Gene Patents Research Articles

유전자특허의 재산권적 불완전성에 관한 소고 : 미국 연방대법원 유전자특허(BRCA 1, 2) 판결을 계기로

유전자특허의 재산권적 불완전성에 관한 소고 : 미국 연방대법원 유전자특허(BRCA 1, 2) 판결을 계기로

A Race Still Unfinished

[Breast Cancer Special Issue Index][1] Few scientific endeavors captured as much public interest as the race to identify BRCA1 , a gene responsible for inherited predisposition to breast and ovarian cancers. The search culminated in a 1994 Science paper reporting the isolation of BRCA1 by positional cloning.[*][2] Isolation of the related cancer predisposition gene BRCA2 followed soon after.[†][3] Twenty years later, the BRCA genes continue to make headlines, sparking a Supreme Court decision on the legality of gene patenting and intense debates on the ethics of genetic testing. ![Figure][4] CREDIT: ANNE WESTON/CANCER RESEARCH UK/VISUALS UNLIMITED INC. In this special section of Science , expert contributors retrace the long and tortuous path leading to the mapping and identification of the BRCA1 gene; discuss the ways in which BRCA mutation status has been integrated into the clinical management of patients in high-risk families; and highlight the role of the BRCA proteins in preserving the structural and numerical integrity of chromosomes throughout the cell cycle, a function that may explain their tumor suppressor activity. Science 's News team explores many of the issues that have arisen since the discovery of the BRCA genes. Advances in molecular medicine have brought new options for treatment and prevention, driving down mortality rates in wealthy countries. But in poor countries, shut out from these advances, mortality rates remain disproportionately high. Widespread breast screening has led to early detection and a new dilemma: whether to aggressively treat noncancerous lesions that may never become invasive or whether to “watch and wait.” Since 1994, dozens more genes have been found that increase a woman's risk of hereditary breast cancer, but by how much is uncertain, confounding already complicated issues in genetic testing and counseling. Throughout this explosion of research, advocacy groups have been a powerful force in boosting funding and shaping the agenda, and they continue pushing for increasingly ambitious, some say unrealistic, goals. Clearly much more needs to be done—both more research and better ways to get existing treatments to women who need them. The discovery of the BRCA genes was transformative. More than a million women and men have been tested for BRCA1 and BRCA2 mutations in the past 20 years, and there is no doubt that the test has saved lives. But mutations in these two genes account for only 5 to 10% of breast cancer cases in the general population, and worldwide, breast cancer remains the most common and most deadly cancer in women. Is it time to start a new race? [1]: http://www.sciencemag.org/site/special/breastcancer/index.xhtml [2]: #fn-1 [3]: #fn-2 [4]: pending:yes

Phase Changes in the BRCA Policy Domain

The recent US Supreme Court ruling against gene patenting has been accompanied by the passage at the federal level of the Patient Protection and Affordable Care Act, both events representing a thawing or phase change in policies that will now make preventive techniques, such as BRCA genetic testing to predict risk for familial breast and ovarian cancer, more affordable and accessible. Authors including Yun-Han Huang in this journal have noted the judicial ruling is one step--a significant one--in the process of patent system reform. This commentary links such changes with policy formation and action taken by members of diverse religious communities in the aftermath of the Human Genome Project and continuing in today's genome sequencing area. Religious engagement has acted as a catalyzing force for change in the creation and dissemination of genetic developments. Religious perspectives are needed to solve the new ethical dilemmas posed by population screening for BRCA mutations and the rise of direct-to-consumer and provider marketing of such genetic tests, which have far-reaching consequences at the individual, family, and societal levels.

Gene patents, patenting life and the impact of court rulings on US stem cell patents and research.

In June 2013, the US Supreme Court ruled that naturally occurring genes were unpatentable in the case Association for Molecular Pathology v. Myriad Genetics. Up until this decision, Myriad Genetics was the only company in the USA that could legally conduct diagnostic testing for BRCA1 and 2, genes that are linked to familial breast and ovarian cancer. The court case and rulings garnered discussion in public about patenting biological materials. This paper will describe the progression of the Myriad Genetics case, similar US rulings and biological intellectual property policies. In addition, it will discuss the impact of the case on biological patents - specifically those for human embryonic stem cells.

Patent Activity in Biotechnology

Biotechnologies are a priority area of development due to the scope of global challenges and social problems they help to resolve. There is demand for updated information about the the current state of research and challenges faced. This paper discusses the potential of patent analysis and surveys the Russian biotechnological market with both quantitative and qualitative methods. It reviews key statistical and analytical findings of empirical research.The main finding is that the Russian biotechnological market has a relatively high level of dependence on foreign technologies: among biotechnological patents published in Russia in 2012, a third was granted to non-residents. In Russia, foreigners are active in patenting universal methods and techniques useful for biotechnological advancement. This may constrain future Russian organizations’ access to results and methods and therefore block some directions of biotechnological research within the country. Among other challenges, are the following: a low involvement of the Russian commercial sector in developing biotechnologies, a lack of cooperation between the segments of the market, and a disadvantaged position of some subfields, such as eco- and aqua biotechnologies and bioenergy.By using patent data, we identify active actors contributing most significantly to progress of biotechnologies in Russia, and we focus on dynamically developing subfields, such as biomedicine and pharmaceuticals.

Patenting Trends in Marine Biodiversity: Issues and Challenges

Marine and terrestrial ecosystems are so fundamentally different in some aspects that many of the issues concerning biodiversity cannot be interpreted using a single theory of common application to all ecosystems. This article firstly gives the current statistics of Marine Biodiversity worldwide with India’s contribution.Marine organisms comprise approximately a half of the total biodiversity, thus offering a vast source to discover useful therapeutics. In recent years, a significant number of novel metabolites with potent pharmacological properties have been discovered from the marine organisms. The ‘marine world’ boasts of innumerable life forms, each with a unique characteristic, making its genetic make-up the most sought after field for marine researchers. Coral reefs are known as the “rainforests of the sea,” it is exploited for cosmetics to pharmaceuticals patents. This research paper discusses the entire issues of exploiting marine biodiversity for Pharmaceutical Patents.Marine biodiversity contains most Phylogenetic and genomic diversity on Earth. Progress in marine and molecular technologies has facilitated “Bio prospecting,” with the number of patent claims associated with genes of marine organisms growing at 12% per year. The global market for marine biotechnology was estimated at U.S. $2.4 billion in 2004, with estimated average growth of 5.9% per year from 1999 to 2007. With this prospective this article concludes with the issues and challenges of Marine Biodiversity and Gene Patents with some suggestions.

Critical Issues Relating to Intellectual Property Rights (IPR) in Biotechnology: Developing Countriess Perspective and India

Till recently, life forms used to be exempted from patenting. However, developments in biotechnology are compelling for revising the approach towards the intellectual property rights regime applicable to the field of biotechnology. Such changes in approach covers a wide range of issues, such as the range of product patents and the patentability of genes, gene sequences and parts of gene-sequences derived from human, animals, plants or microorganisms. Moreover, patenting, especially of human body parts, has posed an ethical limit for biotechnology itself. Consequently, in the light of these developments in biotechnology, the profile of patent regime is fast changing, especially in the developed world. The international trade regime under WTO is yet to address these challenges emanating from advancements in biotechnology. As uncertainty continues with regard to the meaning of the term ‘microorganism’ and the difference between ‘biological’ and ‘microbiological’ processes, some countries argue at TRIPS forum that life forms and living creatures should not be patented raising moral and ethical issues. Some developing countries argue that the TRIPS Agreement should specifically take account of issues, like allowing farmers to save, use, sow, exchange and share the seeds they have harvested and preventing anti-competitive practices, which threaten their ‘food sovereignty’. Many developing countries are yet to put in place national legislations to position themselves vis-a-vis international negotiations at the WTO, which calls for consistent support and capacity building exercises by the international community to enable them to overcome the infrastructural and institutional hurdles. This paper attempts to critically analyze various dimensions of intellectual property right issues, which relate to the filed of biotechnology, and tries to highlight the developing countries perspective in this regard with a focus on India, on these matters.

Trends in genetic patent applications: the commercialization of academic intellectual property

We studied trends in genetic patent applications in order to identify the trends in the commercialization of research findings in genetics. To define genetic patent applications, the European version (ECLA) of the International Patent Classification (IPC) codes was used. Genetic patent applications data from the PATSTAT database from 1990 until 2009 were analyzed for time trends and regional distribution. Overall, the number of patent applications has been growing. In 2009, 152 000 patent applications were submitted under the Patent Cooperation Treaty (PCT) and within the EP (European Patent) system of the European Patent Office (EPO). The number of genetic patent applications increased until a peak was reached in the year 2000, with >8000 applications, after which it declined by almost 50%. Continents show different patterns over time, with the global peak in 2000 mainly explained by the USA and Europe, while Asia shows a stable number of >1000 per year. Nine countries together account for 98.9% of the total number of genetic patent applications. In The Netherlands, 26.7% of the genetic patent applications originate from public research institutions. After the year 2000, the number of genetic patent applications dropped significantly. Academic leadership and policy as well as patent regulations seem to have an important role in the trend differences. The ongoing investment in genetic research in the past decade is not reflected by an increase of patent applications.

The Hurdles in Patenting of Genetic Resources and Biotechnology in Contemporary India

The Hurdles in Patenting of Genetic Resources and Biotechnology in Contemporary India

How a large biotechnology company teamed with a translation service provider to define best practices

According to the World Intellectual Property Organization, nearly 100,000 pharmaceutical and biotechnology patent applications are filed each year around the world, and the trend is increasing. These companies have very little room for error in the work they conduct each day. As a result, the translations of these patent applications need to be completely accurate, which requires a translation service provider who follows best practices. These best practices include centralized processes, highly specialized teams, quality control, terminology management and advanced technologies.By following them, they will ultimately reduce office actions and litigation risks, as well as decrease time to grant. This case study will highlight how a large biotechnology company worked with their translation service provider to develop a series of best practices for the translations of their intellectual property, focused primarily on their patent applications. Readers will come away with an understanding of how their multinational enterprises can leverage these best practices to get improved quality, reduced time to grant and more filings for the budget.Â

Intellectual Property and Regulation of Molecular Pathology Tests

Legal and regulatory issues have assumed heightened importance in molecular pathology. Patents on relationships between human gene variants and clinical phenotypes, as well as on the underlying gene sequences themselves, have been extremely controversial. However, recent Supreme Court decisions appear to have rendered invalid these classes of patents. The Clinical Laboratory Improvement Amendments of 1988 have been the primary basis for laboratory oversight in the United States, whereas the Food and Drug Administration has been responsible for regulating in vitro test kits distributed in interstate commerce. However, the Food and Drug Administration has recently announced its intention to regulate laboratory-developed tests, raising concerns in the laboratory community. This article reviews recent developments impacting the legal status of gene patenting and oversight of molecular pathology testing in the United States.

Transparency tools in gene patenting for informing policy and practice.

The Supreme Court's decision in Myriad highlights the need for tools enabling nuanced and precise analysis of gene patents at the global level.

No one ‘owns’ the genome: The United States Supreme Court rules that human DNA cannot be patented

Modern biotechnological innovation has been fertile ground for profound and critical debate – and policy consideration – regarding its associated legal, social, ethical and moral issues. Patent laws exist to encourage the progress of science, innovation and discovery, but battle to provide a clear and stable regulatory framework. In a decision that looks set to shape the future, the United States Supreme Court recently ruled that isolated human DNA cannot be patented. It is argued that this decision will have a potentially serious negative impact on future biotechnological innovation and discovery, and that the more expansive European approach to ‘gene patenting’ is sounder and enables progress.

Invalidating Human Gene Patenting: The U.S. Supreme Court Rules in Association for Molecular Pathology v. Myriad Genetics

In its June 2013 ruling in the Association for Molecular Pathology v. Myriad Genetics (1), the U.S. Supreme Court held that DNA fragments are naturally occurring phenomena that are ineligible for patenting under Title 35, Section 101 of U.S. patent law, regardless of their isolation from the rest of the human genome. This landmark decision clarifies an important area of intellectual property law and deviates from prior positions of the U.S. Patent and Trademark Office on new plant breeds. The ruling immediately invalidates many breast and ovarian gene patents (BRAC1 and BRAC2) held by Myriad Genetics as well as roughly 4000 other genetic patents now held in the United States. The decision could have a profound impact on health care economics, innovation, and patient care across medical subspecialties worldwide, including neurosurgery. The decision highlights the conflicting interests patent law aims to advance: promoting medical innovation by maximizing personal incentives, while maximizing public access to its benefits. The classic argument supporting genetic patenting has been that companies will not invest in genetic technologies if they do not have protections in place to recoup their substantial investments. In some respects, Myriad Genetics can be viewed as a successful example of this model. BRAC1 and BRAC2 mutation testing by Myriad Genetics has benefited thousands of women in the United States who are at high risk for developing breast or ovarian cancer, and the investors in these technologies have been rewarded. However, this model also has prevented competition from other companies, researchers, and health care providers, likely thwarting further testing innovation and quality improvements. Opponents of genetic patents, including James Watson, the codiscoverer of the double helix structure of DNA and a founding member of the Human Genome Project, believe permitting patents on genes blocks innovation. They believe that this practice has resulted in “hundreds, if not thousands, of individual obstacles to developing and commercializing” new assays. Testifying in the Myriad Genetics case, Watson stated that the practice is unnecessary because “the international effort was proceeding on schedule without the need to file patent applications.” More fundamentally, he argued that patenting genes is morally at odds

Lock Up the Genome, Lock Down Research?

Researchers say that gene patents impede data sharing and innovation; patent lawyers say there's no evidence for this.

DREAMing of a patent-free human genome for clinical sequencing

Can methylation be the key to challenging the interpretation of existing gene patent claims? And can a novel PCR method be used to enable the sequencing of hundreds of genes?

Patently a problem? Recent developments in human gene patenting and their wider ethical and practical implications

The issue of gene patenting has become re-enlivened with the recent decisions of both the Supreme Court of the United States and the Federal Court of Australia in regards to the patentability of isolated genetic material. The latter case, Cancer Voices Australia v Myriad Genetics Inc, upheld the validity of a patent over the isolated BRCA1 gene and has highlighted the wider implications of gene patenting in Australia. This article examines the legal issues arising from that judgment in respect of the ‘manner of manufacture’ requirement for patentability. It also analyses the ethical consequences of gene patenting and the impact of the monopolistic market control that is facilitated by patents upon the delivery of biogenetic healthcare, industry investment and the dissemination of research results. It will further consider community concerns regarding possible limitations in access to genetic testing and treatment and suggest means of redressing such concerns.

Patently a problem? Recent developments in human gene patenting and their wider ethical and practical implications

The issue of gene patenting has become re-enlivened with the recent decisions of both the Supreme Court of the United States and the Federal Court of Australia in regards to the patentability of isolated genetic material. The latter case, Cancer Voices Australia v Myriad Genetics Inc, upheld the validity of a patent over the isolated BRCA1 gene and has highlighted the wider implications of gene patenting in Australia. This article examines the legal issues arising from that judgment in respect of the ‘manner of manufacture’ requirement for patentability. It also analyses the ethical consequences of gene patenting and the impact of the monopolistic market control that is facilitated by patents upon the delivery of biogenetic healthcare, industry investment and the dissemination of research results. It will further consider community concerns regarding possible limitations in access to genetic testing and treatment and suggest means of redressing such concerns.

Are Human Genes Patentable?

IIC (2013) 44:747–749 DOI 10.1007/s40319-013-0102-x EDITORIAL Are Human Genes Patentable? Dan L. Burk Published online: 20 September 2013 O Max Planck Institute for Intellectual Property and Competition Law, Munich 2013 On June 13, 2013 the United States Supreme Court delivered its long-anticipated opinion in Association for Molecular Pathology v. Myriad, 1 a decision addressing the question posed by the Court to the parties, ‘‘Are human genes patentable?’’ 2 As has already been widely reported in the popular press, in a relatively short and essentially unanimous opinion authored by Justice Thomas, the Court held DNA sequences extracted from human cells to constitute products of nature, outside patentable subject matter. But what has been less widely reported is the simultaneous holding that other human gene sequences, entailing equivalent information, remain within patentable subject matter. The reasoning behind this distinction is puzzling and contradictory, and leaves the law in this area far more confused and uncertain than before the Court undertook its answer to the gene patenting question. Two types of claimed nucleotide sequences were at issue in the case: genomic or gDNA that was extracted and isolated from human cells, and complementary or cDNA that is produced in a laboratory procedure called reverse transcription, using messenger RNA as a template. A three-judge panel of the intermediate Federal Circuit court of appeal had unanimously found the cDNA to be the patent eligible product of human intervention, but the Federal Circuit judges split over the patentability of the isolated gDNA molecules. 3 The principal opinion, written by Judge Lourie, found the gDNA molecules to be patentable subject matter due to their chemical separation from the chromosome in which they were naturally 569 U.S. ___ (2013). 133 S.Ct. 694 (2012) (granting certiorari). Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 689 F.3d 1303, 1329 (Fed. Cir. D. L. Burk (&) Professor of Law University of California, Irvine, 401 East Peltason Dr., Law 4800-N, Irvine, CA 92697-8000, USA e-mail: dburk@law.uci.edu

The Future of Gene Patents and the Implications for Medicine

The Supreme Court decision in Myriad Genetics struck down the patenting of human genomic DNA. What will this mean for genetic testing and medicine, more broadly?