A natural disagreement: Markedly different views on the patentability of human genes, as presented in the case history and recent supreme court decision in myriad genetics

Biotechnology Law Report

Volumn 33, Issue 2, 2014, Pages 61-80

  Stauber, Rachel B ^a  

^a HARVARD LAW SCHOOL   (United States)

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EID: 84898997978     PISSN: 0730031X     EISSN: None     Source Type: Journal    
DOI: 10.1089/blr.2014.9994     Document Type: Article

References (178)

1. See Ass'n for Molecular Pathology v. PTO, 702 F. Supp. 2d. 181, 192-93 (S.D.N.Y. 2010)(discussing the history of genetics in the Facts section).
2. Watson and Crick published their findings on the doublehelical structure of DNA in Nature in 1953, earning Watson, Crick, and a collaborator the Nobel Prize in Medicine or Physiology.
3. It is estimated that the PTO has issued 2,645 patents claiming 'isolated DNA' over the past twenty-nine years.
4. That by 2005, had granted 40,000 DNA-related patents relating to, in non-native form, genes in the human genome.
5. Ass'n for Molecular Pathology v. PTO, 689 F.3d 1303, 1333 (Fed. Cir. 2012)(internal citations omitted).
6. See, e.g., Andrew Pollack, Justices Consider Whether Patents on Genes Are Valid, New York Times (Apr. 14, 2013); available at www.nytimes.com/2013/04/15/ business/as-court-considersgene-patents-case-may-overlook-relevant-issues.html
7. Opponents of gene patents say no company should have rights to what is essentially part of the human body. There are also ethical implications of limiting access to genetic testing.
8. Some contend that] Myriad's monopoly has impeded medical progress.
9. Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S.-(slip op., at 1)(2013); available at www.supremecourt.gov/opinions/12pdf/12-398-1b7d.pdf
10. See infra, notes 249-53 and accompanying text.
11. See Ass'n for Molecular Pathology v. PTO, 689 F.3d 1303, 1310 (Fed. Cir. 2012).
12. Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S.-(slip op., at 3)(2013); available at www.supremecourt.gov/opinions/12pdf/12-398-1b7d.pdf
13. See Ass'n for Molecular Pathology v. PTO, 689 F.3d 1303, 1309-10 (Fed. Cir. 2012).
14. At the end of the opinion, the Supreme Court directly states that its opinion does not cover method claims.
15. Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S. (slip op., at 17-18)(2013); available at www.supremecourt.gov/opinions/12pdf/12-398-1b7d.pdf
16. Ass'n for Molecular Pathology v. PTO, 689 F.3d 1303, 1309 (Fed. Cir. 2012).
17. See generally Ass'n for Molecular Pathology v. PTO, 689 F.3d 1303.
18. U.S.C. x101 (2013).
19. See Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980).
20. differentiating between "products of nature" and "human-made inventions".
21. Ass'n for Molecular Pathology v. PTO, 702 F. Supp. 2d. 181, 227-28 (S.D.N.Y. 2010)(citing Chakrabarty, 447 U.S. at 310).
22. quoting Chakrabarty, 447 U.S. at 309-10).
23. This informational quality is unique among the chemical compounds found in our bodies, and it would be erroneous to view DNA as 'no different[]' than other chemicals previously the subject of patents.
24. See id. at 230-1 for a more extensive list of ways Myriad suggests isolated DNA can be used for which native DNA cannot.
25. For example, in genetic testing, "[t]he entire premise behind Myriad's genetic testing is that the claimed isolated DNA retains, in all relevant respects, the identical nucleotide sequence found in native DNA."
26. Id. at 232 (citing Am. Fruit Growers v. Brogdex, 283 U.S. 1, 11 [1931]).
27. Ass'n for Molecular Pathology v. PTO, 689 F.3d 1303, 1309 (Fed. Cir. 2012).
28. Mayo does not control because it governs cases regarding method, not composition, claims.
29. Even if biologists think of molecules like DNA in terms of their uses, genes are in fact materials having a chemical nature.
30. so are best described in patents by their structures rather than their functions.
31. Id. at 1325 ("[D]isapproving of patents on medical methods and novel biological molecules are policy questions best left to Congress.;"
32. id. at 1330 ("Whether [DNA's] unusual status as a chemical entity that conveys genetic information warrants singular treatment under the patent laws as the district court did is a policy question that we are not entitled to address.");
33. id. at 1333 (stating should be Congress's decision whether to change patentability of human genes).
34. Courts should be particularly wary of creating categorical exclusions from patent eligibility. Id. at 1330.
35. In this case, the PTO has issued patents relating to DNA molecules for almost thirty years.
36. In the early 1980s, the Office granted the first human gene patents.
37. By 2005, "[the Office] had granted 40,000 DNA-related patents relating to.genes in the human genome." Id. at 1333 (internal citations omitted).
38. The PTO has issued more than 2,500 patents claiming isolated DNA. Id. at 1333.
39. Id. at 1341 (Moore, J., concurring)(emphasis added).
40. quoting Diamond v. Chakrabarty, 447 U.S. 303, 309-10 (1980).
41. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948).
42. Id. (stating the PTO has held isolated DNA patent-eligible because "[a]n isolated and purified DNA molecule.does not occur in that isolated form in nature")(quoting 66 Fed. Reg. 1092, 1093 [Jan. 5, 2001]).
43. Judge Moore's decision might have been different if the PTO had not already made a practice of granting patents on DNA sequences that include most or all of a gene.
44. Judge Moore emphasized the importance of "settled expectations and extensive property rights" involved with patent law, and thus, should be "particularly wary of expanding the judicial exception to patentable subject matter."
45. Man has whittled the chromosomal DNA molecule down to a 15 nucleotide sequence-defining the parts to be retained and discarded. And the result is a product with a function (primer or probe) that is entirely different from the full gene from which it was obtained.").
46. Bryson, J., dissenting)(attributing to others the mapping of the BRCA gene to its chromosomal location, and the invention of the nucleotide sequencing technique, thus leaving Myriad's discovery to an application and combination of known facts).
47. The only material change made to those genes from their natural state is the change that is necessarily incidental to the extraction of the genes from the environment in which they are found in nature.
48. Ass'n for Molecular Pathology v. PTO, 689 F.3d 1303, 1313 (Fed. Cir. 2012).
49. Id. at 1313-4 ("cDNA is synthesized from mRNA using complementary base pairing in a manner analogous to RNA transcription").
50. Ass'n for Molecular Pathology v. PTO, 702 F. Supp. 2d. 181, 230 (S.D.N.Y. 2010).
51. Ass'n for Molecular Pathology, 689 F.3d at 1329 (majority opinion).
52. Id. at 1326 ("DNA molecules engineered by man, including cDNAs, are patent-eligible compositions of matter because, with rare exceptions, they do not occur in nature, either in isolation or as contiguous sequences within a chromosome.").
53. Although 35 U.S.C. x101 includes compositions of matter that are "discover[ed]" in addition to those "invent[ed]," the courts interpret the "discover" language narrowly to mean something more than mere discovery.
54. See, e.g., Ass'n for Molecular Pathology v. PTO, 689 F.3d 1303, 1337 (Fed. Cir. 2012).
55. Moore, J., concurring) ("These exceptions [of laws of nature, physical phenomena, and abstract ideas] 'rest.
56. on the more fundamental understanding that they are not the kind of "discoveries" that the statute was enacted to protect."')(quoting Parker v. Flook, 437 U.S. 584, 593 (1978)).
57. Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).
58. Id. at 309-10 (internal citations omitted).
59. See Ass'n for Molecular Pathology v. PTO, 702 F. Supp. 2d. 181, 229 (S.D.N.Y. 2010).
60. See Ass'n for Molecular Pathology v. PTO, 689 F.3d 1303, 1330 (Fed. Cir. 2012).
61. See id. at 1354 (Bryson, J., dissenting).
62. Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980)(emphasis added).
63. Moore, J., concurring)("It is not the chemical change alone, but that change combined with the different and beneficial utility that leads me to conclude that small isolated DNA fragments are patentable subject matter.")(citing Chakrabarty, 447 U.S. at 310).
64. Ass'n for Molecular Pathology v. PTO, 702 F. Supp. 2d. 181, 229 (S.D.N.Y. 2010)(internal citations omitted).
65. See Ass'n for Molecular Pathology, 689 F.3d at 1328.
66. See Ass'n for Molecular Pathology, 702 F. Supp. 2d. at 228-9.
67. See Ass'n for Molecular Pathology v. PTO, 689 F.3d 1303, 1332 (Fed. Cir. 2012).
68. Bryson, J., dissenting)("In my view, that structural similarity [of the sameness of nucleotide sequence] dwarfs the significance of the structural differences between isolated DNA and naturally occurring DNA.").
69. Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).
70. Ass'n for Molecular Pathology, 702 F. Supp. 2d at 230-1.
71. For example, the "product of nature" doctrine was created by the Supreme Court in Chakrabarty.
72. See Diamond v. Chakrabarty, 447 U.S. 303 (1980).
73. See also In re Bilski, 545F.3d 943 (Fed. Cir. 2008)(creating machine or transformation test that Supreme Court later determined was a useful, but not the sole, tool in figuring out process x101 subject-matter eligibility).
74. See, e.g., Ass'n for Molecular Pathology v. PTO, 689 F.3d 1303, 1333 (Fed. Cir. 2012)
75. If the law is to be changed, and DNA inventions excluded from the broad scope of x101, contrary to the settled expectation of the inventing and investing communities, the decision must come, not from the courts, but from Congress.
76. Disapproving of patents on medical methods and novel biological molecules are policy questions best left to Congress.
77. The Supreme Court has repeatedly stated that changes to longstanding practice should come from Congress, not the courts.
78. Bryson, J., dissenting)("Congress has performed its constitutional role in defining patentable subject matter in x101; we perform ours in construing the language Congress has employed.")(quoting Chakrabarty, 447 U.S. at 315).
79. See Ass'n for Molecular Pathology, 689 F.3d at 1330-1 ("Congress is presumed to have been aware of the issue [of gene patentability], having enacted a comprehensive patent reform act during the pendency of this case, and it is ultimately for Congress if it wishes.
80. to determine that isolated DNA must be treated differently from other compositions of matter to account for its perceived special function.").
81. Moore, J., concurring)("I decline the opportunity to act where Congress has chosen not to.
82. Congress has at least implicitly approved of the Patent Office's policy of awarding patents on genes and DNA sequences.
83. Judge Moore went on to give evidence of Congress's awareness of the issue and affirmative decision not to change the law.
84. Far from oblivious to the patenting of genes, Congress introduced and declined to pass several bills which would put a moratorium on gene patents, authorize funding for the study of whether genes ought to be patentable
85. and exempt from patent infringement anyone who uses patented genes for non-commercial research purposes or medical practitioners who use genetic diagnostic tests.
86. See Ass'n for Molecular Pathology v. PTO, 702 F. Supp. 2d. 181, 221 (S.D.N.Y. 2010).
87. The lack of Congressional action to specifically prohibit gene patents does not preclude their review by the courts.
88. Judge Sweet supported this conclusion with an example of the Bilski case, where the Federal Circuit developed a test that could invalidate business method patents, despite Congress's silence on the matter.
89. See Ass'n for Molecular Pathology, 689 F.3d at 1330.
90. Id. (quoting Nat'l Fed'n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566, 2579 (2012)).
91. See Biotechnology Industry Organization: Summary, Open-Secrets.org (last updated Oct. 28, 2013); available at www.opensecrets.org/lobby/clientsum.php?id= D000024369&year=2010
92. Id. at www.opensecrets.org/lobby/clientsum.php?id=D000024369&year= 2013
93. See Ass'n for Molecular Pathology, 689 F.3d at 1333.
94. There are now thousands of patents with claims to isolated DNA.
95. Id. at 1358 ("Although my colleagues believe our analysis of the legal question in this case should be influenced by purported expectations of the inventing community based on the PTO's past practice of issuing patents on human genes, that is in effect to give the PTO lawmaking authority that Congress has not accorded it."
96. See Ass'n for Molecular Pathology v. PTO, 702 F. Supp. 2d. 181, 221 (S.D.N.Y. 2010).
97. The Federal Circuit has previously held that it owes no deference to USPTO legal determinations.") (internal citations omitted).
98. See Ass'n for Molecular Pathology, 689 F.3d at 1357 (Bryson, J., dissenting).
99. See, e.g., Alissa K. Lipton, Biopharmaceuticals: The Patent System and Incentives for Innovation 38 (2004 Third Year Paper); available at http://nrs.harvard.edu/urn-3:HUL.InstRepos: 8852103 (explaining justifications for patent system).
100. Ass'n for Molecular Pathology v. PTO, 702 F. Supp. 2d. 181, 228 (S.D.N.Y. 2010).
101. See infra notes 316-319 and accompanying text discussing the future of the biotechnology industry in recombinant DNA.
102. Ass'n for Molecular Pathology v. PTO, 689 F.3d 1303, 1357 (Fed. Cir. 2012)(Bryson, J., dissenting).
103. Caitlyn Ross, The Future of Gene Patenting and the Biotechnology Industry After Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al. 12 (April 2010); available at http://nrs.harvard.edu/urn-3:HUL. InstRepos:8965566
104. Gene patents are particularly powerful because they are impossible to design around. Once a gene is patented, all non-licensed research related to that piece of DNA sequence ends until the expiration of the patent.
105. A researcher cannot create an alternative DNA sequence and still obtain meaningful clinical results. (internal citations omitted).
106. Ass'n for Molecular Pathology at 1357 (Fed. Cir. 2012)(Bryson, J., dissenting).
107. Patents on life-saving material and processes, involving large amounts of risky investment, would seem to be precisely the types of subject matter that should be subject to the incentives of exclusive rights.
108. Id. at 1344 (Moore, J., concurring)("This outpouring of scientific creativity, spurred by the patent system, reflects a substantial investment of time and money by the biotechnology industry to obtain property rights related to DNA sequences.").
109. See John Conley, Some Thoughts on Myriad after the Supreme Court Argument, Genomics Law Report (May 1, 2013); available at www.genomicslawreport. com/index.php/2013/05/01/some-thoughts-on-myriad-after-the-supreme- courtargument/
110. Daniela Hernandez, Gene Patents Are Sabotaging the Future of Medicine, Wired.com (Apr. 18, 2013); available at www.wired.com/business/2013/04/gene- patents-are-impedingthe-future-of-medicine/
111. See, e.g., Pollack, supra n. 4 ("An advisory committee to the Health and Human Services Department said in a 2010 report that gene patents were not necessary to spur development of genetic tests.
112. There are about 50 tests offered for mutations that cause cystic fibrosis, for instance, despite the lack of exclusivity that patents provide.
113. See Bradley J. Fikes, Gene Patent Controversy Winding Down, UT San Diego (Apr. 13, 2013); available at www.utsandiego.com/news/2013/Apr/13/gene-patents- winding-downmyriad-genetics-brca/all/
114. See, e.g., Pollack, supra n. 4, The impact could depend on how the opinion was worded.
115. Drugs, vaccines or crops might still be protectable even without patents on genes because other steps are involved in their creation.
116. Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S.-(slip op., Syllabus at 3)(2013); available at www.supreme court.gov/opinions/12pdf/12-398- 1b7d.pdf
117. Transcript of Oral Argument at 1, Ass'n for Molecular Pathology v. Myriad Genetics (No. 12-398); available at www.supremecourt.gov/oral-arguments/ argument-transcripts/12-398-amc7.pdf
118. Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S.-(slip op., Syllabus at 3)(2013); available at www.supremecourt. gov/opinions/12pdf/12-398- 1b7d.pdf
119. Objects of such analogies included Amazon trees, baseball bats, chocolate chip cookies, gold, and lead.
120. See Transcript of Oral Argument, Ass'n for Molecular Pathology v. Myriad Genetics (No. 12-398); available at www.supremecourt.gov/oral-arguments/ argument-transcripts/12-398-amc7.pdf
121. Chief Justice Roberts commenting that extracting DNA is just "snipping, and you don't have anything new, you have something that is a part of something that has existed previous to your intervention."
122. Justice Sotomayor asking whether cutting off a piece of an organ makes the piece patentable
123. See also id. at 55 ( Justice Breyer asking whether protection extends to "anything from inside the body that you snip out and isolate?").
124. Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S.-(slip op., at 11)(2013); available at www.supremecourt.gov/opinions/12pdf/12-398-1b7d.pdf 203Id.
125. See Transcript of Oral Argument at 26, Ass'n for Molecular Pathology v. Myriad Genetics (No. 12-398); available at www.supremecourt.gov/oral-arguments/ argument-transcripts/12-398-amc7.pdf
126. Justice Roberts stating, "I thought the basic general approach here was we have a very expansive view of what is patent eligible and then we narrow things through things-issues like obviousness.
127. Wouldn't it make more sense to address the questions at issue here in the obviousness realm?");
128. Justice Alito commenting, "This case has been structured in an effort to get us to decide this on the broadest possible ground.that it's just about 101.why should we do that?.
129. Some Justices expressed the sentiment fairly directly. Justice Kennedy, for example, posits, "If we were to accept the Government's position that the DNA is not patentable but the cDNA is, would that give the industry sufficient protection for innovation and research? And if not, why not?
130. See also id. at 61 ( Justice Sotomayor asking about the value and consequences of invalidating isolated DNA but validating cDNA as patentable).
131. Other Justices deliberated on it and inquired about the differences between isolated and cDNA.
132. Justice Ginsburg brings up the manipulation involved with cDNA. Id. at 21. Justice Sotomayor states, "[cDNA] is artificially created in the laboratory, so it's not bound [sic] in nature.
133. It's not taking a gene and snipping something that's in nature.[ I]t is not a product of nature; it's a product of human invention." Id. at 17.
134. Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S.-(slip op., at 16)(2013); available at www.supremecourt.gov/opinions/12pdf/12-398-1b7d.pdf.
135. This is the number given in Myriad's patent claims.
136. See Transcript of Oral Argument at 19, Ass'n for Molecular Pathology v. Myriad Genetics (No. 12-398); available at www.supremecourt.gov/oral-arguments/ argument-transcripts/12-398-amc7.pdf
137. Justice Sotomayor acknowledged that cDNA may be patentable subject matter, but suggests that the fact that the claims for sequences of 15 nucleotides can be contained in just one exon may make those claims unpatentable.
138. Because as I understand it, 15 nucleotides long exists naturally in nature. They get reproduced in that sequence of 15.
139. See Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S.-(slip op., at 15-16)(2013); available at www.supremecourt.gov/opinions/12pdf/12-398-1b7d. pdf
140. Concerns about reliance interests arising from PTO determinations, insofar as they are relevant, are better directed to Congress.
141. Transcript of Oral Argument at 51, Ass'n for Molecular Pathology v. Myriad Genetics (No. 12-398); available at www.supremecourt.gov/oral-arguments/ argument-transcripts/12-398-amc7.pdf
142. See Ass'n for Molecular Pathology, 689 F.3d at 1357-58 (Bryson, J., dissenting)(suggesting Government's current position against patentability of isolated DNA now undermines deference to any past practices of PTO).
143. Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S.-(slip op., at 16)(2013); available at www.supremecourt.gov/opinions/12pdf/12-398-1b7d.pdf 228Id. at 15.
144. See Transcript of Oral Argument at 12, Ass'n for Molecular Pathology v. Myriad Genetics (No. 12-398); available at www.supremecourt.gov/oral-arguments/ argument-transcripts/12-398-amc7.pdf
145. We have claims that if patent eligibility is denied here it will prevent investments that are necessary for the development of new drugs or it will lead those who develop the new drugs.to keep those secret, not to disclose them to the public. Why.should we jump in and.decide the broadest possible question?
146. Why shouldn't we worry that Myriad or other companies like it will just say, well, you know, we're not going to do this work anymore?
147. I hoped you were going to say.[that] notwithstanding that you can't get a patent on this gene, that.there are still.various things that you could get a patent on that would make this kind of investment worthwhile in the usual case.
148. The patent law is filled with uneasy compromises, because on the one hand, we do want people to invent; on the other hand, we're very worried about them tying up some kind of whatever it is, particularly a thing that itself could be used for further advance.
149. giving a metaphor of a lengthy and expensive Amazon expedition where patent was obtained on the process and use of tree sap but not on sap itself
150. Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S.-(slip op., at 11)(2013); available at www.supremecourt.gov/opinions/12pdf/12-398-1b7d.pdf
151. Transcript of Oral Argument at 14, Ass'n for Molecular Pathology v. Myriad Genetics (No. 12-398); available at www.supremecourt.gov/oral-arguments/ argument-transcripts/12-398-amc7.pdf
152. Recombinant DNA is in fact what all the major innovations in the industry are doing these days.
153. All of the change-all of the useful things that we are inventing is done-is done through the process of recombinant DNA.
154. If we lock up the cDNA, it makes it harder to do the recombinant DNA.[I]f someone owns all the cDNA, I can't do recombinant DNA using what the company owns.
155. My understanding is that.the native DNA can be used for recombinant DNA without the step of cDNA.
156. See, e.g., Conley, supra n. 178, Almost everyone who has heard or read the Myriad argument has the same prediction.
157. The Court may well strike down isolated genomic DNA patents while upholding those on cDNA. I agree.
158. See, e.g., Conley, supra n. 178.
159. See also Pollack, supra n. 4, Some experts say patents on human genes are actually fading in importance.
160. Dr. James P. Evans states,] the impact of the Supreme Court's decision 'will be much more ideological than it will be practical.
161. Fikes, supra n. 182 ("No matter which way the Supreme Court rules on the Myriad Genetics [case]., the importance of such patents is diminishing over time.").
162. See Pollack, supra n. 4 ("[T]he Myriad patents at issue are due to expire over the next two years.").
163. Conley, supra n. 178.
164. A relatively small number of. diagnostic tests or drugs are protected by patents on single genes.
165. Pollack, supra note 4.
166. While around four thousand human genes, or twenty percent (20%) of the human genome, are patented, many of those patents would not block genetic testing because either they only mention genes, or they have lapsed.
167. Conley, supra n. 178.
168. See also Fikes, supra n. 182 ("Biotechnology is moving beyond patents derived from naturally occurring gene sequences.").
169. Fikes, supra n. 182.
170. See Ass'n for Molecular Pathology v. Myriad Genetics, 569U.S.-(slip op., at 1)(2013); available at www.supreme court.gov/opinions/12pdf/12-398-1b7d.pdf
171. Conley, supra n. 178.
172. See Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S.-(slip op., at 12)(2013); available at www.supremecourt. gov/opinions/12pdf/12-398-1b7d.pdf
173. See, e.g., Emma Barraclough, What Myriad Means for Biotech, World Intellectual Property Organization, Aug. 2013
174. Jim Greenwood, head of the US-based industry group BIO, said the decision represents "a troubling departure" from decades of judicial and USPTO precedent supporting the patentability of DNA molecules that mimic naturally-occurring sequences, adding that it could create business uncertainty for a broader range of biotechnology inventions.
175. Ass'n for Molecular Pathology v. Myriad Genetics, 569 U.S.-(slip op., at 16)(2013); available at www.supremecourt.gov/opinions/12pdf/12-398-1b7d.pdf
176. See Johanna Jacob, Note, Comment: Should Our Genes Be Part of the Patent Bargain? Maximizing Access to Medical Diagnostic Advances While Ensuring Research Remains Profitable, 28 Santa Clara Computer & High Tech. L.J. 403, 451 (2011).
177. See, e.g., Steven Salzberg, Myriad Genetics CEO Claims He Owns Your Genes, Forbes, Apr. 13, 2013
178. The bottom line is that no one invented your genes, and no private company should be able to tell you that you can't even read your own DNA.