Gene Patents Research Articles

Corporate control and global governance of marine genetic resources.

Who owns ocean biodiversity? This is an increasingly relevant question, given the legal uncertainties associated with the use of genetic resources from areas beyond national jurisdiction, which cover half of the Earth's surface. We accessed 38 million records of genetic sequences associated with patents and created a database of 12,998 sequences extracted from 862 marine species. We identified >1600 sequences from 91 species associated with deep-sea and hydrothermal vent systems, reflecting commercial interest in organisms from remote ocean areas, as well as a capacity to collect and use the genes of such species. A single corporation registered 47% of all marine sequences included in gene patents, exceeding the combined share of 220 other companies (37%). Universities and their commercialization partners registered 12%. Actors located or headquartered in 10 countries registered 98% of all patent sequences, and 165 countries were unrepresented. Our findings highlight the importance of inclusive participation by all states in international negotiations and the urgency of clarifying the legal regime around access and benefit sharing of marine genetic resources. We identify a need for greater transparency regarding species provenance, transfer of patent ownership, and activities of corporations with a disproportionate influence over the patenting of marine biodiversity. We suggest that identifying these key actors is a critical step toward encouraging innovation, fostering greater equity, and promoting better ocean stewardship.

Patenting human genes: Chinese academic articles\u2019 portrayal of gene patents

BackgroundThe patenting of human genes has been the subject of debate for decades. While China has gradually come to play an important role in the global genomics-based testing and treatment market, little is known about Chinese scholars’ perspectives on patent protection for human genes.MethodsA content analysis of academic literature was conducted to identify Chinese scholars’ concerns regarding gene patents, including benefits and risks of patenting human genes, attitudes that researchers hold towards gene patenting, and any legal and policy recommendations offered for the gene patent regime in China.Results57.2% of articles were written by law professors, but scholars from health sciences, liberal arts, and ethics also participated in discussions on gene patent issues. While discussions of benefits and risks were relatively balanced in the articles, 63.5% of the articles favored gene patenting in general and, of the articles (n = 41) that explored gene patents in the Chinese context, 90.2% supported patent protections for human genes in China. The patentability of human genes was discussed in 33 articles, and 75.8% of these articles reached the conclusion that human genes are patentable.ConclusionChinese scholars view the patent regime as an important legal tool to protect the interests of inventors and inventions as well as the genetic resources of China. As such, many scholars support a gene patent system in China. These attitudes towards gene patents remain unchanged following the court ruling in the Myriad case in 2013, but arguments have been raised about the scope of gene patents, in particular that the increasing numbers of gene patents may negatively impact public health in China.

Fortune and hindsight: gene patents' muted effect on medical practice.

Physicians have long worried about gene patents' potential to restrict their medical practices. Fortune and hindsight have proven these worries exaggerated both in the UK and elsewhere. Neither current nor future medical practices appear to be impinged by gene patents, although they may be subject to future intellectual property disputes. Qualitative and quantitative (survey) studies of gene patents' effects on medical practice; recent developments in patent law. Traditional gene patents do not appear to have restricted medical practice in the UK, although their effect elsewhere has been more nuanced. Whether patents will restrict the spread of newer medical technologies is unresolved. Continuing survey data on practitioners' views concerning patents' role in the distribution of newer technologies would be beneficial.

Alienation from the Objectives of the Patent System: How to Remedy the Situation of Biotechnology Patent.

Some fundamental biotechnologies hold unprecedented potential to eradicate many incurable diseases. However, in absence of regulations, the power of patent makes the future use of some important biotechnology in few institution's hands. The excessive patents restrict researcher access to the fundamental technologies. It generates concerns and complaints of deteriorating the public health and social welfare. Furthermore, intellectual curiosities, funding, respect among colleagues etc., rather than patents, are the real motivations driving a major ground-breaking discoveries in biotechnology. These phenomena reveal that some biotechnology patents are alienated from the purpose of patent system. Therefore, it is necessary to take some approaches to stop over-patenting these fundamental biotechnology inventions. This article proposes a model regulatory framework for controlling biotechnology patent alienating from the purpose of patent system.

Patenting human genes: Chinese academic articles' portrayal of gene patents Updated

Patenting human genes: Chinese academic articles' portrayal of gene patents Updated

Office Actions per Grant Ratio (OGR): A New Metric for Patent Examiner Activity

The current metric for examiner prosecution activity is allowance rate, which is calculated by dividing the total number of allowances by the sum of the allowances and abandonments (allowance rate = total allowance/(total allowances total abandonments)). Importantly, however, allowance rates do not consider an examiner’s pending docket. Specifically, allowance rates do not fully capture if the examiner is simply writing office actions thereby prolonging prosecution or allowing cases. This study rectifies this failure by creating and analyzing a dataset that captures every active examiner’s current docket. Calculating the Office Action per Grant Ratio (OGR = Total # of Office Actions/Total # of Grants), this study’s new metric for measuring patent examiner activity captures not only pending cases, but also helps decipher which examiners are spending their time allowing cases or writing Office Actions. This new metric indirectly helps determine if specific examiners are prolonging prosecution compared with peers within their Art Unit, Workgroup and Technology Center. Using the OGR score, this study elucidates how examiners in certain art units and Workgroups behave- specifically, which examiners in certain art units are more likely to write office actions or allow cases. To calculate the OGR, this study captures 8,537,660 office actions, 2,812,177 granted patents and 1,255,552 abandonments from 9,535 examiners from January 1, 2001 to June 8, 2017. This study finds that, overall, there is a wide range of OGR scores across the United States Patent & Trademark Office (USPTO), commonly ranging from approximately 0.2 to 23. Furthermore, overall, most examiners have an OGR of 3.0 or below, which means that most examiners write 3 Office Actions before granting a patent. These OGR scores roughly correlate to allowance rates, but there are a significant number of examiners that do not have an allowance rate that corresponds with OGR scores. There are more examiners with high OGR scores in Technology Centers 1600 and 1700, which may reflect the complex nature associated with biotechnology and chemical patents. In contrast, there are a higher number of examiners with low OGR scores in Technology Center 2800, which corresponds to Semiconductors, Electrical and Optical Systems and Components. Interestingly, when broken down into Workgroups, this study finds that there can be large variation in OGR scores. For example, in Technology Center 1600, workgroups 1610 and 1620 have a disproportionate number of examiners with high OGR scores. Similarly, in Technology Center 3600, Workgroups 3620 and 3680 have many examiners with high OGR scores, which is unsurprising since both Workgroups encompass “Data Processing: Financial, Business Practice, Management, or Cost/Price Determination” or business methods type applications.

Author Correction to: Gene Patents in Canada: Is There a New Legal Landscape?

An error was subsequently identified in the article, and the following correction should be noted.

Biotechnology Patenting in the BRICS Countries: Strategies and Dynamics

The BRICS countries (Brazil, Russia, India, China, South Africa) account for 25% of global biotechnology patents. To understand the current and future landscape of the domain, it is important to better understand the capacity of these contributors. Here, we consider the thematic priorities, strategies, and key players of the BRICS countries in biotechnology patenting.

Explaining the Benefits of Human Genome Patent

Gene patenting has been facing backlash for decades now. Even Michael Crichton, science fiction novelist, as joined the bandwagon speaking against gene patent.1 Such hostility towards patents, the professional interests of academics, researchers and inventors are under the threat of losing their rights over the work they have done. The biotech industry can never be out of discoveries. With constant biological changes, new diseases are appearing and they have to dig deeper. However, not all progress is free. Rewarding the inventors is not at all unfair. This paper will demonstrate that (i) patents are a foundation of the industry. They need to innovate further progress. The reason patent law exists to protect the inventions for a limited period of time. The paper will also demonstrate that (ii) the social myths about gene patent are not really manifested in reality. It will discuss the argument against gene patenting and then will present counter arguments with empirical evidence whether the myths are really true.

The Genealogy of a Gene: Patients, HIV/AIDS, and Race by Myles W. Jackson

Reviewed by: The Genealogy of a Gene: Patients, HIV/AIDS, and Race by Myles W. Jackson Andrew J. Hogan (bio) The Genealogy of a Gene: Patients, HIV/AIDS, and Race. By Myles W. Jackson. Cambridge, MA: MIT Press, 2015. Pp. 344. Hardcover $35. In The Genealogy of a Gene, historian of science Myles W. Jackson traces the history of one human gene, CCR5, using it as a means of probing various aspects of the public and private world of biocapitalism. CCR5 proves an appropriate topic, because its history reveals and intersects with many major issues in recent biomedicine, including patenting and commercialization, efforts at personalized medicine, HIV/AIDS drug development, and debates about genetics and race. Historians of science and technology who work on these issues are likely to be already quite familiar with much of the ground covered in this book but will be impressed by the depth and breadth of Jackson's primary source analysis. Jackson's main argument is that the biocapitalism sector is more diverse in its efforts and motivations than scholars have previously demonstrated. Rather than a clear division in the interests of public and private entities, Jackson seeks to show the multi-faceted considerations of various firms and government institutions. The Genealogy of a Gene comes up somewhat short in this regard, due in part to a lack of explicit and sustained engagement with the previous studies and arguments of other bio-capitalism scholars, which are largely buried in footnotes. As a result, historians not well-versed in this literature will have trouble assessing the strength of Jackson's claim that scholars have oversimplified this history. Throughout The Genealogy of a Gene Jackson deftly shows the role—often unintentional—of U.S. Government agencies in opening up opportunities that biocapital firms exploited. Most notable was the U.S. Patent Office's (USPTO) hesitance to address human gene patenting, with all of its implications for biomedical research—not to mention its significance for our collective sense of humanity—as being distinct from patents on other chemical compositions of matter. As Jackson describes it, the USPTO's willingness to allow gene patents led to a flood of applications that it could not possibly assess sufficiently. Thus, gene patents were granted based on little or no laboratory work, limited knowledge of protein function, and [End Page 997] sometimes even with inaccurate sequence data: a situation that likely stifled biomedical research. Jackson also highlights the unintended consequences of the National Institutes of Health's (NIH) efforts to encourage more diverse biomedical research populations in the 1990s, a topic previously examined with great skill by Steven Epstein in Inclusion (2007). The introduction of racial categories into biomedical research trials, Jackson suggests, opened up an opportunity for biocapital firms to develop and exploit the hypothetical potential for race-based personalized medicine. This added more fuel to the fire of debates about the genetics of race and also created new marketing opportunities for companies to sell drugs that they claimed were more effective in certain racial populations. Even for a book on the history of science and technology, The Genealogy of a Gene is heavy on technical jargon. Jackson warns readers about this at the beginning and provides a glossary of terms in the back. Unfortunately, for most readers, this is not likely to be enough to overcome the unfamiliar language, acronyms, and symbols of molecular biology used throughout the book. Exceptions to this challenging reading are chapters 3 and 4, which offer a useful and detailed primer on U.S. and international patent law. Another notable strength of The Genealogy of a Gene is its examination of race and genetics, especially in chapter 8. There is not much new ground broken here, but the overview and engagement with multidisciplinary perspectives on race is quite useful. Jackson beneficially adds CCR5 to the story, among various other problematic instances of racialized efforts to study human diversity and health through genetics. Jackson also makes an important plea for historians to study and engage with ongoing social debates. Unfortunately, from his own account, it is unclear the extent to which Jackson was actually "the historian at the table while the controversy is ongoing" (p...

Gene Patents in Canada: Is There a New Legal Landscape?

In 2016, the Children's Hospital of Eastern Ontario (CHEO) announced the settlement of its patent lawsuit against US-based Transgenomic, Inc. At issue in the case was CHEO's ability to test for gene mutations associated with long QT syndrome (LQTS) that are described in Transgenomic's patents. CHEO challenged the patents as invalid, and Transgenomic ultimately agreed to license them on a royalty-free basis to CHEO and other healthcare institutions for LQTS testing and research. While widely celebrated in the media, the ethical rhetoric surrounding the settlement has at times obscured the practical and legal context in which it was made and will operate. Here, we provide a nuanced account of the events surrounding the settlement and its implications for research and clinical care. Although the settlement is remarkable for the transparency of its terms and its inclusion of a license intended to benefit unaffiliated test providers, we conclude that another significant implication of the settlement may be its elimination of the opportunity to clarify an increasingly confused area of Canadian law against a backdrop of continued international controversy surrounding the patenting of genes and gene-based diagnostic and therapeutic methods.

Data Exclusivity: A Tool to Sustain Market Monopoly

There has been a general downgrading of patent from its touted original has position of being the unique economic tool to promote innovation. The rhetoric of innovation which has long served as a platform to nestle ‘‘patents’’ have been challenged in all countries. For the pharmaceutical industry, the linking of patents — however unfairly — as the woe affecting pricing of life-saving medication in the developing world, the permeation of the pricing question as an election issue in the developed world, issues from secondary patents that potentially blocked further innovation, the low thresholds of biotechnology patents have all resulted in the industry assuming the avatar of defendants of patents globally. It has also resulted in the industry beginning its quest for new tools to help consolidate market exclusivity. This background has caused the pharmaceutical industry to scramble for tools to help sustain or maintain the longevity of their market monopoly. This paper will examine one such tool — data exclusivity — currently touted by the pharmaceutical industry. The focus of the paper will be on how data exclusivity can impact access to medication, specifically in developing countries. In doing so, the paper will discuss what data exclusivity is in Part II followed by an outline in Part III of the historic origins of data exclusivity. A description of Article 39 of the TRIPS agreement and its requirements are outlined in PartIV after which Part V addresses some of the controversial questions relevant to India. The Conclusion highlights the need to be cautious in adding a more TRIPS–plus form of exclusivity.

After Myriad, what makes a gene patent claim 'markedly different' from nature?

Examining the types of claim amendments that have transformed isolated gene claims from patent-ineligible into eligible subject matter provides clarity into the threshold of eligibility for gene-related patents.

An essential guide to patent practice and portfolio management in the life sciences

Patenting in the life sciences sector has grown exponentially since the 1980s, after the landmark case of Diamond v Chakrabarty 447 U.S. 303 (1980). This has also led to the emergence of national laws and policies, as well as of international treaties focused on patenting in the life sciences. Over the last few decades, research in this field has become even more intensive and competitive. The life sciences industry is no longer the hegemony of huge corporations: start-up companies, as well as companies that research single molecules or drugs, play a major role in the sector. Further, researchers and industry participants have acquired a globalized outlook and an international character. The commercialization of life sciences innovation depends on the intellectual property rights that subsist in it. Patent laws and procedures in this field have evolved to cater to the varied research platforms, industry participants and jurisdictions concerned. The debate on accessibility, which originally characterized a sector focused primarily on medicines and medical devices, has evolved into a debate on ethical and moral issues, related to the patenting of genes and life forms. Further, the adoption of patent strategies tailored to corporate objectives still raises substantial issues in the field, emphasizing the need to balance patenting in the life sciences and safeguarding the public good.

Intellectual Property Challenges for the Modern Biotechnology Enterprise: An Overview

The paper investigates the IP protection in the field of biotechnology among new innovators. Incompatibilities of the development process in modern biotechnology and the current IP systems are highlighted. Development process in biotechnology is notoriously slow, characterized by long delays in obtaining experimental data and marketing approvals. Initial development stages have been accelerated by the development in silico, by the global competition and accessibility of information. Thus, the most valuable part of the innovation (e.g., genetic sequence, protein structure) may be known years before the full experimental data. This significantly increases the risks of losing IP protection due to competing development, espionage, accidental disclosure, urging the premature patenting despite lack of resources to maintain global patents. Moreover, in biotechnology enterprise prohibitive costs of international patenting deplete the limited development resources and adversely affect both patenting and development. Costs are compounded by the increasing complexity of obtaining IP protection. Some of the complexities are recognized and underline multiple legislative interventions in establishing special regulations for biotechnology. The market also adjusted through practices such as evergreening. Unfortunately, legislative and market responses are not serving new innovators and may be contributing to the biotechnology patenting conundrums. The paper suggests that new legal innovation is needed in order to sustain healthy innovation in biotechnology and address the needs of new innovators. Several general and specific features for advancement of the legal protection of biotechnology are proposed for further research and discussion.

Biotechnological Patents Applications of the Deuterium Oxide in Human Health.

Deuterium oxide is a molecule that has been used for decades in several studies related to human health. Currently, studies on D2O have mobilized a "Race for Patenting" worldwide. Several patents have been registered from biomedical and technological studies of D2O showing the potential of this stable isotope in industry and health care ecosystems. Most of the patents related to the applications of the deuterium oxide in human health have been summarized in this review. The following patents databases were consulted: European Patent Office (Espacenet), the United States Patent and Trademark Office (USPTO), the United States Latin America Patents (LATIPAT), Patent scope -Search International and National Patent Collections (WIPO), Google Patents and Free Patents Online. With this review, the information was collected on recent publications including 22 patents related to deuterium oxide and its applications in different areas. This review showed that deuterium oxide is a promising component in different areas, including biotechnology, chemistry and medicine. In addition, the knowledge of this compound was covered, reinforcing its importance in the field of biotechnology and human health.

Patterns of genetic screening for hereditary cancer syndromes: Effect of Supreme Court’s ruling invalidating single gene patent rights.

1580 Background: In 6/2013 the Supreme Court ruled that isolated DNA sequences found in nature could not be patented, resulting in rapid uptake of multigene panels. We sought to explore trends in genetic testing since this ruling. Methods: Results of all patients undergoing genetic testing and counseling at a single institution between 7/1/13 and 12/31/16 were reviewed. Associations between categorical variables were evaluated by chi-square tests or Fisher's exact tests as appropriate for category size. Results: 1663 patients underwent genetic testing over the study period. The median age was 49 years (range 18-86). Use of multigene panels versus targeted gene testing increased significantly in the years following the Supreme Court ruling (Table 1, P<0.001). While the percentage of patients found to have pathogenic mutations remained stable over the study period (9%), detection of variants of uncertain significance (VUS) increased significantly (Table 1, P<0.001). In 2013 BRCA1/2 mutations accounted for 91% of identified mutations; however this number decreased over time (2014-83%, 2015-70%, 2016-58%, P=0.01). Use of multigene panels detected 71% of mutations in non- BRCA1/2 genes such as CHEK(19), APC(44), MSH6(1), P53(1), and PTEN(1). Patients with a personal history of breast and/or ovarian cancer were more likely to have targeted testing than patients with other cancer types (590, 66% vs. 9, 33%, P=0.001). Conclusions: The uptake of multigene panels has increased since the 2013 Supreme Court ruling. While this technology allowed for the identification of many cancer-related genes that would be missed on targeted BRCA1/2 testing, it also resulted in a significantly increased detection of VUS, a finding with unknown clinical implications. [Table: see text]

Gene patents still alive and kicking: their impact on provision of genetic testing for long QT syndrome in the Canadian public health-care system

PurposeAlthough the Supreme Court of the United States limited their availability in Association for Molecular Pathology v. Myriad Genetics, gene patents remain important around the world. We examine the situation in Canada, where gene patents continue to exist, in light of recent litigation relating to familial long QT syndrome (LQTS).MethodsWe conducted in-depth semistructured interviews with 25 stakeholders across five Canadian provinces and supplemented this with a case analysis of the litigation.ResultsThe majority of LQTS testing was carried out outside Canada. Rising costs prompted several provinces to attempt to repatriate testing. However, LQTS gene patents stymied efforts, particularly in provinces where testing was more centralized, increasing costs and lowering innovation. It was in this context that a hospital launched a test case against the LQTS patents, resulting in a novel agreement to free Canadian hospitals from the effects of patents.ConclusionOur analysis reveals a rapidly evolving genetic test provision landscape under pressure from gene patents, strained budgets and poor collaboration. The litigation resulted in a blueprint for free public use of gene patents throughout Canada's health-care system, but it will only have value if governments are proactive in its use.

Reflections on the National Bioethics Advisory Commission and Models of Public Bioethics

The National Bioethics Advisory Commission, of which I was a member, was established by a 1995 executive order that identified its "first priority" as "the protection of the rights and welfare of human research subjects." Not surprisingly, then, most of NBAC's work focused on research involving human subjects or participants. A second priority concerned "issues in the management and use of genetics information, including but not limited to, human gene patenting." NBAC's charter (in contrast to the executive order) listed this charge as "part B" of the "first priority." Nonetheless, NBAC never fully developed it. In addition to responding to requests and recommendations from the National Science and Technology Council, NBAC could accept suggestions from Congress and the public for bioethical issues it should consider, and it could also identify other issues to consider and set priorities among them. From its first meeting on October 4, 1996, until its charter expired on October 3, 2001, NBAC produced six reports, with 120 recommendations. In this essay, I make a few observations about principles and moral reasoning in NBAC's deliberations and about NBAC's attention to religious beliefs in the context of two bioethical controversies, provide a rough evaluation of NBAC's impact, and consider three possible models for future public bioethics directed at federal public policy.

The Population Ecology of Technology: An Empirical Study of US Biotechnology Patents from 1976 to 2003.

A detailed understanding of technological change as an evolutionary process is currently not well understood. To increase our understanding, we build upon theory from organizational ecology to develop a model of endogenous technological growth and determine to what extent the pattern of technological growth can be attributed to the structural or systemic characteristics of the technology itself. Through an empirical investigation of patent data in the biotechnology industry from 1976 to 2003, we find that a technology’s internal (i.e., density and diversity) ecological characteristics have a positive effect on its growth rate. The niche’s external characteristics of crowding and status have a negative effect on its growth rate. Hence, applying theory from organizational ecology increases our understanding of technological change as an evolutionary process. We discuss the implications of our findings for the study of technological growth and evolution, and suggest avenues for further research.