PATENTING OF HUMAN GENE AND ETHICAL DISQUIET

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PATENTING OF HUMAN GENE AND ETHICAL

DISQUIET

BHAVIT SHARMA *

KUSH KALRA**

INTRODUCTION

Concept and Meaning of Human Gene Patenting

The concept of a patent on a human gene seems foreign to most people. Even those who

understand the fundamentals of the patent system seem bewildered and confused by many issues

relating to human genes. The study of biology was radically transformed by the discovery in

1953 of the structure of DNA, which is the genetic material of living organisms . Since then,

scientists have made considerable advances in understanding how DNA works, and how

differences in DNA lead to differences between people. In 1990, the Human Genome Project was

established to co-ordinate research that aimed to identify all the genes in human DNA, and to

determine the order of the three billion chemical base pairs that make up human DNA. In 2001,

the draft map of the human genome was published, which at least partially identified the majority

of the estimated 30,000- 40,000 human genes. Many of these genes play a role in human diseases

and disorders. Their identification may be a first step in the development of new diagnostic tests

and treatments. Research in the rapidly expanding field of genomics aims to discover the

biological function of particular genes, and how sets of genes and proteins work together in

health and disease. Research is also focusing on identifying and understanding the proteins

produced by the genes.

The protection of knowledge about human genes has primarily been achieved through the patent

system, though other devices such as trade secrecy and confidentiality have also played a role.1

* VIII Semester, B.A., LL.B. (Hons.), FYIC, Rajiv Gandhi National University of Law, Patiala, Punjab** VI Semester, B.A., LL.B. (Hons.), FYIC, Rajiv Gandhi National University of Law, Patiala, Punjab1 The importance of secrecy as a method of protecting knowledge was highlighted by a recent survey of academic

geneticists in the US which found that 35% of researchers felt that there had been a decline in the sharing of data in

the past ten years. It also found that researchers who had been engaged in the commercialisation of university

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The patent system is a long-established method of encouraging people to develop new and useful

objects by ensuring that they are able to capitalise on their inventions. A paten confers on the

inventor an exclusive right for a limited period of time (usually 20 years) to prevent others from

exploiting the invention. Patents have been used for over a century to protect a wide range of

inventions including new medicines, new materials and new machines. Naturally-occurring

phenomena such as electricity or wild species of plants or animals are not regarded as inventions

but as discoveries and thus are not eligible to be patented.

Patents and Conditions of Patentability

Patents are exclusive rights granted for a limited period of time by states through their legal

systems to inventors to prevent others from exploiting the patent holders invention. A patent is

the embodiment of a social contract between an inventor and his or her government: If the

inventor thoroughly discloses his or her invention to the public, the government in turn will

enforce the inventors right to be the only one who may commercialize it for about 20 years. The

invention has to be useful, novel, and non-obvious and must be fully described. If the invention is

neither useful, nor novel, nor non-obvious, nor is it fully described, the government cannot grant

the patent, and if it grants the patent by mistake (a not uncommon occurrence) it can then revoke

it. The full description requirement assures that inventions, especially industrial inventions, do

not remain hidden for too long. This requirement is the cornerstone of the patent idea: That

scientific and technical openness benefits the progress of society more than do confidentiality

and secrecy. Patents are granted for all kinds of inventions, such as chemical compositions,

mixtures, machines, methods of manufacture, methods of use, and human genetic materials.

Patent applications contain claims which set out the precise nature of the protection. The

commercial exploitation of something within the scope of the claim of a patent that has been

granted, without the authorisation of the owner of the patent, is called infringement.

Patent claims are normally drafted to ensure that they cover more than exact duplication of the

inventors work. Owners of patents will often themselves exploit commercially the inventions

research were significantly more likely to withhold data from other researchers. The study concluded that the

withholding of data in the field of genetics, though not widespread, was nonetheless affecting essential scientific

activities such as the ability to confirm published results (see Campbell EG et al. Data withholding in academic

genetics: evidence from a national survey. JAMA 2002;287:473-80).

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they have patented (for example, by manufacturing a medicine), but possession of a patent alone

does not require this. It is possible to have a patent but not to enforce or use it. Many patents are

also licensed by the owner to other parties for commercial use. A common misconception is that

a patent gives an inventor an absolute right to exploit the invention. It does not. Exploitation will

depend on whether others have patents which overlap with the subject matter of the invention,

and will be subject to other existing laws, such as those concerning health and safety.

The criteria for granting a Patent-

For a patent to be granted, the followed criteria must be satisfied:

the claimed invention must be eligible for patenting;

it must be novel;

it must be inventive or non-obvious;

it must be useful or have industrial application;

it must be fully disclosed in the patent application.

In addition, to be eligible, the invention must not be contrary to morality orordre public.

PATENTS ACT AND PROTECTION OF HUMAN GENE

The gene is the basic unit of heredity and the ultimate arbiter of what we are. It carries

instructions that allow cells to produce specific proteins. (It should be noted, however, that only

certain genes are active at any given moment and environment.2) A gene is a part of the

deoxyribonucleic acid (DNA) molecule.3 DNA, which is present in all living cells, contains

information coding for cellular structure, organization and function.4 It is made up of two strands

twisted around each other in a helical staircase.5

2National Cancer Institute, Cancer Facts, National Cancer Institute Online; available

from http://cis.nci.nih.gov; Internet; accessed 19 August 2002.3A.J.F. Griffiths, J.H. Miller, D.T. Suzuki, R.C. Lewontin, and W.M. Gelbart, An Introduction to Genetic Analysis

(New York: W.H. Freeman and Company, 1996), 2. [hereafter Griffiths]4The Royal Society, Genetically Modified Plants for Food Use and Human Health An Update, Policy Document

4/02, The Royal Society Online; available from http:// www.royalsoc.ac.uk; accessed 21 July 2002. [hereafter,

Royal Society Update]5U.S. Department of Energy Human Genome Program, Genomics and Its Impact on Medicine and Society: A 2001

Primer, US Department of Energy Online; available from http://www.ornl.gov, accessed 25 June 2002. [hereafter

U.S. Department of Energy Human Genome Program]

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Gene patents-

Genes are chemical compounds and, as such, they qualify as compositions of matter with respect

to patent criteria. Within the parameters of patentability delineated by the Patent Act, there are

several exceptions as interpreted by the courts. Products of nature (a pre-existing substance that

is found in the wild) may not be patented, per se. However, the courts have also determined that

such a product of nature may be patentable if significant artificial changes are made. By unifying,

isolating, or otherwise altering a naturally occurring product, an inventor may obtain a patent on

the product in its altered form.6 Thus, one cannot patent a naturally occurring gene or protein as

it exists in the body, but one can patent a gene or protein that has been isolated from the body and

is useful in that form as a pharmaceutical drug, screening assay or other application.7

6 Scripps Clinic and Research Foundation v. Genentech, Inc., 927 F.2d 1565 (Fed. Cir. 1991).7 Biotechnology Industry Organization, Primer: Genome and Genetic Research, Patent

Protection and 21st Century Medicine, available at [http://www.bio.org/ip/primer].

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The practice of awarding patents on genes, while upheld by the courts, has come under scrutiny

and criticism by some scientists, legal scholars, and politicians. The subject of gene patenting

involves various ethical, legal, and economic components.

Condition of protection of Human Gene

Since natural substances, by definition, already exist in nature, they are not novel and cannot

be patented. Thus, insulin or its gene as they exist in nature cannot be patented. However, the

courts have long recognized that purifying or isolating materials from nature makes them novel

and, thus, patentable. This is because isolated or purified materials do not exist in nature.

Let us provide a few examples.

Purified proteins- The oldest-cited case with regard to patenting of pure natural substances is

Parke-Davis & Co. v.H.K. Mulford & Co. (1912), where the applicant had patented adrenalin.8

The first claim of the patent was as follows:

A substance possessing the herein-described physiological characteristics and reactions of the

suprarenal glands in a stable and concentrated form, and practically free from inert and

associated gland tissue.

The Court held that a substance derived and purified from nature could be patentable.

Purified prostaglandins-In In re Bergstrom (1970) the inventors claimed naturally occurring

prostaglandin compounds PGE2 and PGE3 that they had extracted and purified from the prostate

gland.9 The claim was as follows:

7-[3-hydroxy-2(3-hydroxy-1-octenyl)-5-oxocyclopentyl]-5-heptenoic acid, said acid being

sufficiently pure to give a substantially ideal curve on partition chromatography using an

ethylene chloride: heptane: acetic acid: water (15:15:6:4) solvent system.

The court held that the sufficiently pure prostaglandins did not exist in nature and ruled these

to be patentable.

8Parke-Davis & Co. v. H.K. Mulford & Co., 196 F.496 (2nd Cir. 1912).9In re Bergstrom, 427 F.2d 1394 (C.C.P.A. 1970).

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Purified microbial cultures- In In re Bergy (1977) the applicant claimed a culture of a naturally

occurring bacteria that produced an antibiotic.10 The claim was to a . . . biologically pure culture

of the microorganism Streptomyces vellosus . . . The court again held that biologically pure

cultures of microorganisms did not exist in nature and could be patentable.

A few years later the Supreme Court in Diamond v. Chakrabarty (1980) held that a human-made

non-natural microorganism was patentable.11 The applicant in that case had genetically altered

the bacteria to consume crude oil. The Court stated that anything under the sun that is made by

man is patentable. Since a genetically modified microorganism such as that ofChakrabarty was

not even a product of nature, the legal analysis was simpler than in Bergy.

Purified strawberry flavor extracts- In In re Kratz (1979) the patent was to compositions and

methods involving a natural compound imparting a strawberry flavor.12 Claim 18 stated:

A flavor modifying composition useful in imparting a strawberry flavor to a foodstuff consisting

essentially of (i) from 1 to about 20% by weight of said flavoring composition of synthetically

produced substantially pure 2-methyl-2-pentanoic acid . . . .

The Court held that the applicants tried to claim the compound only in a substantially pure

form that did not exist in nature. It was therefore patentable.

Purified DNAs- Since purified adrenalin, prostaglandin, microbes, and strawberry flavors are

patentable, it follows that purified DNAs are too. As expected, the PTO will allow (and the

courts will uphold) claims to DNAs, but only if they have been isolated or purified. Illustrative is

Ex Parte D (1993), where an anonymous applicant unsuccessfully tried to patent a DNA

sequence coding for human tissue plasminogen activator.13 He requested the following claim:

A DNA sequence containing the DNA sequence coding for human tissue plasminogen activator

produced by human normal cells.

The PTO ruled that the claim did not contain any indication that the DNA sequence had been

isolated or purified, and rejected the claim partly because it was directed to a naturally occurring

10In re Bergy, 563 F.2d 1031 (C.C.P.A. 1977).11Diamond v. Chakrabarty, 447 U.S. 303 (1980).12In re Kratz, 592 F.2d 1169 (C.C.P.A. 1979).13Ex Parte D, 27 U.S.P.Q.2d 1067 (1993).

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substance. The clear implication is that had the claim contained language of isolation, it would

have been granted. And that is precisely how human gene patents are obtained.

PATENTABILITY OF HUMAN GENE AND INTERNATIONAL REGIME

Within most jurisdictions, patents are granted by specialist patent offices. The offices that are

particularly relevant to this paper are the European Patent Office (EPO) and the US Patent and

Trademark Office (USPTO). Patent examiners in these offices are responsible for establishing

whether an application for a patent meets the criteria for patenting in the relevant jurisdiction

although their decisions may be, and often are, challenged. The US and European patent regimes

differ in a number of important ways, including the criteria for deciding who is the first inventor

of an invention, when a patent application can be filed, and, until recently, when it is published.

The EPO is an international patent-granting authority established under the European Patent

Convention (EPC) in 1978 that grants European patents for the contracting states to the EPC.14

The EPO is financed by the fees it charges for assessing patent applications and has a large

degree of administrative autonomy.15 It was established as a result of cooperation in the field of

IP between the states of Europe. The European Patent Organisation, for which the EPO acts as

the executive arm, currently has 24 member states (at 1 July 2002): these members are the EPC

contracting states.16 A patent in a European country which is a member of the EPC can be

obtained either by applying to the national patent office in that country, or by filing an

application at the EPO. The effect of a patent awarded by the EPO is to create, for the European

member states designated by the applicant, a series of parallel national patents, which are treated

as if they had been granted by each national patent office of the designated states. These patents

are valid for 20 years, although extensions are possible for patents relating to pharmaceutical

inventions and plant products.17 The procedure of applying for and being granted a patent takes

an average period of 44 months but can be as long as ten years.18

In this paper, when we refer to14 The majority of patents that assert property rights over DNA taking effect in Europe are granted by the EPO.15 The EPO's operating and investment budgets are funded entirely from fees levied on applications.16 These include all the EU countries plus Bulgaria, the Czech Republic, Cyprus, Estonia, Liechtenstein, Monaco,

Slovakia, Switzerland and Turkey17 Such extensions are authorised under Article 63(2) (b) of the EPC.18 How to obtain a European patent. European-patent-office.org. 29 May 2001. http://www.european-patent-

office.org/epo/obtain.htm (21 May 2002).

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European law, or the patent system in Europe, we refer to those countries that are members of the

EPC.

The USPTO examines applications and issues patents, and examines and registers trademarks. It

is also funded by the fees it charges for examining patent applications. US patents are valid for

20 years from the date of filing, although extensions of time are possible for patents relating to

pharmaceutical and plant protection products. The USPTO has, in the past, been somewhat faster

than the EPO in processing patent applications although recently it appears to have slowed

down.19 The speed at which patent applications can be processed is limited by the availability of

patent examiners and it is common for patent offices to have substantial backlogs of unexamined

patent applications.20

At present there are no supra-national or international patents, although there is considerable

political pressure to create an EU Patent, or Community Patent.21 Although there are a number

of international patent agreements and the criteria of patentability are in outline harmonised

throughout the world, the procedure for processing patent applications varies according to the

prevailing regulatory framework. The Patent Cooperation Treaty (PCT), which is administered

by the WIPO provides an international central body that enables applicants to seek protection in

about one hundred countries worldwide.

19 1999 - 25.2 months, 1998 - 24.4 months, 1997 - 22.9 months, 1996 - 21.5 months (data from the Trilateral patent

office website).20 An important difference between the US system and elsewhere has been that US patents were not published prior

to being granted. This led to many patent applications being in the system for up to 10 years before being

published. Moreover those applications that were rejected were never published. However, this changed in

November 2000 (as a result of the American Inventors Protection Act 1999), and US patent applications are now

published 18 months after the date of filing of the application. This change has brought the US further into line with

Europe and Japan which already publish patent applications. However, there is a significant exception that can be

invoked by those applying for patents in the US: those who declare that they will not file patent applications for their

invention in certain countries outside the US (including Japan, Canada, Australia and many European countries) can

avoid publication. This option may be useful when inventors need a strategic advantage over their competitors orwhen there is some doubt about the patentability of the subject matter. In either circumstance, the inventor can retain

confidentiality until the patent is granted.21 In August 2000 the European Commission formally proposed the creation of a Community Patent, which would

allow patent protection to be secured throughout the single market on the basis of a single patent application. Under

the Commissionsproposal, Community Patents would be issued by the EPO. National and European patents would

coexist with the Community Patent system, allowing inventors to choose which type of patent protection would best

suit their needs. (Community Patents would allow protection in all the member states, while European patents would

cover only those states designated by the applicant).

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This procedure gives the applicant the option of obtaining an international preliminary

examination report about the patentability of an invention before any costs associated with the

procedure for applying for a patent are incurred. Through the PCT procedure, inventors can

apply for patents in different countries in one step.

The processing of patent applications by the USPTO and the EPO tends to be lengthy. In the

EPO, there is a considerable period of uncertainty, during which the fate of an individual patent

is unknown. Between the time of the patent application being filed and the patent being granted,

the technology or product can be used, but those who do use it may be subsequently required to

pay damages for infringement if the patent is granted. 22 In Europe, once the patent has been

granted, the patent holder has a claim against those who have used the invention between the

time of publication of the application and the time when

the patent was granted. In such circumstances, the patent holder can claim 'reasonable

compensation' in circumstances where the other party would be liable under national law for

infringement of a national patent (Article 67(2) of the EPC). Under German law the use of an

invention, which is covered by a published patent application carries no penalty until the patent is

granted. In the US, until recently, the owner of the patents, once granted, have been able to

recover compensation only from the date of the grant of the patent, because only then was a

patent published.

How do the patent offices decide whether to accept or reject a patent application? The roles of

patent examiners at the USPTO and the EPO are broadly similar (see Appendix 1). The patent

examiner undertakes a documentary search of the scientific and patent literature and examines

the application to determine whether it meets the criteria for patentability, what is the scope of

the protection claimed by the inventor and whether the invention is adequately described in the

patent claims. As far as we are aware, under all patent law jurisdictions, a patent office must give

a reason why a patent is not granted and specify which patentability requirement(s) was (were)

not met. The examiner's role is to make a technical

assessment of the application in the light of the law relating to patents. The examiner is not

required to consider the social, ethical or economic implications of granting a particular patent

22 In general, much higher amounts of damages are permissible in the US. The levels in the UK are significantly

lower but higher than those generally prevailing in other European countries.

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except in so far as these concerns are reflected in patent legislation. There are various national

and international laws, regulations and treaties that apply to the patent system. A summary of

relevant legislation and important legal cases is given in.

Challenging patents

Europe

Patents granted by the EPO can be challenged by a third party by submitting what is termed an

opposition to the EPO within 9 months of the patent being awarded. This can be on any of three

grounds:

_ the subject-matter of the patent is not patentable according to the terms of Articles 52 to 57

of the EPC;

_ the invention is not disclosed in the patent in a sufficiently clear and complete way for it to be

reproduced by a person skilled in the art;

_ the breadth of the patents subject-matter exceeds the content of the application which was

originally filed. The opposition procedure can last up to two and a half years. Once a decision is

reached, either party can then appeal against that decision. Such appeals can take up to four years

to be decided. They are heard by an Appeal Board within the EPO, selected to hear the specific

case. Questions may be referred for resolution to the Enlarged Board of Appeal. The decision of

the Appeal Board is final although the validity of granted patents can be challenged through

national courts in infringement disputes.23

United States of America

In the US, patents can be challenged through litigation, or by a request for re-examination. Re-

examination can occur at any point during the life of a patent. To succeed, a request must

demonstrate some undisclosed new and relevant piece of prior art (that is, any previously used

or published technology). Many requests for re-examination are made by the owners of the patent

in question themselves. Unlike the EPO procedure for challenging patents, re-examination is not

an adversarial process in which both sides can present evidence; it is a formal Patent Office

23 If a patent that has been granted is infringed, the owners of patents must seek redress through the various national

courts, who also have jurisdiction to revoke a patent, even one that has survived opposition in the EPO.

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review of the claims of an existing patent to determine whether newly cited prior art affects the

validity of the claims. It has been estimated that almost 7% of EPO patents result in opposition

proceedings, compared to 0.3% of US patents that result in re-examination.24 Of these challenges,

a minority are successful, and fewer are successful in the US than in Europe. In the

biotechnology and pharmaceutical fields, challenges often result in amendment rather than

revocation.

GENETIC ENGINEERING AND ETHICAL DISQUIET

Genetics engineering appeared in the 1900s. The first man who manipulated organisms was

Mendel, who started studying peas by creating different species. At that time, it was such a

wonderful discovery ! These last twenty years, scientists who have kept on searching, have made

fabulous progress. Genetics has improved so much that we are now on the way to discover all its

secrets .

No doubt, genetics engineering represents a revolution for mankind but arent there any terrible

dangers if we modify the planet?

We cant deny the fact that dangers of genetics are as important as its potential advantages. That's

the reason why, genetic engineering is drastically regulated in several countries. Indeed, DNAmanipulations need professional people. For example, the introduction of a diseased gene into a

healthy body would probably have horrible consequences . In spite of all of sorts of tests we can

always fear a possible error, which would certainly lead to a disastrous situation.

Yet, we also have to consider the fact that scientists can manipulate all types of organisms and no

sooner will new inventions have been discovered than a few people will want to take advantages;

for instance by creating human clones or "perfect species", and thus wed be lead to eugenism

which would go against nature; Creating "perfect" intelligent people could even be dangerous

insofar as nowadays people are able to seize power not violently like in a war but with their

brains.We can imagine a clone of Hitler or Saddam Hussein, what would the world be like if they

were to live and rule ?Genetics, used in medicine can also be dangerous. Scientists have to be

24 Merges RP. As many as six impossible patents before breakfast: property rights for business systems and patent

system reform. Berkeley Technology Law Journal 1999;14:577-615.

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careful because by trying to cure a disease, they can also increase the risk of upgrading a more

dangerous one. For example, if they introduce a gene which will eliminate a disease, this gene

could also make another disease stronger.

However, it is generally acknowledged that gene ties can be good for mankind and other species.

Indeed scientists have achieved a lot by manipulating genes. It is true that thanks to genetic

engineering, several diseases do not exist anymore. Scientists are on the right track to cure

"mucovicidose" which is an extremely serious disease. What strikes us most is that we can also

resort to medically assisted procreation. Indeed, in France last year, a woman and her husband

could have a boy whose name is Valentin.

Besides, genetically modified food which consists in manipulating genes to make edible plants

more effective remains an ambiguous issue. It's undeniable that in our country, the majority of

people dont want to eat such food as they think its bad for their health. But this type of food

could be used in order to help poor countries, it will never be worse than their actual situation.

Genetic engineering is the collection of techniques used to:

isolate genes

modify genes so they function better

prepare genes to be inserted into a new species

develop transgenes

The process of creating a transgene includes isolating the gene of interest from the tens of

thousands of other genes in the genome of a gene-donor species. Once that gene is isolated, it is

usually altered so it can function effectively in a host organism. That gene is then combined

with other genes to prepare it to be introduced into another organism, at which point its known

as a transgene.

Changes in the Genetic Landscape.

For at least 10,000 years-since long before the principles of classical genetics had been

scientifically established-human beings have brought about deliberate genetic changes in plants

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and animals through traditional reproductive methods. Many of the domestic animals, crops, and

ornamental plants in existence today are human creations, achieved through selective breeding

aimed at enhancing desired characteristics. In a broad sense, such genetic manipulation by

breeding for a desired outcome might be considered genetic engineering. In addition to these

intended changes, many alterations have occurred inadvertently through other practices,

including the ordinary practice of medicine. Many people with genetic disorders who in the past

would have died without any natural-born children now live into adulthood, passing on genes for

the disorder. The use of exogenous insulin to treat diabetes and the prescription of eyeglasses for

myopia are two examples of interventions that increase the prevalence in the population of

certain genes that can have deleterious effects for individuals. Medical screening for genetic

disorders and carrier status, when followed by decisions by the individuals screened to alter

reproductive behaviour, also affects the occurrence of genes in the population. These changes

have been a by-product of medical and technological interventions aimed at individuals, not at

the general population produced by technological methods rather than through selective

breeding.

Current Developments

Transgenics allow scientists to develop organisms that express a novel trait not normally found in

the species; for example, a type of rice known as golden rice has elevated levels of vitamin A.

Scientists have also developed sunflowers that are resistant to mildew and cotton that resists

insect damage. Possible transgenic combinations can be broken down generally into three

categories (here animal refers to nonhumans):

plant-animal-human combinations

animal-animal combinations

animal-human combinations

Transgenic plants can contain human proteins to produce edible vaccines.

An example of a plant-animal-human transgenic combination would be one in which the DNA of

mouse and human tumor fragments is inserted into tobacco DNA. The harvested plants contain a

potential vaccine against non-Hodgkins lymphoma.25 Other transgenic plants have been used to

25 Richter, R. 1999. Tobacco plant vaccine shows promise against non-Hodgkins lymphoma.

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create edible vaccines. By incorporating a human protein into bananas, potatoes, and tomatoes,

researchers have been able to create prototypes of edible vaccines against hepatitis B, cholera,

and diarrhea.26 The vaccines are proving to be successful in tests on agricultural animals and

humans.

Goats with spider genes produce spider silk proteins in their milk.

BioSteel is a product created from an animal-animal transgenic combination. Scientists at Nexia

Biotechnologies, a company based in Montreal, isolated the gene for silk protein from a spider

capable of spinning silk fibers-one of the strongest yet most resilient substances known- and

inserted it in the genome of a goats egg prior to fertilization. When the transgenic female goatsmatured, they produced milk containing the protein from which spider silk is made. The fiber

artificially created from this silk protein has several potentially valuable uses, such as making

lightweight, strong, yet supple bulletproof vests. Other industrial and medical applications

include stronger automotive and aerospace components and stronger, more biodegradable sutures

for closing wounds.27

Animal-human transgenic combinations represent a booming aspect of biotechnology. Here are

several examples:

Pig organs can be used for human transplants.

Pigs are often chosen as transgenic animals because their physiology and organ size are

so similar to humans. The hope is that pig organs can be used for organ transplantation, known

as xenotransplantation, alleviating the shortage of human hearts and kidneys, which are in

scarce supply. Researchers are also exploring the use of cell transplantation therapy for patients

with spinal cord injury or Parkinsons disease.28 There are several drawbacks to

xenotransplantation (discussed below).

26 Leahy, S. 2001. Edible Vaccines. Environmental News Network.27 See Nexia Biotechnologies web site, http://www.nexiabiotech.com.28 See Alexion Pharmaceuticals web site, http://www.alxn.com/f/15, click on transplantation link

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Other transgenic animals have medical uses, too.

Other uses of this transgenic combination include growing tissue on a scaffolding, or

supporting framework. This then can be used as a temporary skin substitute for healing

wounds29or burns30 or as replacement cartilage, heart valves,31 cerebrospinal shunts, or even

collagen tubes to guide re-growth of nerves that have been injured.32

Additionally, commercial companies seek to derive therapeutic proteins, such as

monoclonal antibodies, from the milk of transgenic cows, goats, rabbits, and mice and use them

to administer drugs in treatment of rheumatoid arthritis, cancer, and other autoimmune

disorders.33

Ethical Issues

Are we crossing species boundaries?

Some individuals have argued that crossing species boundaries is unnatural, immoral, and in

violation of Gods laws. This argument presumes that species boundaries are fixed and readily

delineated. However, a recent issue of theAmerican Journal of Bioethics reflects that the notion

of species boundaries is a hotly debated topic.134 Some bioethicists have pointed out there are a

variety of species concepts: biological, morphological, ecological, typological, evolutionary,

phylogenetic, to name a few.11 All of these definitions of what a species is reflect changing

theories and the varying purposes for which different species are used by individuals.

Will the technology facilitate transmission of disease?

While the issue of the morality of crossing species boundaries reflects differing world views and

may be conceptually unclear, there are known risks associated with xenotransplantation of

transgenic cells or organsfrom animals to humans. For example, there is a small but significant

29See http://www.organogenesis.com, http://www.ortecinternational.com/~johncapa/physicianInfo/orcel/index.shtml30See http://wound.smith-nephew.com/uk/Product.asp?NodeId=2053,http://www.genzymebiosurgery.com31 Seehttp://www.genzymebiosurgery.com32 Seehttp://www.integra-ls.com33 Seehttp://www.transgenics.com34 Glenn, L. M. 2003. Crossing Species Boundaries: Target Article and Open Peer Commentaries. American Journal

of Bioethics

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risk of the transmission of usually fatal zoonotic diseases, such as bovine spongiform

encephalopathy (also known as mad cow disease), porcine endogenous retroviruses (PERVs),

and Nipah encephalitis. The introduction of these diseases to the human population could have

devastating consequences. The U.S. Food and Drug Administration has banned

xenotransplantation trials using nonhuman primates until the procedure has been adequately

demonstrated to be safe and ethical issues have been sufficiently publicly discussed.

Is it ethical to create altered animals that may suffer?

The risks and benefits of the experimental use of animals need to be discussed as well. Similarly,

by combining animal DNA and human DNA with plant DNA, do we run the risk of creating new

diseases for which there is no treatment? The long-term risks to the environment are unknown.

Various bioethicists, environmentalists, and animal rights activists have argued that it is wrong to

create monsters or animals that would suffer as a result of genetic alternation (for example, a

pig with no legs), and that such experimentation should be banned.

Altering Humans

Is it possible the technology may be used to create slaves?

Several bioethicists have called for a ban on species-altering technology that would be enforced

by an international tribunal. Part of the rationale for a ban is the concern that such technology

could be used to create a slave race, that is, a race of subhumans that would be exploited. In April

1998, scientists Jeremy Rifkin and Stuart Newman, who are both opposed to genetically

modified organisms (GMOs), applied for a patent for a humanzee, part human and part

chimpanzee, to fuel debate and to draw attention to potential abuses on this issue. The United

States Patent and Trademark Office (USPTO) denied the patent on the grounds that it violated

the Thirteenth Amendment to the United States Constitution, which prohibits slavery. The

decision has been appealed, but the appeal has not yet reached a court, and it may never do so.

The appeal may be dismissed on other technical grounds.

Can the definition of human be applied to altered species containing human genes?

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Although the USPTO has permitted the extensive patenting of bioengineered life forms and

human DNA, the question that has been raised by Newman and Rifkins application is one that

will not be resolved easily: What constitutes a human being? A genetic definition is not very

helpful, given the variability of gene sequences between individuals. A species definition is

controversial, as mentioned earlier. If we look to characteristics for a definition, there are many

characteristics that humans share with primates and other animals. If we create a being that has

the ability to speak and perhaps even reason but looks like a dog or a chimp, should that being be

given all the rights and protection of a human being? Some bioethicists argue that the definition

of human being should be more expansive and protective, rather than more restrictive. Others

argue that definitions that are more expansive could be denigrating to humanitys status and

create a financial disincentive to patenting creations that could be of use to humanity. The

question of whether or not the definition should be more expansive or more restrictive will have

to be considered as courts, legislatures, and institutions address laws regarding genetic

discrimination.

Will society manipulate the genetic traits of children?

In a similar vein, the International Olympic Committee has expressed concern that athletes will

soon employ genetic engineering to get an edge. If individuals are willing to genetically

manipulate their children to make them better athletes, then its likely individuals will be willing

to manipulate their children to be brighter, better looking, more musically inclined, or whatever

the parents think would give them an advantage. Opponents of genetic manipulation argue that

by allowing this we run the risk of creating a race of superhumans, changing what it means to be

normal and increasing the ever-widening gap between the haves and the have-nots. Proponents of

genetic manipulation argue that currently parents can and do give their children advantages by

sending them to better schools or giving them growth hormone and that banning genetic

manipulation is a denial of individual liberties. These arguments also reflect the opposing

philosophies regarding how scarce resources should be allocated.

Transgenic biotechnology presents an exciting range of possibilities, from feeding the hungry to

preventing and treating diseases; however, these promises are not without potential peril. Some

of the issues that need to be considered are the following:

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Are we blurring the lines between species by creating transgenic combinations?

What are the known health risks associated with transgenics?

What are the long-term effects on the environment when transgenics are released in the

field?

What ethical, social, and legal controls or reviews should be placed on such research?

Transgenic biotechnology presents challenges, such as health risks.

Are we inflicting pain and suffering on sentient creatures when we create certain types of

chimeras?

Will transgenic interventions in humans create physical or behavioral traits that may or

may not be readily distinguished from what is usually perceived to be human?

If the blending of nonhuman animal and human DNA results, intentionally or not, in

chimeric entities possessing degrees of intelligence or sentience never before seen in nonhuman

animals, should these entities be given rights and special protections?

What unintended personal, social, and cultural consequences could result?

Will these interventions redefine what it means to be normal?

Who will have access to these technologies, and how will scarce resources be allocated?

An often held belief is that gene patents permit outsiders ownership of another persons genetic

makeup, often without their knowledge or consent.35

This concern has led to complaints thatpatients no longer control their own bodies and doctors are being constrained from testing for

various diseases.36 Professor Lori Andrews argues that patents hinder access to testing procedures

35 Michael Crowley, They Own Your Body, Readers Digest, August 2006 available at [http://www.rd.com].36 Debra G.B. Leonard, Medical Practice and Gene Patents: A Personal Perspective, Academic Medicine,

December 2002, 1388.

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because ...gene-patent holders can control any use of their gene; they can prevent a doctor

from testing a patients blood for a specific genetic mutation and can stop anyone from doing

research to improve a genetic test or to develop a gene therapy based on that gene.37 This

perceived constraint on research and testing options is an issue to opponents of gene patents. 38

According to Dr. Debra Leonard, patents on ...specific genetic information limits the medical

use of the information and impedes or prevents widespread research on the disease, the

traditional pathway by which medical knowledge is advanced and shared.39 However, other

experts disagree. As noted by Dr. Jorge Goldstein and Attorney Elina Golod, the courts have

consistently ...taken the position that a person does not own any tissues or cells once they are

outside the persons body.40 Attorneys Lee Bendekgey and Dr. Diana Hamlet-Cox found no

evidence of patients unable to utilize existing genetic tests because of patents. Instead, they

maintain, it is a financial issue associated with the cost of health care and/or an issue of profits

for the doctor or clinical geneticist wishing to administer tests patented by other inventors.41

Similarly, Professor Iain Cockburn found ...there is little quantitative evidence thus far of a

negative impact of patents on scientific research activity....42 From his perspective, the

disclosure obligations of the patent system may better serve the objective of encouraging the

diffusion of knowledge and raising social returns than the chief legal alternative, trade secret

protection.

Concerns About Playing God

Hardly a popular article has been written about the social and ethical implications of genetic

engineering that does not suggest a link between God-like powers and the ability to manipulate

the basic material of life. Indeed, a popular book about gene splicing is entitled Who Should Play

God?2, and in their June 1980 letter to the President, the three religious leaders sounded a tocsin

37 Lori B. Andrews, Genes and Patent Policy: Rethinking Intellectual Property Rights, Nature Reviews, October

2002, 80438 John F. Merz, Disease Gene Patents: Overcoming Unethical Constraints on Clinical laboratory Medicine,

Clinical Chemistry, 45:3, 1999, 324.39Medical Practice and Gene Patents: A Personal Perspective, 1388.40 Jorge A. Goldstein and Elina Golod, Human Gene Patents, Academic Medicine, December 2002, Part 2, 1321.41 Lee Bendekgey and Diana Hamlet-Cox, Gene Patents and Innovation, Academic Medicine, December 2002,

Part 2, 137842 Iain M. Cockburn, Blurred Boundaries: Tensions Between Open Scientific Resources and Commercial

Exploitation of Knowledge in Biomedical Research, April 30, 2005, 15, available at

[http://people.bu.edu/cockburn/cockburn-blurred-boundaries.pdf].

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against the lack of a overnmentalpolicy concerning [t]hose who would play God through

genetic engineering.

Religious Viewpoints

The Commission asked the General Secretaries of the three religious organizations to elaborate

on any uniquely theological considerations underlying their concern about gene splicing in

humans. The scholars appointed by the organizations to address this question were asked to draw

specifically on their particular religious tradition to explain the basis of concerns about genetic

engineering; further commentary was provided by other religious scholars.4 In the view of the

theologians, contemporary developments in molecular biology raise issues of responsibility

rather than being matters to be prohibited because they usurp powers that human beings should

not possess. The Biblical religions teach that human beings are, in some sense, co-creators with

the Supreme Creator.43 Thus, as interpreted for the Commission by their representatives, these

major religious faiths respect and encourage the enhancement of knowledge about nature, as well

as responsible use of that knowledge.44 Endorsement of genetic engineering, which is praised for

its potential to improve the human estate, is linked with the recognition that the misuse of human

freedom creates evil and that human knowledge and power can result in harm. While religious

leaders present theological bases for their concerns, essentially the same concerns have been

raised- sometimes in slightly different words-by many thoughtful secular observers of

contemporary science and technology. Concerns over unintended effects, over the morality of

genetic manipulation in all its forms, and over the social and political consequences of new

technologies are shared by religious and secular commentators. The examination of the various

specific concerns need not be limited, therefore, to the religious format in which some of the

issues have been raised.

Fully Understanding the Machinery of Life

43 Seymour Siegel, Genetic Engineering, in PROC. OF THE RABBINICAL ASSEMBLY OF AMERICA, New

York (1978) at 164.44 In the Biblical tradition of the major Western religions, the universe and all that exists in it is Gods creation. In

pagan religion, the gods inhabit nature, which is thus seen as sacrosanct, but the Biblical God transcends nature.

However, since God created the world, it has meaning and purpose. God has placed a special being on earth-

humans-formed in the image of God and endowed with creative powers of intelligence and freedom.

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Although it does not have a specific religious meaning, the objection to scientists playing God

is assumed to be self-explanatory. On closer examination, however, it appears to the Commission

that it conveys several rather different ideas, some describing the power of gene splicing itself

and some relating merely to its consequences. At its heart, the term represents a reaction to the

realization that human beings are on the threshold of understanding how the fundamental

machinery of life works.45 A full understanding of what are now great mysteries, and the powers

inherent in that understanding, would be so awesome as to justify the description God-like. In

this view, playing God is not actually an objection to the research but an expression of a sense of

awe and concern.

Since the Enlightenment, Western societies have exalted the search for greater knowledge, while

recognizing its awesome implications. Some scientific discoveries reverberate with particular

force because they not only open new avenues of research but also challenge peoples entire

understanding of the world and their place in it. Current discoveries in gene splicing like the new

knowledge associated with Copernicus and Darwin further dethrone human beings as the unique

center of the universe. By identifying DNA and learning how to manipulate it, science seems to

have reduced people to a set of malleable molecules that can be interchanged with those of

species that people regard as inferior. Yet unlike the earlier revolutionary discoveries, those in

molecular biology are not merely descriptions; they give scientists vast powers for action,

Arrogant Interference with Nature

By what standards are people to guide the exercise of this awesome new freedom if they want to

act responsibly? In this context, the charge that human beings are playing God can mean that in

creating new life forms scientists are abusing their learning by interfering with nature. But in

one sense all human activity that produces changes that otherwise would not have occurred

interferes with nature. Medical activities as routine as the prescription of eyeglasses for myopia

or as dramatic as the repair or replacement of a damaged heart are in this sense unnatural. In

another sense human activity cannot interfere with nature in the sense of contravening it since all

human activities, including gene splicing, proceed according to the scientific laws that describe

45 As science journalist Nicholas Wade has observed:

We are about to enter an explosive phase of discovery in which we are going to reach close to the great goal of

estern inquiry: the complete understanding of man as a physical-chemical system.

NOVA, LIFE: PATENT PENDING, WGBH Transcripts, Boston (1982) at 24.

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natural processes. Ironically, to believe that playing God in this sense is even possible would

itself be hubris according to some religious thought, which maintains that only God can interfere

with the descriptive laws of nature (that is, perform miracles). If, instead, what is meant is that

gene splicing technology interferes with nature in the sense that it violates Gods prescriptive

natural law or goes against Gods purposes as they are manifested in the natural order, then some

reason must be given for this judgment. None of the scholars appointed to report their views by

the three religious bodies that urged the Commission to undertake this study suggested that either

natural reason or revelation imply that gene splicing technology as such is unnatural in this

prescriptive sense. Although each scholar expressed concern over particular applications of gene

splicing technology, they all also emphasized that human beings have not merely the right but the

duty to employ their God-given powers to harness nature for human benefit. To turn away from

gene splicing, which may provide a means of curing hereditary diseases, would itself raise

serious ethical problems.46

Creating New Life Forms

If creating new life forms is simply producing organisms with novel characteristics, then

human beings create new life forms frequently and have done so since they first learned to

cultivate new characteristics in plants and breed new traits in animals. Presumably the idea is that

gene splicing creates new life forms, rather than merely modifying old ones, because it breaches

species barriers by combining DNA from different species-groups of organisms that cannot

mate to produce fertile offspring. Genetic engineering is not the first exercise of humanitys

ability to create new life forms through nonsexual reproduction. The creation of hybrid plants

seems no more or no less natural than the development of a new strain ofE. coli bacteria through

gene splicing. Further, genetic engineering cannot accurately be called unique in that it involves

46 Pope John Paul II, who had earlier been critical of genetic engineering, recently told a convocation on biological

experimentation of the Pontifical Academy of Science of his approval and support for gene splicing when its aim is

to ameliorate the conditions of those who are affected by chromosomic diseases because this offers hope for thegreat number of people affected by those maladies. I have no reason to be apprehensive for those experiments in

biology that are performed by scientists who, like you, have a profound respect for the human person, since I am

sure that they will contribute to the integral well-being of man. On the other hand, I condemn, in the most explicit

and formal way, experimental manipulations of the human embryo, since the human being, from conception to

death, cannot be exploited for any purpose whatsoever....I praise those who have endeavoured to establish, with full

respect for mans dignity and freedom, guidelines and limits for experiments concerning man. Pope John Paul II, La

sperimentozione in biologia deve contribuire albene integrale delluomo, LOSSERVATORE ROMANO, Rome,

Oct. 24, 1982, at 2.

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the creation of new life forms through processes that do not occur in nature without human

intervention. As described in Chapter Two, scientists have found that the transfer of DNA

between intervention. Yet, as one eminent scientist in the field has pointed out, it would be

unwarranted to assume that a dramatic increase in the frequency of such transfers through human

intervention is not problematic simply because DNA transfer sometimes occurs naturally.47

In the absence of specific religious prohibitions, either revealed or derived by rational argument

from religious premises, it is difficult to see why breaching species barriers as such is

irreligious or otherwise objectionable. In fact, the very notion that there are barriers that must be

breached prejudges the issue. The question is simply whether there is something intrinsically

wrong with intentionally crossing species lines. Once the question is posed in this way the

answer must be negative unless one is willing to condemn the production of tangelos by

hybridizing tangerines and grapefruits or the production of mules by the mating of asses with

horses.

There may nonetheless be two distinct sources of concern about crossing species lines that

deserve serious consideration. First, gene splicing affords the possibility of creating hybrids that

can reproduce themselves (unlike mules, which are sterile). So the possibility of self-perpetuating

mistakes adds a new dimension of concern, although here again, the point is not that crossing

species lines is inherently wrong, but that it may have undesirable consequences and that these

consequences may multiply beyond human control. As noted, the Commissions focus on the

human applications of gene splicing has meant that it does not here address this important set of

concerns, which lay behind the original self-imposed moratorium on certain categories of gene

splicing research and which have been, and continue to be, addressed through various scientific

and public mechanisms, such as RAC.48

47 Robert L. Sinsheimer, Genetic Research: The Importance of Maximum Safety and Forethought (Letter), N.Y.

TIMES, May 30, 1977, at A-14.48 Despite the great attention paid to the biohazards of the research with, and products of, gene splicing, the

nvironmental Impact Statement filed by NIH on its RAC guidelines focuses on the health effects on humans, plants,

and animals and does not deal with ecosystems as entities. Subsequently, however, the Environmental Protection

Agency has supported research on the effects of introducing recombinant organisms on the stability of various

ecosystems.

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Second, there is the issue of whether particular crossings of species especially the mixing of

human and nonhuman genes might not be illicit. The moral revulsion at the creation of human-

animal hybrids may be traced in part to the prohibition against sexual relations between human

beings and lower animals. Sexual relations with lower animals are thought to degrade human

beings and insult their God-given dignity as the highest of Gods creatures. But unease at the

prospect of human-animal hybrids goes beyond sexual prohibitions.

The possibility of creating such hybrids calls into question basic assumptions about the

relationship of human beings to other living things. For example, those who believe that the

current treatment of animals in experimentation, food production and sport is morally suspect

would not be alone in being troubled by the prospect of exploitive or insensitive treatment of

creatures that possess even more human-like qualities than chimpanzees or porpoises do. Could

genetic engineering be used to develop a group of virtual slaves- partly human, partly lower

animal to do peoples bidding? Paradoxically, the very characteristics that would make such

creatures more valuable than any existing animals (that is, their heightened cognitive powers and

sensibilities) would also make the moral propriety of their subservient role more problematic.

Dispassionate appraisal of the long history of gratuitous destruction and suffering that humanity

has visited upon the other inhabitants of the earth indicates that such concerns should not be

dismissed as fanciful.

Accordingly, the objection to the creation of new life forms by crossing species lines (whether

through gene splicing or otherwise) reflects the concern that human beings lack the God-like

knowledge and wisdom required for the exercise of these God-like powers. Specifically, people

worry that interspecific hybrids that are partially human in their genetic makeup will be like Dr.

Frankensteins monster. A striking lesson of the Frankenstein story is the uncontrollability and

uncertainty of the consequences of human interferences with the natural order. Like the tale of

the Sorcerers apprentice or the myth of the golem created from lifeless dust by the 16 th century

rabbi, Loew of Prague, the story of Dr. Frankensteins monster serves as a reminder of the

difficulty of restoring order if a creation intended to be helpful proves harmful instead. Indeed,

each of these tales conveys a painful irony: in seeking to extend their control over the world,

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people may lessen it. The artifices they create to do their bidding may rebound destructively

against them the slave may become the master.

Suggesting that someone lacks sufficient knowledge or wisdom to engage in an activity the

person knows how to perform thus means that the individual has insufficient knowledge of the

consequences of that activity or insufficient wisdom to cope with those consequences. But if this

is the rational kernel of the admonition against playing God, then the use of gene splicing

technology is not claimed to be wrong as such but wrong because of its potential consequences.

Understood in this way, the slogan that crossing species barriers is playing God does not end the

debate, but it does make a point of fundamental importance.49It emphasizes that any realistic

assessment of the potential consequences of the new technology must be founded upon a sober

recognition of human fallibility and ignorance. At bottom, the warning not to play God is closely

related to the Socratic injunction know thyself: in this case, acknowledge the limits of

understanding and prediction, rather than assuming that people can foresee all the consequences

of their actions or plan adequately for every eventuality.50

Any further examination of the notion that the hybridization of species, at least when one of the

species is human, is intrinsically wrong (and not merely wrong as a consequence of what is done

with the hybrids) involves elaboration of two points. First, what characteristics are uniquely

human, setting humanity apart from all other species? And second, does the wrong lie in

bestowing some but not all of these characteristics on the new creation or does it stem from

depriving the being that might otherwise have arisen from the human genetic material of the

49 [W]hat made the Gallilean and the other major scientific revolutions disturbing is the reductionism, that we

become less than what we are. [T]hat is what is so uncertain about gene therapy, because it gets back to a very

fundamental question... Is there anything unique about humans? And if there isnt anything unique about humans,

theres nothing wrong with doing gene manipulation. But if there is something unique about humans, then it iswrong to pass over the barrier, wherever the barrier isbut we dont know where the barrier is. But as soon as you

ask, Where is the barrier? you ask, Is there a barrier? And thats frightening. If theres nothing unique about

humansthats not a theological question but a very real one. Testimony of Dr. French Anderson, transcript of 22nd

meeting of the Presidents Commission (July 10, 1982) at 115-18.50 12 As one physician-scientist has remarked, We must all get used to the idea that biomedical technology makes

possible many things we should never do. Leon Kass, The New Biology: What Price ReducingMans Estate?, 174

SCIENCE 779 (1971). See also, Ethical issues in experiments with hybrids of different species, Appendix I, in

Churchand Society Office, MANIPULATING LIFE, World Council of Churches. Geneva (1982) at 28.

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opportunity to have a totally human makeup? The Commission believes that these are important

issues deserving of serious study.

It should be kept in mind, however, that the information available to the Commission suggests

that the ability to create interspecific hybrids of the sort that would present intrinsic moral and

religious concerns will not be available in the foreseeable future. The research currently being

done on experimentation with recombinant DNA techniques through the use of single human

genes (for example, the insertion of a particular human hemoglobin gene into mouse cells at the

embryonic stage) or the study of cellular development through the combining of human genetic

material with that of other species in a way that does not result in a mature organism (for

example, in vitro fusion of human and mouse cells) does not, in the Commissions view, raise

problems of an improper breaching of the barriers.

CONCLUSION

Whether at academic institutions or private corporations, privatizing isolated or purified human

genes promotes commercialization and risk-taking. These are beneficial to society. There is a

spectrum of human gene patents, however, depending on the subject matter they encompass. This

spectrum ranges from those for which the pro patent arguments are clearest, such as patents on

DNA-encoding protein drugs, to those for which the arguments are the most confusing, such as

patents on DNA-encoding human molecular receptors. Human gene patents on molecular

receptors have more in common with platform technologies than with synthetic drugs, in that

they are broadly enabling and allow the generation of many subsequent inventions. In this sense,

the role of patents in their discovery and exploitation, especially in an academic context, is at the

outer edge of the spectrum. Diagnostic human DNA probe patents are in the middle, closer to the

synthetic drugs.

It is not possible to create an effective legal system that distinguishes between the different

classes of human genes or the different institutions of discovery. This is especially so because

within a given class of genes there are multiple uses. A human receptor can be used as a drug

discovery tool, or as an antigen for the generation of blocking therapeutic antibodies. A human

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DNA sequence can be used as a diagnostic hybridization tool or as a template for ecombinant

production of a protein drug. A university receiving federal funds is urged not to seek patent

exclusivity to human receptor genes, whereas a private firm whose main source of income is the

discovery of novel receptor genes and their uses in drug screening wants to be assured some

exclusivity in order to protect its investments.

The lines are not clear at all. The law would be foolhardyto try and draw sharp lines, asserting

that some genes or uses are patentable to some parties while other genes are not. In addition,

precluding certain genes from patentability would be shortsighted, in that it would create

prohibitions that we might well regret in the future.

Luckily, the system is self-adjusting. For example, if patenting isolated human gene receptors is

seen by some in the market as not a worthy endeavor, patents will not be filed as seems already

to be occurring.

Human gene patents can be enforced against those who are involved in profit seeking ventures

with commercial intent. They cannot be enforced against those who are doing research for the

joy of curiosity or seeking knowledge. The patents do not cover human genes in your body or

mine. We own our genes until such time as they are removed from our bodies, at which point we

no longer do, unless we are prescient enough to do a deal with our doctor before the nurse starts

drawing blood. Even at that time, however, we may not be able to make, use, or sell our own

genes with commercial intent if someone else has a patent on them.

Neither the founders of the patent statute in Venice nor Jefferson, the founder of the U.S. patent

system, could have imagined this discussion. If they heard us now, they might think of this idea

of patenting human genes as lunacy. Of course, they might not have imagined that the patent

system would still be alive and well hundreds of years later, supporting astounding and diverse

technological developments such as birth control pills, jet engines, and computers. Patentable

inventions, by definition, cannot be obvious. There- fore, if the Venetians and Jefferson thought

about it some more and took the time to listen to us, they would understand that it had been

precisely their intent to create a system to protect shockingly unexpected and unpredictable

areas of human research. They would be pleased that the system has worked so well. They would

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then no doubt lustily join us in the debate as to whether university-held patents on purified genes

for human molecular receptors should be exploited by reach-through royalties or not.

We can see them arguing in our minds eye and, although we cannot hear them, we have a pretty

good guess as to what their views would be.

Documents

PATENTING OF HUMAN GENE AND ETHICAL DISQUIET