Abstract
'DNA Theft' is the new term employed to decipher the existing legal regime in the field of gene patenting. The oblivious nature of law has ceded transcending to a more flexible framework concerning the same. DNA is vested with a proprietary interest of ownership. 'Patenting gene' impinges the individual right to privacy. This paper analyzes the issue of ownership of DNA by examining the comparative study of patenting genes in the European Union and the United States.
Introduction
'Stealing DNA' can soon be the metaphor engulfing the field of Intellectual Property Regime. The twenty first century is welcoming the new age of eugenics and it is mandatory to understand the 'public's relationship with these emerging technologies'.1
A prominent question that ponders living in an oracle of losing our autonomy to digital innovations will be whether genes occupy a zone of personal privacy that could be infringed by assigning patent right to a holder.2Latching on natural metaphors to conceptualize isolated DNA portray the language of scientific issues involved in gene patenting to the public.3 Though the judgment of Myriad Genetics4 was laudably appraised, it may have a room to ignite the fire surrounding the Biotech Directive.5 'Dignity is a useless concept'6 as propounded stands relevant pertaining to the fact that respect for person or their autonomy is lost in the murky. When Pharmaceutical Companies yearn to invest millions of dollars in genetic research7, the question of ownership of human DNA becomes apparent. The study of genetics has become a commercialized enterprise. DNA is defined as a 'master blueprint8 for a living being' rather than a string of code. 9
'Gene patent' is a term to encompass a wide variety of patents related to genetics.10 DNA is the most fundamental structure of life which is both a product of nature and the law of nature regardless of whether it is inside our bodies or sitting in the bottom of a test tube.11 It is reserved exclusively to none to claim ownership, as Justice Sotomayor has rightly proclaimed that DNA is just nature sitting there.12
Who Owns The DNA?
Genes are identified as the discrete units of DNA sequence that encode individual proteins.13DNA has been conceptualized as a person's book of life which provides insights into the many dimensions of the person's future.14 The information encoded in one's genetic code is a probabilistic future diary because it describes a solitary feature of personal future.15 The conceptualization leads many people want to control who has access to genetic information about them which calls for a stringent privacy protection or even a personal genetic data ownership.16 DNA sampling intrudes into three forms of individual privacy: bodily privacy in cases where the sample is taken from a person's body; genetic privacy, where predictive health and other information about the person is obtained from the sample; and behavioral privacy, where the information is used to determine where a person has been and what he has done.17 Subservient to human dignity, privacy and confidentiality is the essence of defining respect for a person.18 'Privacy' arises from the principle of respect for persons by conferring on an individual an ethical right to require consent to be obtained prior to disclose of his or her personal information.19It is concerned with personal and sensitive information which is the sole and proper subject of legal protection.20The definition elucidated as the 'state of being free from intrusion of disturbance in one's private life and affairs21 reflects privacy as the 'handmaiden of autonomy'.It is shaped by a tradeoff between an individual's desire for privacy and competing interests in disclosure. Genetic information has a potential predictive power which enormously impacts on how we anticipate about ourselves, our relationships and our roles in society.22The public nature of the genome which is used for low risk research makes it arduous to decide what level of control individuals possess.23The crucial question which arises is whether or not persons have property rights in their genetic material. If the answer is positive, speculation arises as to what extent the rights may become the subject of legally enforceable agreements.24
Can DNA be constituted as a proprietary right?
Genes are a common universal possession representative of humankind's collective heritage and thus not a subject matter for which Intellectual property rights should be granted. 25'Genetic privacy' is not less rich with ambiguity than the concept of 'privacy'.
DNA, the informational molecule of human heredity deciphers the innermost working of our bodies. Whether genes compromise our identities is a difficult question. The notion that the human DNA is a repository of valuable human personality intimate the idea that proprietary interest is vested on it. It is further suggested that human DNA is owned by the person from whom it is taken. If DNA defines the human essence, it ought to belong to the individual from whom it was derived. The two paramount reasons to invest ownership in DNA are firstly to protect expectations. A reasonable prudent person would tend to think that to some degree, he or should continue to own it. Secondly, to indicate that there are limits on exploitative appropriation.26 The exclusive right vested on DNA could qualify as an inalienable property.27
Patenting Genes Breaches The Right To Privacy
'Patenting Life'28 exemplify the spirit of farsighted patent laws one could roll through.29Since the mapping of the human genome, the technical innovations in the field of biotechnology has undergone a transitional phase.30The conventional norm of novelty and non-obviousness apply to patenting life as well.31The zest for patenting genes is visible through the lines of leading biotechnology companies though they feel a blanket denial of patent on genes.32DNA segments are a product of nature and hence not eligible for patent protection.33 The 'monopolization of human genetic information'34 is augmenting towards a fearsome future.
The patenting of genes and gene sequence may interfere with privacy rights as it permits an interference with a bodily part. Genes are the building blocks of human life and a part of every cell in the body. The zone of privacy could be violated by assignment of gene patent right. Critics of gene patenting cite the privacy infringement inherent in assigning ownership interests in which every individual is a part owner merely be virtue of being human. Gene patenting may violate fundamental principles of individual and collective privacy.35
In the United States, the concept of 'isolated and purified' compounds are considered patentable subject matter. Patent on a gene covers the 'isolated and purified' gene but does not extent the protection on a gene as it occurs in nature. In Chakrabarty, the sole ground for dismissing the patent application was that the subject matter concerned was a 'living organism'. The Supreme Court however, adjudicated opining that patent umbrella can be expanded to anything and everything that 'man has made under the sun'. The engineered organism constituted a novel invention and it was not a 'product of nature'. The legal position in the United States has undergone a transitional phase averting from the archaic doctrine to a liberal implication of gene patenting.
The European Jurisprudence revolves around two primary documents- The European Patent Convention and the Biotech Directive. In the European Union, 'biological material, which is isolated from its natural environment or produced by means of a technical process maybe the subject of an invention evenif it is previously occurred in nature.36It is prima facie perceptible that it is extremely difficult for law to join hands with protecting the intangible property vested in biotechnology patents.37
Deciphering The Biotech Dream In The European Union
Nurturing the fruits of the 'biotech dream'38,the dormant impact of patents on biotechnology innovations captured the minds of the academicians and scientists.39 A cardinal principle rooted in the domain of the patent law necessitates that a patentable item must issue from human ingenuity. DNA is not a product of human ingenuity and is therefore not a 'candidate' for patenting.40The discovery of the double helical structure of the DNA molecule in the year 1953 prompted the field of biotechnology broadening its nature and scope. The initial step was the recombinant DNA technology which rapidly became the mainstream technique for manipulating the genome and opened the door to a multitude of possible use of genetic technologies.41
Europe presently has two sources of law that purport to govern patent grants technically vitiating the property rights of biotech interests.42 The European Patent Convention and the Biotechnology Directive are the two legal regimes reigning the fulcrum of biotechnological innovations.
The dogma of the Biotechnology Directive responded to the patentability of biotechnological inventions. It mooted a tendentious concern questioning the ethics of biotech patenting.43 The Biotech Directive revolves on the general patent law principle that only 'new and non-obvious inventions with an industrial application' can be patented.The disparity between 'invention and discovery' is perceptible in the Directive acknowledging the fact that to draw the line between discovery and invention is not an easy route to ponder.
Elucidating the clarity between patentable invention and non-patentable discovery44, the Directive recapitulates that either the human body at the various stages of its formation or development nor the simple discovery of one of its elements including the sequence or partial sequence of a gene, can constitute a patentable invention.45 However, biological material is patentable under certain circumstances – even if the material is structurally identical to material found in nature. This is for the reason that the rights are asserted not over DNA sequences that occur naturally, but rather for DNA sequences that have been isolated and purified.46The Act of isolating biological material from its surrounding or producing it in an artificial way is sufficient to place the material so isolated or produced in the realm of inventions.47 They are only patented in the context of molecules which have been artificially created by cloning and isolated from the human body.48
The Directive mandates that the invention of a human biological material disclose not only the invention but also its industrial application.49 The Directive takes an additional step in clarifying what kind of industrial applications count for obtaining a patent.50 It is obligatory that the inventor must disclose the function and use of the sequence. In the case of DNA sequences that the body uses to produce proteins, it is also necessary to disclose the identity and function of the protein produced by the expression of the sequence.
The storm surrounding the directive continues to plague the Biotech Industry with an adverse impact. Nevertheless the human body itself at every stage of its development cannot be patented.51
The EU Directive explicitly prohibits patenting of parts of the body.52The sensitive data encoded in DNA demands adequate privacy safeguards. The General Data Protection Regulation (GDPR) is the new enhanced instrument for personal data protection. It recognizes the sensitive nature of genetic data. The definition provided by the GDPR maintains the core element determined in the Directive defining personal data as 'any information relating to an identified or identifiable natural person ('data subject'). It includes the term 'genetic' in the catalog of identifiers. The main implication of the provisions of the GDPR suggests that it excludes processing data for statistical or research purposes from the scope of data protection if the data rendered are anonymous.53 However, Article 9.2(j) of the regulation permits processing of special categories of personal data when it is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes. It prima facie means that it can occur without the explicit consent of the data subject by enumerating the grounds for the lawful processing of personal data without consent under Article 6. But the Member States could aim for stronger protection for genetic data by requiring stricter conditions for processing genetic data for research purposes.54
The European Law provides the research exemption for processing personal data but it does not explicitly grant the ownership of DNA to an individual.
Understanding Through The Lens Of American Jurisprudence
The controversial debate on genetic research is complemented by the equally passionate and intense dispute on whether DNA sequences should be shielded under the patent law. 'Playing God' is the metaphor to epitomize the notion of genetic manipulation. DNA sequences has been attacked on religious grounds articulating on the notion that the fruits of such work should not be rewarded with patent control.55 The product of nature cannot be patentable since it fails to satisfy the criterion of novelty.56 As Chief Justice Burger duly noted, the relevant distinction in the field of 'biotechnology' should be 'not between living and inanimate things, but between products of nature, whether living or not, and human made invention.'57
The case of Chakrabarty58marked the inception of a new era for the US Patent system which opened the door for patents grounded in genetic technology.59 The Supreme Court affirmed a judgment which allowed the patent applicant's claims for a human made, genetically engineered bacterium capable of breaking down multiple components of crude oil.60 The Court opined that the bacterium was altered to a sufficient extent to qualify as an 'invention' and thus the mutated organism fulfilled the criterion of novelty and was not a product of nature61 claiming to be Chakrabarty's handiwork.62
However, the resent was culminated in the case of Myriad Genetics63 yet the unanimous ruling had been welcomed enthusiastically adhering that it clears away a major barrier to innovation.64 The case concerned the patentability of two particular breast cancer genes (BRCA1 and BRCA2). Analyzing the primary issues concerned, the Court concluded on the note that a 'naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.
Although the Supreme Court unanimously ruled that genes cannot be patented, the controversial bill proposed tries to change the settled jurisprudence pushed by biopharmaceutical companies and patent lawyers. The draft bill erases a precedent the Supreme Court laid out in the three unanimous rulings between 2012 and 2014.65 The bill proposed allows genes to be patented.66 It not only calls into the question of privacy as a right but it also reverses the settled jurisprudence of patent law on the products of nature.
In 1990, the US embarked on a thirteen year venture called the Human Genome Project (HGP), the purpose of which was to identify all the genes in the human genome. This projection has prompted both the public and private entities to pursue patent protection of isolated DNA sequences in hopes of capitalizing and rejuvenating the new technology.67 As a result, millions of gene and genome related patent applications have been filed in the United States.
The Human Genome Project was initiated as program to decipher the human DNA digital code by mapping and sequencing the twenty three pairs of human chromosomes that reside in the nucleus of ever cell. It was launched as an ever growing wave of increasing genetic information.68The Genetic Privacy and Non Discrimination Act (GPA) of 1995 which is now replaced with Genetic Information Nondiscrimination Act (GINA) expressly placed ownership of DNA in the person from whom the samples were derived. The GPA authorized person collecting a DNA sample to provide specific information verbally before the DNA sample is collected; provide a notice of rights and assurances before the DNA sample is collected; obtain a written authorization that incorporates the required information and restricted access to DNA samples.69 The present law does not delve into the aspect of privacy.70 It further does not explicitly grant ownership.
Conclusion
The matter of DNA sequence patenting and the concept of privacy is still lingering as a dark shadow which continues to haunt the existing legal framework. DNA sequence patents are often referred to as 'gate keepers patents' because DNA manipulation lies at the heart of the cures for so many human diseases. There is no substitute for genes because there can be no improvement on the composition of DNA itself.71 The ownership of DNA has not been explicitly provided both under the European law and the American law. DNA is not less than the concept of privacy which is defined as 'right to be let alone'. A separate unified legislation should be enacted concerning DNA as the sole proprietary right to ownership and hence it cannot be patented.
Footnotes
1 Patten,John,Inventing DNA or Stealing It? The Role of Metaphor in Gene Patenting Debates(May 4, 2012) https;//ssrn.com/abstract=2251341Accessed 20th September.
3 John (n1).
4 Association for Molecular Pathology v. Myriad Genetics, Inc. 569 U.S 576 (2013)
5Lai, Jessica C., Myriad Genetics and the BRCA Patents in Europe: The Implications of the US Supreme Court Decision (2016)https://ssrn.com/abstract= 3053070 Accessed 20th September 2019
7 John (n1).
8 G.T. Laurie, Title: Genetic Privacy: A Challenge to Medico-Legal Norms (1st, Cambridge University Press, Cambridge 2002) 87.
9 John (n1).
10Allison W Dobson, Gene Patents in the US- focusing on what really matters, (29 June 2012)https://genomebiology.biomedcentral.com/articles/10.1186/gb-2012-13-6-161 Accessed 20th September 2019
11 Tania Simoncelli, Should you be able to patent a human gene?, (Speech at the TEDxAmoskeagMillyard, November 2014 https://www.ted.com/talks/should_you_be_able_to_patent_a_human_gene?Accessed 20th September 2019.
12 Id.
13 Kane, Eileen M., Splitting the Gene: DNA Patents and the Genetic Code. Tennessee Law Review, Vol. 71, p. 707, 2004.
14 E. Clayton and ors, ' The law of genetic privacy: applications, implications, and limitations' [2019] JLB 1, 2.
15 Michael J Markett, 'Genetic Diaries: An Analysis of Privacy Protection in DNA Data Banks' (1996) 30 Suffolk U L Rev 185.
16 Clayton (n14).
17 JyotirmoyAdhikary, DNA Technology in Administration of Justice (1st, LexisNexis, New Delhi 2007) 267.
19 Ibid.
20 G.T. Laurie, Title: Genetic Privacy: A Challenge to Medico-Legal Norms (1st, Cambridge University Press, Cambridge 2002) 87.
21 Adhikary (n17).
22 Terry (n18).
23 Clayton (n14).
24 Markett (n15)
25 Barbara Looney, 'Should Genes Be Patented – The Gene Patenting Controversy: Legal, Ethical, and Policy Foundations of an International Agreement' (1994) 26 LPIB 231.
26 Mark A. Rothstein, Genetic Secrets?: Protecting Privacy and Confidentiality in the Genetic Era. New Haven (1st, Yale University Press, New Haven and London 1997) 33.
27 Ibid.
28 M.D Nair, 'Is This Human Gene Robbery?' (@businessline, 2013) https://www.thehindubusinessline.com/opinion/Is-this-human-gene-robbery/article20644771.ece>; accessed 21 September 2019.
29 Achal Prabhala, Sudhir Krishnaswamy, Mr Modi, Don't Patent Cow Urine (June 16, 2016) https://www.nytimes.com/2016/06/17/opinion/mr-modi-dont-patent-cow-urine.htmlAccessed 20th September 2019
30 Radoslav M. Milkov, "Patentability and Scope of Protection for DNA Sequence-Related Inventions from the Perspective of the United States of America and Europe," Journal of Intellectual Property, Information Technology and Electronic Commerce Law 4, no. 1 (2013): 36-52.
31 Ameen Jauhar, Swati Narnaulia, 'Patenting Life the American, European and the Indian way' (2010) 15 Journal of Intellectual Property Rights.
32 Nair (n27).
33 'Patent Justice' (The Hindu, 2013) https://www.thehindu.com/opinion/editorial/patent-justice/article4834421.ece>; accessed 21 September 2019.
34 Ameen Jauhar, Swati Narnaulia, 'Patenting Life the American, European and the Indian way' (2010) 15 Journal of Intellectual Property Rights.
35 Looney (n25).
36 Ibid.
37 Rao, Rameshwari R., Patenting in Biotechnology – An Overview (February 5, 2012)https://ssrn.com/abstract=1999541 Accessed 21st September 2019
38 Gold, E. Richard, and Alain Gallochat. "The European Biotech Directive: Past as Prologue." European Law Journal, vol. 7, no. 3, September 2001, p. 331-366. HeinOnline, https://heinonline.org/HOL/P?h=hein.journals/eurlj7&i=345.
39 Bryan, Erin. "Gene Protection: How much is too much – Comparing the Scope of Patent Protection for Gene Sequences between the United States and Germany." Journal of High Technology Law, vol. 9, no. 1, 2009, p. 52-65. HeinOnline, https://heinonline.org/HOL/P?h=hein.journals/jhtl9&i=58.
40 Murphy P, "David B. Resnik, owning the Genome: A Moral Analysis of DNA Patenting (Albany, NY: State University of New York Press, 2004), 272 Pages.
41 Erin (n37).
42 Richard (n36).
43 Erin (n37).
44 Richard (n36).
45See Article 5(1) of the EU Biotech Directive; Van Overwalle, Geertrui, Biotechnology and Patents: Global Standards, European Approaches and National Accents (2008). GENETIC ENGINEERING AND THE WORLD TRADE SYSTEM, Daniel Wüger, Thomas Cottier, eds., Cambridge University Press, pp. 77-108, 2008 https://ssrn.com/abstract=1719208 accessed 28th September 2019.
46 Radoslav M Milkov, 'Patentability and Scope of Protection for DNA Sequence-Related Inventions from the Perspective of the United States of America and Europe' (2013) 4 J Intell Prop Info Tech & Elec Com L 36.
47 See Article 5(2) of the EU Biotech Directive.Gold, E. Richard, and Alain Gallochat. "The European Biotech Directive: Past as Prologue." European Law Journal, vol. 7, no. 3, September 2001, p. 331-366. HeinOnline, https://heinonline.org/HOL/P?h=hein.journals/eurlj7&i=345.
48 Milkov (n44).
49 See Article 5(3) of the Directive; Recital 22 of the Directive
50 See Recital 23 of the Directive.
51 Richard (n36).
52 Looney (n25).
53 M. Shabani and P. Borry, ' Rules for processing genetic data for research purposes in view of the new EU General Data Protection Regulation' [ 2018] EJHG 149, 151.
54 Ibid.
55 Diana A. Villamil, "Redefining Utility in Determining the Patentability of DNA Sequences," John Marshall Review of Intellectual Property Law 5, no. 2 (Winter 2006): [i]-267
56 Funk Bros. Seed Co. v. Kalo Co., 333 U.S. 127 (1948)
57 Milkov (n44).
58 Diamond v. Chakrabarty, 447 U.S. 303 (1980)
59 Milkov (n44).
60 Diana A. Villamil, "Redefining Utility in Determining the Patentability of DNA Sequences," John Marshall Review of Intellectual Property Law 5, no. 2 (Winter 2006): [i]-267
61 Milkov (n44).
62 Villamil (n56).
63 Milkov (n44).
64EleonorePauwels Nytimescom, 'Our Genes, Their Secrets' (Nytimescom, June 13 2013) https://www.nytimes.com/2013/06/19/opinion/our-genes-their-secrets.html> accessed29 September 2019
65 Paige Winfield Cunningham, ' The Health 202: The Supreme Court banned patenting genes. But Congress might change that.' (http://www.washingtonpost.com2019) https://www.washingtonpost.com/news/powerpost/paloma/the-health-202/2019/06/03/the-health-202-the-supreme-court-banned-patenting-genes-but-congress-might-change-that/5cf1987f1ad2e52231e8e91b/>; accessed 31 October 2019.
66 Z.Fitzner, ' New bipartisan patent bill raises ethical and practical questions' (www.earth.com 2019) https://www.earth.com/news/new-patent-bill-ethical-questions/>; accessed 31 October 2019.
67 Villamil (n56).
68 Terry (n18).
69 Mark A. Rothstein, Genetic Secrets?: Protecting Privacy and Confidentiality in the Genetic Era. New Haven (1st, Yale University Press, New Haven and London 1997) 33.
70 'Genetic Information Privacy' (www.eff.org) https://www.eff.org/issues/genetic-information-privacy>; accessed 31 October 2019.
71 Villamil (n56).
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