International Tale on Gene Patents - between Medical and Legal Uncertainties / Cuento internacional sobre patentes genéticas: entre la incertidumbre médica y jurídica

This work is inspired by the international litigation chronicle of Myriad Genetics that remains of topical importance in the judicial and academic discourse regardless of the time that passed since. It discusses approaches of various jurisdictions to the problem of gene patenting as well as patenting of geneticdiagnostic testing. The article takes under scrutiny the judgments rendered in the U.S., Australia as well as the decisions by the European Patent Office and placesthem into interdisciplinary background of genetic science. The issue is significant, both theoretically and practically. Notwithstanding the expiration of patents that constituted the subject matter of the Myriad’s various lawsuits, the problem still remains currently relevant. Firstly, because the judgments in individual cases did not answer all the questions, but – in some way – only prepared a path for future decisions. Secondly, it is on account of new scientific breakthroughs in the area of human genetics. Consequently, the domain of genetic diagnostics is under continuous development and in the future may continue to reveal new scientific discoveries and (possibly) inventions. The lack of uniform and transparent rules in this field, and well-defined boundaries for potential monopolies constantly brings not only uncertainty for medical practitioners and scientists, but also real disadvantagesfor the patients. (AU)

Esta obra se inspira en la crónica del litigio internacional de Myriad Genetics, que sigue siendo de actualidad en el discurso judicial y académico a pesar del tiempotranscurrido desde entonces. En él se examinan los enfoques de diversas jurisdicciones sobre el problema de las patentes de genes, así como de las patentes de pruebas de diagnóstico genético. El artículo examina las sentencias dictadas en Estados Unidos y Australia, así como las decisiones de la Oficina Europea de Patentes, y las sitúa en el contexto interdisciplinario de la ciencia genética. La cuestión es importante, tanto desde el punto de vista teórico como práctico. A pesar de la expiración de las patentes que constituyeron el objeto de los diversos pleitos de Myriad, el problema siguesiendo de actualidad. En primer lugar, porque las sentencias dictadas en los casos individuales no respondieron a todas las preguntas, sino que –en cierto modo– sólo prepararon el camino para futuras decisiones. En segundo lugar, debido a los nuevosavances científicos en el ámbito de la genética humana. En consecuencia, el ámbito del diagnóstico genético está en continuo desarrollo y en el futuro puede seguirrevelando nuevos descubrimientos científicos y (posiblemente) invenciones. La falta de normas uniformes y transparentes en este ámbito y de límites bien definidos para los monopolios potenciales no sólo genera constantemente incertidumbre para losmédicos y científicos, sino también desventajas reales para los pacientes. (AU)

FDA Regulation and Approval of Medical Devices: 1976-2020.

Importance: US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation. Objective: To review the development of laws and standards affecting the evaluation and oversight of medical devices by the US regulatory system and the outcomes of this system from 1976 to 2020. Evidence Review: Laws enacted by US Congress and regulations promulgated by the FDA through 2020; databases maintained by the FDA of device authorizations from 1976 to 2020; and annual reports of user fees paid to the FDA by industry. Findings: Since Congress and the FDA initiated premarket review of medical devices in 1976, some fundamental innovations in the device regulation system have included special pathways to accelerate availability of investigational devices, more flexible evidence and review requirements, and increased funding to the FDA through industry-paid user fees. From 1987 to 2020, the annual number of novel devices granted premarket approval (which excludes supplements) ranged from 8 to 56 (median, 32), and the number of clearances for 510(k) devices (those that are "substantially equivalent" to marketed devices) ranged from 2804 to 5762 (median, 3404). User fee funding for devices was established in 2002 and annual fees collected increased from $30 million in 2003 (in 2019 dollars) to more than $208 million in 2019; this represented 43% of FDA funding related to the review of medical devices. Although many new devices have led to considerable patient benefit, such as hypodermic needles and magnetic resonance imaging machines, important adverse events caused by some devices, such as an implanted device for birth control and a surgical mesh implant for pelvic organ prolapse, have led to calls to reexamine the regulatory system for such products. Conclusions and Relevance: Over the last 45 years, medical device regulation has become more complex, with more regulatory pathways and greater variations in the evidence and controls required for authorization. Increased FDA support from industry and concern about flexible authorization requirements reflect the tension between efficient access and the need for assurances that products will safely benefit patients.

The proximity of ideas: An analysis of patent text using machine learning.

This paper introduces a measure of the proximity in ideas using unsupervised machine learning. Knowledge transfers are considered a key driving force of innovation and regional economic growth. I explore knowledge relationships by deriving vector space representations of a patent's abstract text using Document Vectors (Doc2Vec), and using cosine similarity to measure their proximity in ideas space. I illustrate the potential uses of this method with an application to geographic localization in knowledge spillovers. For patents in the same technology field, their normalized text similarity is 0.02-0.05 S.D.s higher if they are located within the same city, compared to patents from other cities. This effect is much smaller than when knowledge transfers are measured using normalized patent citations: local patents receive about 0.23-0.30 S.D.s more local citations than compared to non-local control patents. These findings suggest that the effect of geography on knowledge transfers may be much smaller than the previous literature using citations suggests.

Patenting a living microbial cell: 40th anniversary of US Supreme Court decision Diamond versus Chakrabarty.

Patents for microbiology and biotechnology are generally for a process (for example DNA cloning; and polymerase chain reaction, PCR) and not for the microbe itself. The patent for oil degrading bacteria was different in that it covered the modified microbial cell itself, a Pseudomonas strain with laboratory-assembled plasmids that encoded the bacterial degradation of multiple components of crude oil. It was first applied for in 1972, initially refused by the patent office on the basis that it was a living organism, and then eight years later in June 1980 allowed by the US Supreme Court ruling that this did not matter and the only issue was whether it was a novel manufactured product.

Back to the future of digital price display: Analyzing patents and other archives to understand contemporary market innovations.

The article explores reasons for the lack of success of digital electronic shelf labels (ESLs) in US retail settings. It suggests that these reasons can be traced by referring to the triple meaning of 'digital': 'Digital' now means electronic, but the word also long encompassed numerals - a digit is a number - and body parts - digitus is the Latin word for the finger, that is, the index we use to point at things or manipulate them. The current fate of ESLs is linked to a long history that combined these three dimensions. The study unfolds along a twofold narrative. First, it reviews the recent introduction of ESLs in the United States based on the reading of papers and advertisements published in Progressive Grocer, a leading trade press magazine. Then, it goes 'back to the future' by exploring the roots of ESLs over a century. This historical study is based on the analysis of the evolution of US price tag patents (through a network study of patents citations and their evolution); the network analysis is complemented with the history of the US price tag market (through the knowledge gained from Progressive Grocer). The results show that digital price fixing depends on past and present systems and infrastructures, cost constraints and payback schemes, legal frameworks, and social projects.

James M. Osgood: An Inventor Behind Sprague's "Self-Watching" Apparatus for G.Q. Colton's Revival of Nitrous-Oxide Anesthesia.

Inventor J.M. Osgood enabled a fellow Massachusetts inventor, A.W. Sprague, to manufacture heat-regulated nitrous-oxide generators. These generators assisted New Yorker G.Q. Colton in opening exodontia franchises nationwide which revived the use of nitrous-oxide anesthesia.

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.

[Patentability of an antibody: evolution of rules and practices and prospects]. / Brevetabilité d'un anticorps - Évolution des règles et des pratiques et perspectives.

TITLE: Brevetabilité d'un anticorps - Évolution des règles et des pratiques et perspectives. ABSTRACT: Les anticorps monoclonaux représentent aujourd'hui la classe médicamenteuse la plus importante en termes de ventes mondiales. L'obtention d'une protection par brevet de ces molécules est donc cruciale. Une dynamique active de dépôts de demandes de brevets pour protéger les inventions que ces molécules représentent existe donc autant dans l'industrie que dans le monde de la recherche académique. Cependant, les demandeurs doivent faire face à des difficultés récurrentes pour obtenir des brevets de portée importante et faire valoir leurs droits devant les tribunaux. Les trois critères les plus débattus autour des revendications d'anticorps sont : la suffisance/clarté de l'invention, la nouveauté et l'activité inventive. L'objectif de cet article est donc de faire un état des lieux de la pratique en la matière.

Instruments of statecraft: Humphrey Cole, Elizabethan economic policy and the rise of practical mathematics.

This paper offers a re-interpretation of the development of practical mathematics in Elizabethan England, placing artisanal know-how and the materials of the discipline at the heart of analysis, and bringing attention to Tudor economic policy by way of historical context. A major new source for the early instrument trade is presented: a manuscript volume of Chancery Court documents c.1565-c.1603, containing details of a patent granting a monopoly on making and selling mathematical instruments, circa 1575, to an unnamed individual, identified here as the instrument maker Humphrey Cole. Drawing on economic and legal history, the paper argues that practical mathematics needs to be understood as one 'project' among many, at a time when monopoly patents were used to advance industry, lower unemployment, secure the realm and reward invention. Drawing on the history and sociology of technology, it argues that the management and control of materials - mathematical instruments themselves, and the local socio-legal context within which they could be made - needs to be understood as prior to and separate from the rhetoric of mathematical authors, which is of interest in its own right but which may not have a direct relationship to mathematical practice.

Charles T. Jackson and William T.G. Morton Patented the "Ethereal Solution of Opium" of Elton Romeo Smilie.

The Jackson-Morton 1846 patent for surgical insensibility by means of sulphuric ether states that opiates can be added to the ether and co-administered by inhalation. The erroneous concept that ether could carry opiates in its vapor phase at room temperature was proposed in Boston in 1846 by Elton Romeo Smilie (1819-1889), who believed that the opiates were more important than the ether vehicle.

A patent landscape on application of microorganisms in construction industry.

Construction biotechnology includes research and development of construction materials and processes that make use of various microbes. The present technology landscape gives a perspective on how microbes have been used in construction industry as cement and concrete additives by analyzing patents filed in this technology arena. All patents related to the technology of interest published globally to date have been reviewed. The earliest patent filing in this technology domain was recorded in the year 1958 and the patenting activity reached its peak around mid to late 1990s. The early technology was mainly focused on microbial polysaccharides and other metabolic products as additives. Year 2002 onwards, biomineralization has taken precedence over the other technologies with consistent patent filings indicating a shift in innovation focus. Japan has been the global leader with highest number of patents filed on application of microbes in construction industry. Southeast University, China has topped the patent assignee list with maximum number of filings followed by Kajima Corp. and Shin-Etsu Chemical Co., Ltd. Most patent applications have claimed microbe based bio-products. Construction-related microbial technologies are mainly based on activity of different microorganisms such as urease-producing, acidogenic, halophilic, alkaliphilic, nitrate and iron-reducing bacteria. Sporosarcina pasteurii has been the most widely used microbe for biomineralization.