Increases in trade secret designations in hydraulic fracturing fluids and their potential implications for environmental health and water quality.

Hydraulic fracturing is an increasingly common method of oil and gas extraction across the United States. Many of the chemicals used in hydraulic fracturing processes have been proven detrimental to human and environmental health. While disclosure frameworks have advanced significantly in the last 20 years, the practice of withholding chemical identities as "trade secrets" or "proprietary claims" continues to represent a major absence in the data available on hydraulic fracturing. Here, we analyze rates of trade secret claims using FracFocus, a nationwide database of hydraulic fracturing data, from January 1, 2014 to December 31, 2022. We use the open-source tool Open-FF, which collates FracFocus data, makes it accessible for systematic analysis, and performs several quality-control measures. We found that the use by mass of chemicals designated as trade secrets has increased over the study time period, from 728 million pounds in 2014 to 2.96 billion pounds in 2022 (or a 43.7% average yearly increase). A total of 10.4 billion pounds of chemicals were withheld as trade secrets in this time period. The water volume used (and therefore total mass of fracturing fluid) per fracturing job has shown a large increase from 2014 to 2022, which partly explains the increase in mass of chemicals withheld as trade secrets over this time period, even as total fracturing jobs and individual counts of proprietary records have decreased. Our analysis also shows increasing rates of claiming proppants (which can include small grains of sand, ceramic, or other mineral substances used to prop open fractures) as proprietary. However, the mean and median masses of non-proppant constituents designated as trade secrets have also increased over the study period. We also find that the total proportion of all disclosures including proprietary designations has increased by 1.1% per year, from 79.3% in 2014 to 87.5% in 2022. In addition, most disclosures designate more than one chemical record as proprietary: trade secret withholding is most likely to apply to 10-25% of all records in an individual disclosure. We also show the top ten reported purposes that most commonly include proprietary designations, after removing vague or multiple entries, the first three of which are corrosion inhibitors, friction reducers, and surfactants. Finally, we report the top ten operators and suppliers using and supplying proprietary chemicals, ranked by mass used or supplied, over our study period. These results suggest the importance of revisiting the role of proprietary designations within state and federal disclosure mechanisms.

The Role of EU Trade Secrets Law in the Data Economy: An Empirical Analysis.

This article draws on a recently completed study for the European Commission on trade secrets in the data economy. It distils the main findings of that Study and advances it by reflecting on and analyzing these findings in the context of existing legal, management and economics literature, as well as their implications for EU legal policymaking when it comes to trade secrets law. In order to facilitate data sharing, the article argues for a cautious approach, with very modest legislative reforms to the EU Trade Secrets Directive, instead preferring soft law and practical steps to be taken. There is, however, greater scope to reform legal regimes that are complementary to EU trade secrets law, such as the sui generis database right.

Exploring risks of investor claims brought forth after the TRIPS waiver for COVID-19.

This research plans to explore the risks of the investment claims involved in the ongoing technology transfers to COVID-19 vaccine manufacturers based on the recently approved 'Agreement on Trade-Related Aspects of Intellectual Property Rights' (TRIPS) waiver. These investment claims are based on the various intellectual property rights protected under international investment laws. The recently approved TRIPS waiver only deals with the patent rights involved in producing the COVID-19 vaccine but does not deal with the other related intellectual property rights such as trade secrets. This work sounds the alarm of investment dispute for the mass-production of vaccines based on the TRIPS waiver. The research suggests a plan by which the Indian government can address the global issue of COVID-19 technology transfer in India.

Metal 3D printing: Patent law, trade secrets, and additive manufacturing.

There has been significant investment in research and development in respect of metal 3D printing in the United States (as well as a number of other jurisdictions). There has been growing conflict over the ownership of intellectual property in respect of metal 3D printing (involving not only patents but also trade secrets and confidential information, as well as contract law and unfair competition). In 2018, Desktop Metal Inc. launched litigation against Markforged Inc. and Matiu Parangi in relation to intellectual property and metal 3D printing in the United States. As well as complaints of patent infringement, Desktop Metal Inc. has alleged that the defendants had engaged in acts of trade secret misappropriation, unfair and deceptive business practices, and breach of contract. Markforged Inc. made various counter-claims of its own. In July 2018, a Federal Jury found that Markforged Inc. did not infringe two patents held by its rival Desktop Metal Inc. Claims of further violations of trade secrets and contract law were also considered. In the end, the dispute was settled, with neither party obtaining an advantage in the litigation. There was further conflict over whether the terms of the settlement in respect of non-disparagement were honored. The parties have also faced further intellectual property conflict. In 2021, Continuous Composites has filed a patent infringement lawsuit against Markforged Inc. In 2021, Desktop Metal Inc. brought legal action against SprintRay in Germany. Drawing upon this case study, this paper considers whether metal 3D printing will disrupt patent law, policy, and practice. It also explores the tension between the use of trade secrets in commercial 3D printing (such as in metal 3D Printing), and the open source ethos of the Maker Movement. This paper considers the larger implications of this intellectual property dispute over metal 3D printing for scarcity, regulation, and the abundance society. It also explores the innovation policies of the Biden administration in respect of advanced manufacturing-with a focus upon metal 3D printing and additive manufacturing.

An ethico-legal assessment of intellectual property rights and their effect on COVID-19 vaccine distribution: an Australian case study.

This article posits that Australia, as an affluent country with increasing capacity to manufacture vaccines, has an obligation to assist its regional (and global) counterparts in implementing vaccination programs that protect their populations. First, the article explores the capacity of high-income nations to meet their obligations, assist their neighbours and refrain from vaccine nationalism. This inquiry involves an analysis of the optimal ethical strategy for distributing vaccines globally, and the role that Australia might play in this distribution strategy. Secondly, the article examines the intellectual property landscape for vaccines in Australia, focusing on the patents that cover vaccine compositions and manufacturing techniques (recognizing the potential for know-how and access to materials as well as patents to affect manufacturing capacity). This article then discusses the strategies the Australian Government has at its disposal to counter potential intellectual property impediments whilst complying with existing obligations under the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), as an ethically appropriate response to the pandemic. This article also considers whether a so-called TRIPS waiver could provide better options and concludes that the challenge of compelling disclosure of know-how remains.

A concise framework to facilitate open COVID pledge of non-disclosed technologies: In terms of non-disclosed patent applications and trade secrets.

BACKGROUND: As a result of the COVID-19 global pandemic, many intellectual property (IP) owners have signed on to the "Open COVID Pledge", an agreement that makes corporate and university IP available free of charge for the purpose of facilitating the development of technologies that will end the pandemic and minimize the impact of disease. Joining this pledge is relatively straightforward for already-disclosed IPs. However, few, if any, has considered how to encourage owners of "non-disclosed patent applications" and "trade secrets" to sign on to this meaningful pledge. In other words, so far there is no proposal to extend the Open COVID Pledge for confidential pending patents and trade secrets. METHODS: We propose an innovative and flexible framework to cover both non-disclosed patent applications and trade secrets to mobilize inventors to participate in the Open COVID Pledge. RESULTS: By focusing on immediate publication of the patent-applying technology and extending provisional right to such applications which is subject to the Open Pledge during this pandemic, our recommendations are workable for inventors who would like to pledge their non-disclosed technologies for the detection, prevention and treatment of the COVID-19, in the meantime preserving their IP rights for the post-pledge period. CONCLUSION: This paper offers a way forward to guide pledgers and implementers who are interested in supporting the effort by addressing some of the issues associated with the free sharing of non-disclosed patent applications and trade secrets in the fight against COVID-19.

Chemical Use and Associated Health Concerns in the Semiconductor Manufacturing Industry.

BACKGROUND: Research on the status of many chemicals used in the semiconductor industry is needed. The purpose of this study was to describe the overall status of chemical use in the semiconductor industry in Korea and to examine it from a health perspective. METHODS: Data on the status of chemical use and safety data sheets at 11 of 12 major semiconductor workplaces in Korea were collected. The number of chemical products and chemical constituents, quantities of chemicals, and trade secret ingredients used, as well as the health hazards were examined. RESULTS: On average, 210 chemical products and 135 chemical constituents were used at the surveyed workplaces. Among all chemical products, 33% (range: 16-56%) contained at least one trade secret ingredient. Most of the trade secret ingredients were used in the photolithography process. Several carcinogens, including sulfuric acid, chromic acid, ethylene oxide, crystalline silica, potassium dichromate, and formaldehyde were also used. Only 29% (39 of 135) of the chemical constituents had occupational exposure limits, and more than 60% had no National Fire Protection Association health, safety, and reactivity ratings. Based on the aforementioned results, this study revealed the following. First, many chemical products and constituents are being used in the semiconductor industry and many products contained trade secret ingredients. Second, many products contained significant amounts of carcinogenic, mutagenic, and reproductive toxicant materials. CONCLUSION: We conclude that protecting workers in the semiconductor industry against harm from chemical substances will be difficult, due to widespread use of trade secret ingredients and a lack of hazard information. The findings of the status of chemical use and the health and safety risks in semiconductor industry will contribute to epidemiological studies, safe workplace, and worker health protection.

Intellectual property-The Foundation of Innovation: A scientist's guide to intellectual property.

Increasingly, the activities of the practicing scientist inextricably intersect with the business world. Science is central to the development and delivery of many goods or services, and scientific discovery can directly, or indirectly, lead to substantial revenue generation. Scientists, however, have little training in the complex issues of intellectual property (IP), and often little understanding of their rights and obligations. Here, we define IP and disuss what it means to be an inventor or creator of IP. We define and differentiate between the primary forms of IP-trade secrets, copyright, trademarks, and patents-and discuss their implementation and implications for the practicing scientist.

Constraints on gene patent protection fuel secrecy concerns: a qualitative study.

Concern is mounting that innovators are responding to recent changes in patent eligibility by increasingly choosing to protect their discoveries as trade secrets. Due to the clandestine nature of trade secrets, it is impossible to quantify the extent to which innovators actually elect to protect their inventions as trade secrets rather than patents. Nevertheless, interest in each strategy may be gauged through qualitative means. We conducted semi-structured interviews of legal and scientific experts (n = 30) to understand the effect of recent patent eligibility changes on interest in patenting and trade secrecy of genetic innovations. Interview data indicate that secrecy may have increased in strategic appeal relative to patent protection in some areas of genetic innovation, although the actual election of secrecy strategies is often limited as a practical matter. The data also suggest that the burden of navigating the new intellectual property landscape may be falling disproportionately on those who translate gene-based discoveries into clinical applications. Some interviewees expressed concern about the normative implications of secrecy on advancements in and access to genetic medicine. Our findings are potentially relevant to policy proposals intended to restore some of the legal protection that was lost as a result of recent changes to patent eligibility, including amending the federal patent statute and expanding regulatory exclusivities for some genetic technologies.

Commercial Opportunities and Ethical Pitfalls in Personalized Medicine: A Myriad of Reasons to Revisit the Myriad Genetics Saga.

In 1996, the US-based biotechnology company Myriad Genetics began offering genetic diagnostic tests for mutations in the genes BRCA1 and BRCA2, which are linked to hereditary breast and ovarian cancer. Since that time, Myriad has been a forerunner in the field of personalized medicine through the use of effective commercialization strategies which have been emulated by other commercial biotechnology companies. Myriad's strategies include patent acquisition and active enforcement, direct-to-consumer advertising, diversification, and trade secrets. These business models have raised substantial ethical controversy and criticism, often related to the company's focus on market dominance and the potential conflict between private sector profitability and the promotion of public health. However, these strategies have enabled Myriad to survive the economic challenges that have affected the biotechnology sector and to become financially successful in the field of personalized medicine. Our critical assessment of the legal, economic and ethical aspects of Myriad's practices over this period allows the identification of the company's more effective business models. It also discusses of the consequences of implementing economically viable models without first carrying out broader reflection on the socio-cultural, ethical and political contexts in which they would apply.

Management of intellectual property rights in India: An updated review.

The World Trade Organization's agreement on Trade-Related Aspects of Intellectual Property Rights set global minimum standards for the protection of intellectual property, substantially increasing and expanding intellectual property rights, and generated clear gains for the pharmaceutical industry and the developed world. The present review elaborates all aspects of Intellectual Property Rights in detail, along with their protection criteria.

University-industry research relationships in biotechnology: implications for the university.

The growth of university-industry research relationships in biotechnology has raised questions concerning their effects, both positive and negative, on universities. A survey of over 1200 faculty members at 40 major universities in the United States reveals that biotechnology researchers with industrial support publish at higher rates, patent more frequently, participate in more administrative and professional activities and earn more than colleagues without such support. At the same time, faculty with industry funds are much more likely than other biotechnology faculty to report that their research has resulted in trade secrets and that commercial considerations have influenced their choice of research projects. Although the data do not establish a causal connection between industrial support and these faculty behaviors, our findings strongly suggest that university-industry research relationships have both benefits and risks for academic institutions. The challenge for universities is to find ways to manage these relationships that will preserve the benefits while minimizing the risks.

KIE: An analysis is provided of a survey of over 1,200 faculty members at 40 major U.S. universities concerning their research activities and funding by industrial sources. The survey findings suggest that university-industry biotechnology research relationships have both benefits and risks for the university. Faculty members receiving industry support tend to be more productive. They publish, patent, and earn more. They participate in more administrative and professional activities, while teaching as much as other faculty members. However, their research also leads to more unpublished trade secrets, and commercial considerations may influence their choice of projects. The authors recommend public as well as commercial funding of research, protection of the right to publish research results, and university-industry agreements that do not unduly restrict faculty behavior.