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

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. The Necessity of Statutorily Defining Life in Synthetic Biology
Kathleen Broughton, J.D., Ph.D. Bioengineering Student
Synthetic biology, an emerging field of research, is described as “the engineering-driven building of
increasingly complex biological entities for novel applications.” [1]. Technologists believe this field will
likely enter into a phase of exponential growth and such growth is forecasted to progress faster than
genetic engineering has in the past few decades, which invokes principals of Moore’s Law. [2, 3]. A
primary factor driving the research is the presidential initiative for scientific investigators in both the
private and higher education sectors to solve biological question with an end goal of clinical application
solutions and commercial results. [4, 5]. The limitations commercializing synthetic biology technology
will eventually turn on the statutory interpretation of patentable life-based subject matter. Life is not
clearly defined yet by governing bodies and a recommended definition should initially be provided by
an agency that deals with bioethical issues.
Recently, the President’s Commission for the Study of Bioethical Issues published the report NEW
DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies. The report “identified five
ethical principles relevant to considering the social implications of emerging technologies: (1) public
beneficence, (2) responsible stewardship, (3) intellectual freedom and responsibility, (4) democratic
deliberation, and (5) justice and fairness.” [6]. One of the report’s sentiments is that synthetic biology “is
an 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 while
still ensuring public safety and public benefits from the technology. The ethical considerations and
recommendations presented in NEW DIRECTIONS can be viewed as a continuum of previously issued
bioethical reports.
In the last forty years, either the president or Congress has commissioned a team of experts to analyze
current bioethical issues. When recombinant DNA techniques were first introduced in the early 1970s
scientists and regulators defined the debate in terms of safety and efficacy and, in 1974, under the
National Research Act enacted by Congress, the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research was established. By 1978, the US Presidential
Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
was 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” of
death. [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 on
Bioethics, discussed topics ranging from newborn screening to monitoring stem cell research to ethical
caregiving in our aging society as well as reevaluating the determination of death. With the councils
continued compilation of evaluation of various biotechnologies and associated ethical concerns, most
recently with evaluating synthetic biology, timing is appropriate for evaluating and recommending legal
structure 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 sure
to seem like ‘playing God’” with a caution that “we do not as yet possess a conceptual ethical

3. framework that can provide a common context” in defining limitations on synthetic biology. [8]. The
HLEG believes that debating limitations on synthetic biology “will be productive only if we can develop
a more sophisticated appreciation of what is meant by ‘life’ than is current in popular discourse.” [8]. As
no formal recommendations or statutory code is established to define “life” in Europe, the courts will
incrementally tackle the task. On October 18, 2011, the Court of Justice of the European Union ruled
that “the use of human embryos for therapeutic or diagnostic purposes which are applied to the human
embryo and are useful to it is patentable, but their use for purposes of scientific research is not
patentable.” [9]. This ruling is interpreted with two primary views: (1) that any invention based on
human 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 (“Inventions
shall be considered unpatentable if their commercial exploitation is contrary to ordre public or
morality…the following in particular shall be considered unpatentable:…(c) use of human embryos for
industrial 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 will
be crafted by the judicial branch at the cost of time, energy and financial loss in the research, business
and legal communities.
Historically, the courts have broadly interpreted patentable subject matter of Article 35, Section 101 of
the United States Code because “Congress intended statutory subject matter to ‘include anything under
the sun that is made by man.’” [11]. The exceptions to patentable subject matter are “products of
nature,” “phenomena of nature,” and “mental processes.” [11, 12]. Recently, in Association for
Molecular Pathology v. U.S. Patent and Trademark Office, et. al. the Federal Circuit reversed a district
court’s decision and held that isolated DNA gene sequences are patentable but affirmed a ruling that
diagnostic methods that only compare or analyze sequences are not patentable because of a lack of
inventive step. [13]. The courts will continue to heavily interpret statutory patentable subject matter
because, in addition to the exponential growth of biotechnological research and patent applications
presented to the United States Patent and Trademark Office, the Leahy-Smith America Invents Act was
enacted on September 16, 2011. Section 33 of the Act states: “Notwithstanding any other provision of
law, no patent may issue on a claim directed to or encompassing a human organism.” [14]. This broad
language raises questions about what is patentable “life” and what is the limitation between artificial
synthesis 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 legal
system, which will impact the future of research and commercial biotechnology. The Venter Institute is
currently seeking patent rights for the method of producing a synthetic cell. [15, 16]. These patents have
a long state of examination history with the USPTO perhaps, to an extent, because of the unknown
definition as to whether or not the cell is considered natural or synthetic life. Just as the president’s
bioethical advisors provided recommendations in legally Defining Death, it is to the benefit of the public
for a clearly structured definition of ‘life’ and the boundary of artificial and natural occurring products
of nature in synthetic biology to be examined by the President’s Commission for the Study of Bioethical
Issues. Only when a workable definition and interpretation of ‘life’ as patentable subject matter is
presented and statutorily enacted will synthetic biology truly move forward in scientific research and
commercialization.

4. References
[1] Heinemann, M. and S. Panke, Synthetic biology – putting engineering into biology, Bioinformatics
Vol. 22 no. 22, 2006.
[2] Tucker, J. and Zilinskas, R., The Promise and Perils of Synthetic Biology, The New Atlantis, Spring
2006.
[3] Erickson, B. et al., Synthetic Biology: Regulating Industry Uses of New Biotechnologies, Science
Vol. 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 Help
Entrepreneurs Create Jobs, September 16, 2011 (http://www.whitehouse.gov/the-press-
office/2011/09/16/president-obama-signs-america-invents-act-overhauling-patent-system-stim).
[5] Miller, M., Some University professors build research around potential patenting licensing, Red and
Black, October 23, 2011 (http://redandblack.com/2011/10/23/some-university-professors-build-
research-around-potential-patent-licensing/).
[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 the
Determination of Death, President’s Commission for the Study of Ethical Problems in Medicine and
Biomedical 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 (http://curia.europa.eu/jcms/upload/docs/application/pdf/2011-10/cp110112en.pdf).
[10] Directive 98/44/EC of the European Parliament and of the Council on the legal protection of
biotechnological inventions, July 6, 1998
(http://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_1/wipo_grtkf_ic_1_8-annex1.pdf).
[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. [16] Glass et al., Installation of Genomes or Partial Genomes into Cells or Cell-like Systems, US Patent
Appl. 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, The
Netherlands, 2007.