Whose body is it anyway? Human cells and the strange effects of property and intellectual property law

Stanford Law Review

Volumn 63, Issue 6, 2011, Pages 1377-1402

  Feldman, Robin ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; COMMERCIAL PHENOMENA; DONOR; ECONOMICS; HELA CELL; HUMAN; JURISPRUDENCE; LEGAL ASPECT; ORGANIZATION AND MANAGEMENT; PATENT; PERSONAL AUTONOMY; STEM CELL RESEARCH; UNITED STATES;

COMMERCE; HELA CELLS; HUMANS; OWNERSHIP; PATENTS AS TOPIC; PERSONAL AUTONOMY; STEM CELL RESEARCH; SUPREME COURT DECISIONS; TISSUE DONORS; UNITED STATES;

EID: 79959831383     PISSN: 00389765     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (105)

1. See Schmerber v. California, 384 U.S. 757, 767-68 (1966) (stating that the Fourth Amendment prohibits compelled intrusions into the body for blood to be analyzed for alcohol content if intrusions are not justified in the circumstances or are made in an improper manner). But see Unif. Parentage Act § 11(a), 9B U.L.A. 445 (2001) ("The court may, and upon request of a party shall, require the child, mother, or alleged father to submit to blood tests.").
2. A "cell line" is a cell culture that can proliferate indefinitely.
3. Bruce Alberts et al., Molecular Biology of the Cell 474 (4th ed. 2002).
4. See Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1321 (Fed. Cir. 2003) (addressing patents on a non-naturally occurring human erythropoietin product made with recombinant DNA technology). "Recombinant DNA technology" refers to techniques to isolate, clone, characterize, engineer, and screen DNA and study gene functions. See Alberts et al., supra note 2, at 492-93; see also Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980) (granting patent rights on bacterium produced through genetic engineering and having properties not found elsewhere in nature in that combination).
5. See Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 489 (Cal. 1990).
6. See Greenberg v. Miami Children's Hosp. Research Inst., Inc., 264 F. Supp. 2d 1064, 1074 (S.D. Fla. 2003) (noting similarity to Moore and holding that donors had no property interest in body tissue and genetic information voluntarily given). In finding, however, that "the property right in blood and tissue samples also evaporates once the sample is voluntarily given to a third party," id. at 1075, the Greenberg court implicitly suggested that there might be a property right at some point. Otherwise, there would be nothing that could "evaporate."
7. See id. at 1076 (noting the potential to cripple medical research); Moore, 793 P.2d at 493-94 (expressing concerns over creating disabling civil liability for the infant biotechnology industry); id. at 497-98 (Arabian, J., concurring) (noting that the case raises "troubling" questions related to "uplift[ing] or degrad[ing] the 'unique human persona'"); id. at 515 (Mosk, J., dissenting) (discussing laws related to slavery, indentured servitude, and debtor's prison in the context of the profound ethical imperative to respect the human body).
8. Cf. Greenberg, 264 F. Supp. 2d at 1076-77 (dismissing the claim that a registry of people who had Canavan disease constituted a trade secret).
9. See Moore, 793 P.2d at 483.
10. Robin Feldman, Coming to the Community, in Imagining New Legalities (Austin Sarat ed., forthcoming June 2011).
11. Rebecca Skloot, The Immortal Life of Henrietta Lacks 3 (2010);
12. Dwight Garner, A Woman's Undying Gift to Science, N.Y. Times, Feb. 3, 2010, at C1 (reviewing Skloot, supra);
13. Lisa Margonelli, Eternal Life, N.Y. Times, Feb. 5, 2010, http://www.nytimes.com/2010/02/07/books/review/Margonelli-t.html (same).
14. See Margonelli, supra note 10.
15. See sources cited supra note 10.
16. Margonelli, supra note 10.
17. See sources cited supra note 10.
18. 793 P.2d 479, 480-82 (Cal. 1990).
19. See id. at 480-81.
20. See id. at 483.
21. See id. at 482.
22. Id. at 487.
23. See id. at 492;
24. see also supra note 6 (discussing the dissent in Moore and a federal district court decision in Greenberg v. Miami Children's Hospital Research Institute, Inc.).
25. See Moore, 793 P.2d at 492 ("By restricting how excised cells may be used and requiring their eventual destruction, the statute eliminates so many of the rights ordinarily attached to property that one cannot simply assume that what is left amounts to 'property' or 'ownership'....").
26. See id. at 483.
27. Maxwell J. Mehlman, Moore v. Regents of the University of California, in Property Stories 41-53 (Gerald Korngold & Andrew P. Morriss eds., 2004).
28. See Moore, 793 P.2d at 506-23 (Mosk, J., dissenting);
29. E. Richard Gold, Body Parts: Property Rights and the Ownership of Human Biological Materials (1996);
30. Donna M. Gitter, Ownership of Human Tissue: A Proposal for Federal Recognition of Human Research Participants' Property Rights in Their Biological Material, 61 Wash. & Lee L. Rev. 257-281 (2004) (criticizing Moore and describing the importance of recognizing property rights and providing compensation for research participants);
31. Charlotte H. Harrison, Neither Moore Nor the Market: Alternative Models for Compensating Contributors of Human Tissue, 28 Am. J.L. & Med. 77-81 (2002) (noting three principal objections to Moore);
32. Laura M. Ivey, Moore v. Regents of the University of California: Insufficient Protection of Patients' Rights in the Biotechnological Market, 25 Ga. L. Rev. 489, 498 (1991) (discussing Justice Mosk's dissent);
33. Mehlman, supra note 23, at 41-56 (discussing the Moore holding and how it continues to affect biomedicine);
34. Jeffery A. Potts, Note, Moore v. Regents of the University of California: Expanded Disclosure, Limited Property Rights, 86 Nw. U. L. Rev. 453, 453 (1992) (disagreeing with Moore's refusal to allow a cause of action for conversion of property).
35. See Moore, 793 P.2d at 509-10 & nn.6, 8 & 10 (Mosk, J., dissenting) (observing that a homeowner association's right of first refusal over a proposed sale limits the disposition of real property and that a sportsman's right to give away-but not sell-his fish or game limits the disposition of personal property).
36. Vicodin is a narcotic pain reliever available only by prescription.
37. Moore, 793 P.2d at 510 (Mosk, J., dissenting).
38. Alan B. Bennett, Wendy D. Streitz & Rafael A. Gacel, Specific Issues with Material Transfer Agreements, in 1 Intellectual Property Management in Health and Agricultural Innovation 697-698 (Anatole Krattiger et al. eds., 2007) (explaining that a material transfer agreement is a bailment, that is, a transfer of property without a transfer of title, under which the provider maintains ownership of the transferred property);
39. Bruce Goldstein, Overview of Technology Development, in Principles and Practice of Clinical Research 291-300 (John I. Gallin & Frederick P. Ognibene eds., 2d ed. 2007) (describing material transfer agreements).
40. See Moore, 793 P.2d at 515-16 (Mosk, J., dissenting) (discussing this type of concern).
41. See, e.g., Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (containing the frequently used language that "manifestations of... nature [are] free to all men and reserved exclusively to none" (omission in original) (quoting Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)).
42. 130 S. Ct. 3218 (2010).
43. 702 F. Supp. 2d 181 (S.D.N.Y. 2010).
44. Robin Feldman, Rethinking Rights in Biospace, 79 S. Cal. L. Rev. 1-5 (2005) (describing how an analogy taken from mechanical inventions is wreaking havoc in cases related to biotechnology);
45. Robin Feldman, The Role of Science in Law (2009) (describing difficulties encountered when scientific definitions are imported into law without a firm understanding of the assumptions inherent in those definitions).
46. See, e.g., Chakrabarty, 447 U.S. at 309 (noting in a case concerning whether living products constitute patentable subject matter that "a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter"); Funk Bros., 333 U.S. at 130; cf. Diamond v. Diehr, 450 U.S. 175, 185 (1981) (noting, in a case related to process patents rather than product patents, that one cannot patent "laws of nature, natural phenomena, and abstract ideas").
47. While the single-stranded cDNA is a mirror image, it is the double-stranded version that is frequently used in lab applications.
48. In the human body, the uninterrupted coding sequence exists in the form of RNA, not DNA.
49. See Ass'n for Molecular Pathology, 702 F. Supp. 2d at 213-14.
50. Id. at 214.
51. 130 S. Ct. 3218 (2010).
52. In re Bilski, 545 F.3d 943, 959-60 (Fed. Cir. 2008) (en banc).
53. Id. at 954.
54. See Bilski, 130 S. Ct. 3218. Justice Kennedy delivered the opinion of the Court, except as to Parts II.B.2 and II.C.2. Id. at 3221. Chief Justice Roberts and Justices Thomas and Alito joined the opinion in full. See id. at 3218. Justice Scalia joined the opinion except as to Parts II.B.2 and II.C.2. See id. at 3218, 3221. Justice Stevens filed an opinion concurring in the judgment, in which Justices Ginsburg, Breyer, and Sotomayor joined. Id. at 3231. Justice Breyer filed a concurring opinion, in which Justice Scalia joined as to Part II. Id. at 3257.
55. See id. at 3226-27.
56. Id. at 3231.
57. For a detailed history of how various court opinions have slowly tied this Gordian knot and an explanation of how to untangle it, see Robin Feldman, Rethinking Patent Rights (forthcoming) (manuscript at ch. 4) (on file with author) (discussing patentable subject matter in a chapter entitled "Where Do Processes of Nature End and Processes of Human Inventions Begin?").
58. Bilski, 130 S. Ct. at 3229-30.
59. See Diamond v. Diehr, 450 U.S. 175, 187 (1981); Parker v. Flook, 437 U.S. 584 (1978); Gottschalk v. Benson, 409 U.S. 63, 67 (1972).
60. For an explanation of problems with the Benson-Flook-Diehr line of cases, and how to resolve those problems, see Feldman, supra note 45 (manuscript at ch. 4).
61. Bilski, 130 S. Ct. at 3231.
62. E.g., Benson, 409 U.S. at 67.
63. See Diehr, 450 U.S. at 187 (stating that respondent "d[id] not seek to pre-empt" the use of the well-known Arrhenius mathematical formula but "only to foreclose from others the use of that equation in conjunction with all of the other steps in their [patented] process" in holding that the claim satisfies § 101).
64. For a detailed explanation of patentable subject matter in the context of personalized medicine, see Feldman, supra note 45 (manuscript at ch. 4).
65. See id.
66. See id.
67. Such personalized medicine inventions are a statistical approximation based on an amalgamation of interpretive data; they could not possibly represent the natural state of any individual living being.
68. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004).
69. G.D. Searle, 357 F.3d at 923; see also Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc) ("[A] sufficient description of a genus... requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." (quoting Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568-69 (Fed. Cir. 1997))). See generally Robin C. Feldman, The Inventor's Contribution, 2005 UCLA J.L. & Tech. 6 (describing the history of the written description requirement and arguing that a separate written description is unnecessary if the enablement requirement is properly construed).
70. Cf. Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) (noting that a functional description might satisfy the written description requirement if "coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics" (emphasis omitted) (quoting Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1, "Written Description" Requirement, 66 Fed. Reg. 1099, 1106 (Jan. 5, 2001))).
71. Am. Wood-Paper Co. v. Fibre Disintegrating Co., 90 U.S. (23 Wall.) 566 (1874).
72. Id. at 594.
73. See Gen. Elec. Co. v. De Forest Radio Co., 28 F.2d 641, 649 (3d Cir. 1928) (invalidating patent on the grounds that the patent holder had merely produced tungsten in its pure form, and discovered no more than the natural qualities of pure tungsten); In re Merz, 97 F.2d 599, 601 (C.C.P.A. 1938) (finding patent holder not entitled to a patent on what amounts to ultramarine produced to a greater degree of purity unless the new product is of such purity that it differs not only in degree but in kind such that there is a new utility); In re Marden (Marden II), 47 F.2d 958, 959-60 (C.C.P.A. 1931) (rejecting patent on purified vanadium which resulted in greater ductility on the grounds that the greater malleability is one of its inherent qualities); In re Marden (Marden I), 47 F.2d 957 (C.C.P.A. 1931) (holding that the appellant was not entitled to a patent on the supposedly new substance, ductile uranium, on the ground that one may not patent a product of nature or the inherent natural qualities of that metal).
74. See 35 U.S.C. §§ 101-103 (2006).
75. 97 F.2d at 601; cf. Am. Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11 (1931) ("Addition of borax to the rind of natural fruit does not produce from the raw material an article for use which possesses a new or distinctive form, quality, or property.").
76. See Am. Wood-Paper, 90 U.S. (23 Wall.) at 594 ("The substance of the products, therefore, was the same, and so were their uses. The design and the end of their production was the same, no matter how or from what they were produced.").
77. Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95, 103 (C.C.S.D.N.Y. 1911), aff'd in part, 196 F. 496 (2d Cir. 1912).
78. Id.
79. The trial court in Molecular Pathology claimed that Parke-Davis did not address patentable subject matter. See Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181, 225 (S.D.N.Y. 2010) ("Although Myriad argues that the holding in Parke-Davis establishes that the purification of a natural product necessarily renders it patentable, the opinion, read closely, fails to support such a conclusion. The question before the court in Parke-Davis was one of novelty (a modern-day § 102 question), not of patenta-ble subject matter (the § 101 question before this Court)."). Judge Hand did, indeed, begin the Parke-Davis opinion with a decision relating to whether the claimed form had been anticipated by the prior art. See 189 F. 95 at 101-02. It is in the section on technical objec-tions-that is, things other than novelty-that Judge Hand turned to whether the patent was for a new composition of matter, in other words, whether the invention constituted patenta-ble subject matter.
80. See id. at 102-04.
81. Although one can argue over which part of that section should be considered precedent and which part should be considered dicta, Parke-Davis certainly reached a decision on patentable subject matter. Specifically, Judge Hand said: Nor is the patent only for a degree of purity, and therefore not for a new "composition of matter." As I have already shown, it does not include a salt, and no one had ever isolated a substance which was not in salt form, and which was anything like Takamine's. Indeed, Sadtler supposes it to exist as a natural salt, and that the base was an original production of Takamine's. That was a distinction not in degree, but in kind. But, even if it were merely an extracted product without change, there is no rule that such products are not patentable.
82. Ta-kamine was the first to make it available for any use by removing it from the other gland-tissue in which it was found, and, while it is of course possible logically to call this a purification of the principle, it became for every practical purpose a new thing commercially and therapeutically. That was a good ground for a patent. That the change here resulted in ample practical differences is fully proved. Everyone, not already saturated with scholastic distinctions, would recognize that Takamine's crystals were not merely the old dried glands in a purer state, nor would his opinion change if he learned that the crystals were obtained from the glands by a process of eliminating the inactive organic substances. The line between different substances and degrees of the same substance is to be drawn rather from the common usages of men than from nice considerations of dialectic. Id. at 103 (citations omitted).
83. 90 U.S. (23 Wall.) 566 (1873).
84. 189 F. 95 (C.C.S.D.N.Y. 1911).
85. See Am. Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1 (1931); Gen. Elec. Co. v. De Forest Radio Co., 28 F.2d 641 (3d Cir. 1928); In re Merz, 97 F.2d 599 (C.C.P.A. 1938); Marden II, 47 F.2d 958 (C.C.P.A. 1931); Marden I, 47 F.2d 957 (C.C.P.A. 1931). Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130-31 (1948), is often mentioned in the group of cases. Although it concerned a combination of bacteria rather than a purification, the Court rejected the patent, expounding on the difference between uncovering nature's qualities and something that constitutes a product of human invention. The Court may have been distracted, however, by the fact that the patent holder tried to claim all bacteria that might behave in a certain way, rather than simply the ones identified in the patent. See id.
86. William C. Robinson, The Law of Patents for Useful Inventions § 339 (Boston, Little, Brown & Co. 1890).
87. Allen K. Yu, Why It Might Be Time to Eliminate Genomics Patents, Together with the Natural Extracts Doctrine Supporting Such Patents, 47 IDEA 659-702 (2007) (arguing that Parke-Davis improperly mixed utility questions into subject matter patentability).
88. See Alberts et al., supra note 2, at 470 ("Most biochemical procedures require obtaining large numbers of cells and then physically disrupting them to isolate their components [such as protein, DNA, and RNA].... To obtain as much information as possible about an individual cell type, biologists have developed ways of dissociating cells from tissues and separating the various types[,]... result[ing] in a relatively homogeneous population of cells that can then be analyzed-either directly or after their number has been greatly increased by allowing the cells to proliferate as a pure culture."); see also id. at 472 (describing how cell cultures "allow[] the number of cells to be greatly increased and their complex behavior to be studied under the strictly defined conditions of a culture dish").
89. See Parke-Davis, 189 F. at 103.
90. Donna M. Gitter, International Conflicts over Patenting Human DNA Sequences in the United States and the European Union: An Argument for Compulsory Licensing and a Fair-Use Exemption, 76 N.Y.U. L. Rev. 1623-1625 n.11 (2001) (describing the CCR5 patent application and homologous sequencing).
91. See id.;
92. The Fate of Gene Patents Under the New Utility Guidelines, 2001 Duke L. & Tech. Rev. 8, p 6.
93. The Fate of Gene Patents Under the New Utility Guidelines, supra note 76, ¶ 6.
94. Lori B. Andrews, The Gene Patent Dilemma: Balancing Commercial Incentives with Health Needs, 2 Hous. J. Health L. & Pol'y 65-87 (2002);
95. The Fate of Gene Patents Under the New Utility Guidelines, supra note 76, ¶ 6 (describing the CCR5 receptor). Receptors are themselves proteins. Textbook of Biochemistry with Clinical Correlations 936 (Thomas M. Devlin ed., 5th ed. 2002). Thus, descriptions of the CCR5 controversies can be confusing to those without a science background because the descriptions use the term "protein" to refer to both the thing that the CCR5 sequence creates and the thing that the creation binds to.
96. See Andrews, supra note 78.
97. Shanshan Zhang, Proposing Resolutions to the Insufficient Gene Patent System, 20 Santa Clara Computer & High Tech. L.J. 1139-1161 (2004).
98. See id.
99. The Fate of Gene Patents Under the New Utility Guidelines, supra note 76, ¶ 6.
100. See generally Feldman, supra note 33.
101. See id. at 2-3 ("A doorknob is a doorknob, regardless of whether it is made of wood or glass. Can we really say... that an antibody is an antibody, no matter how it works or what materials it is made out of?... [A]re we prepared to say that an antibody is an antibody at a time when our knowledge of why particular antibodies arise in the body and how they fit into the body's overall organic processes is limited?").
102. See Bilski v. Kappos, 130 S. Ct. 3218, 3231 (2010).
103. This logic is described in detail in Feldman, supra note 45 (manuscript at ch. 4).
104. See supra text accompanying notes 51-54; see also Feldman, supra note 45 (manuscript at ch. 4) (providing a detailed explanation of the proper delineation of process claims in personalized medicine inventions in light of concerns regarding patentable subject matter).
105. For an approach that would involve a more paradigmatic shift, see Feldman, supra note 9.