Ethical issues in the patenting of medical procedures

Food and Drug Law Journal

Volumn 53, Issue 2, 1998, Pages 341-351

  Glasson, John ^b   Plows, Charles W ^b   Clarke, Oscar W ^b   Cosgriff, James H ^b   Fuller, Drew ^b   Kliger, Craig H ^b   Rakantansky, Herbert ^b   Tenery Jr , Robert M ^b   Wilkins Jr , George T ^b   Orentlicher, David ^b   Ile, Michael L ^b   Quigley, Rosemary ^b   Jarrad, Anna ^b   Munson, Jeffrey ^b   Latham, Stephen R ^b   Emanuel, Linda L ^a  

^a AMERICAN MEDICAL ASSOCIATION   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

CONFIDENTIALITY; DIAGNOSTIC PROCEDURE; ETHICS; IMAGING; MEDICAL RESEARCH; MEDICAL TECHNOLOGY; PATENT; PATIENT CARE; REVIEW; SURGICAL TECHNIQUE;

AMERICAN MEDICAL ASSOCIATION; ETHICS, MEDICAL; HUMANS; LEGISLATION, MEDICAL; PATENTS; SURGERY; SURGICAL PROCEDURES, OPERATIVE; TECHNOLOGY, MEDICAL; UNITED STATES;

EID: 17144439367     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (77)

1. B. McCormick, Just Reward or Just Plain Wrong?, AM. MED. NEWS, Sept. 5, 1994, at 3; J. Hayes, The War Over Patents, 7 ARGUS 8-9, 14 (1994); S. Pallin, An Unethical Objection to my Surgical Patent, WALL ST. J., Oct. 24, 1994, at A15; Doctors Group Opposes Medical Method Patents, WALL ST. J., Sept. 6, 1994, at A13.
2. B. McCormick, Just Reward or Just Plain Wrong?, AM. MED. NEWS, Sept. 5, 1994, at 3; J. Hayes, The War Over Patents, 7 ARGUS 8-9, 14 (1994); S. Pallin, An Unethical Objection to my Surgical Patent, WALL ST. J., Oct. 24, 1994, at A15; Doctors Group Opposes Medical Method Patents, WALL ST. J., Sept. 6, 1994, at A13.
3. B. McCormick, Just Reward or Just Plain Wrong?, AM. MED. NEWS, Sept. 5, 1994, at 3; J. Hayes, The War Over Patents, 7 ARGUS 8-9, 14 (1994); S. Pallin, An Unethical Objection to my Surgical Patent, WALL ST. J., Oct. 24, 1994, at A15; Doctors Group Opposes Medical Method Patents, WALL ST. J., Sept. 6, 1994, at A13.
4. B. McCormick, Just Reward or Just Plain Wrong?, AM. MED. NEWS, Sept. 5, 1994, at 3; J. Hayes, The War Over Patents, 7 ARGUS 8-9, 14 (1994); S. Pallin, An Unethical Objection to my Surgical Patent, WALL ST. J., Oct. 24, 1994, at A15; Doctors Group Opposes Medical Method Patents, WALL ST. J., Sept. 6, 1994, at A13.
5. See generally 35 U.S.C. (1994)
6. U.S. CONST. art. I, § 8, cl. 8.
7. See 35 U.S.C. §§ 102, 103, 154.
8. See Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negociations, Pub. L. No. 103-465, 108 Stat. 4809, 493-85 (1994) (codified at 21 U.S.C. § 154).
9. See generally S. Chartrand, Extending Patents to 20 Years From Date of Firstfiling Poses Questions About Existing Ones, N.Y. TIMES, Jan. 6, 1995, at C2.
10. 35 U.S.C. § 261.
11. Id. § 271.
12. Id. § 101.
13. Id. § 100(b).
14. Diamond v. Chakrabarty, 444 U.S. 1028 (1980). See also R. Eisenberg, Patenting the Human Genome, 39 EMORY L.J. 720 (1990).
15. D.L. Burk, Patenting Transgenic Human Embryos: A Non-Use Cost Perspective, 30 HOUSTON L. REV. 1597 (1993).
16. B. McCormick, Restricting Patents, AM. MED. NEWS, Mar. 20, 1995, at A3.
17. H.R. 1127, 104th Cong., 1 st Sess. (1995) (introduced by Congressmen Ganske and Wyden, to limit the issuance of patents on medical procedures). See also T. Riordan, New Legislation Seeks to Exclude Surgical Procedures From Patent Protection, N. Y. TIMES, Mar. 6, 1995, at C2.
18. See generally McCormick, supra note 1; G. Burch, Ethical Considerations in the Patenting of Medical Processes, 65 TEXAS L. REV. 1139 (1987); T. McCoy, Biomedical Process Patents: Should They be limited by Ethical Restrictions?, 13 J. LEGAL MED. 501 (1992).
19. See generally McCormick, supra note 1; G. Burch, Ethical Considerations in the Patenting of Medical Processes, 65 TEXAS L. REV. 1139 (1987); T. McCoy, Biomedical Process Patents: Should They be limited by Ethical Restrictions?, 13 J. LEGAL MED. 501 (1992).
20. See Burch, supra note 15; McCoy, supra note 15.
21. See McCormick, supra note 1.
22. See id.; Hayes, supra note 1; Pallin, supra note 1; Doctors Group Opposes Patents, supra note 1.
23. Pallin v. Singer, 36 U.S.P.Q.2d (BNA) 1050. See also McCormick, supra note 1.
24. Hayes, supra note 1.
25. McCormick, supra note 13.
26. See, e.g., COMMITTEE ON ETHICS OF THE AM. COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS, COMMERCIAL VENTURES IN MEDICINE: CONCERNS ABOUT THE PATENTING OF PROCEDURES No. 129 (1993); COUNCIL ON ETHICAL AND JUDICIAL AFFAIRS, AMERICAN MED. ASS'N, CODE OF MEDICAL ETHICS: 1994 EDITION (1994); Martin v. Wyeth, Inc., 96 F. Supp. 689 (D. Md. 1951); E. Marshall, Data Sharing: A Declining Ethic?, 248 SCI. 952 (1990); R. Eisenberg, Proprietary Rights and the Norms of Science in Biotechnology Research, 97 YALE L.J. 177 (1987).
27. See, e.g., COMMITTEE ON ETHICS OF THE AM. COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS, COMMERCIAL VENTURES IN MEDICINE: CONCERNS ABOUT THE PATENTING OF PROCEDURES No. 129 (1993); COUNCIL ON ETHICAL AND JUDICIAL AFFAIRS, AMERICAN MED. ASS'N, CODE OF MEDICAL ETHICS: 1994 EDITION (1994); Martin v. Wyeth, Inc., 96 F. Supp. 689 (D. Md. 1951); E. Marshall, Data Sharing: A Declining Ethic?, 248 SCI. 952 (1990); R. Eisenberg, Proprietary Rights and the Norms of Science in Biotechnology Research, 97 YALE L.J. 177 (1987).
28. See, e.g., COMMITTEE ON ETHICS OF THE AM. COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS, COMMERCIAL VENTURES IN MEDICINE: CONCERNS ABOUT THE PATENTING OF PROCEDURES No. 129 (1993); COUNCIL ON ETHICAL AND JUDICIAL AFFAIRS, AMERICAN MED. ASS'N, CODE OF MEDICAL ETHICS: 1994 EDITION (1994); Martin v. Wyeth, Inc., 96 F. Supp. 689 (D. Md. 1951); E. Marshall, Data Sharing: A Declining Ethic?, 248 SCI. 952 (1990); R. Eisenberg, Proprietary Rights and the Norms of Science in Biotechnology Research, 97 YALE L.J. 177 (1987).
29. See, e.g., COMMITTEE ON ETHICS OF THE AM. COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS, COMMERCIAL VENTURES IN MEDICINE: CONCERNS ABOUT THE PATENTING OF PROCEDURES No. 129 (1993); COUNCIL ON ETHICAL AND JUDICIAL AFFAIRS, AMERICAN MED. ASS'N, CODE OF MEDICAL ETHICS: 1994 EDITION (1994); Martin v. Wyeth, Inc., 96 F. Supp. 689 (D. Md. 1951); E. Marshall, Data Sharing: A Declining Ethic?, 248 SCI. 952 (1990); R. Eisenberg, Proprietary Rights and the Norms of Science in Biotechnology Research, 97 YALE L.J. 177 (1987).
30. CODE OF MEDICAL ETHICS, supra note 22, at xiv (Principle V) (emphasis added).
31. Id. at 139 (Opinion 9.08) (emphasis added).
32. See, e.g., Eisenberg, supra note 11; Burch, supra note 15; McCoy, supra note 15; CODE OF MEDICAL ETHICS, supra note 22, at 140.
33. See Burk, supra note 12; McCoy, supra note 15; Embryo Transfer Technique Patent Questioned by Rep. Gore; House Subcomm. Should Review "Generic" Issue of Medical Process Patents, Ethicist Says, F-D-C REP. ("The Blue Sheet"), Aug. 22, 1984, at 4-5.
34. See Burch, supra note 15; McCoy, supra note 15.
35. See Burch, supra note 15; McCoy, supra note 15; S. Chartrand, A Detection Method for Breast Tumors May Add Fire to a Debate Over Patents for Medical Procedures, N.Y. TIMES, Jan. 30, 1995, at C2.
36. McCoy, supra note 15, at 515.
37. Burch, supra note 15; McCoy, supra note 15; C. Annas, Surrogate Embryo Transfer: The Perils of Patenting, 14 HASTINGS CENTER REP. 25 (1984).
38. See Annas, supra note 30.
39. See Eisenberg, supra note 11, at 742; McCoy, supra note 15, at 513.
40. F. Chapman, Going for Gold in the Baby Business, FORTUNE, Sept. 17, 1984, at 41.
41. See Eisenberg, supra note 11; McCoy, supra note 15.
42. Eisenberg, supra note 22.
43. P. Tarini, Inventive Approach May Be the Answer, AM. MED. NEWS, Oct. 6, 1989, at 22-23.
44. See Eisenberg, supra note 11.
45. Ethics Comm. of the Am. Fertility Ass'n, Ethical Considerations of Patents in Reproductive Medicine, 62 FERTILITY & STERILITY 278 (1994).
46. See, e.g., Eisenberg, supra note 11; Burch, supra note 15; McCoy, supra note 15; Eisenberg, supra note 22.
47. See, e.g., Eisenberg, supra note 11; Burch, supra note 15; McCoy, supra note 15; Eisenberg, supra note 22.
48. McCoy, supra note 15.
49. Id.; Eisenberg, supra note 22.
50. Pallin, supra note 1; Doctors Group Opposes Patents, supra note 1; COMMITTEE ON ETHICS, supra note 22; Ethics Comm. of the Am. Fertility Ass'n, supra note 38.
51. Pallin, supra note 1; Doctors Group Opposes Patents, supra note 1; COMMITTEE ON ETHICS, supra note 22; Ethics Comm. of the Am. Fertility Ass'n, supra note 38.
52. V. Slind-For, The Trouble With Techno Transfers, NAT'L L.J., Oct. 3, 1994, at A 1, A26-27.
53. See, e.g., Hayes, supra note 1; Pallin, supra note 1.
54. Ethics Comm. of the Am. Fertility Ass'n, supra note 38; E. Felsenthal, Medical Patents Trigger Debate Among Doctors, WALL ST. J., Aug. 11, 1994, at B1.
55. Burch, supra note 15; Annas, supra note 30; Ethics Comm. of the Am. Fertility Ass'n, supra note 38.
56. Felsenthal, supra note 46.
57. See, e.g., Eisenberg, supra note 11; Burch, supra note 15; McCoy, supra note 15; Eisenberg, supra note 22; R. Eisenberg, Patents and the Progress of Science, 56 U. CHI. L. REV. 1021 (1989).
58. Burch, supra note 15; McCoy, supra note 15; Eisenberg, Patents and Progress, supra note 49.
59. Embryo Transfer Technique, supra note 26.
60. Ethics Comm. of the Am. Fertility Ass'n, supra note 38.
61. See Eisenberg, supra note 11.
62. Annas, supra note 30.
63. Burch supra note 15; McCoy, supra note 15; Eisenberg, supra note 49.
64. A. Bloomberg, S.J. Marylander, & P.M. Yeager, Patenting Medical Technology: "To Promote the Progress of Science and Useful Arts," 317 NEW ENG. J. MED. 565 (1987).
65. Eisenberg, supra note 22, at 206.
66. Id.; Burch, supra note 15: McCoy, supra note 15.
67. H. SPEER, OBSTETRICS AND GYNECOLOGY: A HISTORY AND ICONOGRAPHY 270-72 (1994).
68. See Marshall, supra note 22.
69. See McCormick, supra note 1.
70. Burch, supra note 15; McCoy, supra note 15; Eisenberg, Patents and Progress, supra note 49.
71. See, e.g., Burch, supra note 15; McCoy, supra note 15.
72. Eisenberg, supra note 11.
73. B. Cannon, Toward a Clear Standard of Obviousness for Biotechnology Patents, 79 CORNELL L. REV. 735 (1994).
74. U.S. Patent No. 5,267,570 (approved Dec. 7, 1993).
75. See McCormick, supra note 1.
76. SPEER, supra note 59, at 272.
77. See McCoy, supra note 15.