are stem cells patentable?

7/27/2019 Are Stem Cells Patentable?

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Nirma University

Institute of Law

VII Semester, B.Com. LL.B. (Hons.) Course

Article Writing

Area: Stem Cells Patent

Topic: Are Stem Cells patentable? - A Case study on WARF

Subject: Intellectual Property Rights

Submitted To

Mr. Anandkumar Shindhe (Asst. Professor)

Prepared & Submitted By

Parth Patel

(10BBL108)


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Abstract

Stem Cell exploration and other branches of the biotechnology have led to the innovations,

which are likely to be protected by the Intellectual Property Rights. To be more precise, patents

are the most prominent structure of protection. An innovation with the protection is a stairway tothe development of any nation. Before marching towards the actual problem, we need to

understand what stem cells are and what they are capable of. Stem Cells are those cells which

has the capability to become any category of cell in the body and which is a rich source in curing

the diseases and cancer and also which has the ability in regenerating some of the lost body parts.

But after all, every development has some or the other huddle. The question arises as to whether

the things which are produced naturally are patentable or not. Some arguments tell us that people

are not property, patenting human tissues, genes, etc. as if they are some sort of market

commodities and so on. These arguments do hold some strength but what is the correct thing to

do depend upon the various judgments given by the courts around the globe. One of the

landmark case studies is the WARF (Wisconsin Alumni Research Foundation) case, in which the

European Patent Office had taken a stand by stating that it might deny the patent of the human

body parts on the ethical grounds, commercial purposes and against the public order. The debate

on this ground is still on the run as the judgments from the nations contradict each other. On the

other hand, USPTO (United States Patent and Trademark Office) had accepted and issued the

patent application made by the WARF on patenting genetic materials. This might seem

confusing as the judgments given by the courts of different nations contradict but at the same

time the question remains a question as to whether the stem cells are patentable or not.

Keywords: WARF ((Wisconsin Alumni Research Foundation), Patent, Stem Cell, European

Patent Office, USPTO (United States Patent and Trademark Office), Innovations, Intellectual

Property Rights, Development, European Court of Justice, Morality, Commercial, Enlarged

Board of Appeal, European Patent Convention, European Union.


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What is a Patent?

The patent owner obtains the exclusive right to make, use, and sell an invention in exchange for

publicly disclosing the invention.1

Whatever object or a thing a person invents which is a

novelty, non obvious and which can be later on used for industrial and commercial purpose is

known as a Patent. Generally a patent owner is being granted 20 years of monopoly over his

invention and after this time-limit, the invention becomes public.

What is a Stem Cell?

Stem cells are mother cells that have the ability to develop into any type of cell in the body. One

of the main characteristics of stem cells is their ability to self-renew or multiply while

maintaining the potential to develop into other types of cells.2

Stem cells can become cells of theblood, heart, bones, skin, muscles, brain etc.

3They have the ability to reproduce themselves and

to fix and replace other tissues in the human body. Other stem cells repair damage to the bodys

tissues, for example, rebuilding damaged muscle tissue.4

The potential use of stem cell cures

heart diseases, leukemia (blood cancer), diabetes and other chronic ailments according to one of

the major bio-tech breakthroughs.

What is an Embryonic Stem Cell?

Embryonic stem cells are Pluripotent5

stem cells resulting from the inner cell mass of

a blastocyst, an early-stage embryo. Human embryos reach the blastocyst stage 45 days

post fertilization.6

Extracting the inner cell mass will result into destruction of the fertilized

human embryo. This raises the issues on the grounds of immorality and against the public order.

1 Stem Cell Research Patent Landscape (BriefingNote), information retrieved from The Hinxton Group: An

International Consortium on Stem Cells, Ethics & Law.2 Mandal, Dr. Ananya, What are Stem Cells. Information is retrieved from medical news distribution channel

namely News Medical.3Ibid4 What are Stem Cells? Information is retrieved from: http://www.stemcellnetwork.ca5 ESCs are Pluripotent which means that they have the ability to develop into each of the more than 200 cell types

of the adult body.6 Information is retrieved from: http://encyclopedia.thefreedictionary.com/Embryonic+stem+cell


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Patenting (Embryonic) Stem Cells and Life Forms

Over the years there has been a controversy over classifying the human body parts and tissues as

property.7

Some would argue that people are not property as the living things are the products of

nature and they cannot be put into the purview of property. These arguments have been raised

when it comes under the context of patenting human genes and stem cells. Apart from these

arguments, classifying the human tissues or the living things as property has raised an issue that

such life forms have been treated and referred to as a commodity as if is a subject to the market

forces. Where applied to human cells or tissues, property notions are often seen as offensive to

human dignity.89

For last three to four decades, the outlaw of patenting the natures products has been under

attack. While customarily the patenting of animals and plants were prohibited but in 1980 the

United States Supreme Court in the case ofDiamond v. Chakrabarty10

allowed the patenting of

those living substances which were created artificially or in a laboratory. As a result of Diamond

v. Chakrabarty, since 1980 virtually any living thing that can be reproduced or tainted by human

intervention has been patentable.11

The question before the Court was whether the claimed

microorganism constituted a manufacture or composition of matter within the meaning of

the US Patent Act.12

The Supreme Court concluded by stating that anything under the sun that

is made by man is eligible for patenting. But in India, as per the Guidelines for Examination ofBiotechnology Applications for Patent, discovery of living and non living substances occurring

in nature is not patentable13

except microorganisms. Although, microorganisms are barred from

the list of non-patentable item/objects, but if Section 3(j) is read with Section 3(c) of The Patents

Act, 1970, it implies that only modified microorganisms, which do not represent the invention of

living thing occurring in nature, are patentable.

7 Knowles, Lori, Stem Cell Patents, (pg.1). Stem Cell Network8 See also id. at pg. 29 Knowles, Lori, Commercialization and Stem Cell Research, Stem Cell Network10 447 US 303 (1980)11 Supra note 712 Robinson, Douglas and Medlock, Nina (October, 2005), Diamond v. Chakrabarty: A Retrospective on 25 Years

of Biotech Patents, Intellectual Property and Technology Law Journal, (Vol. 17) (10). 13 Section 3 (c) of The Patents Act, 1970


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In many countries patent laws; there is one exception that those inventions which results into the

rise of ethical issues, immorality and which are against the public order are not patentable. The

example of such exception is patenting Human Embryonic Stem Cells, which is one of the most

hotly contested topics in patenting bio-technological inventions. Every country has different

exceptions in patent law; for example Canada and U.S have no morality exception in patent law14

but European countries have. In Europe, the European Patent Convention states that the

European Patent Office may reject patents on moral grounds, if the commercial misuse of those

patents is against ordre public (public order) or morality. Examples of things that are against

public order include patents using human embryos for industrial or commercial purposes.15

The core question in patenting stem cells is that whether patenting human embryonic stem cells

is acceptable from a moral point of view. There is no easy and nave answer to the issue.

Although, the European Patent Convention has wider interpretation subject to the above stated

issue out of which the most common interpretation is the prohibition of patenting of inventions

whose commercial exploitation would be contrary to the public order or morality.16

European

Patent Convention says that Community patents shall not be granted for biotechnical inventions

that engage the use of human embryos for commercial purposes.17

In Oliver Brstle v.

Greenpeace e.V.18

, the European Court of Justice held that the EU B iopatent D ir ective was

meant to assure harmonized patent protection for biotechnological inventions in the European

Union. Article 6 of the European Biopatent Directive was referred in this case which states that

patents contrary to ordre public and morality are excluded from patentability.

The European Biopatent Directives and European Patent Convention has inserted the provisions

which would provide the protection from patenting human embryonic stem cells on the grounds

that it would be contrary to public order if it is used commercially or for industrial purpose. But

why would it be against morality? What is the reason behind including the embryonic stem cell

in the list of Non-Patentability? Perhaps, the questions could be answered in the case study of

Wisconsin Alumni Research Foundation (WARF).

14 Supra note 115 Supra note 716 Article 53(a) in the European Patent Convention (EPC)17 Stenbck, Maria, (2009), Human embryonic stem cells - one step closer to a clearly established practice.

Available from: http://www.awapatent.com/?id=15951

18 C-34/10
http://www.awapatent.com/?id=15951http://www.awapatent.com/?id=15951


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Case Study on WARF

Background

In 1990s, James Thomson from University of Wisconsin-Madison developed a technique whichcan develop primate embryonic stem cells. So, in the year 1996, Wisconsin Alumni Research

Foundation filed a patent application for patenting Primate Embryonic Stem Cells. The other two

stem cell patents19

were issued between the year 1998 and 2006. It is important to note that

WARF tried to patent embryonic stem cells overseas in Europe, but it was refused on the moral

grounds.20

It is also necessary to note that United States Patent and Trade Mark Office (USPTO)

had granted the stem cell patents to WARF because U.S has no moral exceptions in filing patent

application unlike Europe. WARF has permitted two companies, Geron and Wicell, to license its

patents to various users including the National Institutes of Health (NIH), Centers for Diseases

Control (CDC) and the US Food and Drug Administration (FDA) to utilize the human embryonic

stem cells in research.21

This agreement also allows the NIH to issue embryonic stem cells to

educational institutions for research.

In 2006 the USPTO received request to reconsider the WARF patents from the California-based

Foundation for Taxpayer and Consumer Rights and the New York-based Public Patent

Foundation. It was in dispute that it is a non-patentable subject matter, as the separation of stem

cells was obvious given the position of earlier scientific discoveries and non-patentable subject

matter as in contravention to the Patent Act provisions on morality. In 2008 the USPTO upheld

the WARF patents as it would mean that WARF will continue to control primary Intellectual

Property Rights to embryonic stem cell research in the United States.22

Later on, in the light of

the decision of USPTO, the EPO denied patenting on human embryonic stem cell.

In the patent application filed by WARF, was a claim covering compositions containing

Pluripotent Human Embryonic Stem Cells and such compositions could only be made by a

19 WARF had three stem cell claims known as 780, 806 and 913 patents.

20 Klntz, Stephen, (May 13, 2012), Stem Cell Monopoly: The Debate over Wisconsin Alumni Research

Foundations stem cell patents. Information retrieved from: http://www.patexia.com/feed/stem-cell-monopoly-the-

debate-over-wisconsin-alumni-research-foundation-s-stem-cell-patents21 Mandal, Dr. Ananya, Stem Cell Patents. Information retrieved from medical news distribution channel namely

News Medical.22 Supra note 7


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process that involved the destruction of human embryos but the application was filed long before

in the year 1996.23

The European Patent Offices Examining Division contended that the patent

claim must be rejected according to the provisions of Rule 28 (c) and Article 53 (a) of the

European Patent Convention. Article 53 (a) of EPC reads as: European patents shall not be

granted in respect of ... inventi ons the commercial exploitati on of which would be contrary to

ordre public or morality; such exploitation shall not be deemed to be so contrary merely

becauseit is prohibited by law or regulation in some or all of the Contracting States. Also,

Rule 28 (c) reads as: under Article 53(a), European patents shall not be granted in respect of

biotechnological inventions which, in particular, concern theuses of human embryos for

industrial or commercial purposes.The EPO highlighted that it was not ruling out all patents

on Embryonic Stem cells, rather it issued the elimination because derivation of Embryonic Stem

cells at the time of patent filing necessarily involved destruction of human embryos.24

Before noting the issues and decision of the case, it is necessary to understand some factual

aspects such as potentiality of human embryonic stem cell. The Embryonic Stem Cells have the

potential to contribute to all tissue types in the body25

, thats why it has a property which is

termed as Pluripotency. When Embryonic Stem Cells are extracted, they are not fully developed

which makes them more flexible in becoming any one of the 200 cell types that can make up any

part of the human body. It must also be noted that the Embryonic Stem Cells exist only at the

earliest stages of embryonic development and go on to form all the cells of the adult

body.26

When these cells are separated from the embryo and developed in a lab they can continue

isolating for an indefinite period, maintaining the ability to shape more than 200 adult cell types.

Subsequently, the WARF had made an appeal on the rejection of their patent application and on

hearing the appeal; the Technical Board of Appeal of EPO had referred four questions which

arose after interpreting the Rule and Article27

to the Enlarged Board of Appeal (EBoA).

23 S Sterckx and J Cockbain, "Assessing the Morality of the Commercial Exploitation of Inventions Concerning

Uses of Human Embryos and the Relevance of Moral Complicity: Comments on the EPOs WARF Decision",

(2010) 7:1 SCRIPTed 83, http://www.law.ed.ac.uk/ahrc/script-ed/vol7-1/sterckx.asp24 Supra note 125 Gepstein, Lior, Derivation and Potential Applications of Human Embryonic Stem Cells. Circulation Research.

2002; 91:866-87626

Stem Cell Definitions (Californias Stem Cell Agency)27 Here, Rule and Article refers to Rule 28(c) and Article 53 (a) of European Patent Convention.


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I ssues Raised

Issues which were put to the EBoA were:

WARF application was filed before the Rule was enacted. So does the rule apply to the

application?

If the rule is applicable, then does the rule deny the patentability to compositions of

Pluripotent Human Embryonic Stem Cells28

, the creation of which would lead to the

destruction of human embryo?

If the answers to the above Questions are in negation, then does the Article reject

patentability to compositions of Human Embryonic Stem Cells?

Would the answer to Question (2) or (3) have been different if, after the WARF application

was filed, it had become possible to produce the claimed Human Embryonic Stem Cell

compositions without having to destroy human embryos?29

Decisions

From the above issues, the initial question which arises is that does the Rule apply to the

application which has been filed before the enactment of the rule. The Enlarged Board of Appeal

answered in strong affirmation that, The in troduction of thi s new chapter [ i.e. of the Rule]

without any tr ansiti onal provisions, can only be taken as meaning that thi s detail ed guidance

[ i.e. that provided by the Rule] on what was patentable and un -patentable was to be applied as

a whole to all then pending applications.30

The EBoA also took the stand by referring to the

Dolder31

article by stating that, instrumentalization of the human body, thus degrading it to

an object of technology, had been considered as barr ier to patentabil ity. There is no indication

that the commercial exploitation of human embryos was ever r egarded as patentable.32

The

main reason behind the decision was that there has never been anything which would suggest

that commercial exploitation is considered as patentable. Even the WARF and majority ofamicus curiae had supported the decision. Thus, relating to question 1, Rule 28 (c) of EPC would

28 Supra note 2329

Id.30 European Patent Office (2009), Official Journal, Issue 5, pg. 321-32231 (Dolder), 1984, Barriers to patentability of biotechnological inventions under the EPC 32 Supra note 30. See pg. 322


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be applicable to all the pending patent applications, even those which were filed before the

enactment of the rule.

The second issue was based on the fact that the research would include the destruction of the

human embryos. The question is that whether the destruction of human embryos falls under the

purview of Rule 28 (c) which excludes the patenting of the biotechnological inventions that uses

human embryos for industrial purpose. The EBoA answered the question in affirmatively. But

according to some industrialists such decision would be an obstacle in the way of further

progress of Human Embryonic Stem Cell research. Certainly, I cannot jump to the conclusion by

stating that Yes it would put an end to the further research. If the embryonic stem cell research

is allowed for achieving the development in the field of Biotech, then it must not be forgotten

that it happened by destroying human embryos. The EBoA explained that biotechnical

inventi ons that involve the use of human embryos for industri al or commercial pur poses

constitute a form of inventi ons whose commercial exploitati on would be contrar y to public

order or morality.33

The EBoA also explained that why this Board considers the performing of

this creation as industrial exploitation by stating that, it is not the fact of the patenting itself that

is considered to be against public order or morality, but it is the performing of the creation which

includes the step of necessary destruction of human embryo that has to be considered.34

In other words, it can be said that this research compels a human being to give up their life

without permission in the hope that their cells will be used in treatment to cure another human

being someday. Human beings, whether they are in embryonic or infant stage differ from only

extraneous factors like age, development stage, size, lack of understanding, etc. from the mature

human beings; and in view of that they should be and are equally entitled to the lawful

protection.35

If a reply to issue (3) is to be given then the scope of Article 53 (a) has to be taken in a broader

sense. But, if we refer to the reply given by EBoA, it seems incomplete. The EBoA commentedthat Rule 28 (c) does fall under the ambit of Article 53(a) of EPC and no further explanation was

made because Question (1) and (2) were already in affirmation. Instead there was supposed to be

33 Supra note 1734 Supra note 30. See pg. 32935 The Ethics of Embryonic Stem Cell Research and Human Cloning,Family Research Council. Available from:

http://www.frc.org/content/the-ethics-of-embryonic-stem-cell-research-and-human-cloning


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an analysis made as to whether the WARF application disregards the Article. From the wordings

of the bare reading of Article 53(a), it must be noted that inventions excluded from patenting on

the grounds of immorality, should not be merely decided on the basis of law or regulation, but it

must also be decided ethically. The aim of taking the ground of ethically putting a ban on

patenting is to stop the commercialization.36

The statement which was provided by the Enlarged

Board of Appeals that there is no indication that the commercial exploitation of human embryos

was ever regarded as patentable clearly marks as conflicting. The main reason behind this is that

Edinburgh Patent37

concerns a lot when we refer it to the present case. The Edinburgh Patent

case had raised issues that are identical to the WARF case. The Edinburgh Patent was opposed,

but what needs to be taken care of is that EPO had granted the patent for the same. This clearly

contradicts the statement by EBoA that there is no indication that the commercial exploitation of

human embryos was ever regarded as patentable. This raises an issue that the decisions given by

EBoA are not uniform in nature. Human dignity is an essential concept when any ethical issue

arises as has been recognized by EBoA. But apart from this issue, however, the Enlarged Board

of Appeal had successfully recognized the intention of the Rule as being to prevent the

commercialization of human embryos and to prevent human embryos from being used as a

commodity.

To sum up the segment, while stating that since the WARF claims could be rejected under the

Rule it was not necessary to consider the Article, the Enlarged Board of Appeal however hinted

that the root for rejecting the WARF application under the Article would be that commercial

exploitation of the claimed subject matter would involve commercialization and

commodification of human embryos, which would be a violation of human dignity.38

Thus, the

issue of the WARF patent application clearly disregards the Article.

In the light of the fourth issue, the EBoA stated that technical progress which became widely

accessible only after the filing date cannot be taken into consideration. The EBoA only holds the

36 Supra note 2337 Prof. Smith and Dr. Mountford patented their invention in 1993 at the Institute for Stem Cell Research (then

Centre for Genome Research). The patent consisted of rights over methods of isolating, selecting and propagating

animal stem cell. The opposition raised an issue that animal included human under scientific classification. This

case has faced a great controversy because EPO had granted and issued the patent. The patent is now valid in the

amended form resulting from the opposition procedure held in 2002.38 Supra note 23. See question 5. Does the Article preclude patentability?


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decision that unpatentable creation regarding human stem cell can only be acquired by

destroying human embryos.


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Ethical Issues

If the research of embryonic stem cells would have been allowed, then there would be a

tremendous achievement in the medical science. WARFs development on embryonic stem cells

would have made these cells so flexible that they can take form of over 200 cell types in human

body. The patent of this research represents a step ahead in scientific growth. The granting of

patents on embryonic stem cells vary from country to country, based on their morality principles,

which some countries have and some may not. As discussed earlier, the patenting of the

embryonic stem cell can be granted, in fact was granted to WARF, in United States and

Canada39

, because these countries dont have morality as an exception.

Granting patent behind such researches might be a valuable investment, but EPO refuses to

provide such researches a patent because The EPC has a law that nothing can be patented if that

research is against the public order and immoral, which includes the destruction of human

embryos. This can be considered as a great disadvantage for some of the researchers. These

regulations bring us closer to the reality as after this, we question ourselves that is an embryo a

human being? This question brings us to the heart of human cloning. Those who oppose human

cloning, including me, argues that such procedure represents children as a commodity which is

being made in the laboratory-which can also raise a serious problem pertaining to personality,

empathy and self image. University of Chicago Professor Dr. Leon Kass, Chairman of thePresident's Council on Bioethics explains that:

40

Any attempt to clone a human being would constitute an unethical experiment upon the

resulting child-to-be. In all the animal experiments, fewer than two to three percent of all

cloning attempts succeeded. Not only are there fetal deaths and stillborn infants, but many of the

so-called 'successes' are in fact failures. As has only recently become clear, there is a very high

incidence of major disabilities and deformities in cloned animals that attain live birth. Cloned

cows often have heart and lung problems; cloned mice later develop pathological obesity; other

live-born cloned animals fail to reach normal developmental milestones.

39 The Canadian Intellectual Property Office (CIPO) has granted WARF a patent for primate embryonic stem cell.40 Supra note 35


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The debate is still on-going whether human embryos can be termed as under human beings. We

can assume that if they are not human beings, then (1) the promise of progress in scientific

understanding, (2) the vision of developing useful therapies, and (3) the general principle of

freedom of scientific inquiry would make a devastating case for funding research involving

embryo destruction.41

But, if they are termed as human beings then, there would be a total ban on

the funding embryonic research and a ban on carrying out such destructive research.

On the other hand, WARF decision has not been able to clear up the status of patentability. The

decisions have not been uniform in nature because there are many cases in which the patents

have been granted such as in the case of OliverBrstle v. Greenpeace e.V., wherein the patent

pertaining tomammalian embryonic stem cells was granted in the year 2006, the case of

Edinburghs Patent, etc. But as far as the morality and ethical issues are concerned, there is a

need for an amendment in the regulations of USPTO and CIPO to exclude the patenting of those

methods which are immoral and involves necessary destruction of human embryos. If such law is

formulated then it would be a great achievement not in terms of scientific development but in the

terms of protecting and respecting humanity around us.

41 id


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Conclusion

Based on the above analysis, I would like to conclude by highlighting that human dignity and

right to life shouldnt be denied. Humans, when they are in the embryonic stage of infant, they

do not differ in category from the matured human beings, but only differ in factors like age,

developmental stage and size. On the basis of this, they are also equally entitled to lawful

protection and shouldnt be used as a product, which is beneficial to others. Every person who is

born and who will be born possess the right to life, as they cannot be used as an apparatus in the

laboratory to achieve scientific progress.


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References

Mandal, Dr. Ananya, What are Stem Cells. Information is retrieved from medical news

distribution channel namely News Medical.

Stem Cell Research Patent Landscape (BriefingNote), information retrieved from The

Hinxton Group: An International Consortium on Stem Cells, Ethics & Law.

What are Stem Cells? Stem Cell Network. Information is retrieved from:

http://www.stemcellnetwork.ca/index.php?page=what-are-stem-cells

Knowles, Lori, Stem Cell Patents, Stem Cell Network. Available from:

http://www.stemcellnetwork.ca/uploads/File/whitepapers/Stem-Cell-Patents.pdf

Knowles, Lori, Commercialization and Stem Cell Research, Stem Cell Network. Availablefrom: http://www.stemcellnetwork.ca/uploads/File/whitepapers/Commercialization-and-

Stem-Cell-Research.pdf

Robinson, Douglas and Medlock, Nina (October, 2005), Diamond v. Chakrabarty: A

Retrospective on 25 Years of Biotech Patents, Intellectual Property and Technology Law

Journal, (Vol. 17) (10).

Diamond v. Chakrabarty 447 US 303 (1980)

Stenbck, Maria, (2009), Human embryonic stem cells - one step closer to a clearly

established practice. Available from: http://www.awapatent.com/?id=15951

OliverBrstle v. Greenpeace e.V. C-34/10

Klntz, Stephen, (May 13, 2012), Stem Cell Monopoly: The Debate over Wisconsin Alumni

Research Foundations stem cell patents. Information retrieved from:

http://www.patexia.com/feed/stem-cell-monopoly-the-debate-over-wisconsin-alumni-

research-foundation-s-stem-cell-patents

Mandal, Dr. Ananya, Stem Cell Patents. Information retrieved from medical news

distribution channel namely News Medical.

S Sterckx and J Cockbain, "Assessing the Morality of the Commercial Exploitation of

Inventions Concerning Uses of Human Embryos and the Relevance of Moral Complicity:

Comments on the EPOs WARF Decision", (2010) 7:1 SCRIPTed 83,

http://www.law.ed.ac.uk/ahrc/script-ed/vol7-1/sterckx.asp


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Gepstein, Lior, Derivation and Potential Applications of Human Embryonic Stem Cells.

Circulation Research. 2002

Stem Cell Definitions (Californias Stem Cell Agency)

(Dolder), 1984, Barriers to patentability of biotechnological inventions under the EPC

European Patent Office (2009), Official Journal, Issue 5

The Ethics of Embryonic Stem Cell Research and Human Cloning, Family Research

Council. Available from: http://www.frc.org/content/the-ethics-of-embryonic-stem-cell-

research-and-human-cloning

Gran Hermern, (2011), Stem Cell Patents: Ethical Aspects. Available from:

http://www.eurostemcell.org/commentanalysis/stem-cell-patents-ethical-aspects

are stem cells patentable?

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