Term Paper on "Patent Law and Genetic Medicine"

Term Paper 17 pages (4660 words) Sources: 6 Style: Chicago

[EXCERPT] . . . .

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… READ MORE

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