Martin M. H. Estimating the Effects of Regulation on Innovation, The Journal of Law & Economics, Volume XXI(1) April 1978, The University of Chicago A. U.S. District Court Eastern District of New York, Roche Products, Inc., plaintiff against Bolar Pharmaceuticals Co., Inc., defendant, dated Octo- 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. 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). A. The "Decent Burial" of Patent Licensee Estoppel, 1970 Duke L.J. 375 1577 B. Patent Law-Estoppel Doctrine of Licensee Estoppel Overruled; State Protection of Unpatented Inventions Questioned: Lear, Inc. v. Adkins, |