Attack of the Clones... and the Issues of Clones

Paul Lesko and Kevin Buckley


Human cloning became a hotly debated topic after Advanced Cell
Technology's (ACT) press release of November 25, 2001.  ACT announced they
had successfully cloned a human embryo--the first step in the process of
human reproductive cloning, therapeutic cloning, and the creation of stem
cells.[1] ACT's press release caused a worldwide uproar, peaking with
President Bush and the Vatican denouncing all types of human cloning
within 24 hours of ACT's announcement.[2]

A shocked and confused populace, finding themselves confronted with new
ethical dilemmas, called for legislative reform.  A number of foreign
legislatures as well as the U.S. House of Representatives acted quickly
through November and December in an attempt to outlaw human cloning and
aspects of human cloning.  The frenetic mood, however, has slowed and
legislators, scientists and the general public are trying to analyze the
situation to obtain a better understanding of human cloning as well as the
related legal, moral and economic issues.

Part I of this article is a hypothetical situation which examples some of
the difficult situations which should be addressed by comprehensive human
cloning legislation.  Part II examines the processes of reproductive and
therapeutic human cloning as well as their future markets.  Part III
discusses the current international and national legislation regulating
human cloning.  Part IV discusses the future of legislation in the United
States as well as a number of factors which need to be considered in order
that any legislation that is drafted is comprehensive.


[*2]
PART I

JOHN SMITH HYPOTHETICAL SITUATION

The year is 2007.  John Smith, a 67 year-old multimillionaire, has been
given only two months to live after a kidney received from a transplant
was rejected.  John realized well before his operation that the rate of
success for kidney transplants was low, and therefore had a back-up plan
which could save his life--but in the process, would make him a fugitive.

Over the past year, John had been in covert contact with Dr. Alpha, one of
the world leaders in therapeutic cloning--a practice outlawed in 2002 in
the United States, but still legal (or at least not illegal) on Dr.
Alpha's small Caribbean island.  Through this procedure, Dr. Alpha can
grow replacement organs for transplant which have close to a 100% success
rate because the organs were grown from the recipient's own cells.

Dr. Alpha, an interesting case himself, was one of a growing breed of
black market scientists born, raised and educated in the U.S., that left
during the 'Brain Drain' which began in 2002 when a number of doctors and
molecular biologists fled the U.S. [*3] to other countries with less stringent
regulations in the exceedingly lucrative field of therapeutic cloning.

Soon after John's failed U.S. transplant operation, he traveled secretly
to Dr. Alpha's Caribbean island (because even conspiring to clone is
punishable by ten years in prison and at least one million dollars in
fines) where a cloned kidney produced from his own cells was successfully
transplanted into his body.  After six months of recuperation, John was
given a clean bill of health and began his return trip home.  Upon arrival
in the U.S., John was held in customs for a standard 'cloning materials
search' where airport security determined that John had recently received
an illegal kidney transplant.  John was then arrested for violating the
Human Cloning Prohibition Act of 2002 which, among other things, outlawed
the importation of cloned products into the U.S.

At trial, John was sentenced to one year in prison and a million dollar
fine.  John happily accepted his punishment (which was more lenient than
the maximum sentence he could have received) because, as he told the
reporters, "It's definitely better to be incarcerated than buried or
cremated."

After his release, John lived to be 79 years old.

This hypothetical situation of fantastical procedures and black market
scientists may sound farfetched, but it is not pure science fiction.  
Based on recent events such a scenario could happen in the near future.  
Because of the enormous implications, proposed legislation should address
all the potential issues so as to give guidance prior to a judge finding
himself attacked by the issues of clones.

[*4]
PART II

WHAT IS CLONING?

Although a large portion of society and a great number of legislatures
believes there is only one form of human cloning, the concept of cloning
really encompasses three different processes.  Each process uses machinery
within a living cell to divide, differentiate and eventually produce
groups of cells, tissues and organs.  The cellular machinery required for
a cell to divide and differentiate generally begins with the expression of
proteins which are encoded in DNA within the nucleus of a cell.  Nuclear
DNA determines the sequence of the protein, but does not determine the
timing, rate or amount of protein which is expressed in each cell.  Each
of these processes, can be used to produce an embryo, a fetus and
eventually a living organism.

The first type of cloning is Embryo cloning, more commonly referred to as
"twinning".[3] This process begins by activating an embryo to produce
twins and is in essence a duplication of the natural process that produces
"identical twins."  Embryo cloning begins with the removal of one or more
cells from a fertilized embryo.  The removed cells are later encouraged to
develop into duplicate embryos.  These cloned embryos contain an exact
copy of the nuclear DNA as well as copies of the mitochondrial DNA from
the original embryo.[4]

Therapeutic cloning is the process with the most foreseeable benefits to
mankind.  This process uses an unfertilized egg as a host for the nuclear
DNA of the [*5] organism being cloned.  In essence, the nuclear DNA of the host
egg is exchanged for the nuclear DNA of a donor.  This process is commonly
referred to as "nuclear transfer" or "nuclear replacement."  Therapeutic
cloning differs from twinning in that the mitochondrial DNA of the
unfertilized egg is retained in the developing clone; the donor's
mitochondrial DNA is not transferred.  In therapeutic cloning, the cells
produced are not "identical twins," but have the same potential to develop
into organs and tissues having the same outward characteristics, or
phenotype, of the donor's cells.

Therapeutic cloning produces tissue or an entire healthy organ for
transplantation into the DNA donor.  A therapeutic cloning market will
compete with and surpass the current organ transplant market because the
risk of rejection of therapeutically cloned organs is very low (likely as
low as 0%).  In addition, the need for immunosuppressant drugs is
eliminated since rejection would be unlikely because a more reliable
supply of transplantable, or cloned, organs is provided.  Furthermore,
therapeutic cloning has the potential to eliminate the long waiting lists
which currently exist.

[*6]
	Reproductive cloning is the most controversial form of cloning.  Much of
the public views this technology as mankind meddling with the natural
process of reproduction.  In reproductive cloning, the cloned embryo
produced by nuclear transfer is implanted into a womb.  This implanted
embryo could develop into a new human or other organism depending on the
origin of the DNA transferred.  Reproductive cloning has the potential of
producing a "twin" of an existing person, albeit a younger "twin."  This
"twin" would have genetically identical nuclear DNA, but would differ
physically because of embryological factors including womb placement,
nutrient uptake and treatment in the womb.  A cloned "twin" could have a
different phenotype and would be physically different from the DNA donor
because they are not true identical twins.  This was recently demonstrated
by the birth of "Cc:" the kitten, the first born cloned cat that looks
similar to, but not exactly like, her genetic mother.[5] The differences
continue in that the "twin" does not contain the donor's mitochondrial DNA
(approximately 5% of the total DNA in the cell).[6]

As of the date of this article, nobody has successfully completed the
process of human therapeutic or reproductive cloning, although Dr.
Severino Antinori has indicated that a woman taking part in his human
cloning program has been pregnant [*7] since February of 2002.[7] Therefore, it
is possible the first human clone could be born as early as October 2002.

Until then, ACT's successful nuclear replacement represents the
state-of-the-art.  Their accomplishment makes it clear that human
therapeutic and reproductive clones will be produced in the near future.

Because human embryos can theoretically be grown to become a new person,
some view therapeutic cloning as reprehensible a practice as reproductive
cloning.[8] Although therapeutic cloning shares a number of common
elements with reproductive cloning, a vast potential therapeutic cloning
market exists because of the potential to treat and cure existing medical
problems.  Therefore, it is important that society and legislatures should
not combine therapeutic cloning and reproductive cloning together as one
market because both types of cloning encompass two very different markets.


THE MARKET FOR THERAPEUTIC CLONING

The potential market for therapeutic cloning is enormous.  In 2000, there
were 22,953 organs transplanted in the United States; this included 13,372
kidneys, 4,954 livers, 435 pancreases, 911 combination kidney-pancreases,
2,198 hearts, 956 lungs, 48 [*8] heart and lungs, and 79 intestinal
transplants.[9] Considering that the average cost for an organ transplant
is $214,860[10] and that almost 80,000[11] patients were hoping for an
organ transplant in 2001, it is apparent that a market of just over $17
billion dollars exists in the U.S. alone.

The technological advances in the therapeutic cloning market overcome the
current problems associated with the existing organ donor market including
long waiting lists, uncertainty as to the availability of organs and
unpredictability of when the operation will occur.  For example, in 1999
there were 3,536 registrants for heart transplants with a median waiting
time of 206 days.[12] However, only 2,162 of those registrants received
heart transplants in 1999.[13] More troubling numbers can be seen in
kidney transplants for 1997 where 19,022 individuals waited an average of
1,099 days and only 11,536 of those on the waiting list actually received
organs.[14] With therapeutic [*9]cloning, these waiting lists[15] would be
limited to the time necessary to grow the organ.[16] This would assure
that everyone who needs a transplant could receive one.

Therapeutic cloning is not science fiction.  In January of 2002, ACT
scientists reported the successful use of cells derived from a cloned cow
embryos to grow kidney-like organs.[17] These therapeutically cloned
organs were not rejected when implanted into cows.  Further, these organs
functioned by removing toxins and producing urine.[18] This is the first
reported successful use of therapeutic cloning technology to grow a
specific, transplantable organs.  This shows that therapeutic cloning is a
viable technology and therefore will produce a viable market.


PART III

CURRENT LEGISLATION ON CLONING

A quick summary of the world's laws on human cloning is virtually
impossible, especially with the newly revived activity of many
international legislatures.  The patchwork of legislation worldwide is
difficult to untangle and is not uniform.  General observations can be
made about the current world legislative landscape:

     (1)  A trend is developing to outlaw only reproductive cloning
     while still allowing therapeutic cloning with varying degrees 
     of oversight,
[*10]
     (2)  Very few countries have laws specifically addressing human
     cloning or aspects of human cloning.  Therefore, human cloning
     is legal in the almost 180 countries worldwide which are silent
     on the matter, and

     (3)  No country has yet come forward and taken the position
     that human cloning for all purposes is legal.[19]

[*11]
The Western Hemisphere

The American Convention on Human Rights of 1969 is a regulatory provision
which developed an Inter-American human rights system.[20] Twenty-six
countries have ratified this Convention.[21] Although the Convention does
not expressly discuss human cloning, it may inadvertently regulate human
cloning in the Americas.  The Convention states that "every person has the
right to have his life respected.  This right shall be protected by law
and, in general, from the moment of conception."[22] Arguably, a cloned
human embryo could fall within this Convention because it protects life
"from the moment of conception" (implying at embryo formation).[23] A more
modern view would be that conception would not encompass the term
"cloning", or at least therapeutic cloning, because conception involves a
pregnancy.[24] Therefore, there is no conception.  This Convention then
does not appear to regulate or ban all human cloning.
[*12]
The only countries in the Western Hemisphere which explicitly ban or have
attempted to ban human cloning are Argentina,[25] Brazil,[26] Peru,[27]
Trinidad and Tobago,[28] and Bolivia.  Cloning is implicitly banned in
Mexico,[29] Ecuador[30], Bolivia[31] and Costa Rica.[32]

In March of 2002, Canada issued guidelines for stem cell research which in
essence banned both reproductive and therapeutic cloning, although
allowing government funded research on supernumerary embryos.[33] Although
these guidelines provide researchers with government funding more freedom
in Canada than in the U.S., it places greater restrictions on private
research than is currently in place in the U.S.

[*13]
Europe

Europe appears to have few supporters of human cloning.  Research on human
embryos in Europe is either expressly or implicitly prohibited in many
countries.  A few countries permit human cloning with varying degrees of
supervision.  Efforts at a uniform European law failed in late November
2001 as the European parliament rejected a move to ban human cloning in
Europe.[34] If the ban had been approved it would still have been up to
each individual state to ratify the uniform law.[35]

The trend in Europe appears to lean towards banning aspects of human
cloning.  The Czech Republic, Denmark, Georgia, Greece, Hungary, Portugal,
Romania, San Marino, Spain, Slovakia and Slovenia have all ratified the
Additional Protocol to the Convention on Human Rights and Biomedicine, on
the Prohibition of Cloning Human Beings of 1998.[36] This protocol outlaws
reproductive cloning.[37] This protocol has been [*14] signed by thirty of the
forty-three European states[38] although is not effective law until
ratified by each signatory state.[39]

In addition, the majority of European countries have explicitly banned
research on human embryos (which, for all intents and purposes, outlaws
human cloning) including France,[40] Germany,[41] Austria,[42]
Hungary,[43] Poland,[44] Norway,[45] Switzerland,[46] [*15] Ireland[47] and
Italy.[48] Denmark[49] and Greece[50] have enacted legislation outlawing
human cloning either explicitly or implicitly.  Cloning of human beings is
also illegal in Spain,[51] although in June of 1999, the Spanish Committee
of Experts on Cloning indicated it would be beneficial to lift the
existing ban on cloning for some therapeutic procedures.[52]

European countries which have approved various aspects of human cloning
include the United Kingdom, which has legalized therapeutic cloning, as
well as [*16] Sweden[53] and Finland[54] which allow the use of supernumerary
embryos[55] for research purposes, with a few prohibitions[56] on
research.  A bill is being prepared in the Netherlands tracking the laws
of Sweden and Finland.[57]

The United Kingdom appears to be the most the open to therapeutic cloning.  
The U.K. allows the creation of embryos for research purposes under the
1990 Human Fertilisation and Embryology Act with approval of the Human
Fertilisation and Embryology Authority (HFEA).[58] This organization
controls the use and creation of human embryos in the U.K.  On January 22,
2001, the House of Lords passed a law previously approved by the House of
Commons, which, among other things, made it legal to create embryos for
stem cell research by nuclear replacement.[59] This law was challenged in
court by the Pro-Life Alliance prompting the HFEA not to grant any
[*17] licenses for research involving nuclear replacement until judicial review
of the Pro-Life Alliance's application.[60] In November 2001, a High Court
judge ruled in favor of the Pro-Life Alliance indicating that embryos not
created by fertilization (union of sperm and egg) were not covered by the
1990 Act or any additions to it.[61] This judgment, contrary to the intent
of the Pro-Life alliance, left human cloning unregulated in the U.K.[62]
The U.K. government was granted permission to challenge this ruling in
January of 2002 and has, in the interim, approved emergency legislation on
November 23, 2001 to explicitly ban human reproductive cloning.[63] This
legislation has met with disapproval by opponents who point out that the
current law, as worded, would allow human clones to be born by other
methods (such as through embryos being placed in animals).  Further, a
House of Lords Select Committee reviewed the issues surrounding human
cloning and stem cell research and in February of 2002 ruled that embryo
cloning should be allowed to proceed in the U.K.[64] Therefore, although
the U.K. appears to be more open to at least therapeutic cloning, their
laws are still in flux.

[*18]
The Non-Western World

Legislation in the Eastern Hemisphere differs from the patchwork of Europe
in that there is not much legislation dealing with human cloning.  
Existing legislation tends to be more lenient than laws in Europe by
allowing therapeutic cloning while outlawing reproductive cloning.  In
December of 2001, China announced its official support for therapeutic
cloning while declaring its opposition to reproductive cloning.  
Japan[65], Australia[66] and India[67] allow varying degrees of use of
stem cells for therapeutic cloning but have banned all aspects of
reproductive cloning.  Korea does not have any law addressing cloning,
although in 1999 the National Assembly discussed revising the
Biotechnology Promotion Act to add regulations concerning bioethics and
biosafety.[68] New Zealand is currently attempting to ban all cloning for
two years, although their law would allow a minister to authorize
exemptions.

Other countries addressing human cloning include Russia and Israel.  On
December 20, 2001, the Russian Duma (lower house of parliament) voted to
place a five [*19] year ban on human cloning.  If approved at a third reading,
this ban will apply to human cloning as well as to the import or export of
cloned human embryos.  In 1998, Israel passed a law to ban human cloning
for five years, but allows therapeutic cloning if a showing can be made to
an advisory committee that the research does not violate the ban.[69] In
2003, the Israeli parliament will decide whether to renew this ban.[70]

The United Nations ("UN") on February 25, 2002 began an initial round of
talks concerning an international treaty to ban the cloning of human
beings.[71] Quick action from the UN however is not likely as the treaty
drafting process typically takes years because all 189 member-nations are
free to participate in the deliberations.[72]

This review of international law provides support for the Hypothetical
Situation of Part I, because regardless of U.S. action, cloning will be
legal in other countries.  Therefore, if the U.S. would ban all aspects of
human cloning, this situation could easily arise.

[*20]
The United States

In the U.S., federal financing of human cloning activities is prohibited
via President Bush's 2001 order.[73] Authorization to conduct research on
human embryos has been left to the discretion of the states themselves,
subject to the approval of the U.S. Food and Drug Administration[74] (FDA)
(although the FDA's self-assertion of jurisdiction over an entire human
being would likely be held in question).[75] Like the rest of the world,
most states do not have legislation addressing human cloning and provide
no control over private research.  Only California,[76] Louisiana,[77]
Rhode Island,[78] Virginia,[79] Missouri[80] and Michigan[81] have laws
addressing human cloning, with the [*21] majority of these states allowing
specific exceptions for scientific research as well as for cell-based
therapies.  Fines for violating these statutes in some states reach as
high as $10 million.  Criminal sanctions exist only in Michigan, however,
where human cloning is punishable by imprisonment for up to 10 years.

A number of other states have pending legislation addressing human
cloning.[82] Recently, the California Advisory Committee on Human Cloning
(CACHC), a committee assembled to evaluate "medical, ethical and social
implications, review public policy and advise the Legislature and the
Governor in this Area"[83] released a report recommending that California
modify its laws to allow therapeutic cloning, while continuing to ban
reproductive cloning.[84] The CACHC also proposed legislation which if
enacted would prohibit reproductive cloning while allowing therapeutic
cloning.

The states' autonomy in this field may soon end as the federal government
has taken up the issue of human cloning.  In July of 2001, the House of
Representatives passed the Human Cloning Prohibition Act of 2001.[85] This
Act bans all human cloning, making it punishable by up to 10 years in
prison with a fine of at least $1 million.  The Senate is expected to
debate and vote on a cloning bill in the spring of 2002.  Already, Senator
Sam Brownback has introduced Senate bill S.1899, which is very similar to
H.R. 2505.[86] If enacted into law, S.1899 would ban therapeutic cloning,
reproductive [*22]cloning and the importation of products produced by such
processes into the U.S. with penalties of up to ten years in jail and
fines of at least $1 million.  Two bills which only outlaw reproductive
cloning were introduced by Senator Tom Harkin as S.1893 and Senator Dianne
Feinstein as S. 1758.[87] These bills prohibit reproductive cloning while
allowing therapeutic cloning by outlawing the implantation of products of
human cloning.[88] Both bills also penalize violators with fines of at
least $1 million and not more than 10 years in prison.[89]

At this time, the Senate appears more open to allowing some aspects of
human cloning; they did not approve a December 3, 2001 bid to place a
six-month moratorium on human cloning in order to have more time to
further discuss the issues involved.  Support is growing in the U.S. for a
ban on reproductive cloning while allowing therapeutic cloning.  The
National Academy of Sciences released a report in 2002[90] recommending
banning reproductive cloning in the U.S. by legislation.[91] The Council
indicated that a ban criminalizing implanting a cloned embryo should be
sufficient to stop reproductive cloning.[92]
[*23]
Although the exact language of the legislation is still uncertain, it
appears that Congress will pass federal legislation on human cloning
within the coming year.  Federal legislation would most likely make
legislation by the states unnecessary or will preempt state enacted
legislation under the Supremacy Clause.[93] Any bill passed by Congress
that does not completely ban human cloning likely will run into a
Presidential veto as President Bush has announced his opposition to any
type of human cloning.[94] A Presidential veto or congressional inaction
would relegate the responsibility to enact comprehensive legislation to
the states.  However, the states are incapable of regulating international
trade, patents and immigration issues.

In this current climate, Part I's hypothetical situation becomes rather
probable.  The House of Representatives has already passed a complete ban
on human cloning.  Although the Senate has not proposed a bill yet, it is
clear there is heavy pressure from President Bush to completely ban all
aspects of human cloning.  If the Senate would approve a complete ban on
human cloning, the John Smith hypothetical situation could easily occur.


PART IV

FACTORS TO CONSIDER FOR FUTURE U.S. LEGISLATION
[*24]
The House-approved anti-cloning bill outlaws both therapeutic and
reproductive cloning and makes it unlawful to perform or attempt to
perform human cloning, participate in an attempt to perform human cloning
or ship or receive the product of human cloning for any purpose.[95] This
bill penalizes the performers and participants[96] in human cloning with
fines of at least $1 million (plus up to double any profits) and up to 10
years in prison.  The bill also makes it illegal to receive or to attempt
to receive an organ produced by therapeutic cloning.

The current proposed legislation does not consider (1) a separated
analysis of the economic effects of therapeutic cloning and reproductive
cloning on the United States (including loss of revenue and relocation of
biotechnology companies, as well as medical and scientific professionals),
(2) the inadequacy and unique nature of the House approved penalties, (3)
the potential unconstitutionality of any legislation banning all forms of
human cloning, (4) the uncertain impact U.S. and foreign patents could
play and (5) the reversal of somatic cells to an embryological state for
use in human cloning.[97] The Senate should also consider that cloning
will be legal in some part of the world regardless of U.S. actions.  
Therefore a cloning industry will appear with or without U.S.
participation.  Therefore, the Senate needs to consider the possibility of
approving and allowing aspects of human cloning in the U.S. in order to
stay involved in worldwide regulation of this industry during its
formative stage.  If the [*25] U.S. completely outlaws human cloning, it
relinquishes any control over the future direction of this industry to
other countries.  Therefore, additional issues need to be examined in
order to ensure that comprehensive human cloning legislation is passed.


Economic Impact on the U.S.

If the U.S. completely bans human cloning (therapeutic and reproductive),
the U.S. would be at an economic disadvantage with respect to other
countries.  From the above discussion, it is apparent that a
multi-billion-dollar per year market potentially exists for therapeutic
cloning (transplants).  A market of this size will develop regardless of
U.S. involvement.  Already, major world powers including China, Japan,
Russia and the U.K. have indicated they will allow aspects of therapeutic
cloning thereby keeping open the opportunity to capitalize on this
fledgling market as well as collecting the taxable proceeds which
accompany it.  Major world powers with definitive, but less stringent
legislation clearly provide more promising locations for a start-up
industry than countries which continue to ban human cloning or which are
uncertain about the future direction of legislation.

A complete U.S. ban on human cloning carries with it the danger of losing
startup biotechnology companies and hindering large U.S.-based
pharmaceutical conglomerates by restricting them from entering newly
developed peripheral markets.  This exodus will also include a "brain
drain" as scientists and doctors involved in this industry leave the U.S.
for less restrictive environments.  The individuals leaving would include
not only scientists who are directly involved in cloning, but also
individuals in peripheral industries.  These adjunct companies could
incidentally find themselves in violation of the Human Cloning Prohibition
Act through their day-to-day business and [*26] subject to massive fines and
prison time for simply conducting research or engaging in scientific
activity.  The attractiveness of other countries with more lenient laws
could potentially harm the U.S. biotech market, currently the strongest in
the world.

A total U.S. ban or even a moratorium on human cloning would result in the
loss of start-up companies and the loss of pioneering inventions which
could be patented elsewhere, thereby preempting this U.S. industry.  
These pioneering inventions need not fall in the areas of cloning.  There
are peripheral markets for discoveries relating to pharmaceuticals,
treatments and biologics made during therapeutic and reproductive cloning
which have implications outside human cloning.  Although patents in the
U.S. may not be enforceable if they involve outlawed technologies, it is
still apparent that inventions outside the area of human cloning would be
patentable.  Former Commissioner of Patents and Trademarks Q. Todd
Dickinson recently stated that human stem cells are patentable.[98] This
peripheral market could be stunted by a U.S. ban on human cloning (or on
the ability to work with human embryos). [99] Future patents on drug
treatments or of human cloning techniques outside the U.S. would preempt
pharmaceutical companies from using these technologies.

Currently, the number of companies leaving the U.S. for other locations is
small and limited to relatively obscure companies such as Clonaid (a
company founded by a [*27] religious group called the Raelians).[100] However,
with such a large potential worldwide market, it is probable that the
numbers will increase over time in the event of a complete legislative ban
on all forms of cloning in the U.S.


A New Class of Violators and Penalties that Are Not Deterrents

Anti-cloning laws, such as the House passed bill, could create unique
fugitive classes in the United States.  Initially, only researchers would
be subject to criminal penalties under such an anti-cloning act.  This is
a new concept in the U.S. where researchers are not generally viewed as
criminals in our society, especially when the U.S. prides itself on its
researchers' ingenuity.  The fines and penalties will be an effective
deterrent because researchers have little incentive to violate such a
statute, especially when it makes good economic sense to simply leave the
U.S. or to redefine their career to avoid any contact with human embryos.

As shown in Part I's hypothetical situation, with the development of an
international therapeutic cloning industry, a second round of criminals
will develop - terminally ill individuals looking to increase their
lifespan by finding organs for transplant.  Because this would be a unique
class of felons (those who want to extend their lives), penalties will
need to be examined to see if they are in fact deterrents.  It should be
apparent that fines and prison sentences will not deter this second round
of potential violators because when it comes to a choice between life
(subject to a huge fine and potential jail time) or death, the punishment
would be viewed simply as an [*28] additional cost of the life-saving procedure.  
If legislation seeks to fine recipients of illegal transplants, it will
only deter poor individuals who cannot afford the operations and the
additional fines incurred.

A separate issue which should be addressed (if therapeutic cloning is
banned) is how to treat foreign citizens who have had organs replaced
using therapeutic cloning techniques where it is legal in their country.  
Under the House's bill, they would violate the proposed legislation while
vacationing in the U.S.!

Finally, if only therapeutic cloning is allowed by statute, a potential
international industry which may develop is recreational cloning.  This
industry would involve replacing organs grown through therapeutic cloning
when the organs do not need to be replaced.  Currently, transplants are
only available in the U.S. once organs have failed or are close to
failure.  However, if therapeutic cloning were legalized, organs could be
replaced at will.  This could lead to a new industry similar to plastic
surgery where individuals could replace their organs on demand (because it
worked better two years ago) rather than only when necessary (at failure).


Constitutional Challenges

Despite Congress's best intentions, any bill drafted will certainly be a
target for a challenge on Constitutional grounds.  Any statute that bans
human cloning appears to violate the Due Process Clauses of both the Fifth
and Fourteenth Amendments which prohibit state and federal governments
from depriving an individual's "life, liberty or [*29] property without due
process of law."[101] [102] The Supreme Court in Skinner v. Oklahoma
indicated that one of the fundamental rights of man was the right to
procreate.[103] In Skinner, the Court struck[104] down a sentence of
sterilization for a chronic thief stating that procreation was "one of the
basic civil rights of man … fundamental to the very existence and survival
of the race."[105] The Court citing Stanley v. Illinois[106] stated that
Skinner set forth a right to "conceive and to raise one's children" which
is a right "far more precious … than property rights."[107] Therefore,
conception is more precious than even property rights.  Further, the
Court's use of the term "conceive" does not exclude the implantation of
cloned embryos.[108]

The Court in Planned Parenthood of Southeastern Pennsylvania v. Casey also
recognized that procreation is included among the liberties protected by
the Due Process clauses of the Fifth and Fourteenth Amendments.[109] In
striking down a Pennsylvania abortion law, the Court stated that:
[*30]
     Our law affords constitutional protection to personal decisions
     relating to marriage, procreation, contraception, family
     relationships, child rearing, and education. . . . These
     matters, involving the most intimate and personal choices a
     person may make in a lifetime, choices central to personal
     dignity and autonomy, are central to the liberty protected by
     the Fourteenth Amendment.[110]

Therefore, an individual's fundamental right to procreation is protected.  
This fundamental right also applies to unmarried persons as indicated by
Eisenstadt v. Baird where the Court stated that "[i]f the right of privacy
means anything, it is the right of the individual, married or single, to
be free from unwarranted governmental intrusion into matters so
fundamentally affecting a person as the decision whether to bear or beget
a child."[111] Although these cases discussed coital relations, the
Court's use of language such as "bear[ing] or beget[ting] a child" is
broad enough to encompass other forms of procreation including human
cloning.[112]

A constitutional challenge to a complete ban on human cloning appears
valid in that an infertile individual may have the only opportunity to
"bear" a child containing his/her own genetic material through the process
of reproductive cloning.  Therefore, reproductive human cloning most
likely is included in, "the right of the individual, married or single, to
be free of unwarranted governmental intrusion into matters so
fundamentally affecting a person as the decision whether to bear or beget
a child." [113] [*31] Any statute would appear to eviscerate this right and
would likely result in a successful constitutional challenge.  One prime
candidate for a challenge (if enacted) would be a recently submitted bill
into the Senate proposing to outlaw the use of somatic cell nuclear
transfer to initiate human pregnancies.[114] The plain language of this
bill appears very close to intruding on the fundamental right of
procreation.

A completely unexpected and counterintuitive result could also occur under
the current House bill (which bans both therapeutic and reproductive
cloning).  If only the ban on reproductive cloning were found to be
unconstitutional[115], the worst of both worlds would exist because
individuals would be free to practice reproductive cloning but would be
prohibited from practicing therapeutic cloning.[116]


The Role of Patents in Human Cloning

The patentability of human cloning as well as the products of human
cloning in the U.S. is similarly murky.  There are no statutory or
judicial restrictions against issuing patents claiming human clones.  
Several bills have been introduced addressing the issuance of patents on
humans including the Transgenic Animal Patent Reform Act.[117] The bill
was approved by the House and would have prohibited the patenting of human
[*32]beings.[118] However, the Senate did not approve the bill and it never
became law.  In 1987, then Assistant Secretary and Commissioner of Patents
and Trademarks Donald J. Quigg stated in a public letter that "the grant
of a limited, but exclusive property right in a human being is prohibited
by the Constitution" while indicating that the Patent and Trademark Office
(PTO) would consider non-human animals as patentable subject matter.[119]
This PTO ban on patents however may not actually be valid because case law
suggests that human clones are indeed patentable.

A human clone is a man-made invention.  The Supreme Court in their
landmark decision Diamond v. Chakrabarty[120], held that the subject
matter of patents "include[s] anything under the sun that is made by
man."[121] The Supreme Court recently reiterated this broad interpretation
of what is patentable in J.E.M. Ag Supply Inc. v. Pioneer Hi-Bred Int'l.,
Inc., by stating, "As this Court held in Chakrabarty, 'the relevant
distinction' for purposes of §101 is not 'between living and inanimate
things, but between products of nature, whether living or not, and
human-made inventions.'" [122] Because a cloned human being is a
human-made invention, they are patentable.

If Congress passes a law outlawing reproductive cloning or completely
banning human cloning, then patents or patent applications claiming
processes of cloning or products of human cloning could violate 35 U.S.C.
§ 101.  Section 101, provides that [*33] "whoever invents or discovers any new
and useful process, machine, manufacture, or composition of matter, or any
new and useful improvement thereof," may obtain a patent on that invention
or discovery.  The Supreme Court in Brenner v. Manson[123] indicated that
an invention lacks utility if that invention is "injurious to the morals,
health, or good order of society, or frivolous and insignificant."[124]
The commonly cited examples of inventions injurious to the morals, health
or good order of society are found in In re Nelson[125], where the United
States Court of Customs and Patent Appeals stated that, "[A] new invention
to poison people, or to promote debauchery, or to facilitate private
assassination, is not a patentable invention."[126] Human cloning does not
fall within this standard because unlike the listed examples, it does not
cause immediate physical harm.  More recently, the Federal Circuit
indicated in Juicy Whip, Inc. v. Orange Bang, Inc., that "the principle
that inventions are invalid if they are principally designed to serve
immoral or illegal purposes has not been applied broadly in recent years."
[127] The Court held that although the patent at issue claimed an
invention that could defraud customers, "we find no basis in section 101
to hold that inventions can be ruled unpatentable for lack of utility
simply because they have the [*34] capacity to fool some members of the
public."[128] [129] The Court reasoned, "The requirement of "utility" in
patent law is not a directive to the Patent and Trademark Office or the
courts to serve as arbiters of deceptive trade practices" and that "Other
agencies, such as the Federal Trade Commission and the Food and Drug
Administration, are assigned the task of protecting consumers from fraud
and deception in the sale of food products."[130] The court found support
in Webber v. Virginia in that, "Congress never intended that the patent
laws should displace the police powers of the States, meaning by that term
those powers by which the health, good order, peace and general welfare of
the community are promoted." [131]

The court also indicated that if the invention at issue was unlawful, then
it would most likely lack utility under Section 101.[132] Therefore, if
all human cloning were outlawed by federal legislation, then any form of
human cloning would lack the requisite utility of Section 101 and
therefore would not be patentable.  The Court of Appeals for the Federal
Circuit however has stated the better way to limit the scope of patentable
subject matter would be through explicit legislation such as 42 U.S.C. §
[*35] 2181(a).[133] However, until Congress outlaws human cloning or
specifically removes human cloning from patentable subject matter (the
more preferred route), it does appear patentable.

Also, although the Thirteenth Amendment prohibition on slavery would
appear to be ban patents on human clones themselves, it may not preempt a
patent claiming a clone as a product of cloning.[134] A patent does not
grant ownership to the product claimed therein; rather, it grants to the
patent owner the right to exclude others from making, using, offering to
sell, selling or importing into the United States the product of that
patent.[135] Therefore, arguably, because there is no 'ownership right' or
grant of slavery, it appears that the Thirteenth Amendment would not be
violated by a grant of a patent claiming a human clone.

If Congress bans human cloning or explicitly remove human cloning from
patentable subject matter, then patent applications to those outlawed
processes and products would be rejected.[136] Similarly, any issued
patents claiming products or processes of human cloning would also be
unenforceable in court.  These rejections and bans to enforceability
however would only apply to the outlawed human cloning and not to
inventions related to discoveries made during the development of a cloning
[*36]industry (such as pharmaceuticals which control cell differentiation,
etc.) unless they too were specifically outlawed.

Although Europe is one of the most active regions in the human cloning
industry, an interesting situation will arise if the U.S. bans all forms
of human cloning.  The European Patent Office (EPO) issued a patent
claiming a process of human cloning to the Roslin Group.[137] This patent
is licensed to a U.S. company, Geron Corporation.  This patent issued in
direct violation to a 1998 European directive on biotechnical inventions
stating that human cloning is unpatentable.[138] The EPO immediately
admitted that issuance of this patent had been "a mistake" because the
patent did not disclaim cloning of humans.[139] This disclaimer was
required before the patent was allowed to issue.[140] Because the EPO
could not act by itself, it asked third parties to file a notice of
opposition so that it could revoke the patent.[141] Although this patent
was mistakenly issued, it is still a valid patent claiming aspects of
human cloning.[142] By licensing this patent, Geron Corporation is liable
if Congress passes legislation [*37] prohibiting human cloning.[143] This
problem awaits other unwitting U.S. companies who similarly license or own
technologies related to human cloning.  This will be especially troubling
because the penalties for human cloning or even attempting to clone humans
would be calculated based on the unrealized profits derived from human
cloning.[144]


The Reproductive Cloning Industry

Another issue likely to arise is how the U.S. should deal with an
international reproductive cloning industry specifically banned by the
U.S.  As discussed above, a sterile individual has the best and perhaps
only chance to have genetically-related offspring through reproductive
cloning.  Because many people share an instinctive desire to sire their
own genetically-related progeny, a reproductive cloning market will
materialize.  This market currently includes at least one member--Clonaid,
which has predicted they will successfully produce the first human clone
by February 2004. [145] [146] (146)  This market, even if outlawed in the
U.S. could still be legalized in other countries hoping to cash in on the
tax revenue and other economic advantages which would arise from this
profitable industry.  Therefore, some biotech companies will leave along
with the corresponding brain drain should reproductive cloning be
outlawed.

[*38]More importantly, new issues and advances in technology arising from
reproductive cloning should be addressed by Congress legislatively.  This
is preferable to having litigable arguments open to judicial
interpretation, especially because Congress is in a much better position
to determine the full extent and scope of issues and to have full and
complete hearings including input from all sides.

Issues which should be addressed include:

     (1)  What happens if a cloned individual applies for American
     citizenship?

     (2)  Should a ban be placed on citizenship status of one group
     of people?  Or would that in itself be a Constitutional
     violation?

     (3) Would denying a human clone citizenship in effect be
     punishing the innocent?

     (4)  If citizenship would be granted, what would happen when
     the parents of the clone would visit the clone in the U.S.?
     Should they be arrested?

     (5)  How would international tourists be treated?  Should
     foreign tourists who are clones be denied access to the
     country?

     (6) Are technological advances such as artificial wombs also
     outlawed by legislation banning reproductive cloning?[147]


CONCLUSION

Although most of society has to wait until May of 2002 to see Attack of
the Clones, the world has been given a preview of an assault of human
cloning issues.  Unlike the George Lucas film, these issues will not be
resolved after two hours.  The [*39] U.S. Senate is now preparing to debate the
merits of human cloning.  Within this debate a number of unaddressed
issues should be discussed including the economic impact of a therapeutic
cloning industry as well as of a reproductive cloning industry.

To be comprehensive, any enacted legislation should address the creation
of a new class of criminals and the possible non-deterrent nature of
monetary penalties.  Further, to ensure that congressional time is not
wasted, any proposed legislation needs to be evaluated to ensure its
constitutionality.  Congress should also address peripheral issues such as
the economic impact of international patents on U.S. pharmaceutical and
biotechnology corporations, the loss of U.S. patent rights and potential
nationalization problems with expatriate human clones.

In light of recent events, it is clear that a multi-billion-dollar per
year market will soon appear.  Therefore, well thought out legislation
needs to be enacted.  Internationally, therapeutic human cloning has been
legalized in a few economic super powers.  180 other countries do not even
address human cloning.  Therefore, the chance exists that the U.S. could
be excluded from the financial and technological gains of this
international marketplace.

Furthermore, because of the desire of some to have genetically related
offspring, a reproductive cloning industry will appear, and most likely
without the U.S. as an active participant.  Therefore, U.S. legislation
needs to address all of these issues to ensure that the U.S. and its
biotechnology industry are not lost in a galaxy far, far, away…


FOOTNOTES

[1] Press Release, Advanced Cell Technology Reports Publication of Results
of Human Somatic Cell Nuclear Transfer and Parthenogenesis (November 25,
2001), available at http://www.advancedcell.com/pr_11-25-2001.html (last
visited April 15, 2002).

[2] Press Release, U.S. cloning advance shocks world (November 27, 2001),
available at
http://www.cnn.com/2001/TECH/science/11/26/human.cloning.reax/ (last
visited April 15, 2002).

[3] This process has commonly been referred to as "twinning" because
embryo cloning results in the creation of identical twins.

[4] The mitochondria is a separate organelle found in every living cell.  
The mitochondria also contains DNA but generally replicates independently
of the nuclear DNA.  The mitochondrial DNA is transmitted via the egg's
cytoplasm and hence is not affected by fertilization egg and is not
affected by fertilization.

[5] David Braun, Scientists Successfully Clone Cat, National Geographic
News (February 14, 2002), available at
http://news.nationalgeographic.com/news/2002/02/0214_021402copycat.html.

[6] Additional differences may occur in clones that do not have identical
mitochondria including differences in parts of the body that have high
demands for energy--such as muscle, heart, eye, and brain--or in body
systems that use mitochondrial control over cell death to determine cell
numbers.

[7] Dhabi, Abu and Daniel, Kavitha, Human cloning project claims progress,
Gulf News, Online Edition (April 3, 2002), available at
http://www.gulf-news.com/Articles/news.asp?ArticleID=46275 (last visited
April 15, 2002).

[8] The produced cloned embryo from both therapeutic cloning and
reproductive cloning processes could theoretically be implanted into a
womb and develop into a human clone.  Because of this, some view
therapeutic cloning as controversial as reproductive cloning, even though
therapeutic cloning itself does not utilize implantation.

[9] See U.N.O.S. Critical Data, U.S. Facts About Transplantation, Table:
Number of Transplants Performed in 2000, available at
http://www.unos.org/frame_Default.asp?Category=Newsdata (last visited May
1, 2002).

[10] New York State Conference of Blue Cross and Blue Shield Plans, values
of U.S. average billed charges per transplantation as of July 1, 1999:
Calculated by rounding down to the nearest ten the average of the average
cost of five transplant operations (heart transplant ($303,400), kidney
transplant ($111,400), liver transplant ($244,600), pancreas transplant
($113,700) and heart/lung transplant ($301,200)), available at
http://acme.webway.com/filecatalgo/1163/ACF1AF3.pdf.

[11] 79,368 patients were waiting for organs.  See U.N.O.S. Critical Data,
U.S. Facts About Transplantation, Table: On April 12, 2002 The UNOS
national patient waiting list for organ transplant included the following,
available at http://www.unos.org/frame_Default.asp?Category=Newsdata (last
visited April 30, 2002).

[12] 1999 Annual Report of the U.S. Scientific Registry of Transplant
Recipients and the Organ Procurement and Transplantation Network:
Transplant Data 1989-1998. (February 21, 2000), available at
http://www.unos.org/Data/anrpt_main.htm (last visited December 15, 2001).

[13] Id.

[14] Id.  Numbers not available for 1998 and 1999 related to kidney
transplantation.

[15] Id.  Additionally, the median waiting time in days ranged from 439
for livers and 267 for pancreases in 1997.  With therapeutic cloning,
organs could even be grown well in advance of their actual need
(reproductive as well as therapeutic).

[16] With therapeutic cloning, organs could even be grown well in advance
of their need.

[17] Rick Weiss, Scientists Claim an Advance in Therapeutic Cloning,
Washington Post, Page A04 (January 30, 2002), available at
http://www.washingtonpost.com/ac2/wp-dyn/A58739-2002Jan29?language=printer.

[18] Id.

[19] Reproductive as well as therapeutic cloning.

[20] See generally, American Convention on Human Rights, Pt. 1, Ch. I,
Art. 1 and Ch. VIII, Sec. 1.

[21] Countries which have ratified the American Convention in Human Rights
include Argentina, Barbados, Bolivia, Brazil, Chile, Colombia, Costa Rica,
Dominica (Commonwealth), Dominican Republic, Ecuador, El Salvador,
Grenada, Guatemala, Haiti, Honduras, Jamaica, Mexico, Nicaragua, Panama,
Paraguay, Peru, Suriname, Trinidad and Tobago, United States of America,
Uruguay and Venezuela.

[22] See Pt. 1, Ch. II, Art. 4, Sec. 1, Note 20, supra.

[23] Id.

[24] See, Note 108, infra.

[25] Presidential Decree No. 200/97, Prohibition on Human Cloning
Research, Article 1 (July 1997), available at
http://infoleg.mecon.gov.ar/txtnorma/42213.htm.

[26] Biosafety Law, Art. 8 and Art. 13, II, Sec. 3, Law No. 8974 (May
1995). (Prohibits production, storage and manipulation of human embryos),
available at http://www.mct.gov.br/legis/leis/8974_95.htm.

[27] General Health Law, Art. 7, Law No. 26842 (1997), available at
ftp://ftp.minsa.gob.pe/intranet/leyes/L-26842_LGS.doc; Children and
Adolescence Code, Article I, Law No. 27337, available at
http://www.promudeh.gob.pe/Gpna/Ley27337.html.  (Protects children from
the time of conception).

[28] Trinidad and Tobago Gazette, Vol. 38, No. 18, Legal Supplement Part C
(1999).  ("An act respecting human reproductive technologies and
commercial transactions relating to human reproduction"), available at
http://www.ttparliament.org/bills/senate/1999/b1999s04p.pdf.

[29] General Health Law, Art. 330 (1997).  (Bans the use of embryonic or
fetal tissue from induced abortions for any purposes), available at
http://info4.juridicas.unam.mx/ijure/fed/140/343.htm?s=.

[30] ECUADOR CONSTITUTION, Art. 49, Par. 1 (1998).  (Indicates that the
right to life begins at the moment of conception), available at
http://www.georgetown.edu/pdba/Constitutions/Ecuador/ecuador98.html.

[31] Law of Boys, Girls and Adolsecents, Arts. 1 and 5, Law No. 2026
(October 27, 1999).  (Protect adolsecents from conception),available at
http://www.cajpe.org.pe/RIJ/bases/legisla/bolivia/2026.HTM.

[32] Children's and Adolescent's Code, Art. 12, Law No. 7739 (1998).  
(Recognizes the right to life from the moment of conception), available at
http://www.cinterfor.org.uy/public/spanish/region/ampro/cinterfor/temas/youth/legisl/c_rica/ii/ii/index.htm.

[33] Canada Bans Human Embryo Cloning, Associated Press (March 4, 2002),
available at
http://www.washingtonpost.com/wp-dyn/articles/A37086-2002Mar4.html.

[34] Europe rejects human cloning ban, BBC News (November 29, 2001),
available at
http://news.bbc.co.uk/hi/english/sci/tech/newsid_1682000/1682591.stm.

[35] See id.

[36] Additional Protocol to the Convention for the Protection of Human
Rights and Dignity of the Human Being with regard to the Application of
Biology and Medicine, on the Prohibition of Cloning Human Beings, ETS No.
168 (1998), available at
http://conventions.coe.int/Treaty/en/Treaties/Html/168.htm.

[37] Id. at Art. 1, Sec. 1.  ("Any intervention seeking to create a human
being genetically identical to another human being, whether living or
dead, is prohibited").

[38] Signatory states include Bulgaria, Croatia, Cyprus, the Czech
Republic, Denmark, Estonia, Finland, France, Georgia, Greece, Hungary,
Iceland, Italy, Latvia, Lithuania, Luxembourg, Moldova, the Netherlands,
Norway, Poland, Portugal, Romania, San Marino, Slovakia, Slovenia, Spain,
Sweden, Switzerland, Turkey and the former Yugoslav Republic of Macedonia.  
For updates of signatories, see
http://conventions.coe.int/Treaty/EN/news.htm (last visited April 30,
2002).

[39] ETS No. 168 at Art. 4.  ("This Protocol shall be open for signature
by Signatories to the Convention.  It is subject to ratification,
acceptance or approval").  See Note 36, supra.

[40] Art. L 152-3, Law No. 94-654 (1994), available at
http://www.chu-rouen.fr/uchpg/LOI5.html. France is also seeking to pass a
bioethics bill to outlaw human cloning.

[41] Embryo Protection Law (Dec. 13, 1990), Bundesgesetzblatt, Pt. I, 19
Dec. 1990, pp. 2746-2748.  (Criminalizes a variety of acts in reproductive
and genetic technologies), available at
http://www.bmgesundheit.de/rechts/genfpm/embryo/embryo.htm.

[42] Reproductive Medicine Law, Serial No. 275 (1992) (Regulating
Medically Assisted Procreation); The Marriage Law, and the Rules of
Jurisdiction, General Civil Code, 44(2) IDHL 247 (1993).

[43] Public Education Act LXXIX, Magyar Közlöny, No. 2000/65, p.
3978 (1993).

[44] Act Concerning Family Planning, Protection of the Human Fetus and
Conditions of Permissibility of Abortion (1993) (amended 1996).

[45] Medical Use of Biotechnology, Act No. 56 of 5 August 1994 ("The Act
relating to the application of biotechnology in medicine").

[46] SWITZ. CONST. Art.119, §(2)(c) (amended 1999) (Prohibiting the use of
medically assisted reproduction for research purposes as well as for the
fertilization of more ova than are capable of being immediately
implanted).

[47] IR. CONST. art. 40, §3 (amended 1983) (Implying that research on the
embryos are prohibited by equating the right to life of the "unborn child"
to that of the mother).

[48] For a discussion of Italian law, see generally
http://www.cnn.com/2001/WORLD/europe/08/07/clone.legislation/.  ("Italian
law forbids "all form of experimentation or intervention whose objective,
even indirectly, is the cloning of humans or animals."")

[49] Medically Assisted Procreation, Art. 25, Act No. 460 (1997).  
(Implicitly prohibiting the creation of human clones, chimeras and hybrids
and prohibits the reimplantation of genetically modified embryos as well
as embryos that might have been harmed by research activities).  See also
Cloning - Statement from the Danish Council of Ethics (2001), available at
http://www.etiskraad.dk/publikationer/Kloning_UK/app1.htm.

[50] The General Council of Health issued a statement in 1988 implicitly
prohibiting the practice of cloning.  See Embryos, scientific research and
European legislation, European Parliament Directorate General for Research
- Directorate A, Briefing Note No. 14/2001 (May 2001), available at
http://www.europarl.eu.int/stoa/publi/pdf/briefings/14_en.pdf.

[51] Law No. 35 of 22 (November 1988).  (On techniques of assisted
reproduction).  See generally
http://www.pcb.ub.es/inauguration/OBiDangl.html.

[52] Id.  The Spanish Committee of Experts on Cloning published a report
in June 1999 supporting legislation to lift the existing ban on cloning in
order to allow the creation of tissue to cure certain diseases.  However,
the report continued to support outlawing legalization of the reproductive
cloning of human beings.

[53] Concerning Measures for the Purposes of Research or Treatment in
Connection with Fertilized Human Oocytes, Law No. 115, Sec. 2 (1991).
("The purpose of experimentation shall not be to develop methods aimed at
causing heritable genetic effects").

[54] Medical Research Act, Law No. 488 (1999).  (Explicitly prohibiting
research which modifies the germ line, but makes an exception for research
done for the purposes of curing or preventing serious hereditary disease),
available at http://www.finlex.net.  See also Statement of Embryo and Stem
Cell Research in Finland, Forum of Embryo and Stem Cell Researchers
(November 2, 2001), available at
http://life2000.helsinki.fi/english/results/statement021101.PDF.

[55] See id., Medical Research Act, Sec. 15, Law No. 488 (1999).  
(Embryos donated by persons following treatment against sterility and not
intended for implantation).

[56] Id. at Sec. 14.  Research cannot continue after the 14th day of
existence of the embryo and consent must be granted by the couple
supplying the embryo.

[57] Embryo Bill (2000).  (Bill containing rules relating to the use of
gametes and embryos), available at
http://www.minvws.nl/document.html?folder=393&page=16897.

[58] Human Fertilisation and Embryology Act, Sec. 3 (1990), available at
http://www.hmso.gov.uk/acts/acts1990/Ukpga_19900037_en_2.htm#mdiv3.

[59] Human Fertilisation and Embryology (Research Purposes) Regulations
(2001).  ("Explanatory Notes Referring to the Human Reproductive Cloning
Bill as brought from the House of Lords on 26th November 2001 [Bill 57]"),
available at
http://www.parliament.the-stationery-office.co.uk/pa/cm200102/cmbills/057/en/02057x--.htm.

[60] R v. Secretary of State for Health, ex parte Bruno Quintavalle (on
behalf of Pro-Life Alliance) (Fam. 2001).

[61] Justice Crane on November 15, 2001 held that human embryos created by
cell nuclear replacement do not constitute embryos as defined under the
U.K. Human Fertilisation and Embryology Act (1990).

[62] Roger Moorgate, Human Cloning Legal in United Kingdom, The
Reproductive Cloning Network, available at
http://www.reproductivecloning.net/hosting/news/news7.html (last visited
January 24, 2002).  (The British Medical Association says it is extremely
concerned by the court's judgement: "Ironically, this 'victory' for the
Pro-Life Alliance means that there currently exists no legal prohibition
to human cloning... It is extremely important to remember that it was the
clear intention of Parliament that research using (cloned) embryos should
be permitted with the strict controls set out in the HFE Act of 1990….
This was because embryonic stem cell research offers huge potential to
patients suffering very debilitating diseases," the association said).

[63] New round in UK human clone battle, CNN.com (January 18, 2002),
available at
http://www.cnn.com/2002/WORLD/europe/01/18/uk.clone/index.html.

[64] UK backs human embryo cloning, CNN.com (February 27, 2002), available
at http://www.cnn.com/2002/WORLD/europe/02/27/cloning/index.html.

[65] The Law Concerning Regulation Relating to Human Cloning Techniques
and Other Similar Techniques (2000).  (Japan adopted a law prohibiting
reproductive cloning and prescribing the adoption of guidelines to allow
the use of stem cells derived from supernumerary embryos and therapeutic
cloning), available at http://www.biol.tsukuba.ac.jp/~macer/eclone.pdf.

[66] Australia, in early 2002, changed from allowing their states to
decide on how to legislate cloning (which resulted in cloning being banned
in three of the six Australian states), to uniform national legislation
banning reproductive human cloning, while still allowing stem cell
research and therapeutic cloning.  See Communique of the Council of
Australian Governments' meeting, 11th, Canberra (April 5, 2002), available
at http://search.aph.gov.au/search/.

[67] India also has banned reproductive cloning but allows therapeutic
cloning in limited circumstances.  See Guidance for International
Collaboration for Research in Biomedical Sciences, Pharmacology 1999; 31:
383-384 (reprint of ICMR Bulletin, Vol. 29, Pages 73-74), available at
http://www.ijp-online.com/archives/1999/031/05/r0383-0384fi.pdf.

[68] Yang Sung-jin, Cloning of human embryos to be strictly banned: draft,
The Korea Herald (May 19, 2001).  (In May 2001, the Korean government
indicated that it is drafting a law which would strictly ban artifical
cloning of human embryos as well as research on embryos in principle),
available at
http://www.koreaherald.co.kr/SITE/data/html_dir/2001/05/19/200105190024.asp.

[69] Human Beings and Genetic Modifications for Reproductive Cells, Law
No. 5759 (1998).  See generally Report of the Bioethics Advisory Committee
of The Israel Academy of Sciences and Humanities on the Use of Embryonic
Stem Cells for Therapeutic Research (August 2001), available at:
http://www.academy.ac.il/bioethics.html.

[70] See generally Report of the Bioethics Advisory Committee of The
Israel Academy of Sciences and Humanities on the Use of Embryonic Stem
Cells for Therapeutic Research, Note 69, supra.

[71] Irwin Arieff, UN Panel Begins Drafting Global Ban on Cloning, Reuters
(February 26, 2002), available at
http://story.news.yahoo.com/news?tmpl=story&cid=594&u=/nm/20020226/hl_nm/clone_2.

[72] Id.

[73] Remarks by the President on Stem Cell Research, Office of the Press
Secretary (August 9, 2001).  (President Bush indicated that the federal
government would only finance stem cell research from stem cells produced
before August 9, 2001), available at
http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html.

[74] The FDA indicated in 1998 that it had regulatory jurisdiction "over
clinical research using cloning technology to create a human being" under
the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act
(FFDCA).  See Department of Health and Human Services Protection of Human
Subjects, 45 C.F.R. §46 (2000), available at
http://www.access.gpo.gov/nara/cfr/waisidx_00/45cfr46_00.html.

[75] Because the FDA has asserted its jurisdiction, FDA approval is now
required for products of human cloning until a court states that the FDA
does not have jurisdiction.  See 30 Seton Hall L.Rev. 464 (2000); and
Elizabeth C. Price, Does the FDA Have Authority to Regulate Human Cloning?
11 Harv. J.L & Tech. 619 (1998).

[76] CAL. BUS & PROF. CODE §2260.5, §16004, §16105: "Medical Practices
Act" (1997), CAL. HEALTH AND SAFETY CODE, ANN. §24185, §24187, §24189
(1997).

[77] LA. REV'D STAT. ANN., Title 40, §§1299.36 through 1299.36.6 and Title
37, §1285(A)(31) (1999).

[78] R. IS. GEN. LAWS §§23-16.4-1 - 23-16.4-4 (Supp. 1998).

[79] VA. CODE ANN. §§32.1-162.21 - 32.1-162.22 (2001).

[80] MO. ANN. STAT., Title 1, Chapter 1, §1.217 (1998).

[81] MICH. STAT. ANN., §§333.16274-333.16275, §333.20197,
§§333.26401-333.26406, §750.430a (1999).

[82] New York, Massachusetts, Indiana, Illinois, Kentucky and Texas.

[83] Final Report of the California Advisory Committee on Human Cloning,
pp. 17 and 38, citing Senate Concurrent Resolution 39.

[84] CACHC (2002).

[85] Human Cloning Prohibition Act of 2001, H.R. 2505, 107th Cong. 1st
Sess. (2001).

[86] Human Cloning Prohibition Act of 2001, S.1899, 107th Cong. 2nd Sess.
(2002).

[87] Human Cloning Prohibition Act of 2001, S.1893, 107th Cong. 2nd Sess.
(2002) and Human Cloning Prohibition Act of 2001, S. 1758, 107th Cong. 1st
Sess. (2001).

[88] S.1893 at (c)(1); S. 1758 at 301(a)(1).

[89] S. 1893 at (b)(1)-(2); S. 1758 at (d)(2)-(3).

[90] SCIENTIFIC AND MEDICAL ASPECTS OF HUMAN REPRODUCTIVE CLONING,
COMMITTEE ON SCIENCE, ENGINEERING, AND PUBLIC POLICY, NATIONAL RESEARCH
COUNCIL, National Academy Press (2002).

[91] Id. at ES-1 ("The panel therefore unanimously supports the proposal
that there should be a legally enforceable ban on the practice of human
reproductive cloning").

[92] Id. at ES-11 ("But a legally enforceable ban that criminalizes the
implantation step should be sufficient to prevent such proscribed
activity").

[93] U.S. CONST., Art. VI, cl. 2 ("This Constitution, and the laws of the
United States which shall be made in pursuance thereof; and all treaties
made, or which shall be made, under the authority of the United States,
shall be the supreme law of the land; and the judges in every state shall
be bound thereby, any thing in the Constitution or laws of any State to
the contrary notwithstanding").

[94] Alan Bjerga, Abortion foes cheer Bush on cloning - Activists Add
Human Cloning To Political Agenda, San Jose Mercury News (Jan. 23, 2002).  
("I urge the United States Senate to support a comprehensive and effective
ban on human cloning"), available at 2002 WL 6718280.

[95] H.R. 2505, Note 85, supra.

[96] As used, performers means those who actually perform the operation or
produce a twin and participants are defined as the DNA donor and host.

[97] Although the reality of somatic cell reversal to an embryological
state has been discounted, the future of technology is unpredictable.  
Therefore, legislation should address all potential violators to be fully
comprehensive.

[98] Statement of Q. Todd Dickinson Acting Assistant Secretary of Commerce
and Acting Commissioner of Patents and Trademarks before the Subcommittee
on Labor, Health and Human Services, Education and Related Agencies of the
Senate Appropriations Committee (January 12, 1999).  ("Accordingly, it is
the present position of the Patent and Trademark Office that purified and
isolated stem cell lines are patentable subject matter under 35 U.S.C.
§101"), available at
http://www.uspto.gov/web/offices/ac/ahrpa/opa/bulletin/stemcell.pdf.

[99] The human stem cell market is envisioned as a pharmaceutical market
built on manipulative gene expression to reprogram one cell type to be
converted into another cell type.

[100] After investigation by the FDA, Clonaid announced they would be
relocating their reproductive cloning activities outside the U.S.  See
'Raelian' biochemist insists she will clone human, CNN.com, (June 30,
2001), available at http://www.cnn.com/2001/HEALTH/06/30/clone.lab.txt/
(last visited January 24, 2002).

[101] U.S. CONST. amend. V ("No person shall be…deprived of life, liberty,
or property, without due process of law").

[102] U.S. CONST. amend. XIV, § 1 ("nor shall any state deprive any person
of life, liberty, or property, without due process of law").

[103] 316 U.S. 535 (1942).

[104] Although Skinner utilized and Equal Protection Clause argument, the
fact that the Court found procreation to be a fundamental right applies
equally to the Due Process Clause.

[105] 316 U.S. at 541.

[106] 405 U.S. 645 (1972).

[107] Id. at 651.

[108] Webster's dictionary defines "conceive" as "to become pregnant."  
See Merriam-Webster OnLine: Collegiate Dictionary (2000), available at
http://www.merriam-webster.com/dictionary.htm (8 Oct. 2000) (last visited
January 24, 2002).

[109] 505 U.S. 833 (1992).

[110] Id. at 851.

[111] 405 U.S. 438, 453 (1972).

[112] Webster's dictionary defines "bear" (v.) as "to give birth".  See
Merriam-Webster OnLine: Collegiate Dictionary (2000), available at
http://www.merriam-webster.com/dictionary.htm (8 Oct. 2000) (last visited
January 24, 2002).

[113] 405 U.S. at 453.

[114] Human Cloning Prohibition Act, S.2076, 107th Cong. 2nd Sess. (2002).

[115] Because therapeutic cloning may of itself not implicate these
constitutional considerations.

[116] It should also be noted that if reproductive cloning falls within
constitutionally proscribed fundamental rights, then its protection likely
only extends to those individuals who either bear or beget a child and
thus would be available only to the mother of the child (bearer) as well
as the DNA donor (begetter).

[117] Transgenic Animal Patent Reform Act, H.R. 4970, 100th Cong. (1988).

[118] See 134 CONG. REC. H.R. 7436-02 (1988).

[119] 1077 Off. Gaz. Pat. Office 24 (Apr. 21, 1987).  See Animal Legal
Defense Fund v. Quigg, 932 F.2d 920, 923 (Fed. Cir. 1991).

[120] 447 U.S. 303 (1980).

[121] Id. at 309.

[122] ___ U.S. ___, 122 S.Ct. 593, 598 (2001) citing 447 U.S. at 313.

[123] 383 U.S. 519 (1966).

[124] Id. at 533.

[125] 280 F.2d 172, 178 (C.C.P.A. 1960).

[126] Id. at 179.

[127] 185 F.3d 1364, 1367-68 (Fed. Cir. 1999).

[128] 185 F.3d at 1368.

[129] For example, courts had invalidated patents on gambling devices on
the ground that they were immoral.  See, e.g., Brewer v. Lichtenstein, 278
F. 512 (7th Cir. 1922); Schultze v. Holtz, 82 F. 448 (N.D. Cal. 1897);
National Automatic Device Co. v. Lloyd, 40 F. 89 (N.D. Ill. 1889).  That
is no longer the law.  See In re Murphy, 200 U.S.P.Q. (BNA) 801 (PTO Bd.
App. 1977).

[130] 185 F.3d at 1368.

[131] Webber v. Virginia, 103 U.S. 344, 347-48 (1880).

[132] 185 F.3d at 1367-8 ("Orange Bang has not argued that it is unlawful
to display a representation of the beverage in the manner that fluid is
displayed in the reservoir of the invention" and did not reach this issue.  
Therefore, the court left this issue open).

[133] This section exempts inventions useful only in connection with
special nuclear material or atomic weapons from patent protection.

[134] U.S. CONSTITUTION, amend. 13, Sec. 1 ("Neither slavery nor
involuntary servitude, except as a punishment for crime whereof the party
shall have been duly convicted, shall exist within the United States, or
any place subject to their jurisdiction").

[135] 35 U.S.C. § 271(a).

[136] These inventions would be rejected for lacking utility under 35
U.S.C. § 101 or for specifically being removed from patentable subject
matter.

[137] EPO Patent No. 1,005,789, published June 7, 2000 (entitled Quiescent
cell populations for nuclear transfer).  Claim 1 of EP 1005789 recites, "A
method of nuclear transfer, the method comprising the transfer of the
nucleus of a quiescent diploid donor cell into a suitable recipient cell"
and is clearly broad enough to claim human cloning.

[138] Directive 98/44/EC of the European Parliament and of the Council of
6 July 1998 on the Legal Protection of Biotechnological Inventions, 1998
O.J. (L 213) 13, Ch. I, Art. 5. ("The human body, at the various stages of
its formation and development, and the simple discovery of one of its
elements, including the partial sequence of a gene, cannot constitute
patentable inventions").

[139] See Patently Human, European Patent Appears to Cover Clones of
People, Reuters, Feb. 22, 2000, available at
http://abcnews.go.com/sections/science/DailyNews/cloningpatent000222.html#top.
(last visited April 24, 2002).

[140] Directive 98/44/EC at Chapter I, Article 5.

[141] See id.

[142] See EP 1,005,789, claim 1.

[143] Until EP 1005789 is amended with the required disclaimer.

[144] H.R. 2505, Note 85, supra.

[145] The self-proclaimed "First Human Cloning Company"  See
http://www.clonaid.com.

[146] Canadian Cult Head Predicts Human Clone in 2 Years, Reuters, London
(February 14, 2002), available at
http://ca.news.yahoo.com/020214/5/j8ib.html.

[147] See Robin McKie, Men redundant? Now we don't need women either, The
Observer International (Feb. 10, 2002), available at
http://www.observer.co.uk/international/story/0,6903,648024,00.html. (last
visited April 24, 2002).


(c) 2002, Paul Lesko and Kevin W. Buckley