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)

1|Page

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 to the 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.

2|Page

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 the blood, 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.

Stem Cell Research Patent Landscape (Briefing Note), 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. 3 Ibid 4 What are Stem Cells? Information is retrieved from: http://www.stemcellnetwork.ca 5 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

3|Page

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.8 9 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 of Diamond 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 of Biotechnology 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 8

Knowles, Lori, Stem Cell Patents, (pg.1). Stem Cell Network See also id. at pg. 2 9 Knowles, Lori, Commercialization and Stem Cell Research, Stem Cell Network 10 447 US 303 (1980) 11 Supra note 7 12 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

4|Page

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 Biopatent Directive 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 15

Supra note 1 Supra note 7 16 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

5|Page

Case Study on WARF

Background In 1990s, James Thomson from University of Wisconsin-Madison developed a technique which can 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 20

WARF had three stem cell claims known as 780, 806 and 913 patents. 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-thedebate-over-wisconsin-alumni-research-foundation-s-stem-cell-patents 21 Mandal, Dr. Ananya, Stem Cell Patents. I nformation retrieved from medical news distribution channel namely News Medical. 22 Supra note 7

6|Page

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 ... inventions the commercial exploitation of which would be contrary to ordre public or morality; such exploitation shall not be deemed to be so contrary merely because it 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.asp 24 Supra note 1 25 Gepstein, Lior, Derivation and Potential Applications of Human Embryonic Stem Cells. Circulation Research. 2002; 91:866-876 26 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.

7|Page

Issues 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 introduction of this new chapter [i.e. of the Rule] without any transitional provisions, can only be taken as meaning that this detailed 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 barrier to patentability. There is no indication that the commercial exploitation of human embryos was ever regarded 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 of amicus curiae had supported the decision. Thus, relating to question 1, Rule 28 (c) of EPC would
28 29 30 31 32

Supra note 23 Id. European Patent Office (2009), Official Journal, Issue 5, pg. 321-322 (Dolder), 1984, Barriers to patentability of biotechnological inventions under the EPC Supra note 30. See pg. 322

8|Page

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 inventions that involve the use of human embryos for industrial or commercial purposes constitute a form of inventions whose commercial exploitation would be contrary 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 commented that 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 34

Supra note 17 Supra note 30. See pg. 329 35 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

9|Page

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 37

Supra note 23 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?

10 | P a g e

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

11 | P a g e

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 the President'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 40

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

12 | P a g e

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 Oliver Brstle v. Greenpeace e.V., wherein the patent pertaining to mammalian 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

13 | P a g e

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.

14 | P a g e

References
Mandal, Dr. Ananya, What are Stem Cells. Information is retrieved from medical news distribution channel namely News Medical. Stem Cell Research Patent Landscape (Briefing Note), 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. Available from: http://www.stemcellnetwork.ca/uploads/File/whitepapers/Commercialization-andStem-Cell-Research.pdf Robinson, Douglas and Medlock, Nina (October, 2005), Diamond v. Chakrabarty: A Retrospective on 25 Years 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 Oliver Brstle 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-alumniresearch-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
15 | P a g e

of Biotech Patents, Intellectual Property and Technology Law

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-cellresearch-and-human-cloning

Gran Hermern, (2011), Stem Cell Patents: Ethical Aspects. Available from: http://www.eurostemcell.org/commentanalysis/stem-cell-patents-ethical-aspects

16 | P a g e