Patenting everything under the sun: Invoking the first amendment to limit the use of gene patents

UCLA Law Review

Volumn 58, Issue 4, 2011, Pages 1123-1174

  Kauble, Krysta ^a  

^a NONE

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EID: 79959311968     PISSN: 00415650     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (273)

1. Bonnie A. Maybury Okonek & Linda Morganstein, Development of Polio Vaccines, ACCESS EXCELLENCE, http://www.accessexcellence.org/AE/AEC/CC/polio.php (last visited Nov. 3, 2010).
2. Could You Patent the Sun?, UNDER THE SAME SUN (Aug. 25, 2004), http://www.underthesamesun.org/content/2004/08/could-you-paten.html.
3. For example, the U.S. Patent and Trademark Office (USPTO) has awarded patents over a method of exercising a cat (encouraging it to follow a handheld laser), a method of swinging on a swing, a method of playing a bowling game, a tricycle lawnmower, and a motorized ice cream cone. See U.S. Patent Nos. 5, 443, 036 (filed Nov. 2, 1993), 6, 368, 227 (filed Nov. 17, 2000), 6, 142, 880 (filed Feb. 24, 1999), 4, 455, 816 (filed June 29, 1982), and 5, 971, 829 (filed Mar. 6, 1998), respectively.
4. In fact, the federal government recently recognized the flaws inherent in the USPTO's patent system when it filed an amicus brief in fevor of Myriad Genetics, the plaintifis in the case that inspired this Comment. Brief for the United States as Amicus Curiae Supporting Neidier Party, Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010) (No. 09 Civ. 4515), avmlahk at http://graphics8.nytimes.com/packages/pdf/ business/genepatents-USamicusbrief.pdf.
5. For purposes of this Comment, "gene patents" are defined as any patents over genomic sequences that have been isolated and purified. An isolated and purified gene sequence is a gene sequence that has been separated from its other cellular components.
6. An estimated 47, 000 patents discussing deoxyribonucleic acid (DNA) or ribonucleic acid have been granted in the United States. See Robert Cook-Deegan, Gene Patents, in FROM BIRTH TO DEATH AND BENCH TO CLINIC: THE HASTINGS CENTER BIOETHICS BRIEHNG BOOK FOR JOURNALISTS, POLICYMAKERS, AND CAMPAIGNS 69, 70 (Mary Crowley ed., 2008).
7. Debate over the merits of granting gene patents has raged for over a decade. Compare Arti K. Rai, Regulating Scientific Research: Intellectual Property Rigfits and the Norms of Science, 94 NW. U. L. REV. 77, 121-29 (1999) (arguing that genes generally should not be patentable).
8. F. Scott Kieif, Facilitating Scientific Research: Intellectual Property Rights arid the Norms of Science-A Response to Rai and Eisenberg, 95 Nw. U. L. rev. 691, 699-700 (2001) (arguing that genes should be patentable).
9. See generally Complaint, Ass'n for Molecular Padmlogy, 702 R Supp. 2d 181 (No. 09 Civ. 4515).
10. Id.
11. The USPTO defines a natural phenomenon as "a thing occurring in nature, which is substantially unaltered, is not a 'manufacture.'" The USPTO further explains that "[a] shrimp with the head and digestive tract removed is an example." U.S. PATENT & TRADEMARK OFFICE, Rejections Under 35 U.S.C. 101 [R-5]-700 Examination of Applications, http://www.uspto.gov/ web/ofRces/pac/mpep/document5/D700-706-03-a.htm (last visited Jan. 18, 2011) (citing Exparte Grayson, 51 U.S.P.Q. (BN A) 413 (B.P.A.1.1941)).
12. See In re Meyer, 688 F.2d 789, 795 (C.C.P.A. 1982) ("Scientific principles and laws of nature, even when for the first time discovered, have existed throughout time, define the relationship of man to his environment, and, as a consequence, ought not to be the subject of exclusive rights of any one person.").
13. See 69 C.J.S. Patents §26 (2010) ("Abstract idea or abstractions, i.e., concepts, are not patentable subject matter. While the means by which an idea may be made practically useful may be the subject of a patent, an idea, of itself, is not patentable, however new and useful, or even revolutionary and beneficial, to humanity it may be, or, as otherwise stated, regardless of its importance or the ingenuity with which it was conceived. The mere existence of an intellectual notion that a certain thing could be done, and, if done, might be of practical utility, does not furnish a basis for a patent. Mere mental theories are not comprehended within the subject matter described by Congress. A scientific explanation of a successful operation of a patented device is not patentable." (internal citations omitted)).
14. See generally Shubha Ghosh, Patents and the Regulatory State: Rethinking the Patent Bargain After Eldred (Aug. 9, 2004) (working paper), available at http://ssrn.com/abstract=574141.
15. See O'Reilly v. Morse, 56 U.S. (15 How.) 62, 113, 120-21 (1853).
16. Id. at 116, 120.
17. While the diagnostic test or therapeutic treatment should receive patent protection, as it is a product of human innovation, the actual genomic sequence, even in conjunction with such tests or treatments, would still belong in the public domain.
18. Zinc finger proteins are proteins that bind to DNA. They are frequently used for therapeutic gene modulation.
19. See Found, for Taxpayer & Consumer Rights v. Patent of Wis. Alumni Research Found., 2010 WL 1734377 (B.P.A.I.).
20. Subhashinin Chandresekharan et al., Proprietary Science, Open Science and the Role of Patent Disclosure: The Case of Zinc-Finger Proteins, 27 NATURE BIOTECH. 140 (2009).
21. 425 U.S. 748 (1975).
22. Id.
23. What Is a Gene?, GENETICS HOME REFERENCE (Feb. 13, 2011), http://ghr.nlm.nih.gov/handbook/basics/gene.
24. see also BRCA: Genes and Patents, ACLU.ORG (May 27, 2009), http://www.aclu.org/free-speech/brca-genes-and-patents.
25. The New Genetics: Chapter I, How Genes Work, NAT'l INST. OF GEN. MED. SCI. (2006), http://publications.nigms.nih.gov/thenewgenetics/chapterl.html.
26. See Helen Pearson, What Is a Gene?, 441 NATURE 398, 401 (2006).
27. Elizabeth Pennisi, DNA Study Forces Rethink of What It Means to Be a Gene, 316 SCI. 1525, 1556-57 (2007). (Pubitemid 46982006)
28. See generally lnt'l Human Genome Sequencing Consortium, Finishing the Euchromatic Sequence of the Human Genome, 431 NATURE 931 (2004).
29. See Facts About Genome Sequencing, Human Genome Project Information, GENOMICS.ENERGY.GOV, http://www.ornl.gov/sci/techresources/Human-Genome/faq/ seqfacts.shtml#whatis (last modified Sept. 19, 2008).
30. See id. When scientists apply for a patent regarding a genomic sequence, typically they will merely identify the genomic sequence in question, spelling out the orders of the DNA bases as they appear for that genomic sequence (for example, adenine-thymine, guanine-cytosine, guanin-cytosine, guanine-cytosine, adenine-thymine, etc.).
31. See GEORGE JOHNSON & JONATHAN LOSOS, THE LIVING WORLD 279 (6th ed. 2010).
32. Id.
33. See BRCA: Genes and Patents, supra note 20.
34. Id.
35. DAVID KOEPSELL, WHO OWNS YOU?: THE CORPORATE GOLD-RUSH TO PATENT YOUR GENES 10 (2009) ("[H]umans have long exploited the natural world for profit....Only within the last 50 years have profits begun to be made not solely by increased production... but rather by claiming rights over the 'types' of objects themselves-the universal form of the item....").
36. Id.
37. Id.
38. Can a Genetic Test Predict Parkinson's, ALS?, CNN.COM (Nov. 19, 2008), http://articles.cnn.com/2008-11-19/health/als.parkinson.genetic. muration-1-als-mutations-parkinson?-s=PM:HEALTH.
39. see also JOHNSON & LOSOS, supra note 26, at 282-83.
40. See JOHNSON & LOSOS, supra note 26, at 282-83.
41. See id.
42. See Marcy Damovsky & Jesse Reynolds, The Battle to Patent Your Genes: The Meaning of the Myriad Case, AM. INTEREST ONLINE (Sept.-Oct. 2009), http://www.the-american-interest.com/article-bd.cfm?piece=653. Although Celera had developed this technique, it still had to determine the function of each gene.
43. See supra note 2 and accompanying text.
44. 447 U.S. 303 (1980).
45. Id.
46. See id. at 309-10.
47. Damovsky & Reynolds, supra note 36.
48. See Tony Dutra, Genes Unpatentable Under §101, CTR. FOR GENETICS & SOC'Y (Mar. 31, 2010), http://www.geneticsandsociety.org/article.php?id= 5204.
49. See Association far Molecular Pathology, et al. v. United States Patent and Trademark Office, et al. and Patenting DNA Sequences Under 35 U.S.C. § 101, 2010 a.b.a. SPEC. COMM. ON BIOTECH., CHEMISTRY, MED. AND PHARMACOLOGY REP.
50. Deborah L Lu, The Uncertain Future of DNA Patents, NAT'L L REV. (Dec. 21, 2010), http://www.ratkwreview.conVarticle/uncertain-fuaire-isolated-dna-patents ("The isolation of a gene is not necessarily a standard and routine process of extracting and amplifying a desired gene. A gene is not merely the necessary sequence to express a protein. Rather, a gene may have several components, including, but not limited to, promoters, enhancers, exons, introns and untranslated regulatory sequences that are not ultimately translated into a protein. In other words, genes are not merely products of nature that can be routinely isolated. Furthermore, an isolated gene does differ from what is naturally occurring. For example, in a naturally occurring state, DNA is often coiled and bound to DNA binding proteins, such as histones. In contrast, isolated DNA is often relaxed and free of DNA binding proteins and exists in a buffered environment").
51. See Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010) (arguing that isolated and purified DNA is not patentable because it is not "markedly different" than what occurs in nature).
52. See Tom Reynolds, Gene Patent Race Speeds Ahead Amid Controversy, Concern, 92 JNCI J. NAT'L CANCER INST. 184 (2000).
53. Id.
54. See supra Part I.A.
55. Brief for American Medical Association et al. as Amici Curiae Supporting Plaintiffe at 9, Ass'n for Molecular Pathology, 702 F. Supp. 2d 181 (No. 09 Civ. 4515) ("Further, Myriad has obtained patents on the act of 'comparing' a person's breast cancer gene sequence to the normal ('wild-type') BRCA2 gene sequence.... .These patents prohibit others from performing the simple mental step of comparing gene sequence information.").
56. John Schwartz, Cancer Patients Challenge the Patenting of a Gene, N.Y. TIMES, May 12, 2009, http://www.nytimes.com/2009/05/13/health/13patenthtml?-r=1 ("In the future, genetic tests are likely to involve the analysis of many genes at once, or even of a person's full set of genes... [Researchers. warn] that 'it may be difficult for any one developer to obtain all the needed licenses' to develop the next generations of tests.").
57. DAMOVSKY & REYNOLDS, supra note 36 ("The U.S. Patent and Trademark Office ... has granted somewhere between 3, 000 and 5, 000 patents on human genes themselves, including those associated with Alzheimer's disease, muscular dystrophy, colon cancer, asthma and many other illnesses... 63 percent of them |have been patented] by private firms.").
58. Id.
59. See A Brief History of the Patent Law of the United States, LADAS & PARRY, LLP (July 17, 2009), http://www.ladas.com/Patents/USPatentHistory.html.
60. KOEPSELL, supra note 30, at 6.
61. Final Guidelines for Determining Utility of Gene-Related Inventions, USPTO (Jan. 4, 2001), http://www.uspto.gov/news/pr/2001/01-01.jsp.
62. See Anna E. Morrison, The U.S. PTO's New Utility Guidelines: Wil They Be Enough to Secure Gene Patents?, 1 J. MARSHALL L REV. INTELL. PROP. LAW 142, 153 (2001).
63. The Fate of Gene Patents Under the New Utility Guidelines, 2001 DUKE L & TECH. REV. 0008, 110 (Feb. 28, 2001), http://www.law.duke.edu/joumals/ dltr/articles/2001dltr0008.html.
64. See Utility Examination Guidelines, 66 Fed. Reg. 1092-02, 1105 (Jan. 5, 2001).
65. Darnovsky & Reynolds, supra note 36 ("Celera used newly developed techniques to identify short sections of DNA that can be used to identify genes, though their function may be unknown. Its business model was to patent these DNA fragments quickly, and then to sort out their usefulness later. These patents... alarmed many scientists...."). The revised PTO guidelines were a response to the gene patent gold rush, in which Celera was the frontrunner.
66. See John Carey, The Genome GM Rush, BUS. WK., June 12, 2000, http://www.businessweek.com/2000/00-24/b3685001.htm.
67. The Fate of Gene Patents Under the New Utility Guidelines, supra note 57, ∥∥ 12, 22.
68. Id. ∥ 37 (citing Revised Utility Examination Guidelines; Request for Comments, 64 Fed. Reg. 71440, 71441 (Dec. 21, 1999)).
69. This is because the standard for utility is based on the perception of a person of ordinary skill in the art. As long as those within the genetics industry find gene patents to be useful, the patent examiners will continue to approve applications.
70. Tanya Wei, Patenong Genomic Technology-2001 Utility Examination Guidelines: An Incomplete Remedy in Need of Prompt Reform, 44 SANTA CLARA L. REV. 307, 327 (2003).
71. After all, a twenty-year moratorium on inventions may have seemed appropriate two hundred years ago, but with rapid increases in biotechnology, it hardly seems workable.
72. KOEPSELL, supra note 30, at 14 ("In many ways, it seems like the Wild West. Claims are being staked out, and it's just a matter of time before a shoot-out ensues. What is clear is that our instincts about our self-ownership of our bodies and the information that makes them up is not in sync with the present patent law.").
73. See id. at 21.
74. Id. at 85.
75. 702 F. Supp. 2d 181 (S.D.N.Y. 2010).
76. Id. at 220 (citing Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980)).
77. Chakrabarty, 447 U.S. at 309.
78. In an American Bar Association committee meeting regarding the Association of Molecular Pathology case, a resolution in favor of filing an amicus brief in the case was proposed. The authors of the resolution claimed that the following language was indicative of a more stringent standard than the "markedly different" standard that the court in this case claimed to apply. The § 101 standard discussed below analyzes whether an object is patentable under the patent statute: There will almost inevitably be some identifiable differences between a claimed invention and a product of nature; the appropriate § 101 inquiry is whether, considering the claimed invention as a whole, it is sufßciendy distinct in its fundamental characteristics from natural phenomena to possess the required "distinctive name, character, [and] use." Only two members of the Committee voted for the resolution. A.B.A. SPEC. COMM. ON BIOTECH., CHEMISTRY, MED. AND PHARMAOOLOGY, supra note 43.
79. Christopher M. Holman, Patent Border Wars: Defining the Boundary Between Scientific Discoveries and Patentable Inventions, 25 TRENDS IN BIOTECH. 539 (2007).
80. Complaint, supra note 7, at 3, 13.
81. BRCA: Genes and Patents, supra note 20 ("The BRCA genes-BRCA1 and BRCA2-are two genes that have been associated with hereditary forms of breast and ovarian cancer....Women who have certain mutations along these genes have an elevated lifetime risk of developing breast and ovarian cancer because their ability to suppress cancerous growth has been reduced.").
82. See generally Caryn Lerman et al., BRCA1 Testing in Families With Hereditary Breast-Owirian Cancer, 275 JAMA 1885-92 (1996).
83. BRCA1 and BRCA2: Cancer Risk and Genetic Testing, NAT'L CANCER INST, (reviewed May 29, 2009), http://www.cancer.gov/cancertopics/factsheet/Risk/BRCA.
84. Bryn Williams-Jones, History of a Gene Patent: Tracing the Development and Application of Commercial BRCA Testing, 10 HEALTH L.J. 123, 128 (2002).
85. Id.
86. Damovsky & Reynolds, supra note 36 ("For 20 years (after which the protected inventions are supposed to enter the public domain), they give their holders the right to prevent anyone... from studying or testing 'their' genes....They can determine who can do diagnostic tests involving those genes, and... how much the tests cost.").
87. Turna Ray, Myriad's BRCA Patents Not Only Illegal, but Also Unconstitutional, ACLU Lawsuit Alleges, GENOMEWEB (May 13, 2009), http://www.genomeweb.com/dxpgx/myriads-brca-patents-not-only-illegal-also- unconstitutional-aclu-lawsuit-alleges ("According to ACLU's estimates, as much as 20 percent of all human genes are currently patented, including genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, and asthma.").
88. See infra Part II.B.
89. 35 U.S.C. § 101 (1996).
90. See, e.g., Gen. Elec. Co. v. De Forest Radio Co., 44 F.2d 931 (3d Cir. 1930) (holding that when GE tried to patent the element tungsten without doing anything to that element, GE had not satisfied the novelty requirement).
91. 35 U.S.C. § 101.
92. Andrew Yates, The American Gene Patent Legal FAQ, THINK GENE (Feb. 19, 2009), http://www.thinkgene.com/the-american-gene-patent-legal-faq ("Hypothetically, the 'use' of the patent could be how to read the gene sequence itself, but this use is not within the USPTO's stated guidelines. Disclosing only the nucleic acid molecular structure (the sequence) of a gene itself is not patentable. The gene plus a specific use is patentable.").
93. See Mark A. Chavez, Gene Patenting: Do the Ends Justify the Means?, 7 COMPUTER L REV. & TECH. J. 255, 258-60 (2003).
94. Chavez, supra note 82, at 259 ('"When scientists clone sequences, they isolate only the protein-coding portions, thus isolating and purifying the gene sequence.' This isolation creates the requisite novelty necessary to satisfy patent law." (quoting Carrie F. Walter, Beyond the Harvard Mouse: Current Patent Practice and the Necessity of Clear Guidelines in Biotechnology Patent Law, 73 IND. L.J. 1025, 1037-38 (1998))).
95. 84-Id. at 260 ("The Federal Circuit... [determined] that non-obviousness could be established for a specific gene despite the feet that the engineer isolated the gene through an already existing technique.").
96. The fair use doctrine is used to provide some access to copyrightable materials, typically when they are being used for educational rather than commercial purposes. It is the primary mechanism for balancing copyright law and the First Amendment to ensure that necessary information is present in the public sphere.
97. See, e.g., Madey v. Duke Univ., 413 F. Supp. 2d 601 (M.D.N.C. 2006).
98. A Brief History of the Patent Law of the United States, supra note 53.
99. See Aaron Larson, Patent Law, EXPERT L. (Sept. 2003), http://www.expertlaw.com/library/intellectual-property/patent-law.html.
100. Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 48 U.S. 124, 134 (2006) (Breyer, J., dissenting) ("[T]he category of non-patentable '[p]henomena of nature'... is not easy to define.").
101. 153 CONG. REC. E315-16 (daily ed. Feb. 9, 2007).
102. Reps. Becerra and Weldon Introduce Bill to Ban the Practice of Gene Patenting, BECERRA.HOUSE.GOV (Feb. 9, 2007), http://becerra.house.gov/index.php? option=com-content&view=article&id=218:reps-becerra-a-weldon-introduce- bill-to-ban-the-practice-of-gene-patenting&catid=24:2007-press- releases&Itemid=4.
103. Damovsky & Reynolds, supra note 36 ("Writing for the four-justice minority, William Brennan agreed that 'it is the role of Congress, not this court, to broaden or narrow the reach of patent laws, ' and said that Congressional guidance is crucial because 'the composition sought to be patented uniquely implicated matters of public concern.'" (quoting Diamond v. Chakrabarty, 447 U.S. 303, 321-22(1980))).
104. Xavier Becerra, Gene Patenting Should Be Banned, in GENETIC ENGINEERING: OPPOSING VIEWPOINTS 193, 195 (David M. Haugen & Susan Musser eds., 2009).
105. See Brief for International Center for Technology Assessment et al. as Amici Curiae Supporting Plaintiffs at 12, Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010) (No. 09 Civ. 4515) ("Patents should not be granted for genes, which are res communis, the common heritage and inheritance of mankind. Under the common heritage theory, public resources are available for use by all without restriction for the benefit of humanity.").
106. Brief for National Women's Health Network et al. as Amici Curiae Supporting Plaintiffs at 17, Ass'n for Molecular Pathology, 702 F. Supp. 2d 181 (No. 09 Civ. 4515) ("Human genes help to determine who we are and how we function. Although individuals' genes differ in a few respects, the human genome that each of us inherits-the result of millions of years of natural evolution-links us closely to each other.").
107. Christopher M. Holman, The Impact of Human Gene Patents on Innovation and Access: A Survey of Human Gene Patent Litigation, 76 UMKC L REV. 295, 297 (2007) ("Moral opponents of gene patents tend to be concerned with the implications of gene patents with respect to personal autonomy and human dignity. For many, the genome possesses a singularly important, perhaps even sacred status as the blueprint of life.").
108. Melissa L Sturges, Who Should Hold Property Rights to the Human Genome? An Application of the Common Heritage of Humankind, 13 AM. U. INT'L REV. 219, 245 (1997) (arguing that the "Common Heritage of Mankind" is an important international legal concept).
109. Ricki Lewis, Living Things, DOUBLE HELIX DEBATE, http://www.columbia.edu/ cu/21stC/issue-3.1/lewis.html (last visited Nov. 3, 2010) ("DNA is considered to be so intimately related to species identity that no parts of it should be controlled by corporate interests. In the case of human beings, human DNA is unique because it is human, and therefore possessing intrinsic value of a sacred kind. As one critic puts it, DNA bears the image of God.").
110. Elizabeth Landau, How Human Genes Become Patented, CNN.COM (May 13, 2009), http://wwww.crm.com/2009/HEALTH/05/13/genes.patent.myriad/index.html ('"I think that legal arguments about why this kind of thing isn't really something that should be patentable are really strong at a theoretical level... I wouldn't be that confident that the American court system would agree.'" (quoting Josephine Johnston, Bioethicist at the Hastings Institute)).
111. Debra Greenfield, Freedom of Genes, GENE WATCH, http://www. councilforresponsiblegenetics.org/GeneWatch/GeneWatchPage.aspx?pageId=308 (last visited Mar. 3, 2011).
112. Id. ("[A]ny given form of any gene is present in many people and can be synthesized. The DNA molecule is defined at the atomic level by a genetic sequence. Scientists can make purefied substances with the same characteristics as human genes, whereas they cannot exactly manufacture any person's eyeball." (quoting Lee Silver, Professor of Molecular Biology and Public Policy at Princeton University)).
113. See Jordan Paradise, European Opposition to Exclusive Control Over Predictive Breast Cancer Testing and the Inherent Implications for U.S. Patent Law and Public Policy: A Case Study of the Myriad Genetics' BRCA Patent Controversy, 59 FOOD & DRUG L.J. 133, 144 (2004) (explaining that Myriad's actions were ethically questionable because it was taking "information [that] was largely in the public domain").
114. Lewis, supra note 95.
115. The public domain is explicitly recognized in patent law by judicial exclusion of the laws of nature, natural phenomena, and abstract ideas from patent protection. The U.S. Supreme Court has held that existing knowledge (such as the laws of nature) and materials (such as natural phenomena) that exist in the public domain are, by default presumption, not to be patented. See Brief for International Center for Technology Assessment, supra note 94, at 12 ("Congress may not authorize the issuance of patents whose effects are to remove existent knowledge from the public domain, or to restrict free access to materials already available." (internal quotation marks omitted)).
116. Lewis, supra note 95 ('"When you isolate something as it appears in its natural state you change it, even if the only change is the isolation. You have left behind the natural product and created something artificial. No isolated gene sequence occurs in nature, ' [asserts Harold Edgar, Columbia Law Professor]."). In 1990, the USPTO changed its regulations to include rules for filing claims on DNA sequences. See also Stephen Albainy-Jenei, ACLU Mob Attacks Breast Cancer Test Patent, PATENT BARISTAS (May 13, 2009), http://ww.patentbaristas.com/archives/2009/05/13/aclu-mob-attacks-breast-cancer- test-patent ("While human genes are products of nature, the Myriad patents claim isolated forms of the genes not the genes in there [sic] natural state. That is, imagine pulling out a gene in its unrecognizable natural state hidden among a million other base pairs in the genetic code.").
117. The presence of genes and even the presence of mutations "is dictated by nature, not any scientist." Declaration of Sir John E. Sulston, Ph.D., at 7, Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010) (No. 09 Civ. 4515). The patenting of genes requires only "placing [genes] in a form so that they can be sequenced and possibly used in other ways.... But isolating and purifying a gene is simply copying it into another format. It's like taking a hardback book written by someone else, publishing it in paperback and then claiming authorship because the binding is different." Brief for American Medical Association, supra note 49 ("Myriad has not... invented any chemical or mechanical methods of determining whether there is a mutation in a breast cancer gene. Rather, what the patentee claims to have discovered are preexisting genetic sequences and a natural relationship (correlation) between certain mutations and breast cancer.").
118. Myriad's patents prevent others "from performing a simple mental process of comparing a mutant sequence....The basic method claimed by Myriad-comparing the patient's sequence to the non-mutated sequence, and thereby drawing a conclusion as to susceptibility to breast cancer-is nothing more than a law of nature." Brief for March of Dimes Foundation et al. as Amici Curiae Supporting Plaintiffs, Ass'n for Molecular Pathology, 702 F. Supp. 2d 181 (No. 09 Civ. 4515).
119. 2; nor could Newton have patented the law of gravity. Such discoveries are 'manifestations of... nature, ... reserved exclusively to none.'").
120. (quoting Funk Bros. Seed Co. v. Kalo Co., 333 U.S. 127, 130(1948))).
121. 28 F.2d 641 (3d Cir. 1928).
122. Id. at 643.
123. 333 U.S. 127(1948).
124. Id. at 130-31.
125. A scientific principle "reveals a relationship that has always existed." Parker v. Flook, 437 U.S. 584, 593 n.15 (1978).
126. See Brief for International Center for Technology Assessment, supra note 94.
127. 90 U.S. 566 (1874).
128. See id. at 594. The Court found that a patent for using bamboo pulp to make purified cellulose for the manufacture of paper was not valid because there was already a similar patent involving vegetable pulp. However, the Court seemed to indicate in dicta that if the patent had met the novelty requirement, it would be considered patentable.
129. See Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 146(1989).
130. See Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 126-27 (2006) (Breyer, J., dissenting).
131. Brief for March of Dimes Foundation, supra note 103, at 18 ("The key to this balance-which distinguishes human-made inventions from products of nature and laws of nature-is the recognition that there are interests in promoting innovation on both sides of any patent.").
132. Id. at 19-20 ("Patents on products of nature, like gene sequence patents, take information out of the public domain rather than putting ideas into the public domain as is the intention of the Constitution and of the patent disclosure provisions.").
133. see also Oskar Liivak, Maintaining Competition in Copying: Narrowing the Scope of Gene Patents, 41 U.C. DAVIS L REV. 117, 220 (2007) ("[Although the patent system currently grants gene discoveries the same broad claim scope as a traditional invention, patent law has left no room for competition. The first gene researcher to isolate and purify a gene blocks any second-arriving researcher from independently trying to purify and isolate the gene.").
134. See O'Reilly v. Morse, 56 U.S. (15 How.) 62, 120-21 (1853).
135. Brief for March of Dimes Foundation, supra note 103, at 16 ("Myriad's claims are similar to a method of estimating the risk of heart attack on the basis of measurements of blood pressure. Such a claim, like Myriad's methods claims here, preempts all uses of a particular law of nature.").
136. Id. at 11 ("Similarly, laws of nature, such as bare correlations between a gene sequence and a disease, are not patentable. '[R]ecognition of a theretofore existing phenomenon or relationship carries with it no rights to exclude others from its enjoyment."' (quoting Parker v. Flook, 437 U.S. 584, 593 n.15 (1978))).
137. See, e.g., Parke-Davis & Co. v. H.K. Mulford & Co., 189 F. 95, 103 (C.C.S.D.N.Y. 1911) (upholding the validity of a patent over purified adrenaline).
138. Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1218-19 (Fed. Cir. 1991).
139. Annabelle Lever, Is It Ethical to Patent Human Genes?, in INTELLECTUAL PROPERTY AND THEORIES OF JUSTICE 246, 247 (Axel Gosseries, Alain Marciano & Alain Strowel eds., 2008).
140. Liivak, supra note 116, at 192 ("Patent law has yet to contend with the feet that the resulting purified and isolated DNA molecules at the heart of these patents are the result of copying a naturally occurring molecule. The gene discoverer uses a naturally occurring DNA molecule as the template for making their patented purified and isolated gene sequence.").
141. 927 F.2d 1200 (Fed. Cir. 1991).
142. Laurie L. Hill, The Race to Patent the Genome: Free Riders, Hold Ups, and the Future of Medical Breakthrough, 11 TEX. INTELL. PROP. L.J. 221, 230 (2003) (citing Amgen, 927 F.2d at 1218).
143. Amgen, 927 F.2d at 1206.
144. Id. at 1214.
145. Id. at 1206.
146. See Bryan J. Boyle, Comment, Fishing for Utility With Expressed Sequence Tags After In re Fisher, 23 SANTA CLARA COMPUTER & HIGH TECH. L.J. 589, 590 (2007).
147. Lewis, supra note 95 ('"When you isolate something as it appears in its natural state you change it, even if the only change is the isolation. You have left behind the natural product and created something artificial. No isolated gene sequence occurs in nature, ' [asserts Harold Edgar, Columbia Law Professor]."). In 1990, the USPTO changed its regulations to include rules for filing claims on DNA sequences. See also Stephen Albainy-Jenei, ACLU Mob Attacks Breast Cancer Test Patent, PATENT BARISTAS (May 13, 2009), http://ww.patentbaristas.com/archives/2009/05/13/aclu-mob-attacks-breast-cancer- test-patent ("While human genes are products of nature, the Myriad patents claim isolated forms of the genes not the genes in there [sic] natural state. That is, imagine pulling out a gene in its unrecognizable natural state hidden among a million other base pairs in the genetic code.").
148. The presence of genes and even the presence of mutations "is dictated by nature, not any scientist." Declaration of Sir John E. Sulston, Ph.D., at 7, Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010) (No. 09 Civ. 4515). The patenting of genes requires only "placing [genes] in a form so that they can be sequenced and possibly used in other ways.... But isolating and purifying a gene is simply copying it into another format. It's like taking a hardback book written by someone else, publishing it in paperback and then claiming authorship because the binding is different." Brief for American Medical Association, supra note 49 ("Myriad has not... invented any chemical or mechanical methods of determining whether there is a mutation in a breast cancer gene. Rather, what the patentee claims to have discovered are preexisting genetic sequences and a natural relationship (correlation) between certain mutations and breast cancer.").
149. Myriad's patents prevent others "from performing a simple mental
150. 2; nor could Newton have patented the law of gravity. Such discoveries are 'manifestations of... nature, ... reserved exclusively to none.'").
151. (quoting Funk Bros. Seed Co. v. Kalo Co., 333 U.S. 127, 130(1948))).
152. 28 F.2d 641 (3d Cir. 1928).
153. Id. at 643.
154. 333 U.S. 127(1948).
155. Id. at 130-31.
156. A scientific principle "reveals a relationship that has always existed." Parker v. Flook, 437 U.S. 584, 593 n.15 (1978).
157. See Brief for International Center for Technology Assessment, supra note 94.
158. 90 U.S. 566 (1874).
159. See id. at 594. The Court found that a patent for using bamboo pulp to make purified cellulose for the manufacture of paper was not valid because there was already a similar patent involving vegetable pulp. However, the Court seemed to indicate in dicta that if the patent had met the novelty requirement, it would be considered patentable.
160. See Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 146(1989).
161. See Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 126-27 (2006) (Breyer, J., dissenting).
162. Brief for March of Dimes Foundation, supra note 103, at 18 ("The key to this balance-which distinguishes human-made inventions from products of nature and laws of nature-is the recognition that there are interests in promoting innovation on both sides of any patent.").
163. Id. at 19-20 ("Patents on products of nature, like gene sequence patents, take information out of the public domain rather than putting ideas into the public domain as is the intention of the Constitution and of the patent disclosure provisions.").
164. see also Oskar Liivak, Maintaining Competition in Copying: Narrowing the Scope of Gene Patents, 41 U.C. DAVIS L REV. 117, 220 (2007) ("[Although the patent system currently grants gene discoveries the same broad claim scope as a traditional invention, patent law has left no room for competition. The first gene researcher to isolate and purify a gene blocks any second-arriving researcher from independently trying to purify and isolate the gene.").
165. See O'Reilly v. Morse, 56 U.S. (15 How.) 62, 120-21 (1853).
166. Brief for March of Dimes Foundation, supra note 103, at 16 ("Myriad's claims are similar to a method of estimating the risk of heart attack on the basis of measurements of blood pressure. Such a claim, like Myriad's methods claims here, preempts all uses of a particular law of nature.").
167. Id. at 11 ("Similarly, laws of nature, such as bare correlations between a gene sequence and a disease, are not patentable. '[R]ecognition of a theretofore existing phenomenon or relationship carries with it no rights to exclude others from its enjoyment."' (quoting Parker v. Flook, 437 U.S. 584, 593 n.15 (1978))).
168. See, e.g., Parke-Davis & Co. v. H.K. Mulford & Co., 189 F. 95, 103 (C.C.S.D.N.Y. 1911) (upholding the validity of a patent over purified adrenaline).
169. Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1218-19 (Fed. Cir. 1991).
170. Annabelle Lever, Is It Ethical to Patent Human Genes?, in INTELLECTUAL PROPERTY AND THEORIES OF JUSTICE 246, 247 (Axel Gosseries, Alain Marciano & Alain Strowel eds., 2008).
171. Liivak, supra note 116, at 192 ("Patent law has yet to contend with the feet that the resulting purified and isolated DNA molecules at the heart of these patents are the result of copying a naturally occurring molecule. The gene discoverer uses a naturally occurring DNA molecule as the template for making their patented purified and isolated gene sequence.").
172. 927 F.2d 1200 (Fed. Cir. 1991).
173. Laurie L. Hill, The Race to Patent the Genome: Free Riders, Hold Ups, and the Future of Medical Breakthrough, 11 TEX. INTELL. PROP. L.J. 221, 230 (2003) (citing Amgen, 927 F.2d at 1218).
174. Amgen, 927 F.2d at 1206.
175. Id. at 1214.
176. Id. at 1206.
177. See Bryan J. Boyle, Comment, Fishing for Utility With Expressed Sequence Tags After In re Fisher, 23 SANTA CLARA COMPUTER & HIGH TECH. L.J. 589, 590 (2007).
178. Id.
179. See id.
180. See Bernstein, supra note 132.
181. see also KOEPSELL, supra note 30, at 18 ("Patents can have a chilling effect as each potential area for study must now be thoroughly researched not just within the scientific literature, but also through a patent search to see who owns what parts of the segment of the genome one wishes to study.").
182. Damovsky & Reynolds, supra note 36 ("For example, the Human Genome Project website points out that because U.S. patent applications must remain confidential for 18 months after filing, researchers who use genetic sequences 'risk facing a future injunction if those sequences turn out to be patented by a private company.'").
183. Williams-Jones, supra note 74, at 138-39.
184. Id. at 139. While the Myriad test is effective and can often determine whether someone is likely to develop breast or ovarian cancer, it does have some instances of false negatives. Institut Curie's more recently developed test has fewer false negatives.
185. See GRAHAM DUTFIELD, INTELLECTUAL PROPERTY, BIOGENETIC RESOURCES AND TRADITIONAL KNOWLEDGE 22 (2004) ("Furthermore, as some critics point out, gene function is so complex that treating genes as patentable inventions on the basis of a single discovered function is more a reflection of ignorance than of insight.").
186. Cynthia Ramnarace, BRCA Genetic Testing: What You Need to Know, EVERYDAY HEALTH, http://wvvw.everydayhealth.com/breast-cancer-awareness/brca-gene.aspx (last visited Mar. 3, 2011).
187. Damovsky & Reynolds, supra note 36.
188. Danny Townsend, Myriad Genetics Can't Patent a Breast Cancer Gene, SLATE, Apr. 7, 2010, http://www.slate.com/id/2250082.
189. See Lori B. Andrews & Jordan Paradise, Gene Patents: The Need for Bioethics Scrutiny and Legal Change, 5 YALE J. HEALTH POL'Y L. & ETHICS 403, 405 (2005).
190. see also Alan Devlin & Neel Sukhatme, Self-Realizing Inventions and the Utilitarian Foundation of Patent Law, 51 WM. & MARY L REV. 897 (2009).
191. Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806, 806 (1945) ("The far-reaching... consequences of a patent give the public a paramount interest in seeing that patent monopolies spring from backgrounds free from... inequitable conduct and that such monopolies are kept within their legitimate scope.").
192. See Jim Greenwood, Opposing View: Patents Promote Innovation, USA TODAY, June 16, 2009, at 9A ("Even so, banning patents on gene-related breakthroughs would slow biomedical innovation to a halt-taking away the hope biotechnology offers to patients suffering from debilitating diseases such as cancer, Parkinson's and HIV/AIDS-while doing nothing to address what is really a much more complicated set of issues.").
193. see also Geoffrey M. Karny, In Defense of Gene Patenting: The Pinciples of Our Patenting System Are Sound and Bring Immense Benefits, GENETIC ENG'G & BICOECH. NEWS, Apr. 1, 2007.
194. Mark Sagoff, Some Patents on Genes Are Acceptable, in GENETIC ENGINEERING: OPPOSING VIEWPOINTS 172, 174 Games D. Torr ed., 2001) ("[PJatents serve the utilitarian purpose of encouraging technological progress by offering incentives-temporary commercial monopolies-for useful innovations. One could argue, as the biotech industry does, that these temporary monopolies are not intended to recognize individual genius but to encourage investments that are beneficial to society as a whole.").
195. Damovsky & Reynolds, supra note 36.
196. Id. (noting that Celera, Incyte, and Human Genome Sciences were among the research companies).
197. Kamy, supra note 144 ("As a practical matter, however, academic scientists who ignore patent rights have little to fear. The vast majority of patent owners simply do not want the adverse publicity of suing scientists and their universities, and the economic recovery is seldom worth the effort and money spent").
198. See id.
199. Genetics and Patenting, HUMAN GENOME PROJECT INFO. (Sept. 16, 2008), http://www.ornl.gov/sci/techresources/Human-Genome/elsi/patents.shtml#4 ("Wasteful duplication of effort is prevented.").
200. Id. ("Secrecy is reduced and all researchers are ensured access to the new invention.").
201. Complaint, supra note 7, at 3.
202. Damovsky & Reynolds, supra note 36.
203. BRCA: Genes and Patents, supra note 20.
204. See Schwartz, supra note 50 ("[T]he restrictions on competition that... Myriad... put in place-blocking alternatives to the patented tests, and even the practice of interpreting or comparing gene sequences that involved those genes-... started to look like... [a violation of the First Amendment].").
205. Michael Davidson, First Amendment Protection for Biomedical Research, 19 ARIZ. L REV. 893, 918 (1977) (stating that "most biomedical research is speech").
206. KOEPSELL, supra note 30, at 146.
207. Estelle Derclaye, Intellectual Property Rights and Human Rights: Coinciding and Cooperating, IN INTELLECTUAL PROPERTY AND HUMAN RIGHTS: ENHANCED EDITION OF COPYRIGHT AND HUMAN RIGHTS 133, 158 (Paul L.C. Torremans ed., 2008).
208. See Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 6 (1966) ("Congress may not authorize the issuance of patents whose effects are to remove existent knowledge from the public domain, or to restrict free access to materials already available.").
209. 1 JAY DRATLER JR. & STEPHEN M. MCJOHN, Intellectual Property Law: commercial Creative and Industrial Property § 2.03 (2010) ("From the founding of our nation, the... structure of intellectual property law has reflected this basic rule, consistent with the First Amendment's guarantee of free speech: abstract ideas are nobody's property. Rather, they inure to everybody's benefit; they are the building blocks... with which future advances may be made.").
210. Id.
211. Emilie Bouliong & Sandrine de Montgolfier, Patentability and the Human Genome: Issues, Debates, and Controversies (June 2000), http://infodoc.inserm.fr/ethique/etheng.nsf/7adab9aba4615f8dc12569c9005670ca/ 9c2efd02ef7d19b580256b0b005f7731?OpenDocument.
212. (quoting UNESCO, Universal Declaration on the Human Genome and Human Rights (Nov. 11, 1997)).
213. Brian Gargano, The Quagmire of DNA Patents: Are DNA Sequences More Than Chemical Compositions of Matter?, 2005 SYRACUSE SCI. & TECH. L REP. 3, 16.
214. (citing U.K. Prime Minister Tony Blair & U.S. President Bill Clinton, Joint Statement to Ensure That Discoveries From the Human Genome Are Used to Advance Human Health, Mar. 14, 2000, available at http://www.genome.gov/ 10001356).
215. BRCA: Genes and Patents, supra note 20.
216. Id.
217. See generally JOHN STUART MILL, ON LIBERTY (1859).
218. Phillip J. Cooper, The Supreme Court, the First Amendment, and Freedom of Information, 46 PUB. ADMIN. REV. 622, 623 (1986).
219. DRATLER & MCJOHN, supra note 159, § 2.03.
220. See Gary E Marchant & Lynda L. Pope, The Problems With Forbidding Science, 15 SCI. & ENG'G ETHICS 376 (2009).
221. See Griswold v. Connecticut, 381 U.S. 479, 482-83 (1965) ("The right of freedom of speech... includes not only the right to utter or to print, but the right to distribute, the right to receive, the right to read and freedom of inquiry....Without those peripheral rights the specific rights would be less secure.").
222. John A. Robertson, The Scientist's Right to Research: A Constitutional Analysis, 51 S. CAL L. REV. 1203, 1217-18 (1977) (concluding that "[i]f the First Amendment serves to protect free trade in the dissemination of ideas and information, it must also protect the necessary preconditions of speech, such as the production of ideas and information through research").
223. Malla Pollack, The Right to Know?: Delimiting Database Protection at the Juncture of the Commerce Clause, the Intellectual Property Clause, and the First Amendment, 17 CARDOZO ARTS & ENT. L.J., 47, 69-70 (1999).
224. Saxbe v. Wash. Post Co., 417 U.S. 843, 864 (1974) (Powell, J., dissenting).
225. See Richard Delgado & David R. Millen, God, Galileo, and Government: Toward Constitutional Protection for Scientific Inquiry, 53 WASH. L REV. 349, 378 (1978) (analogizing scientific research to newsgathering and arguing that scientists should receive at least as much free speech protection as journalists).
226. See W. Bernard Lukenbill & James F. Lukenbill, Censorship: What Do School Library Specialists Really Know? A Consideration of Students' Rights, the Law and Implications for a New Education Paradigm, 10 SCH. LIBR. MEDIA RES. (2007), http://www.ala.org/ala/mgrps/divs/aasl/aaslpubsandjoumals/slmrb/ slmrcontents/volume10/lukenbill-censorship.cfm.
227. see also Marc Jonathan Blitz, Constitutional Safeguards for Silent Experiments in Living: Libraries, the Right to Read, and a First Amendment Theory for an Unaccompanied Right to Receive Information, 74 UMKC L REV. 799 (2006).
228. The framers of the U.S. Constitution discussed the sacred nature of scientific inquiry. Gary L. Francione, Experimentation and the Marketplace Theory of the First Amendment, 136 U. PA. L REV. 417, 428 (1987).
229. see also Roy G. Spece Jr. & Jennifer Weinzierl, First Amendment Protection of Experimentation: A Critical Review and Tentative Synthesis/Reconstruction of the Literature, 8 S. CAL INTERDISC L.J. 185, 213, 218 (1998) (arguing that scientific experimentation should enjoy First Amendment protection because the scientific method fits uniquely within the marketplace of ideas or, alternatively, because that experimentation is "uniquely and powerfully fecilitative of highly valued thought").
230. Zona F. Hostetier, Report and Recommendation to the House of Delegates, 2002 A.B.A. SEC. INDIVIDUAL RIGHTS & RESPONSIBILITIES, available at http://www.abanet.org/irr/polides/committees/health/0802scientificknowledge.pdf (claiming that First Amendment protection is warranted for scientific inquiry because such inquiry is "essential to the advancement of knowledge and the discovery of truth").
231. Steven Goldberg suggests that scientific research does not just require First Amendment protection but actually requires even higher protection than other forms of speech typically protected under the First Amendment. See Steven Goldberg, The Constitutional Status of American Science, 1979 U. ILL. L.F. 1, 1-7.
232. 425 U.S. 748 (1976).
233. Id. at 756-57.
234. Pollack, supra note 171, at 70-71 (discussing scholarship detailing "multiple entitlements in the First Amendment, including the rights 'to hear the views of others and to listen to their version of the facts, ' 'the right to inquire, ' and 'to a degree, the right of access to information'").
235. See discussion, supra note 180. Alexander Meikeljohn similarly asserted that the First Amendment does not just extend to an individual's right to speak but also to a community's right to hear. See Frederick Schauer, Must Speech Be Special?, in THE FIRST AMENDMENT: A READER (John H. Garvey & Frederick Schauer eds., 1992).
236. see also Cass Sunstein, Beyond the Republican Revival, 97 YALE L.J. 1539, 1549 (1988) (explaining the public's constitutional right to be informed so as to promote effective dialogue).
237. See Anthony Lewis, A Public Right to Know About Public Institutions: The First Amendment as a Sword, 1980 SUP. CT. REV. 1, 6 ("After Lament it was clear, as the Court later explained, that where there is 'a willing speaker, ' the First Amendment gives protection 'to the communication, to its source and to its recipients both."'.
238. (quoting Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc., 425 U.S. 748, 756 (1976))).
239. Cooper, supra note 166, at 623 ("In Garrison v. Louisiana, the Court underscored the need to protect 'the paramount public interest in a free flow of information to the people.'").
240. Pollack, supra note 171, at 67 (explaining that the United States was "founded [on] the resounding rhetoric of a public need to know [and] James Madison penned the famous matching bromides that '[knowledge will forever govern ignorance' and '[a] popular government without popular information or the means of acquiring it is but a prologue to a farce or a tragedy or perhaps both"').
241. Bruce EH. Johnson, Advertising and First Amendment in Speech, FIRST AMENDMENT CTR., http://www.firstamendmentcenter.org/speech/advertising/overview. aspx (last visited Mar. 3, 2011).
242. 425 U.S. 748 (1976).
243. See id. at 748.
244. See BRCA: Genes and Patents, supra note 20 (calling gene patenting "a civil liberties issue because gene patents undermine the free exchange of information and scientific freedom, bodily integrity, and women's health[, and i]n granting exclusive rights to gene patent holders, the U.S. government in essence gives those patent holders complete control over those genes and the information contained within them").
245. Thomas I. Emerson, Colonial Intentions and Current Realities of the First Amendment, 125 U. PA. L REV. 737, 744 (1977) ("Not only was freedom of speech, press, assembly, and petition considered as a social good, essential for the progress of society, but it was also viewed as an important means for personal fulfillment.").
246. In a May press statement, ACLU Executive Director Anthony Romero stated: "Knowledge about our own bodies and the ability to make decisions about our health care are some of our most personal and fundamental rights. The government should not be granting private entities control over something as personal and basic to who we are as our genes." OBOS Joins ACLU Lawsuit Challenging Breast and Ovarian Cancer Gene Patents, OUR BODIES OURSELVES (June 4, 2009), http://ww.ourbodiesourblog.org/blog/2009/06/obos-joins-aclu-lawsuit- challenging-breast-and-ovarian-cancer-gene-patents.
247. See generally Julie Wallbank, The Role of Rights and Utility in Instituting a Child's Right to Know Her Genetic History, 13 SOC. & LEGAL STUD. 245 (2004).
248. See generally Carolyn Burke, Note, The Adult Adoptee's Constitutional Right to Know His Origins, 48 S. CAL. L REV. 1196 (1975).
249. 702 F. Supp. 2d 181 (S.D.N.Y. 2010).
250. See First Nat'l Bank of Bos. v. Bellotti, 435 U.S. 765, 783 (1978) ("|T]he First Amendment goes beyond protection of the press and the self-expression of individuals to prohibit government from limiting the stock of information from which members of the public may draw.").
251. See Eileen M. Kane, Patent Ineligibility: Maintaining a Scientific Public Domain, 80 ST. JOHN's L REV. 519, 541 (2006) (explaining that "a discussion and analysis of the subject matter that [the public domain] contains is essential").
252. See generally Brief for the ACLU as Amicus Curiae for Affirmance in Support of Appellee, In re Bilski, 546 F.3d 943 (Fed. Cir. 2008) (No. 2007-1130).
253. Violations of constitutional freedoms like the freedom of speech may be overcome only by a governmental objective of the highest order attainable in the least intrusive way. See Press-Enterprise Co. v. Super. Ct. of Cal., 478 U.S. 1, 13-14 (1986).
254. Brief for the ACLU, supra note 195, at 13 ("Under strict scrutiny, [a restriction] may be saved only if it is narrowly tailored to promote a compelling government interest.".
255. (quoting Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 582 (2001))).
256. See Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n, 447 U.S. 557 (1980).
257. Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc., 425 U.S. 748, 748 (1975).
258. Va. State Bd. of Pharmacy, 425 U.S. at 771, 774, 776 (referring interchangeably to a substantial government interest and a significant government interest in describing the test for the commercial speech doctrine).
259. The archetypal compelling government interest is national security. See Korematsu v. United States, 323 U.S. 214 (1944) (justifying the internment of Japanese Americans during World War II by identifying national security as a compelling governmental interest).
260. See City of Ladue v. Gilleo, 512 U.S. 43, 48 (1994) (recognizing a substantial government interest in maintaining the aesthetics of a neighborhood).
261. See Ward v. Rock Against Racism, 491 U.S. 781, 800 (1989) (recognizing that there was a substantial government interest in regulating loud music played near a residential area).
262. Brief for the ACLU, supra note 195, at 12.
263. Jason Schultz & Corynne McSherry, Patent Injunctions and Speech Technologies 11 (unpublished working paper), available at https://www.law. berkeley.edu/files/Schultz-McSherry2.doc (explaining that the Intellectual Property Clause supports upholding a compelling government interest in encouraging innovation).
264. Brief for the ACLU, supra note 195, at 13.
265. Technically, the patent is owned by Stanford University, though Google owns all licensing rights to the patent. See Lisa M. Krieger, Scanford Earns $336 Million Off Google Stock, SAN JOSE MERCURY NEWS, Dec. 1, 2005.
266. see also U.S. Patent No. 6285999 (filed Jan. 9, 1998).
267. While many conceive of the commercial speech doctrine as applying only to corporations, the commercial speech doctrine can apply both to individuals and corporations. See Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc., 425 U.S. 748, 764 (1976) ("[S]ociety also may have a strong interest in the free flow of commercial information. Even an individual advertisement, though entirely 'commercial, ' may be of general public interest."). The commercial speech doctrine requires that the speech in question have the motive of obtaining a profit. It is irrelevant who is attempting to earn such a profit, whether an individual or a corporation.
268. 56 U.S. (15 How.) 62 (1853).
269. See Thompson v. W. States Med. Ctr., 535 U.S. 357 (2002).
270. Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n, 447 U.S. 557, 580 (1979).
271. See Schultz & McSherry, supra note 203.
272. See KOEPSELL, supra note 30, at 18 ("But all bargains require balance, and at some point it is possible we went too far in favoring the rights of innovators over the necessity for public good. Intellectual property laws have changed over the past hundred years, shifting their focus away from moving innovations into the public domain....").
273. Adejoke Oyewunmi, The Right to Development, African Countries and the Patenting of Living Organisms: A Human Rights Dilemma, in PATENTING LIVES: LIFE PATENTS, CULTURE, AND DEVELOPMENT 53, 67 (Johanna Gibson ed., 2008) ("Ultimately, what is needed is a framework which strikes the right balance between the regulation of access and utilisation of biological resources and the protection of innovations and knowledge systems... without discrimination, while at the same time, taking care to put in public interest safeguards.").