The Necessity of Statutorily Defining Life in Synthetic Biology


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An introduction to the necessity of statutorily defining life for the future of research and commercialization of synthetic biology.

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The Necessity of Statutorily Defining Life in Synthetic Biology

  1. 1. The Necessity of Statutorily Defining Life in Synthetic Biology An Introduction to Statutorily Defining Life, The Limitations of Patentable Subject Matter, And the Critical Role of Bioethics November 1, 2011 Kathleen Broughton Ph.D. Student Bioengineering University of Illinois, Chicago College of Engineering & College of Medicine Department of Bioengineering Institute of Biological Engineering 1200 Word Bioethics Essay Contest 2011-2012
  2. 2. The Necessity of Statutorily Defining Life in Synthetic Biology Kathleen Broughton, J.D., Ph.D. Bioengineering StudentSynthetic biology, an emerging field of research, is described as “the engineering-driven building ofincreasingly complex biological entities for novel applications.” [1]. Technologists believe this field willlikely enter into a phase of exponential growth and such growth is forecasted to progress faster thangenetic engineering has in the past few decades, which invokes principals of Moore’s Law. [2, 3]. Aprimary factor driving the research is the presidential initiative for scientific investigators in both theprivate and higher education sectors to solve biological question with an end goal of clinical applicationsolutions and commercial results. [4, 5]. The limitations commercializing synthetic biology technologywill eventually turn on the statutory interpretation of patentable life-based subject matter. Life is notclearly defined yet by governing bodies and a recommended definition should initially be provided byan agency that deals with bioethical issues.Recently, the President’s Commission for the Study of Bioethical Issues published the report NEWDIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies. The report “identified fiveethical principles relevant to considering the social implications of emerging technologies: (1) publicbeneficence, (2) responsible stewardship, (3) intellectual freedom and responsibility, (4) democraticdeliberation, and (5) justice and fairness.” [6]. One of the report’s sentiments is that synthetic biology “isan extension of genetic engineering” and “does not necessarily raise radically new concerns or risks.”[6]. A recommendation presented is for regulation and governance to be kept to a minimal level whilestill ensuring public safety and public benefits from the technology. The ethical considerations andrecommendations presented in NEW DIRECTIONS can be viewed as a continuum of previously issuedbioethical reports.In the last forty years, either the president or Congress has commissioned a team of experts to analyzecurrent bioethical issues. When recombinant DNA techniques were first introduced in the early 1970sscientists and regulators defined the debate in terms of safety and efficacy and, in 1974, under theNational Research Act enacted by Congress, the National Commission for the Protection of HumanSubjects of Biomedical and Behavioral Research was established. By 1978, the US PresidentialCommission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Researchwas established by Congress, and in 1981 this commission issued the report Defining Death Medical,Legal and Ethical Issues in the Determination of Death, which provided a clear statutory “definition” ofdeath. [7]. By 1996, the National Bioethics Advisory Commission was evaluating biological materials,mental capacity and cloning of human beings. The previous commission, the President’s Council onBioethics, discussed topics ranging from newborn screening to monitoring stem cell research to ethicalcaregiving in our aging society as well as reevaluating the determination of death. With the councilscontinued compilation of evaluation of various biotechnologies and associated ethical concerns, mostrecently with evaluating synthetic biology, timing is appropriate for evaluating and recommending legalstructure and definition in the meaning of life in light of the current biotechnology progress.In 2005, the European Union High-Level Experts Group (HLEG) stated that to some people “this is sureto seem like ‘playing God’” with a caution that “we do not as yet possess a conceptual ethical
  3. 3. framework that can provide a common context” in defining limitations on synthetic biology. [8]. TheHLEG believes that debating limitations on synthetic biology “will be productive only if we can developa more sophisticated appreciation of what is meant by ‘life’ than is current in popular discourse.” [8]. Asno formal recommendations or statutory code is established to define “life” in Europe, the courts willincrementally tackle the task. On October 18, 2011, the Court of Justice of the European Union ruledthat “the use of human embryos for therapeutic or diagnostic purposes which are applied to the humanembryo and are useful to it is patentable, but their use for purposes of scientific research is notpatentable.” [9]. This ruling is interpreted with two primary views: (1) that any invention based onhuman embryonic stem cells cannot be patented because it is, prima facie, unethical to patent life, (2)that the Court was interpreting Art. 6.1,2 (c) of the European Institutions Directive 98/44 (“Inventionsshall be considered unpatentable if their commercial exploitation is contrary to ordre public ormorality…the following in particular shall be considered unpatentable:…(c) use of human embryos forindustrial or commercial purposes.”). [10]. In time, the Court of Justice will interpret this ruling. Likely,if recommendations of a clear definition of “life” is presented and enacted in the US, the definition willbe crafted by the judicial branch at the cost of time, energy and financial loss in the research, businessand legal communities.Historically, the courts have broadly interpreted patentable subject matter of Article 35, Section 101 ofthe United States Code because “Congress intended statutory subject matter to ‘include anything underthe sun that is made by man.’” [11]. The exceptions to patentable subject matter are “products ofnature,” “phenomena of nature,” and “mental processes.” [11, 12]. Recently, in Association forMolecular Pathology v. U.S. Patent and Trademark Office, et. al. the Federal Circuit reversed a districtcourt’s decision and held that isolated DNA gene sequences are patentable but affirmed a ruling thatdiagnostic methods that only compare or analyze sequences are not patentable because of a lack ofinventive step. [13]. The courts will continue to heavily interpret statutory patentable subject matterbecause, in addition to the exponential growth of biotechnological research and patent applicationspresented to the United States Patent and Trademark Office, the Leahy-Smith America Invents Act wasenacted on September 16, 2011. Section 33 of the Act states: “Notwithstanding any other provision oflaw, no patent may issue on a claim directed to or encompassing a human organism.” [14]. This broadlanguage raises questions about what is patentable “life” and what is the limitation between artificialsynthesis made by man and a naturally occurring product of nature.Defining what “life” is in terms of patentable subject matter will incrementally continue in the legalsystem, which will impact the future of research and commercial biotechnology. The Venter Institute iscurrently seeking patent rights for the method of producing a synthetic cell. [15, 16]. These patents havea long state of examination history with the USPTO perhaps, to an extent, because of the unknowndefinition as to whether or not the cell is considered natural or synthetic life. Just as the president’sbioethical advisors provided recommendations in legally Defining Death, it is to the benefit of the publicfor a clearly structured definition of ‘life’ and the boundary of artificial and natural occurring productsof nature in synthetic biology to be examined by the President’s Commission for the Study of BioethicalIssues. Only when a workable definition and interpretation of ‘life’ as patentable subject matter ispresented and statutorily enacted will synthetic biology truly move forward in scientific research andcommercialization.
  4. 4. References[1] Heinemann, M. and S. Panke, Synthetic biology – putting engineering into biology, BioinformaticsVol. 22 no. 22, 2006.[2] Tucker, J. and Zilinskas, R., The Promise and Perils of Synthetic Biology, The New Atlantis, Spring2006.[3] Erickson, B. et al., Synthetic Biology: Regulating Industry Uses of New Biotechnologies, ScienceVol. 333, no. 6047, 2011.[4] Office of the Press Secretary, The White House, President Obama Signs America Invents Act,Overhauling the Patent System to Stimulate Economic Growth, and Announces New Steps to HelpEntrepreneurs Create Jobs, September 16, 2011 ([5] Miller, M., Some University professors build research around potential patenting licensing, Red andBlack, October 23, 2011 ([6] Gutmann, A. et al., New Directions: The Ethics of Synthetic Biology and Emerging Technologies,Presidential Commission for the Study of Bioethical Issues, Washington, DC, December 16, 2010.[7] Abram, M. et al., Defining Death A Report on the Medical, Legal and Ethical Issues in theDetermination of Death, President’s Commission for the Study of Ethical Problems in Medicine andBiomedical and Behavioral Research, Washington, DC, July 9, 1981.[8] Serrano, L. et al., Synthetic Biology – Applying Engineering to Biology, Report of a NEST High-Level Expert Group; Directorate-General for Research. EUR 21796, 2005.[9] Oliver Brustle v. Greenpeace, Judgment in Case C-34/10, Press Release No 112/11, October 18,2011 ([10] Directive 98/44/EC of the European Parliament and of the Council on the legal protection ofbiotechnological inventions, July 6, 1998([11] Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).[12] Gottschalk v. Benson, 409 U.S. 63, 37 (1972).[13] Assoc. Molec. Pathology et al. v. USPTO, Myriad Genetics et al., Fed. Cir. (2011).[14] Leahy-Smith America Invents Act, H.R. 1249 (signed into law September 16, 2011).[15] Venter et al., Synthetic Genomes, US Patent Appl. No 11/635,355, Pub. Date: Nov. 15, 2007.
  5. 5. [16] Glass et al., Installation of Genomes or Partial Genomes into Cells or Cell-like Systems, US PatentAppl. No 11/644,713, Pub. Date: Nov. 22, 2007.Additional Readings[1] Bhutkar, A., Synthetic Biology: Navigating the Challenges Ahead. J. BIOLAW & BUS., Vol. 8, No.2, 2005.[2] De Vriend, H., Synthetics: the ethics of Synthetic Biology, IDEA League Summerschool, TheNetherlands, 2007.