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Bangladesh Journal of Bioethics 2016;7(2): 14- 24 

 

 

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Original Article 

SCNT Method and the Application for Patent Eligibility on Cloned Animals 

 

Norman K. Swazo, Ph.D., M.H.S.A. 
Professor of Philosophy, Department of History and Philosophy 

School of Humanities and Social Sciences 

North South University 

Dhaka, Bangladesh 

Email: norman.swazo@northsouth.edu; Mobile: +8801746881234 

 

Abstract: Patents recognize economic right and are important for both individual and social 

economic benefit.  Nonetheless, mere economic right does not eliminate the requirement for 

moral assessment when adjudicating intellectual property claims, especially in the case of 

claims associated with applications of biomedical technology [e.g., somatic cell nuclear 

transfer (SCNT) methods].  This is so for applications for patent in the case of live-born 

animal clones, as governed in the setting of the judicial system of the USA.  Here recent 

federal court decisions in the USA are reviewed, and the ethical ambiguities of this judicial 

review are engaged in light of the current prohibitions on human reproductive cloning.  It is 

concluded that the legal proscription of patents on animal clones bodes well for human 

accountability to present and future generations in the event of human reproductive cloning.  

 

Keywords: SCNT; intellectual property; live cloned animals; human reproductive cloning; 

US federal court decisions 

 

Introduction:  

 

“Patents cannot issue for the discovery of the phenomena of nature…” 

---U.S. Court of Appeals for the Federal Circuit 

 

According to positive law, a patent is a legal entitlement to intellectual property that is 
intended “to promote creation,” i.e., to provide an incentive to invention1. “A patent 

confers the right on the holder to prevent anyone else from using, making, selling or 

distributing their invention. No one else will be able to make use of the invention, 

during the term of the patent, without obtaining the right from the patent holder…An 

invention, which is eligible for a patent usually has to be something that is new, useful 

and not obvious. It can be an improvement on an earlier device or process, or it can be a 

completely new invention.”  Patents are important for both individual and social 

economic benefits.  As Audrey Chapman put it, “Intellectual property regimes seek to 

balance the moral and economic rights of creators and inventors with the wider 

interests and needs of society.  A major justification for patents and copyrights is that 
incentives and rewards to investors result in benefits for the society” 2.  But, of course, 

mere economic right is not sufficient to outweigh the need for further moral evaluation 



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associated with claims to intellectual property, despite whatever may be said about the 

scientific grounds or legal basis for adjudicating intellectual property claims.  

Consider the question of application for patent in the case of live-born animal clones, in the 

setting of the judicial system of the USA.  A decision issued on 08 May 2014 from the United 

States Court of Appeals for the Federal Circuit affirmed an earlier decision of the Patent Trial 

and Appeal Board (hereafter, “Board”) that live-born animals cloned by way of the somatic 

cell nuclear transfer method (SCNT)—including here cattle, sheep, pigs, and goats—are 

themselves not patentable, in which case a scientist using the method is not eligible for a 

patent claim on the animals3. This decision has ethical implications related to deliberation 

about and resolution of the moral status of cloned animals. 

The Legal Background: The ruling from the Federal Circuit Court (FCC) is not surprising, 

given the decision from the U.S. Supreme Court (USSC) in “Association for Molecular 

Pathology et al. v. Myriad Genetics, Inc., et al.,” issued on 13 June 20134. In the Myriad case, 

the USSC recognized that Myriad’s “principal contribution” in its scientific research was to 

uncover “the precise location and genetic sequence of the BRCA1 and BRCA2 genes” (i.e., 

the genes involved in breast cancer oncogenesis).  Referencing Diamond v. Chakrabarty (447 

U.S. 303), the USSC considered the central question whether Myriad’s research involved a 

legitimate claim on a “new and useful…composition of matter” (both novelty and utility 

being essential elements of claim eligibility for what is supposedly “a nonnaturally occurring 

manufacture or composition of matter”) or instead a claim on “naturally occurring 

phenomena.” The former clearly has to be (1) “a product of human ingenuity ‘having a 

distinctive name, character [and] use” and (2) an action that is new “with markedly different 

characteristics from any found in nature.” 

If Myriad’s argument were successful, then it would have a right “‘to exclude others from 

making’ its patented composition of matter under the Patent Act.” Anyone who did so would 

infringe the patent and thus be legally liable.  The USSC reasoned that although Myriad 

“found an important and useful gene,” it nevertheless “did not create or alter either the 

genetic information encoded in the BRCA1 and BRCA2 genes or the genetic structure of the 

DNA.”  At issue here is the legally governing taxonomy, in this case what counts as “a 

product of nature” in contrast to an “invention,” the latter characterized by the manufacture of 

“something new.” 

Delivering the opinion of the USSC, Justice Clarence Thomas clarified that Myriad’s petition 

required the USSC “to resolve whether a naturally occurring segment of deoxyribonucleic 

acid (DNA) is patent eligible under 35 U.S.C. §101 by virtue of its isolation from the rest of 

the human genome.”   The USSC also considered the question of patent eligibility of 

“synthetically created DNA known as complementary DNA (cDNA), which contains the 

same protein-coding information found in a segment of natural DNA but omits portions 

within the DNA segment that do not code for proteins.”  Justice Thomas held that, “a 

naturally occurring DNA segment is a product of nature and not patent eligible merely 

because it has been isolated, but that cDNA is patent eligible because it is not naturally 

occurring.”  For the purpose of entitlement to patent, discovery (no matter how “iterative” the 

research process), in short, does not entail invention.  That said, however, it is noteworthy 

that the USSC left open the question whether “scientific alteration of the genetic code,” i.e., 

“DNA in which the order of the naturally occurring nucleotides has been altered,” presents a 

different inquiry…” 



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In the FCC’s opinion, an animal cloned by way of SCNT “is an exact genetic replica of the 

adult mammal from which the somatic cell nucleus was taken.” At issue in the earlier Board 

decision was whether the claimed clone “may be called a composition of matter or a 

manufacture.”  This disjunction is not clearly dispositive so as to represent accurately the 

ontological status of such an animal, since the former refers to a naturally occurring 

substance while the latter refers to human agency and an action that manipulates a natural 

substance in a process of manufacture.  Thereby, one distinguishes conceptually two distinct 

categories, viz., substance and process.  According to the applicable federal statute (35 U.S.C. 

§ 101), both a “composition of matter” and a “manufacture” are allowable categories of 

“subject matter” for a patent claim to be issued.  But, there are exceptions to eligibility—(1) 

“laws of nature,” (2) “natural phenomena,” and (3) “abstract ideas.”  Thus, a “naturally 

occurring organism” falls into the category of natural phenomena and is, therefore, not 

patentable. 

In oral argument before the FCC, counsel for Roslin Insitute emphasized the idea of 

infringement on a patent claim in the case of a production of a clone of a clone, accounting 

for “obvious” phenotypic presentation that differentiates individual animals.  However, the 

main point for substantiating the patent claim was the fact of “time delay” in the process of 

production, i.e., the time frame from donor to copy/clone produced, which then ostensibly 

allows the claim that the clone is an invention and, therefore, eligible for patent against 

infringement on the manufactured “product.”  But, the FCC insisted on the fact of genetic 

identity (genetically donor = clone, despite individuation of donor and clone and time delay) 

as controlling for the purpose of argument, rather than the factor of time delay privileged in 

argument by Roslin.  DNA, according to the USSC decision in Myriad, is not patentable 

subject matter; in which case, an animal having genetic identity (i.e., identical DNA, such as 

a clone has) is thereby not patent eligible.  

The Scientific Ambiguity: The foregoing legal determinations presuppose a reasonably clear 

conception of what counts as an organism and what is meant by ‘naturally occurring.’  This 

seems, at least prima facie, to be a matter of scientific proposition and only thereafter a legal 

definition, since it is the science of biology and not positive law that is to govern the validity 

of an empirical claim that is then taken up into legal discourse for a purpose such as that of 

adjudication of patent claims.  But, then, the scientific claim itself presupposes an ontological 

commitment as to the being of the organism, which is by no means clear for either theoretical 

or experimental biologists.  And, where “ontological status” of an organism is ambiguous, 

more often than not there is associated ethical ambiguity about the morally permissible 

disposition of the organism in question. 

Indeed, Stephen Talbott correctly reminds that, “biologists have gone on for decades using 

the language of meaning while remaining content never to reckon with it… 5.” As Pepper and 

Herron notes yet more basically, “Among biologists, there is no general agreement on exactly 

what entities qualify as ‘organisms’ 6.” In fact, given the ambiguity of the concept among 

biologists, rather than speak of “organism” in terms of distinct categories, Pepper and Herron 

construe organisms to be “continuously variable.”  To put the point differently, as Talbott 

explains, “Because every local activity of the organism must find its meaningful place within 

the encompassing activity of a striving, developing, self-transforming whole, there can be no 

fixed syntax, no mechanical constancy of relations among the parts.” 



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The above claim is meaningful also in terms of a position advanced by philosopher of 

biology Michael Ruse, who has considered the status of organisms so as to be understood in 

three senses—ontological, methodological, and epistemological 7 . By ‘ontological’ Ruse 

means “the ultimate status of the entities of the organic world;” by ‘methodological’ he 

“refers to the question of organization;” and by ‘epistemological’ he intends that sense that 

“refers to the relationship between theories,” e.g., “in particular whether the theories of the 

biological sciences can be shown to be logical consequences of the theories of the physical 

sciences.” 

Bearing Ruse’s distinctions in mind, consider, for example, Schneider and Grosschedl (2007) 

observing that, “The clarification of the cause-and-effect relationship of nuclear organization 

and the function of the genome represents one of the most important future challenges.  

Further experiments are needed to determine whether the spatial organization of the nucleus 

is a consequence of genome organization, chromatin modifications, and DNA-based 

processes, or whether nuclear architecture is an important determinant of the function of the 

genome8.” Surely, this question of cause-effect relationship remains unanswered in the case 

of the somatic cell that is used by an investigator in the context of SCNT method.  Such an 

investigator is aware of the nuclear architecture of the somatic cell, understands to some 

degree the spatial organization of the nucleus of this cell in relation to the whole of the cell, 

removes the nucleus in view of any number of empirical claims about that cell’s genome 

organization, chromatin modifications, and DNA-based processes, etc.  Indeed, there would 

be no SCNT method were it not for the hypothesis at the base of this method that assumes 

much of this without, however, being precisely clear as to cause-effect relations and 

determinants. 

Randall Prather reminds us that when Hans Spemann first described the concept of cloning, 

“He wanted to test the theory that cells become irreversibly differentiated because they 

inherit an unequal amount of ‘nucleoplasm’ and thus are not totipotent,” otherwise 

understood as the concept of “nuclear equivalence9.” Subsequent research has continued 

investigations of “nuclear remodeling” and reprogramming by way of transfer of nuclei into 

the cytoplasm of oocytes, the operating assumption being that “structure confers function,” 

i.e., there is an “exchange of proteins between the donor cell nucleus and the oocyte 

cytoplasm” which then “remodels the chromatin such that the nucleus is reprogrammed to 

behave as though it were a pronucleus 10.” 

In their original paper outlining the experiment that resulted in Dolly, Wilmut et al., 

explained the purpose of their method: “an opportunity to investigate whether cellular 

differentiation to that stage [of fertilization of a mammalian egg] involved irreversible 

genetic modification11.” The Dolly experiment investigated “whether normal development to 

term is possible when donor cells derived from fetal or adult tissue are induced to exit the 

growth cycle and enter the G0 phase [i.e., quiescence] of the cell cycle [of replication] before 

nuclear transfer.”   For these scientists, the experiment confirmed that, “differentiation of [an 

adult cell] did not involve the irreversible modification of genetic material required for 

development to term.” Further, for them the results “indicate[d] that nuclei from a wide range 

of cell types should prove to be totipotent after enhancing opportunities for reprogramming 

by using appropriate combinations of these cell-cycle stages.”  Finally, the authors opined, 

“Birth of the lamb shows that during the development of that mammary cell there was no 

irreversible modification of genetic information required for development to term.  This is 

consistent with the generally accepted view that mammalian differentiation is almost all 



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achieved by systematic, sequential changes in gene expression brought about by interactions 

between the nucleus and the changing cytoplasmic environment 12.” 

One may, therefore, ask:  Is it reasonable to assert that an un-manipulated “natural state” 

somatic cell (a) counts as an organism and that (b) it is naturally occurring, consistent with 

the evidential empirical claims of cell biology?  Surely, such a cell is naturally occurring.  

But, whether it counts as an organism in and of itself depends on meaning in use.  Cell 

biology identifies its domain of investigation, viz., cell structure and cell function, premising 

“the cell” as “the fundamental unit of life.”  From the perspective of cell biology, a single cell 

can count as an organism, e.g., when one has in mind a unicellular entity13.  In the context of 

SCNT, a somatic cell is taken from a multicellular organism, yet it can be said that this cell 

has its own “physiological independence” or “physiological discreteness” for the purpose of 

cell biology, even as a cell is “physiologically integrated” with the multicellular organism 

from which it is extracted.  One can consider, thus, whether a somatic cell that is to be used 

for the purpose of SCNT counts as a “unitary organism” (in the sense articulated by 

Santelices) or as a “paradigm organism” (in the sense expressed by Wilson) 14, 15. 

Either way, it seems that, “Many of the commonly used organism criteria are in fact 

descriptions of various boundaries on functional integration,” so that “The essence of the 

organism syndrome is a discrete package of functional integration.” A somatic cell would 

then, in this sense, be construed as such a discrete package.  The latter proposition, taken as 

probably true, therefore yields a practical definition for ‘organism’: “a complex structure of 

inter-dependent and subordinate elements whose relations and properties are largely 

determined by their function in the whole16.”  But, when one examines reports of ongoing 

DNA studies, the discourse suggests ongoing dynamics further complicating the question of 

definition17. In the latter discussion, at issue is what contemporary science understands from 

the genetics, of course; but also, what they do not understand currently from the epigenetics 

in organismal development. 

Thus, Talbott comments, “The activity of individual genes reflects the choreography of 

chromosomes, which reflects the larger choreography of the nucleus, which reflects the 

choreography of the cell and organism as a whole.  Who, then, is sculpting whom?”  

Accordingly, there is ample reason for us to say, as Talbott summarizes, that biological 

research informs us of “the importance of organismal context, and of the organism’s 

plasticity, and of its dynamism, and of the complexity of its interweaving process, and of the 

causal ambiguity of our explanations.”  What this means in terms of the taxonomy at issue, is 

that, “Organisms cannot be fully elucidated in terms of the definitive lawfulness so 

satisfactory to the physicist—a lawfulness lend in itself to the application of mathematics and 

other reduced ‘skeletons’ of language18.” “Organisms,” properly understood, “are revealing 

themselves as intentional wholes not governed by any particular parts19.”  Thus, despite the 

technologies with apparent successes of SCNT method in the case of animal cloning, 

“Epigenetics and the organism’s almost unfathomably complex and intricate skill in 

managing its genes” require us to reconsider and disabuse ourselves of “the notion that DNA 

embodies a linear code that spells our destiny”—or, indeed, the destiny of any other 

biological organism at whatever level of organization and complexity. 

But, once a somatic (diploid donor) cell (e.g., a mammary epithelial cell with complete 

genome of the individual animal, e.g., a Finn Dorset ewe as in the case of Dolly the sheep) is 

“manipulated” by way of the SCNT method, with the cell’s nucleus and genetic content 



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extracted (enucleated at metaphase II), and the cell nucleus and genetic content transferred 

into another cell (i.e., into the recipient cytoplasm of an unfertilized ovum from which its 

own haploid nucleus has been removed, e.g., as in the case of the  ovum taken from a 

Scottish Blackface ewe for the Dolly experiment), and then these two cells juxtaposed and 

subjected to an electric pulse to fuse them and start cell division, then it may be said that a 

process of manufacture surely occurs thereby.  It is a process of asexual reproduction that 

contrasts to “normal mammalian sexual reproduction,” with the otherwise natural process of 

“sperm-mediated fertilization…subverted in SCNT 20.” 

The scientist in this case manipulates what is a naturally occurring composition of matter and 

alters it according to the intent of the SCNT method. Rather than a natural substance that is a 

naturally occurring composition of matter, one now has a substance the material composition 

of which has been altered by way of SCNT method in a way that does not occur naturally.  

This is why one says the clone is both novel and useful.  It is reasonable to assert, then, that 

the “product” from the SCNT method is no longer in se “naturally” occurring, even if it 

cannot be said (as a matter of contrast) that this is an “artificially constructed life form” such 

as pertains to genetic engineering techniques of synthetic biology.  The latter allows for a 

distinction of “synthetic DNA” and “natural DNA,” thus a distinction of a synthetic or semi-

synthetic “artificial” life-form and a natural life-form21. 

It is, therefore, important to ask the question (the implicature of which is legal, ethical, and 

scientific): Does the fact of mixture of naturally occurring cell components constitute an 

“invention?”  The SCNT method itself is already patented, of course; so, this is not at issue in 

present case as reviewed by the USSC and the FCC.  What is at issue is whether the end 

product of a SCNT application, viz., the live-born cloned animal (as distinct from the 

manipulated/altered somatic cell)—is the “equivalent” of an invention even if it remains a 

composition of matter.  If the method of SCNT merely discloses “a secret of nature,” e.g., 

discloses the natural mechanism of genetic replication despite the alteration/substitution of 

the nucleus as a cell component, then this is not an invention per se but only a disclosure of 

the way nature operates at the level of the cellular organism. 

Under the applicable statute in the USA, as noted above, such disclosure is not patentable—

“patents cannot issue for the discovery of the phenomena of nature.”  Indeed, the building 

blocks of the animal clones involved in the patent application are still the “natural DNA” 

codified in the base-pairs (“chemically joined nucleotides”) of cytosine-guanine (C-G) and 

adenine-thymine (A-T); and not, e.g., a composition such as results from the most recent 

“artificial DNA” base pair of “X-Y” that has been added to these natural base-pairs to create 

a new genetic content and, thus, a new synthetic life-form.  The latter product of synthetic 

biology may count ontologically, legally, and, insofar as any ethical issue arises, as an 

invention rather than as a process of human ingenuity that merely duplicates a natural process. 

Given the contrast, it is not surprising that the Board “concluded that the claimed subject 

matter was ineligible for patent protection” under the defined statute, “because it constituted 

a natural phenomenon that did not possess ‘markedly different characteristics than any found 

in nature.’”  Arguably, then, the distinction here provides a central criterion by which to 

determine what counts as “manufacture”—simply, an item of manufacture must be markedly 

different in characteristics from those characteristics found in a naturally-occurring entity.  

Where the two are “identical” or “substantially identical,” or are “produced by identical or 

substantially identical processes”—each of these predicates by no means transparent in its 



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meaning—then there is no legitimate patent claim for the item produced, even if the prior 

item (e.g., the donor animal) is a naturally occurring animal.  Moreover, the FCC (as did the 

Board) accounted for prior artificial cloning methods, viz., embryotic nuclear transfer and in 

vitro fertilization, to hold that the cloned animals were both “anticipated” and “obvious,” 

despite the difference in method (SCNT), and thus indistinguishable from a product issued 

from these methods. 

Ethical Ambiguities at Issue: Given the foregoing overview of legal and biological 

elements of the question before the courts in the USA, the judgments taken, while important 

generally for animal cloning per se, can also be considered presumptively guiding in any 

moral question involving human reproductive cloning, just in case researchers should be 

inclined to translate such results into the clinical setting of human reproduction (including 

here any goals associated with human fertility by way of in vitro technologies and associated 

prospects of genetic enhancement). 

We may be reminded that Stanford University Nobel laureate Joshua Lederberg has already 

(in 1966) written in favor of human reproductive cloning.  Commenting on the scientific 

desideratum of a “new evolutionary theory needed to model a self-modifying system that 

makes imperfect plans for its own nature,” Lederberg championed the goal of human 

eugenics against “the cultural process” that “poses contradictory requirements of uniformity 

(for communication) and heterogeneity (for innovation)” and, thus, an impediment to eugenic 

goals 22. “Humanistic culture rests on a definition of man which we already know to be 

biologically vulnerable,” Lederberg observed.  “Inevitably,” therefore, so he opined, 

“biological knowledge weighs many human beings with personal responsibility for decisions 

that were once relegated to divine Providence.”  Commenting on “tempered clonality,” 

Lederberg anticipated that “we would at least enjoy being able to observe the experiment of 

discovering whether a second Einstein would outdo the first one.”  Indeed, taking a global 

perspective on the implications of developments in molecular biology, specifically “any 

conceivable program of calculated eugenics,” Lederberg asked: “Western culture and its 

limited population is being succeeded by a much broader world culture.  Is there much point 

in setting eugenic standards relevant only to a small minority of the world’s population even 

as we watch the unprecedented breakdown of intercultural barriers?” 

Writing in 1994, and accounting for developments in the period since Lederberg’s 

contribution to the periodical literature on the subject, John A. Robertson allowed that, “The 

idea of splitting off cells from embryos to clone human beings sounds so bizarre and 

dangerous that one would think the practice should not be permitted 23.” Yet, at that time 

Robertson argued that such cloning promised to be ethically acceptable.  Noting that the 

scientific procedures had not succeeded with mammals (and only with frogs at the time) and 

appeared “highly unlikely to be accomplished in even the mid-range future,” even so, were 

scientists so inclined, Robertson remarked, “If this form of cloning were possible, scientists 

could fabricate as many copies as one wished of any available human genome, subject only to 

the limits of uterine or artificial gestation” (emphasis added). 

Accounting for various uses of cloning, Robertson argued that, this scientific enterprise was 

“neither so harmful nor so novel that all research and development should not stop until the 

ethics of the practice are fully aired, or that governmental restrictions on cloning research or 

applications are needed.” That, of course, changed with the production of Dolly (1996-1997); 

and the near-term prospect of human reproductive cloning moved the matter center-stage as a 



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matter of public policy and government regulatory intervention.  Leon Kass and James 

Wilson, surveying the scene of public opinion at the time, underscored the fear: “ ‘I a child 

and Thou a lamb,’ despite our differences, have always been equal candidates for creative 

making, only now, by means of cloning, we may both spring from the hand of man playing at 

being God 24.” 

Granted, at our point in time, applicable national and international regulatory instruments 

continue to proscribe human reproductive cloning.  In June 1997, following President Bill 

Clinton’s ban on federal funding that might support human cloning research, the US National 

Bioethics Advisory Commission recommended a moratorium on reproductive human 

cloning25. Any legal decision to permit patenting in the case of human reproductive cloning 

would contradict international commitments to “democratic principles of dignity, equality, 

and mutual respect of men,” as stipulated in the Preamble of UNESCO’s constitution and as 

reiterated in the Universal Declaration on the Human Genome and Human Rights (1997) 

hereafter UDHGHR)26. 

So long as rights recognized under international law are considered to be “human” rights 

(thus distinguished in principle from social, political/civil, economic, cultural rights) 

reproductive human cloning would entail a morally problematic situation: viz., in the case 

where “patented” “human clones” may not be recognized ontologically to have the status of 

the naturally occurring human being and so be diminished in moral status so as not to be 

permitted a claim to the ordinary human entitlements of dignity, equality, and mutual respect.  

The United Nations Convention on Biological Diversity of 1992 anticipated the probability 

of ongoing scientific research and developments in biomedical technology so as to emphasize 

the genetic diversity of humanity, with the expressed injunction that there must be no 

interpretation of a social or political nature that would call into question “the inherent 

dignity” or “the equal and inalienable rights” of “all members of the human family27.”  The 

introduction of a “human clone” into the natural human population that now expresses this 

genetic diversity would presumably add to that diversity but also raise any number of moral 

and political questions. 

Clearly, a human clone having the legal status of a patented entity would have neither 

inherent dignity (intrinsic worth, rational nature, etc.) nor equal and inalienable rights such as 

the naturally occurring human being has—and, importantly, has not only as a matter of 

conventions of law (thus civil right) but as a matter of natural right.  Patenting in the case of 

human reproductive cloning would open the door to prospective discrimination against 

human clones in any number of ways, contrary to Article 2(b) of the UDHGHR that, “dignity 

makes it imperative not to reduce individuals to their genetic characteristics and to respect 

their uniqueness and diversity.”  Here, ‘uniqueness’ may not be interpreted negatively so as 

to authorize or justify the reductive argument according to which a human clone would be 

identified merely or primarily genetically.  Hence, research integrity is a matter of 

anticipation (e.g., the moral virtue of prudence, having forethought that precludes vice on the 

side of scientific excess or scientific deficiency) as well as currently permitted practices 

under both national and international regulations. The UNDHGHR (Article 10) aptly 

stipulates that, “No research or research applications concerning the human genome, in 

particular the fields of biology, genetics and medicine, should prevail over respect for the 

human rights, fundamental freedoms and human dignity of individuals or, where applicable, 

groups of people.”  Thereby, developments in human genetics may not proceed merely for 

the sake of advancing knowledge and must maintain the scientific integrity so expressed in 



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the declaration.  Therefore, as Article 11 of the Declaration states the point explicitly: 

“Practices which are contrary to human dignity, such as reproductive cloning of human 

beings, shall not be permitted.” 

The judicial assessments in the USA, deliberating and deciding on the question of patenting 

of animal clones, provide important barriers to human reproductive cloning research.  

Thereby, they safeguard the long-standing and time-honored moral and legal commitment to 

human dignity that would otherwise succumb to hubris or to posit of merely instrumental 

ends.  It is meritorious indeed that, were human reproductive cloning to be permitted, as a 

matter of moral and legal principle patenting of human clones would be proscribed even 

more so, ensuring human accountability to present and future generations. 

 

Author’s contribution: 

Author developed the conceptual idea, data collection, data analysis and manuscript writing. 

 

Conflict of Interest: Declared none.  

 

 

                                                        
1 Fedcirc.us Patent Law Information, “The Definition of a Patent,” 

http://www.fedcirc.us/definition-patent.php, accessed 13 May 2014. 

 
2    Chapman, A.R. (no date) ‘A Human Rights Perspective on Intellectual Property, Scientific 

Progress, and Access to the Benefits of Science’, 

http://www.wipo.int/edocs/mdocs/tk/en/.../wipo_unhchr_ip_pnl_98_5.doc; accessed 20 

November 2014. 

3 United States Court of Appeals for the Federal Circuit, “In Re Institute (Edinburgh), 2013-

1407, Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal 

Boar in Serial No. 09/225,233,” Decided 08 May 2014; 13-407.Opinion.5-6-2014.pdf. 

4 Supreme Court of the United States, No. 12-398, Association for Molecular Pathology et al., 

Petitioners v. Myriad Genetics, Inc., et al., On Writ of Certiorari to the United States Court of 

Appeals for the Federal Circuit, 13 June 2013. 

 
5 Talbott, S.L. (2012) ‘From Physical Causes to Organisms of Meaning’, Toward a Biology 

Worthy of Life, The Nature Institute, http://natureinstitute.org/txt/st/mqual/genome_6.htm, 

accessed 09 May 2014. 

 
6 Pepper JW, Herron MD. (2008) ‘Does Biology Need an Organism Concept?’ Biological 

Reviews, 83. http:// eebweb.arizona.edu/grads/mherron/publications/BR_08.pdf. 

 
7 Ruse, M. (1989) ‘Do Organisms Exist?’ Integrative and Comparative Biology, 29/3: 1061-

66. 

 



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8  Schneider R, Grosschedl R. (2007) ‘Dynamics and Interplay of Nuclear Architecture, 

Genome Organization, and Gene Expression’, Genes and Development, 21, 3027-43. 

 
9 Prather, R.S. (2007) ‘Reprogramming for Making Transgenic Pigs by Nuclear Transfer’. In: 

Sutovsky, P. (ed.) Somatic Cell Nuclear Transfer, Landes Bioscience and Springer 

Science+Business Media. 

10 Prather, 2007, p. 2 

11  Wilmit I., Schnieke A.E., McWhir J., Kind A.J., Campbell K.H.S. (1997) ‘Viable 

Offspring Derived from Fetal and Adult Mammalian Cells’, Nature, 385/6619, 27 February; 

PDF version. 

 
12  However, see Jaenisch R. and Wilmut, I. (2001) ‘Don’t Clone Humans’’ Science, 

291/5513: 2552. The authors here evaluate the many failures in animal cloning, and on those 

grounds oppose reproductive human cloning. 

     
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