Human Stem Cell Medical -

Human Stem Cell Medical - Legal Implications

How Do Legal Issues in Patent Law Shape Ethical Decision in Human Stem Cell Research?

Patent Law & Genetic Medicine

This work examines the issue of human stem cell research from the view of the medical profession with an eye on funding, the public perspective and legislation historically affecting and futuristically possible in relation to research of the human genome. Specifically this work takes a look a the patenting process and how it is disputable as to whether patenting the human genome is plausible and what consequences might exist in this patents. This work notes the veritable quietness of the legal community at large in relation to this medical research issue and while this document is of the general nature noted are many areas of research that are in need to examination in relation to the new technological applications and creations that are being made possible and the new promise that exists in the treatment of diseases via the research of the human stem cell and the patent of the same.

How Do Legal Issues in Patent Law Shape Ethical Decision in Human Stem Cell Research?

Patent Law & Genetic Medicine

Objective

Terms & Definitions of Study

Introduction

I. Implications of Diamond v. Chakrabarty (1980) 9

II. Implications of Later Cases 10

III. Free Market System Impacts 11

IV. What Ways Do Patents Objectify Human Dignity? 12

V. Is there a 'just' way of thinking about intellectual property law? 14

VI. Rights - Technological 16

VII. Ethics of Patenting the Technique for Human Stem Cell Lines 16

Summary & Conclusion

How Do Legal Issues in Patent Law Shape Ethical Decision in Human Stem Cell Research?

Patent Law & Genetic Medicine

Objective

The objective of this work is to examine the legal issues that exist in patent law and how this issues shape the ethical decision in human stem cell research. This work will review the implications of Diamond v. Chakrabarty (1980) and cases that followed later as well as the impacts that human stem cell research has on the free market system. This work will also examine if and how stem cell patents objectify human dignity and answer the question of whether there is a 'just" manner in thinking about intellectual property law in this area and further will take a look at technological application rights in human stem cell research. Finally this work will examine the ethics of patenting the technique for human stem cell lines.

Terms & Definitions of the Study

Patent - The grant to an inventor of an exclusive right to make and sell an invention for a nonrenewable period of 17 years.

USPTO - U.S. Patent and Trademark Office

Xenotransplant - technique of endless supply of replacement organs from pigs and sheep genetically engineered to carry human cell-surface antigens, available for transplant into humans.

Multi-potent stem cell: Produces several different cells that are specialized (red blood cells, white blood cells, platelets)

Pluri-potent stem cell - may produce all cells in the body (embryonic stem cell)

Toti-potent stem cell - may produce 'an entire organism'.

A cDNA - a molecule that is laboratory manufactured version of a gene with only the information rich regions

SNPs - single-nucleotide polymorphisms

Introduction

The legal issue relating to stem cell research is just as stated by President Bush in his address to the nation, a subject that is..."profound." A complex intersecting of many sectors of life is focused upon stem cell research now as never before including the biological, biomedical, clinical, legal, regulatory and governmental sectors. According to Kadereit & Hines (2005) a stem cell is defined as."..a cell that self-renews but also can give rise to several differentiated cell types, such as muscle cells, heart cells or brain cells." During the normal division of cells the 'original cell' produces two "identical daughter cells, and is thus supplanted by two new and different cells. Further division of the cells take place through a process that maintains through asymmetric division and active maintenance of the stem cell phenotype in one cell assuring that the stem cell lineage is not lost. It is important to understand that there are several categories of the stem cells which are those of the: (1) Multipotent; (2) Pluripotent; and (3) Totipotent. (Kadereit & Hines, 2005) The multipotent stem cell may produced 'several' different specialized cells (adult stem cells, red blood cells, white blood cells and platelets) The Pluripotent stem cell may produce all cells in the body (embryonic stem cell). The Totipotent stem cell is one that can produce "an entire organism" (Ibid) Those against human stem cell research and applications are in fear of the "spectre of potentially authoritarian societies" who might clone a "super-race of genetically engineered humans. (Genesis of Eden Diversity Encyclopedia, 2006) However, for medical science gene therapy "raises the promise of correcting genetic diseases such as muscular distrophy, Parkinsonism and certain forms of mental retardation which plague a small proportion of the human population." (Ibid) Xenotransplants are another field that "has been heralded as a triumph of genetic technology. The idea of having endless replacement organs from pigs or sheep, possibly engineered to carry human cell-surface antigens, available for ready transplant into humans is a crutch many middle-aged people long to see arrive, as a latch ditch defense against physical deterioration. However xenotransplants carry significant risk of spreading animal disease to humans and facilitation the adaptation of alien pathogens to become human epidemics." The HIV disease is reported and generally known to be a disease human's caught when coming in contact with a virus that a monkey was carrying. Other concerns expressed include the concern that the natural process of evolution in human beings will be altered irrevocably effectively ending the human race, while others express more radical, although not unheard of concerns that chimeras (half human- half animals) will be the next focus of genetic engineering for those who are on the borderline of insanity and experimentation in this area.

Prior to Diamond v. Chakrabarty (1980) "life forms were considered a part of nature and were not patentable" however with the U.S. Supreme Court decision in Diamond v. Chakrabarty (1980) the court ruled that "genetically engineered [or modified] bacteria were patentable because they did not occur naturally in nature." (Genetics and Patenting, 2006) Chakrabarty had "modified bacteria to create an oil-dissolving bioengineered microbe." (Genetics and Patenting, 2006) Since the Diamond v. Chakrabarty case the issuance of patents has occurred on the whole genes with a known function. The genes with no known function are able to be patented under guidelines of the Patent Office. Patenting of human stem cells is regulated by the United States Patent and Trademark Office (USPTO) (Barton, 2002) The precedent for patenting of human stem cells or biological material is the 1980 court case of Diamond v. Chakrabarty. During the years between 1997 and 1999 the USPTO granted approximately 9,000 gene-related patents (Bonetta, 2001) There are several existing patents with those relating to technology being within one of four categories. Those categories are:

1) Patents for medical or surgical procedures;

2) Patents for surgical or diagnostic instruments;

3) Patents on drugs and 4) Patents on genes or tests based on genes. (Koporc, n.d.)

In review of the patent laws in the United States, the U.S. Patent laws provides that the patent begin on the date that the patent is issued and ends 20 years later on the same date however, in special circumstances that date might be different and patents are considered for extensions as well. In order for issuance of a patent the invention must be a process that is both 'new' and 'useful' and must be a 'process, machine, manufacture or composition of matter' furthermore the invention must bee the standards of 'utility, novelty and non-obviousness' and must be something that is not in use publicly, not in written form or known to others in the same field of study. In order to file for a patent submitted must be the patent application which consist of (1) an abstract; (2) a specification with a written description of the invention or of the manner or process of practicing the invention without undue experimentation which is referred to as "enablement" and the "best mode" of the invention. Generally three examples are included that serve as 'teaching examples' explaining the invention to the examiners; (3) drawings; (4) at least one claim; and (5) gene or protein sequences (American College of Medical Genetics Intellectual Property Committee, 2003) In the latter part of February 2003 the U.S. House of Representatives passed a bill into law that effectively bans cloning of humans for both reproductive and therapeutic purposes making it illegal for anyone to "perform or attempt to perform human cloning: to participate in an attempt to perform human cloning; or to ship or receive for any purpose an embryo produced by human cloning of any product derived from such embryo." (HR 534- Human Cloning Prohibition Act of 2003) Punishment for breaking this law carried a sentence of up to ten years with fines up to one million dollars. This bill was sent to the U.S. Senate and set for vote mirroring a bill previously passed by the House during the Summer of 2003 which failed to pass the Senate because of vehement disagreement that was even "within the parties over the prohibition of therapeutic cloning.(National Legislation Concerning Human and Reproductive Cloning, 2004; paraphrased) As of the date of the report on legislation eight U.S. states had passed laws that explicitly prohibited reproductive cloning using human embryos and another five U.S. states have placed a prohibition on cloning for any purpose whatsoever with 22 other U.S. states introducing bills outlawing the reproductive cloning of humans. (Ibid; paraphrased) Patenting laws for genetics allow inventors to patent genetics but only specific genetic factors may be patented and inventors are required to:

1) Identify novel genetic sequences;

2) Specify the sequence's product, 3) Specify how the product functions in nature --i.e. its use; and 4) Enable one skilled in the field to use the sequence for its stated purpose.

The USPTO issued out patents relating to gene fragments due to the fact that the full sequence and function of the gene is not known. The gene fragments are 300 to 500 base and are referred to as sequence tags (ESTs) which represent only about 10 to 30% of the cDNA while the genomic genes may be often ten to twenty times larger than the cDNA. The cDNA is a molecule that is laboratory manufactured version of a gene with only the information rich regions and it is these that provide the capability for researchers in the genome field to go forward to the important areas of the biology. There has been much controversy among scientists and with most scientists urging the USPTO that the broad patenting of the human genome should not be done at this state of research.

I. Implications of Diamond v. Chakrabarty (1980)

Diamond v. Chakrabarty was decided by the Supreme Court and was a case dealing with man-made, genetically-engineered bacteria capable of breaking down crude oil and having significant value in the treatment of oil spills. The Patent Office allowed method claims for producing the bacteria and for a combination of a floating carrier and the bacteria, but it rejected claims for the new bacteria itself. According to the examiner's decision statutory subject matter does not govern living things and the bacteria were living things and not subject under Section 101. Accompanying the 1952 act are the Committee Reports that inform the reader that the statutory subject matter intended by Congress to be included was: "anything under the sun that is made by man." The same year as the case Diamond v. Chakrabarty, 1989) the Bayh-Dole Act was passed in order that patent rights be granted to universities and other recipients of grants and other receiving or using federal funds.

IV. Implications of Later Cases

The case that followed Chakrabarty was Diehr's Rubber Molding. In this case Diehr and Lutton were inventors of a method used in operation of molding presses manufacturing rubber items such as car tires. The method that they used "produced properly cured rubber articles by ensuring that the articles remained in the press for the proper time so that they were not either over-processed or under-processed. It did this by continually monitoring the actual temperature in the mold and repeatedly calculating the cure time using a well-known formula, the Arrhenius equation." (Legal Protection of Digital Information, 2006) The claim was rejected by the examiner because he believed that the men were stating a type of computer programming claim. However the CCPA reversed and held that a claim that is staked upon a process or method does not depend on gaining validity under 35 USC 101 because if the claim is drawn upon 'subject matter' it does not become non-statutory simply because a computer is part of the execution process. If the rejection of a claim is solely due to the fact a computer program is involved this is not supported in law due to the broadness of the issue. The court ruled that this must be reversed because it did not have its basis in the law." (Legal Protection of Digital Information, 2006; paraphrased)

V. Free Market System Impacts

Impacts to the free market are positive in that "Gene patents are allowed because of the benefits that these patents can provide to the patentee.

One of these benefits is that gene patents can be seen as an incentive to encourage research by scientists. The research required to conduct studies is expensive, and researchers need a way to make up for the expenses lost in conducting their research. Patents and licensing fees provide a way for companies and researchers to regain the funds spent on studies. Some believe that researchers would be less likely to invest in research if there was not a way to regain some of the money spent on the research (Hill, 2003, "Patents, Medicine," 2002). In this way patents can help to protect against market failure and foster innovation (Walpole, Dawkins, Sinden, O'Leary, 2003). Also, funds generated by patents can be reinvested in future research." (Koporc, nd)

Koporc,. further states: "Gene patents are also widely defended as a means of free enterprise ("Patents, Medicine," 2002). As a researcher puts his or her time and effort into creating something, he or she may deserve to reap the benefits from such a discovery. This argument would support licensing fees and restrictive access to the invention. In this understanding of the role of gene patents, research and drug development is similar to any other business, which is encouraged to make a profit from its endeavors. This view may seem harsh when considering that the inventions being patented can directly impact human health, but it is a principle found throughout the business world and is highly valued in the United States today.

Koporc states that: "Another argument that supports gene patenting states that patents are important because they encourage the sharing of information and innovations (Walpole et al., 2003, Hill, 2003, "Patents, Medicine," 2002). Once a patent is granted for an innovation, that innovation becomes available to the public ("Patents, Medicine," 2002). This required sharing of information would prevent researchers from hoarding information for their own benefit. This requirement could provide other companies and researchers with databases of relevant information and the potential to research that product further." There is a dilemma presented in the patenting of the human stem cell in that much of the stem cell application is technological which if protected by patent would bar the release of the information and effectively bar research or use by any other than those who could afford to pay the patentee. (Caulfield, 2003) reveals that there are concerns in relation to patenting of stem cells. The patent to the "Primate Embryonic Stem Cell" is retained by the Wisconsin Alumni Research Fund. In the U.S. where government policy state that research is only to be done on stem cell lines already in existence these stem cell lines are important and they are valuable. The owners of the stem cell lines effectively have a monopoly because new stem cells are now lawful at this time for collection. (Caulfield, 2003

VI. What Ways Do Patents Objectify Human Dignity?

Because of the potentiality of human stem cell research in radical science and eugenics groups the human dignity factor is objectified in view of the ethnic cleansing goals of some in society, although let it be noted that not all who forge the path in eugenics are completely radical and it is said that many of those who study eugenics do not believe in any type of force or coercion. Another problem is with the factor of 'ownership' of human stem cell lines and specifically of the human embryo by corporations, organizations, or individuals in that 'ownership' of any part or whole of a human being is inherently believed by most to be wrong. The Human Genetics Alert publication in the article entitled: "Why Should I be Concerned About Human Genetics" states that:

It is hard to see how creating embryos purely as a source of biological raw material (ES cells) is compatible with respect: it seems part of the trend of turning human life into a commodity. (2006)

Further stated is that:

The commercialization of human biological samples has also led to the exploitation of indigenous peoples. Several cell lines from indigenous tribes have been patented by U.S. government institutions, without the consent of the people from whom the samples were derived, although some of these patents were withdrawn, following protests by the tribespeople. Concern over such 'biopiracy' has led countries such as India to try to restrict foreign scientists' access to their wealth of human genetic diversity."

VII. Is there a just way of thinking about intellectual property law?

According to the Hugo Ethics Committee statement on Stem Cells (2004) in its address to "issues directly related to stem cell technologies in its Statement on Cloning (1999) that the conclusion of the HUGO Ethics Committee are as follows:

1) Therapeutic cloning is acknowledged to be of value;

2) Deliberate creation of embryos for research is widely regarded as unacceptable;

3) However, creation of 'embryos' by somatic cell nuclear transfer to grow stem cells is suggested to be permissible where deemed to be both of indisputable benefit and the only course of action available;

4) Reproductive cloning of an existing human being is firmly advised against. (HUGO Ethics Committee Statement on Human Stem Cell Research, nd)

The HUGO Ethics Committee states that "progress in stem cell technologies crates further ethical issues that warrant particular attention and elaboration." The HUGO Ethics Committee believes that the medical research and healthcare industry has the potential to revolutionize under stem cell science but this makes it impact upon the scientific community and indeed upon the entire human population a great one. Four principles are outline in the HUGO "Statement on the Principles Conduct of Genetic Research" which are the principles as follows:

Principle One: Recognition that the human genome is part of the common heritage of humanity;

Principle Two: Adherence to international norms of human rights;

Principle Three: Respect for the values, traditions, culture and integrity of participants in research; and Principle Four: Acceptance and upholding of human dignity and freedom.

Recommendations of the HUGO Committee include the following: (1) Investigation of all potential sources of stem cells should be pursued; (2) The interest of stem cell donors and recipients of therapy should be respected; (3) The repercussions that stem cell therapies may have for society as a whole should be carefully considered; (4) Freedom of research should be fostered; (5) Coherent regulation should replace prohibition of research; and (6) Given the rapid pace of change and development in stem cell research, the issues addressed in this statement should be kept under review.

VIII. Rights - Technological

Barton (2000) states that:

Genomics and the availability of high-speed automated sequencing capability pose a new generation of questions for patent law." Questions exist as to when should an 'expressed sequence tag' (EST) be patentable and what rights pertain under the patent as to the rights relating to the entire gene that contains the EST; and further "what about single-nucleotide polymorphisms (SNPs)? What about claims on computer exploration of a genome? (Barton, 2000) Barton goes on to state that there are "three further limitations that deserve consideration" with each of these offering a response to: "...insights that many of us share about patent law, each could be implemented in actual patent doctrine, and each will be raised in patent-law contexts" other than only within the patenting of genomes. Those limits are expressed by Barton to be: