The Supreme Court is poised to take up the highly charged question of whether human genes can be patented. But another question could trump it: Has the field of genetics moved so far so fast that whatever the court decides, it has come too late to the issue?
The Return of Results in Genetic Testing: Who Owes What to Whom, When, and Why? by Stephanie Alessi :: SSRNMarch 21, 2013
With the advent of large-scale genetic research, discoveries about the human race that never before seemed possible are becoming a reality. To support these scientific discoveries, biobanks catalog library-sized collections of DNA samples and offer researchers access to an increasingly diverse supply of genetic material on which to do research. These stored samples provide the means for studies that, over time, will uncover benefits about which we can now only speculate.
Despite the enormous potential that the future of genetic research holds, the research process has potentially troublesome implications for the human subjects who contribute their genetic materials. Chief among these concerns is the question of what to do with the individual data that arise as a result of genetic research. Genetic material may reveal features of a person that she was not even aware existed, providing potentially useful insight into one’s health status that, if available, many individuals would want to know. On the other hand, some people, for moral reasons or otherwise, may prefer not to learn about their genetic predispositions due to the inherent uncertainty of such information. Thus, research design and governance must allow individuals to make their own decisions.
Furthermore, placing a responsibility on researchers to provide their subjects with all theoretically interesting or useful information can detract time and resources from a study’s primary purpose. As such, researchers frequently find themselves forced to balance the subjects’ personal interests against their research goals. Yet there exist no uniform standards on which either researchers or subjects may rely as they perform this balancing act; there is little guidance for either party as to what information should be communicated. They are thus left with the unanswered question: To what extent is there an ethical obligation, and to what extent should there be a legal duty to return genetic results to a research subject?
This paper balances three competing goals — promoting socially beneficial genetic research, protecting individual health and access to personal information, and protecting individual autonomy and privacy — and proposes the adoption of specific, limited duties regarding planning for, acquiring informed consent about, and reporting genetic results.
“When finally interpreted, the genetic message encoded within our DNA molecules will provide the ultimate answers to the chemical underpinnings of human existence” : A passion for DNA, Genes, Genomes, and Society, James D. Watson, 2 August 1989.
Genes are the medium through which living organisms transmit genetic information from one generation to next. It is our genetic code that make us the unique individuals that we are. The double-helical structure of DNA, initially admired for its intellectual simplicity, today represents to many a double-edged sword that can be used for evil as well as good. Since 1980 after the grant of first patent for living organisms by USPTO in Diamond v Chakrabarty the subject of patents has moved from human-made bacterial microorganisms to human cells to human genes today. Patents encourage invention and innovation but everyone must be careful not to rope off far-reaching areas of patent eligibility.
The patenting of human genetic material raises too opposing ethical questions. At first is it ethically permissible to patent segments of the human genome when these segments represent part of our individual & collective natural heritage & secondly is it ethical to deny patenting parts of human genome given the vast economic resources & human effort expended in identifying it.
The research paper will begin with the legal developments that led to patenting of a bacteria to the patenting of genes in human beings. Further it will discuss the ethical questions that surface with this controversy.The paper will then conclude with the future implication of gene patenting on humanity.
Pigs Fly – The Validity of Gene Patenting vis-a-vis the Myriad Patent Case and Other Cases by Manveer Sandhu, Abhinav Gaur :: SSRNMarch 14, 2013
In the past 20 years, inventions in the field of biotechnology have become a new focus of the patent system, particularly in relation to genetic materials and technologies. For over two hundred years living organisms had been excluded from patent laws; life forms were considered a “product of nature” and not an intellectual result of a human brain.
The non-patentable status of living organisms changed with the 1980 landmark United States Supreme Court case Diamond v. Chakrabarty, wherein, the court decided that a strain of bacteria that had been modified by the insertion of new genes was patentable.
Through this paper, we make an effort to deduce the word “Patent” in its most indispensable form. We analyse the meticulous history of the Patents with the contemporarily done research and development of Bio-technology in the field of Patents. We also analyse and scrutinize the system of DNA patenting followed in India. We also make an effort to put forward as to how the need for patent of Life forms arose with special reference to various cases such as the Myriad case in which the court found the claims of seven patents on the BRCA1 and BRCA2 genes invalid, and however the Federal appeals court overturned the ruling of the lower court.
The paper shall explore and give answers to some of the most vital questions such as: Is DNA patenting morally and ethically correct? Is it correct to give ownership of a whole pedigree of living organisms to a person or company? How can the flaws in the DNA patenting system be removed and how can it be made more reliable and made sure that it isn’t misused?
Copyright and Trademark Issues in the Pharmaceutical Industry: Generic Compliance or Brand Drug Imitating: ‘Copycat or Compliance’ by Roseann B. Termini, Amy Miele :: SSRNFebruary 21, 2013
Imitation is the sincerest form of flattery; that is, unless the imitation is of a product produced by a multi billion-dollar industry. Then, imitation has the potential to involve intellectual property litigation. For the pharmaceutical industry, the majority of intellectual property litigation stems from the interplay between generic or imitator drug and brand name or pioneer drug manufacturers.
The recent emergence and rapid growth of biotechnology as a commercial industry has raised serious questions concerning the role of patent law as the industry’s dominant form of intellectual property protection. Several commentators, drawing on an analogy to computer software protection, have suggested copyright law as an alternative method of protecting recombinant DNA innovation. This article reviews these arguments in light of recent court decisions and scholarly commentary concerning copyright of computer software.
The article argues that copyright law is not sacrosanct, but rather represents a particular scope of proprietary interests that may be used to accommodate the needs of new technologies such as biotechnology. The article asserts, however, that the decision to apply copyright protection to such a technology should be based on policy rather than on analogy. The article reviews the basic characteristics ofboth the science of molecular biology and of the biotechnology industry, and, by contrasting these characteristics to those of the software industry, concludes that, as a matter of policy, copyright is not the most appropriate form of intellectual property protection for biotechnology.
The Myriad Case: Association for Molecular Pathology & Others v. USPTO & Others by Ujwal Nandekar :: SSRNFebruary 11, 2013
Human genetics is the study of heredity in human beings. The human genome, the entirety of human genetic information, contains approximately 25,000 genes, which form the basis of human inheritance. The majority of genes act by specifying polypeptide chains that form proteins. Proteins in turn make up living matter and catalyze all cellular processes. There are currently more than 3,000 patents on human genes, and that number is growing all the time! There are more than 47,000 patents involving genetic material. This includes patents on not only individual genes, but also on strands of genes and processes and equipment used to research and isolate them.
Now recently on August 16, 2012 a federal appeals court has for a second time reversed a lower district court’s decision that isolated genes are not patentable, but it also partly affirmed the District Court’s decision that certain methods patents “comparing” or “analyzing” gene sequences may not be patentable. Before it the Supreme Court recently asked the US Court of Appeals for the Federal Circuit to reconsider its earlier decision in the case, The Association for Molecular Pathology v. the US Patent and Trademark Office and Myriad Genetics, in light of its ruling in another lawsuit, called Mayo Collaborative Services v. Prometheus Laboratories.
Researchers here want to give a comprehensive research over the case study of The Association for Molecular Pathology v. the US Patent and Trademark Office and Myriad Genetics and various issues associated with it.
On November 30, 2012, the U.S. Supreme Court granted certiorari in Association for Molecular Pathology v. Myriad Genetics, Inc. on the question, “Are human genes patentable?” For over 150 years Supreme Court decisions have excluded from the federal patent power laws of nature and physical phenomena. The words “invention,” “new” and “useful” in §101 are consistent with these exclusions from the federal patent power, so they are not the result of a judicially active court limiting the will of Congress.
The conclusions of Judges Lourie and Moore in Myriad Genetics that the isolated DNA segments of claim 1 constitute patentable subject matter disregard the Supreme Court’s decisions in Chakrabarty and Funk Brothers on products derived from nature. “Isolation” is not an inventive step to change an unpatentable physical phenomenon into patentable subject matter. Turning to claim 2, even if the isolated cDNA segments do not under Chakrabarty and Funk Brother constitute a patentable product, under Prometheus the isolated cDNA segments capture an unpatentable law of nature – the genetic code. Since no inventive step has been added to the genetic code in claim 2, the cDNA of claim 2 constitutes unpatentable subject matter under Prometheus.
The Federal Circuit’s disregard in Myriad Genetics of the laws of nature threatens to eviscerate the public domain of basic scientific knowledge.
The venture, 23andMe Inc., raises a host of issues in respect of patent law, policy, and practice in respect of lifestyle genetics and personalised medicine. The company observes: ‘We recognize that the availability of personal genetic information raises important issues at the nexus of ethics, law, and public policy’. 23andMe Inc. has tested the boundaries of patent law, with its patent applications, which cut across information technology, medicine, and biotechnology. The company’s research raises fundamental issues about patentability, especially in light of the litigation in Bilski v. Kappos, Mayo Collaborative Services v. Prometheus Laboratories Inc. and Association for Molecular Pathology v. United States Patent and Trademark Office and Myriad Genetics Inc. There has been much debate and controversy over 23andMe Inc. filing patent applications – particularly in respect of its granted patent on ‘Polymorphisms associated with Parkinson’s Disease’. The direct-to-consumer marketing of genetic testing by 23andMe Inc. has also raised important questions of bioethics and human rights. It is queried whether the terms of service for 23andMe Inc. provide adequate recognition of the concepts of informed consent and benefit-sharing, especially in light of litigation in this area in the United States. Given the patent thickets surrounding genetic testing, the case study of 23andMe Inc. also highlights questions about patent infringement and patent exceptions. The future reform of patent law, policy, and practice needs to take into account new developments in lifestyle genetics and personalised medicine – as exemplified by 23andMe Inc.
How universities handle potentially patentable discoveries made by their faculty reflects important policy decisions that affect the greater public. The University of Utah’s decision to patent and then license exclusively to Myriad Genetics isolated human genes with positive predictive value for cancer provides an important example of the tensions that can arise when non-profit altruism confronts the legal and for-profit norms of commercial bioscience. This article examines the ongoing litigation over the Utah/Myriad patents – now before the U.S. Supreme Court for a second time – from the lens of the greater university innovation environment, a traditionally public space increasingly the focus of policymaker attention in discussions over how best to further commercialization and entrepreneurialism objectives in a struggling economy.
While many commentators, as well as Federal Circuit judges, dismiss as irrelevant the public impact of university patenting and licensing decisions on the question of patent eligibility, I argue, as a matter of higher education and innovation policy, for a renewed focus on the position of universities in the public sphere and the extent to which university patenting and licensing decisions in the health sciences further, and do not frustrate, the public good. Whether human genes should be eligible for patent protection, and whether universities should continue to seek such rights if the U.S. Supreme Court holds that they are, will propel policy decisions for all universities active in biotech research. But just because prevailing law allows certain forms of patent activity does not mean universities must engage in it. Amidst calls for increased commercialization and entrepreneurialism by universities, we should continue to demand a public-serving approach from universities as the social and scientific catalysts for potentially life-saving discoveries of wide application.