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The patentability of stem cells, reforms to patent law

190483 Title: 'Advances in stem cell technology have triggered questions about the patentability of stem cells which have been isolated from human embryos and processes involving those cells. Uncertainty has arisen about what can be patented in this field because the Patents Act 1977, as amended to implement Directive 98/44/EC on the legal protection of biotechnological inventions, does not directly address the patentability of human embryonic stem cells.' Critically evaluate the above statement and suggest what reforms, if any, might be made to patent law to deal with this matter.

Section 1 of the 1977 Patents Act defines the kinds of things and activities that can be patentable.

1.-(1) A patent may be granted only for an invention in respect of which the following conditions are satisfied, that is to say -

(a) the invention is new;

(b) it involves an inventive step;

(c) it is capable of industrial application;

(d) the grant of a patent for it is not excluded by subsections (2) and (3) below;

and references in this Act to a patentable invention shall be construed accordingly.

The above would appear to suggest that stem cell research might be included as a patentable item as it could be described as new, inventive, and capable of industrial application. However, s1(2) then goes onto to list those items which are not deemed to be inventions and includes any discovery or scientific theory. On this basis this would suggest that scientific inventions may not be patentable.

In Biogen Inc v Medeva Plc [1995] Hobhouse LJ questioned the validity of the patent granted to Biogen stating that he doubted that the molecule created by Biogen was even an invention at all and therefore should not have been patentable. Subsequently in Biogen v Medeva [1997] RPC 1, 42 Lord Hoffman made the comment that

Judges would therefore be well advised to put on one side their intuitive sense of what constitutes an invention until they have considered the questions of novelty, inventiveness and so forth".

It seems from both the 1995 case and the subsequent 1997 case that the judges are at a variance as to whether scientific advances can be properly classified as inventions thereby evoking the issue of whether such advances are patentable or not. Other cases have also raised the issue on the classification of the definition of an invention[1].

Deputy Judge Peter Prescott in CFPH's Application [2005] went on to say

How, then, does the law define what is an ‘invention’? The answer is that nobody has ever come up with a satisfactory, all-embracing definition and I do not suppose anybody will".

Since this case the Patent Office suggested a four step test to decide on patentability which is being used by the Patent Office with effect from 3 November 2006. The four step test was endorsed in Aerotel v Telco [2006] EWCA 1371 and requires the individual applying for a patent to

  1. Properly construe the claim
  2. Identify the actual contribution
  3. Ask whether it falls solely within the excluded subject matter
  4. Check whether the actual or alleged contribution is actually technical in nature.

Using the formula above enables scientific discoveries to fulfil the criteria necessary for a patent to be issued so long as the subject matter does not fall solely within the list of excluded subject matter[2]

When dealing with the issue of stem cells which have been isolated from human embryos and processing involving these cells several ethical issues are raised and the subject of patentability is challenged. The European Group on Ethics in Science and New Technologies are of the opinion that

Isolated stem cells, which have not been modified, do not, as product, fulfil the legal requirements, especially with regards to industrial applications, to be seen as patentable. In addition, such isolated cells are so close to the human body, to the foetus or to the embryo they have been isolated from, that their patenting may be considered as a commercialisation of the human body[3].

In their opinion

Only stem cell lines which have been modified by in vitro treatments or genetically modified so that they have acquired characteristics for specific industrial application fulfil the legal requirement for patentability[4].

Directive 98/44 does not entirely agree with the above proposition in that it states

Article 5

2. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.

Whilst it would appear that the Directive is endorsing stem cell research of human embryos as patentable it goes on further to distinguish those activities which for ethical or moral reasons may not be patentable.

Article 6

1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.

2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable:

(a) processes for cloning human beings;

(b) processes for modifying the germ line genetic identity of human beings;

(c) uses of human embryos for industrial or commercial purposes;

(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

In order to address future issues on the patentability of stem cells the European Convention has established two groups[5] of experts consisting of members from the legal profession, scientists, and economic industry, as well as representatives from the European Patent Office and the World Intellectual Property Organisation. The remit of these groups is not to deal with the ethical issues surrounding the patenting of stem cell research but to concentrate on the legal and technical aspects of the research[6].

There have been several meetings of the group to discuss the patentability of stem cell that have been isolated from human embryos the latest one of these being 14 July 2005[7]. At this meeting the group examined the question by making a distinction between pluripotent stem cells and totipotent stem cells. Human embryonic stem cells can differentiate into all cell types in the body thereby making them pluripotent. At present only pluripotent cells can be isolated and grown in culture in sufficient numbers to be useful. Pluripotent stem cells do not have the capability of developing into a human being whereas totipotent stem cells do have that capability[8].

The results of experiments using therapeutic cloning leading to the development of a cell line of pluripotent stem cells was released by Korean researchers in 2004. Using this method the cells are developed with the same genetic information as a particular patient and use of such cells reduces the risk of rejection of treatments on the patient by the body’s immune system[9].

Following the opinion expressed by the European Group of Ethics that there is no ethical reason for a complete ban on the patenting of inventions relation to stem cells or stem cell lines the expert group concluded that pluripotent stem cells were capable of being patented, although further discussion would be needed in the deciding of what constitutes an embryo and the scope of the research that should be allowed accordingly[10].

The decision in relation to totipotent stem cells was far more clear cut since each cell could develop into a human being on its own. Article 5 (1) of the Directive clearly stipulates

Article 5

  1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.

Effectively the group of experts reached the obvious conclusion that totipotent stem cells cannot be patentable.

Although as mentioned above there is the potential for pluripotent stem cell research to be patented there has been no real move forward in the achieving of this. Part of the reason for this would appear to be caused by the morality clause in Article 6 of the directive which expressly states that inventions cannot be patentable where their commercial exploitation would be contrary to ordre public or morality[11].

In July 2002 the European Patent Office refused to grant a application for a patent on pluripotent stem cells on the grounds that the specific exclusion in the Directive was intended to preclude the granting of a patent on any process or cell obtained from a human embryo which had necessitated the destruction of a human embryo, whether directly or not[12].

The decision above would appear to reject the Opinion No 16 of the European Group of Ethics who had been mandated under the Directive to give guidance on applicable ethical issues[13].

Despite this decision by the European Patent Office in 2002 some Members states have allowed applications for patents on pluripotent stem cells under national law[14]. The effect of this shows that despite a rejection by the European Patent Office on an application for the issuing of a patent sometimes the country in which the application is made will allow the application under national law.

Effectively Article 6 of the Directive makes the therapeutic cloning discovered by the Korean researchers in 2004 unpatentable and therefore further investigations into this area are likely to be limited as anything discovered as a result of testing will not be patentable.

At present only the UK and Belgium allow by law for the creation of human embryos either by fertilisation of an egg by a sperm or by therapeutic cloning for stem cell procurement. The Dutch have allowed for a 5 year period for the creation of embryos for research purposes under the Dutch Embryo Act 2002. The rest of the Member states have yet to take an action to legalise the creation of embryos for research and have so far prohibited such practice[15].

Problems can arise in applying for patents in proving that the research done constitutes a patentable invention[16] as opposed to an unpatentable discovery[17]. There is a very narrow line between the two and the applicant has to be careful to ensure that the research can fulfill the criteria to be categorised as an invention so as to be patentable. Article 52 of the Directive does little to assist the applicant with regards to clarity as to what can be deemed to be an invention and what can only be truly classified as a discovery.

In order to simplify the process of application for patents the Directive needs greater clarification. A definitive list of excluded items in respect of stem cell research would assist the scientist in deciding whether his invention was patentable or not.

Removing the morality clause from the Directive would open the floodgates for all research on human embryonic stem cells to be patentable. The difficulty with this would be that even though no moral element was written into the Directive there are still likely to be many factions of society that would find such experimentation morally objectionable. This could lead to the formation of protest groups attacking the facilities where the experiments are undertaken.

In the past animal welfare groups have attacked research centres[18] where animal experimentation is undertaken and destroyed property associated with those working in that industry[19]. There is an even greater likelihood that such groups would form in protest of experimentation on human embryos especially from anti abortion groups[20] and pro life groups[21].

The present legislation deems that an embryo is capable of becoming a human life form after 14 days from when it was created. Under the Directive any embryo under 14 days[22] of gestation is classed as pluripotent and therefore experiments conducted on such an embryo can be patentable presuming they fulfill the necessary criteria as laid down by the Directive. In reality, an embryo just beyond the 14 day period, whilst having the capability of becoming a human life form, is not able to sustain life on its own at that point in time.

It might be possible to raise a convincing argument that experimentation should be allowed to continue beyond the 14 day period on the grounds that without the intervention of humans and technology the embryo would not be able to sustain itself onto maturity[23]. This would open the door to allowing patentable inventions to be conducted on totipotent stem cells.

The Directive was supposed to assist in the decision making process fro patentable biotechnology but has instead created some more diverse problems.

Throughout the Member States there has been a variety of ways in which individual countries have interpreted Article 6 (2) (c) of the Directive. Some countries have kept to the literal wording of the directive and will not allow any of the acts mentioned under Article 6 to be patentable. Other countries have interpreted Article 6 less stringently.

In Estonia the Estonian Patents Act 1994 has limited the exclusion to commercial purposes and allows industrial purposes to be patented. This has the effect of narrowing areas of stem cell research that are unpatentable. By contrast in Austria the Austrian Reproductive Medicine Act 1992states that human embryos and cells produced from them may only be used for medically assisted reproduction. The interpretation of the Act is such that although stem cells are not specifically mentioned the procurement of embryonic tissue is prohibited.

The European Court of Justice was asked to decide in a case brought against the Commission by Italy[24] as to how the Directive should be interpreted in respect of Article 6 (2). The court held that the list of exclusions had to be transposed in their entirety into national law. In this case Italy were arguing that despite the fact that they had not directly transposed the elements of Article 6 (2) into their national law because under their own domestic patent law inventions which were contrary to ordre public or morality were already excluded. The ECJ disagreed stating that the purpose of inserting a list of inventions which were unpatentable under Article 6 (2) was to give clarity to the interpretation of the general moral clause and give some form of legal certainty as to those inventions would be unpatentable on moral grounds. The ECJ went on further to state that alterations to the specific wording of the exclusions may be potentially invalid under EU law if the legal effect is such that it broadens or narrows the scope of the exclusions.

It is obvious from the above that further amendments may be needed in the Directive in the future if researchers are to be allowed to make further advances in the area of biotechnical research. There are obvious limitations to the experimentation on pluripotent stem cells. There is less likelihood of patents been granted in respect of such experiments on pluripotent stem cells in the future, as it will become increasingly difficult to establish that this is a new invention an not just an extension of a previous invention.

In the UK at least 14 patents have been issued on pluripotent stem cells that make specific reference to human embryonic stem cells but have not allowed patents to be issued for processes for obtaining stem cells from human embryos. The UK has also adhered to the letter of Article 5 (1) in not allowing the patenting of any totipotent stem cells[25].

In Sweden an application for a patent was allowed as it was deemed to fall outside of the scope of the exclusion of uses of embryos for industrial and commercial purposes[26]. This involved an application for a method of differentiation of pluripotent human embryonic stem cells into haematopoietic cells. The Swedish authorities reasoned that the application did not require direct repetitive use of a human embryo so therefore fell outside the scope of Article 6 (2).

Whilst the Member states have interpreted the use of pluripotent stem cells as not being excluded for the issuing of patents the European Patent Office as taken the opposite view and has disallowed the request for patents in pluripotent stem cells as well as totipotent stem cells. In the Edinburgh Case[27] the Opposition Division relied on the morality exemptions in the Directive in refusing the application for a patent and similarly the Examining Division took the same view in the Warf case[28].

It is quite ironic that the Warf case which was disallowed by the European Patent Office was on the whole very similar to the one presented in the Swedish case for which the Swedish authorities allowed a patent to be issued.

All of the above research demonstrates the problems faced with the use of Directives as opposed to Regulations for the instigation of instructions to the Member States. If the rules regarding the patentability of inventions brought about through human embryonic stem cells had been put in the form of a Regulation all Member States would have had to incorporate the Regulation into their national laws to the exact letter of the Regulations.

As the instruction was in the form of the Directive there is leeway for the Member state to interpret the instructions in a wider context. Directives are only binding in as far as the result to be achieved under Article 249 of the Convention. Over time the European Court of Justice has accepted implementation through existing national laws or settled case law to satisfy the requirements that the wording of the Directive has been properly implemented. Even preparatory Acts have on some occasion been accepted as evidence that the spirit of the Directive has been imposed into the legal system of the country concerned[29].

If improvements are to be made in the patenting system of stem cell research it may well be advisable to include any further instructions as to the way that patentable inventions can be so classified in the form of a Regulation thereby ensuring unity in the way all Member states apply the ruling.

The present Directive fails to deal adequately with the question of patentability in respect of stem cell research as it is not sufficiently clear in content covers too broad an approach and is not enforceable to the full letter of the instruction as it is only in Directive format.

It may well be necessary in the future to readdress the issue of patentability as the demand grows for the use of totipotent stem cells to further advance medical research. This will mean having to tackle once again the moral issues that surround embryonic usage in experimentation and putting forward strong arguments as to why moral issues should be disregarded in the name of technological advances.

One way in which the moral issue might be circumvented in the future might be if the use of totipotent stem cell inventions could help cure diseases that at this point in time are incurable such as certain forms of cancer. Such a discovery would persuade many that the moral debates around the use of embryos are outweighed by the good of finding a cure for a previously incurable disease.

The present legislation in all countries disallows the use of totipotent stem cells for research on moral grounds and until moral objections can be suitably addressed it is likely that there will be a saturation point in the inventions using pluripotent stem cells such that no new patents will be issued in respect of these inventions.

Bibliography

Mason & McCall Smith, Law and Medical Ethics, 5th Ed, 1999, Butterworths, London

EGE, Opinion No 16, Ethical Aspects of Patenting Inventions Involving Human Stem Cells, 7th May 2002

Report from the Commission to the Council and the European Parliament, Brussels 14 July 2005

http://education.guardian.co.uk

http://eur-lex.europa.eu

http://jme.bmj.com

http://www.european-patent-office.org

http://www.nottingham.ac.uk

http://www.opsi.gov.uk

http://www.parliament.uk

http://www.patent.gov.uk

http://www.phgu.org.uk

http://www.thescientist.com

http://www.wsws.org

http://www.sciencemag.org

Table of Cases

Aerotel v Telco [2006] EWCA 1371

Biogen Inc v Medeva Plc [1995]

Biogen v Medeva [1997] RPC 1, 42

Case C 456/03 Commission v Italy [2005] ECR 1-5335

Case C 478-99 Commission v Sweden 2002 ECR I -4147

CFPH's Application [2005] EWHC 1589

Edinburgh case European patent no EP 0695351

European Patent Application No 96903521 Wisconsin Alumni Research Federation ‘Primate embryonic stem cells’ 13th July 2004.

Patent No SE 526940: Method of differentiation of pluripotent human embryonic stem cells into haematopoietic cells. (Applicant: Wisconsin Alumni Research Foundation)

Table of Statutes

Austrian Reproductive Medicine Act 1992

Directive 98/44

Dutch Embryo Act 2002

Estonian Patents Act 1994

European Patent Convention

Human Fertilisation and Embryology Act 1990

Patents Act 1977

1


Footnotes

[1] CFPH's Application [2005] EWHC 1589

[2] European Patent Convention Article 52.

[3] EGE, Opinion No 16, Ethical Aspects of Patenting Inventions Involving Human Stem Cells, 7th May 2002

[4] EGE, Opinion No 16, Ethical Aspects of Patenting Inventions Involving Human Stem Cells, 7th May 2002

[5] Directive 98/44 Article 16c

[6] http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52002DC0002:EN:HTML

[7]http://eurlex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=en&numdoc=52005DC0312&model=guichett

[8] Report from the Commission to the Council and the European Parliament, Brussels 14 July 2005 para 2.2 & 3

[9] http://www.sciencemag.org/cgi/content/full/303/5664/1669

[10] Report from the Commission to the Council and the European Parliament, Brussels 14 July 2005 para 3

[11] Directive 98/44 Article 6

[12] Edinburgh case European patent no EP 0695351; http://www.european-patent-office.org/news/pressrel/2002_07_24_e.htm

[13] EGE, Opinion No 16, Ethical Aspects of Patenting Inventions Involving Human Stem Cells, 7th May 2002

[14] Swedish Patent No SE 526490 (Applicant: Wisconsin Alumni Research Foundation)

[15] http://www.nottingham.ac.uk/law/StemCellProject/project.report.pdf

[16] Directive 98/44 Article 5 (2)

[17] Directive 98/44 Article 5(1) and Article 6

[18] http://www.thescientist.com/news/display/24364/

[19] http://education.guardian.co.uk/businessofresearch/story/0,9860,1555287,00.html

[20] http://www.phgu.org.uk/ecard?link_ID=1003

[21] http://www.wsws.org/articles/2003/jan2003/clon-j08.shtml

[22] Human Fertilisation and Embryology Act 1990 s3 (4)

[23] http://jme.bmj.com/cgi/content/full/31/4/215

[24] Case C 456/03 Commission v Italy [2005] ECR 1-5335

[25] http://www.patent.gov.uk/patent/notices/practice/stemcells.htm

[26] Patent No SE 526940 : Method of differentiation of pluripotent human embryonic stem cells into haematopoietic cells.

[27] Edinburgh case European patent no EP 0695351

[28] European Patent Application No 96903521 Wisconsin Alumni Research Federation ‘ Primate embryonic stem cells’ 13th July 2004.

[29] Case C 478-99 Commission v Sweden 2002 ECR I -4147


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