Patent Research Articles

Ethics, Patents and Genome Editing: A Critical Assessment of Three Options of Technology Governance

Current methods of genome editing have been steadily realising the once remote possibilities of making effective and realistic genetic changes to humans, animals and plants. To underpin this, only 6 years passed between Charpentier and Doudna’s 2012 CRISPR-Cas9 paper and the first confirmed (more or less) case of gene-edited humans. While the traditional legislative and regulatory approach of governments and international bodies is evolving, there is still considerable divergence, unevenness and lack of clarity. However, alongside the technical progress, innovation has also been taking place in terms of ethical guidance from the field of patenting. The rise of so-called “ethical licensing” is one such innovation, where patent holders’ control over genome editing techniques, such as CRISPR, creates a form of private governance over possible uses of gene-editing through ethical constraints built into their licensing agreements. While there are some immediately apparent advantages (epistemic, speed, flexibility, global reach, court enforced), this route seems problematic for, at least, three important reasons: 1) lack of democratic legitimacy/procedural justice, 2) voluntariness, wider/global coordination, and sustainability/stability challenges and 3) potential motivational effects/problems. Unless these three concerns are addressed, it is not clear if this route is an improvement on the longer, slower traditional regulatory route (despite the aforementioned problems). Some of these concerns seem potentially addressed by another emerging patent-based approach. Parthasarathy proposes government-driven regulation using the patent system, which, she argues, has more transparency and legitimacy than the ethical licensing approach. This proposal includes the formation of an advisory committee that would guide this government-driven approach in terms of deciding when to exert control over gene editing patents. There seem to be some apparent advantages with this approach (over traditional regulation and over the ethical licensing approach mentioned above—speed and stability being central, as well as increased democratic legitimacy). However, problems also arise—such as a “half-way house” of global democratic legitimacy that may not be legitimate enough whilst still compromising speed of decision-making under the “ethical licensing” approach). This paper seeks to highlight the various advantages and disadvantages of the three main regulatory options—traditional regulation, ethical licensing and Parthasarathy’s approach—before suggesting an important, yet realistically achievable, amendment of TRIPS and an alternative proposal of a WTO ethics advisory committee.

Local search or beyond? The influence of interfirm technological distance on co-innovation success

AbstractIn the interfirm co-innovation process, knowledge search spanning organizational boundaries is believed to be essential to innovation but is often technologically, geographically, and socially bounded. Given that spanning any type of boundary may lead to both decreased learning and increased creativity, its influence on co-innovation success remains unclear. Using a sample of 18,575 US utility patents co-invented by 6,595 dyads of firms during 1993–2002, the net effect of interfirm technological distance (which depicts cognitive boundary-spanning search) on the quality of a co-invented patent is found to depend largely on other types of boundary-spanning searches, such as cross-regional and cross-network partnerships. The net effect is negative when co-inventing partners are within the same region and network, whereas the net effect becomes positive when partners originate from distinct regions and networks. The findings advance the understanding of boundary-spanning searches of various types and their complicated interactions, suggesting that boundary spanning is crucial to co-innovation success.

Identifying Automotive Industry Trends: Data Mining from Intellectual Property Databases

Patents protect the patent holders in that the patented process, design and invention can only be used or sold by the holder exclusively. Therefore, manufacturers use patents to gain a competitive edge against the competition. A patent analysis discovers which car parts are considered the most for future development in the automotive sector. The purpose of this paper is to identify and analyze major trends and the potential implementation of patents. Furthermore, the research may reveal in detail the common R&D trends within a certain industry, differences among the major representative manufacturers and support to identify feasible future strategies for lagers. The patent analysis will be launched with the data collection from a patent database. To avoid the extensive computing time in R, only each patent document's abstract is deployed for the research. After data cleansing, the term frequency-inverse document frequency algorithm is used to find the keywords in the patent abstracts. To visualize results, the social network analysis is conducted. It identifies trends and relationships among the mapped keywords. The discovered major keywords constitute the graphs of the most important parts related to each other and are considered for the future.

Global access to COVID-19 vaccines: a scoping review of factors that may influence equitable access for low and middle-income countries

ObjectiveTo identify the factors contributing to equitable access to COVID-19 vaccines for low and middle-income countries (LMIC).MethodsWe conducted a scoping review following the guidelines for Preferred Reporting Items for Systematic...

OUTLOOK OF ARBITRARY MEASURES OF FAIR AND EQUITABLE TREATMENT UNDER HEALTH URGENCY: THE WAIVER OF PHARMACEUTICAL PATENT

Patent has long been recognized as an important subject of investment particularly for Pharmaceutical Companies. In its development, patents have become one of the most prominent tools in international health investment for its economic benefit sourced from its exclusive right. Most of the Multilateral and Bilateral Investment Treaties recognized intellectual property rights as protected investments, which allows patent holders to benefit from the substantive and procedural safeguards granted by the applicable treaty for foreign investments. In the situation of health urgency, many patents rights are being waived by the government to make the innovation more affordable and accessible to citizens. In this situation, tension in the governance of pharmaceutical patents between patent holders and state authorities is an example of a broader recurring dynamic in international law: the tension between foreign investors' private interests and the host state's regulatory autonom. This research paper will discuss whether the patent waiver enacted by the government is considered as an arbitrary action under the Fair and Equitable Treatment standard as it causes harm to the foreign investor by analyzing several precedent jurisprudences through juridical normative methods

PEMBATASAN TERHADAP PERSAINGAN UNTUK MEMBENTUK PASAR DALAM KASUS STANDARD ESSENTIAL PATENT (SEP) (PERBANDINGAN HUKUM PERSAINGAN USAHA DI INDONESIA DAN UNI EROPA)

The role of patents is complex when dealing with the problem of technological interoperability in cases where patented technology becomes standard. In such cases, a balance is needed between the protection of the interests of the inventor, i.e. the standard essential patent (SEP) holder, and of users who need the technology to enter the market. There is a susceptibility to restrictions on competition to create markets (competition for the market). Market dominance can be created by the adoption of SEP holder technology as a standard and hence, a key for other business actors to enter the market. With the potential for the formation of a dominant position in the relevant market, the competition law intervention is required when patent abuse occurs, as it appears typical in the pharmaceutical and information technology industries. The normative research examines how competition law in the European Union deals with SEP cases in comparison to Indonesian competition law.

Growing Convergence: The Limited Role of Antitrust in Standard Essential Patent Disputes

In the last couple of years, the United States Department of Justice (“DOJ”) and several European countries have reversed previous interventionist decisions and limited the role of antitrust in the resolution of disputes concerning Standard Essential Patent (“SEPs”). These jurisdictions recognize the need to protect intellectual property rights (“IPRs”) by making available injunctions against infringers. Courts have realized that hold-up by a patent holder demanding excessive royalties is not a widespread problem and that patent implementers may hold-out against paying any royalties whilst they continue to practice a patent. They have accordingly adopted new standards for granting injunctions in disputes involving SEPs with the goal of increasing efficiency and legal certainty. We discuss this shift and its implications for competition policy and innovation.

Creative AI-based inventions: How incumbents strategically renew their invention portfolios

Artificial Intelligence (AI) is often considered a general purpose technology with the potential for disruption in most existing markets. When facing a substantial technological disruption, it has been shown that incumbents are confronted with many challenges to develop new products (conflicting customer incentives, cognitive lock-in, lack of complementary assets), despite that this activity is critical to ensure companies' survival. Overcoming those issues lies with companies' capacity to strategically renew their resources and remain competitive in their market. However, while the literature has shown how incumbents used AI technologies to increase efficiency or productivity, little is known about how they rely on AI technologies in their inventive process. It has also been observed that companies broadly vary in the ways they are embracing AI technologies, but most studies approach AI-based inventions as homogeneous. Hence, to cope with this research gap, we adopted a strategic renewal perspective (e.g., Agarwal & Helfat, 2009), and we conceptualized a new taxonomy of different types of AI technology usages in companies' inventive processes. Creative AI-based inventions focus on implementing AI technologies that serve new-to-company applications and open up new technological paths. Follow-up creative AI-based inventions indicate the company's efforts in following the newly created technological path. Low AI-based inventions specify the usage of AI to extend the existing technology portfolio without disrupting the current business of the company. By drawing upon an example from the agricultural sector, we developed techniques relying on patent data to implement our taxonomy by dealing with 39,000 utility patents from the sector's top-19 companies. First, we explored how incumbents and new entrants from different industry origins relied on different AI technology usages with different adoption patterns. Second, by relying on patent indicators, we reviewed the performances of the different types of AI technology usages in companies' inventive process. We contribute to strategic renewal theory by revealing that incumbents from the industry we focus on others rely on AI to renew their patent portfolio to strategically develop new business. Second, we demonstrated the co-existence of different usages of AI technologies in companies' inventive processes to complement incumbents' portfolios and open new innovative paths. Consequently, companies should plan which type of strategic renewal is appropriate for their organisations based on their strategic playing field to achieve the desired outcome.

Patent Enforcement and Innovation

This paper investigates the effect of patent protection on cumulative innovation. While one of the main functions of the patent system is to foster innovation, patents might block sequential innovation. Consequently, the actual impact of patent rights on innovation is still under debate. To investigate this relationship, I analyze the impact of patent infringement litigation on cumulative innovation. The results for a sample of U.S. patents imply that patent citations increase after a case is filed in a court. While citations increase during the litigation period, the relative effect size decreases in the years following the closure of the case. Further results imply that this effect is particularly driven by patents subject to litigation with a high degree of novelty and patents with a narrow breadth. Analyzing the impact of non-practicing entities shows that the change in citations is lower for patents owned by this type of patent holders. Moreover, citations of litigated patents stem particularly from patents that are close in terms of technological proximity and general similarity.

IP Analytics and Machine Learning Applied to Create Process Visualization Graphs for Chemical Utility Patents

Researchers must read and understand a large volume of technical papers, including patent documents, to fully grasp the state-of-the-art technological progress in a given domain. Chemical research is particularly challenging with the fast growth of newly registered utility patents (also known as intellectual property or IP) that provide detailed descriptions of the processes used to create a new chemical or a new process to manufacture a known chemical. The researcher must be able to understand the latest patents and literature in order to develop new chemicals and processes that do not infringe on existing claims and processes. This research uses text mining, integrated machine learning, and knowledge visualization techniques to effectively and accurately support the extraction and graphical presentation of chemical processes disclosed in patent documents. The computer framework trains a machine learning model called ALBERT for automatic paragraph text classification. ALBERT separates chemical and non-chemical descriptive paragraphs from a patent for effective chemical term extraction. The ChemDataExtractor is used to classify chemical terms, such as inputs, units, and reactions from the chemical paragraphs. A computer-supported graph-based knowledge representation interface is developed to plot the extracted chemical terms and their chemical process links as a network of nodes with connecting arcs. The computer-supported chemical knowledge visualization approach helps researchers to quickly understand the innovative and unique chemical or processes of any chemical patent of interest.

Composite value index of trademark indicators: A market value analysis using Tobin's Q

This paper provides novel empirical evidence on the market valuation of a firm's intangible assets for U.S. firms during the period 1991–2015, exploring the relationship between Tobin's q, R&D, advertising, utility patents, international patent applications, design patents, trademarks, and value weighted IP measures. The Tobin's q is found to be positively and significantly associated with the proposed composite value index of trademark indicators above and beyond the other measures of intangible assets. The paper articulates some managerial implications on how firms could benefit from investing in trademarking and enlarge market value through the combination of multiple IP strategies.

COVID-19 AND INTELLECTUAL PROPERTY LAW: COMPULSORY LICENSING AND THE ACCESS TO COVID-19 TREATMENT

This essay concerns the problematic of the access to Covid-19 treatment at an international scale and the role of Intellectual Property Law. As in past outbreaks, one of the most raised questions is the possibility of patent holder’s rights being an obstacle to the access to treatment. Since the beginning of this pandemic, Compulsory Licensing has been presented as the mechanism capable to guaranteeing Covid-19 treatment globally and rapidly. We propose to analyse this figure and its possible alternatives - Voluntary Licensing, Patent Pools and the Proposal to waive TRIPS Intellectual Property provision. We will then assess which is the most effective solution to overcome this humanitarian crisis without compromising the balance between the right to health and intellectual property rights.

Exclusivity in Times of a Public Necessity: Balance of Interests in South Asia’s Compulsory Licensing Regime

The catastrophic impact of the COVID-19 pandemic on every facet of human life has made the requirement of a pharmaceutical breakthrough in the form of a vaccine more urgent than ever. The urgency has led to a hundred plus researches being underway, with tremendous amounts of capital and intellect invested. The vaccine being an invention, invites patent regulations and the rights of the patent holder associated with the invention. However, given the urgency of the situation, countries need to ensure hassle free access to the vaccine. Here, Compulsory Licensing regulations would play an important role. Beginning with a historical background of Compulsory Licensing under TRIPS, the authors analyse its subsequent amendment keeping in view the right of countries to give primacy to public health over intellectual property protection. The authors then highlight the diverse legislative positions of Compulsory Licensing in South Asia through the lens of the TRIPS position. The authors also comment upon Patent Pools, a comparatively new concept in the area of public health which is gaining spotlight. Further emphasis has been laid on keeping administrative impediments minimal with regards to the working of the intellectual property. This is important since firstly, the majority of the attempts underway are a collaborative innovation involving multiple stakeholders and secondly, multiple patent applications could be filed for different parts of a single invention leading to complexities while licensing. Finally, suggestions have been given as to how the patent regulations could be worked so as to maintain a balance between the rights of the patent holder and public health.

The new middle-maturing winter barley variety ‘Marusya’

Last years the Rostov region has faced a significant climate continentality increase during the growing season of winter crops. This factor makes necessary to develop new varieties of intensive winter barley with a high level of ecological adaptability, resistance to lodging and leaf diseases, with a high level of potential productivity. The purpose of the current study was to develop a new highly productive, stress-resistant winter barley variety with a high level of adaptability and to evaluate it according to economically valuable traits. The current paper has presented the agrobiological characteristics of the winter barley variety ‘Marusya’, the originator and patent holder of which is the Federal State Budgetary Scientific Institution “Agrarian Research Center “Donskoy”. The research was carried out from 2018 to 2020 in the fields of experimental crop rotation of the department of barley breeding and seed production of the FSBSI “ARC “Donskoy”. The forecrop was peas. The accounting plot area was 10 m², the number of repetitions was 6. The winter barley variety ‘Timofey’ was used as a standard variety. The species was parallelum. The type of development was facultative. Over the years of study in the Competitive Variety Testing of the FSBSI “ARC “Donskoy” (2018–2020), the variety produced from 8.0 to 11.2 t/ha, that exceeded the standard variety ‘Timofey’ on 0.5–1.5 t/ha. Since 2020, the State Commission for Variety Testing of Agricultural Crops decided to include the variety ‘Marusya’ in the State List of Breeding Achievements in the North Caucasus region. The variety is being studied in the Central Blackearth and Lower Volga regions of the Russian Federation. The consistently high productivity of the new variety is achieved due to the large grain and higher indicators of the yield structure elements and resistance to diseases in comparison with those of the standard variety ‘Timofey’

Promoting Electric Vehicle Cell Innovation Diffusion Considering Patent Licensing Strategy: A Combination of Evolutionary Game and Optimization Algorithm Approach

Electric vehicle cell industry is an emerging area with fierce competition on technical innovation, in which the patent holder can choose different innovation diffusion options to maximize the return; however, the strategy is unclear in certain scenarios. We tried to explain the question of how to maximize the patent holder’s return by appropriate patent license strategy to promote EV cell innovation diffusion, when competition and patent licensing relationship exist in the supply chain. A multistage and multichannel diffusion model of EV cell comprising the patent holder, EV cell producer and EV producers is developed; the evolutionary game is analyzed considering the competition among same stage players and patent licensing relationship among different stage players; and an optimization algorithm is introduced to find the maximum weighted object function of the patent holder. We established the multistage and multichannel diffusion model and found a nonlinear complex relationship between patent holder object function and the key factors including patent royalty pricing and innovation advantage coefficient; in addition, an optimization algorithm is developed based on adopters’ decision-making related with competition and patent licensing.

Importance of Public Interests in Patent Law

The article is focused on studying and explaining the legal nature and content of public interests from point of view оf the patent protection system in the context of globalization processes. The problems of the influence of patent rights on the possibility of individuals to realize their rights in the health care sector are identified. The concepts of private and public interests, their ratio, content featurs in patent law are analyzed. The defining value of interest is fixed at the normative level in civil law, where intellectual property law is its sub-branch. In general, private interest can be both property and non-property. In this context, the provisions of national and international legislation of the necessity оf balance the interests of society and patent holders are analyzed; on restricting the rights of patent owners with the aim to ensure the public interest; about necessity in certain cases to break the monopoly of patent owners through compulsory licensing, etc. The tendency to strengthen the protection of public interests has been revealed. Attention is paid to the issue of distinguishing between the private interests of patent holders and the interests of society. It is clarified why these interests collide and what rules justify such conflicts. The conclusion that necessity to ensure a balance between private and public interests is substantiated as the urgent task of modern legislation in the legal regulation of patent relations.
 One of the legal ways to achieve a balance between the interests of society and patent holders is a compulsory license. The institution of compulsory licensing fully corresponds to the peculiarities of patent legal relations and does not deprive the patent owner of the protection of his exclusive right. But it does not prevent the latter to independently use and effectively commercialize the relevant technical solution. Compulsory license is possible to apply precisely in those cases when the harm to the public interest from the exercise of the exclusive patent right exceeds the benefits received by the right holder.
 The authors have determined the direction of the development of legal regulation of patent relations in this area taking into account the requirements of international treaties.

A Phase 1 Trial of the Combination of Ibrutinib and Azacitidine for the Treatment of Higher Risk Myelodysplastic Syndromes: University of California Hematologic Malignancies Consortium (UCHMC) Study 1503

Introduction: Higher risk myelodysplastic syndromes (HR-MDS) have poor outcomes, particularly after hypomethylating agent (HMA) failure. The HMA azacitidine (AZA) is a standard of care for HR-MDS and works through several mechanisms, including inhibition of NF-kB signaling. Ibrutinib (IBR) inhibits Bruton9s Tyrosine Kinase (BTK) and has an antiproliferative effect on myeloblasts in preclinical models through BTK binding and inhibition of NF-kB signaling. IBR also has immunomodulatory activity mediated through binding interleukin-2-inducible kinase (ITK) and promoting Th1-polarized immunity, which is decreased in HR-MDS. These features suggest that the combination of IBR and AZA may improve outcomes in HR-MDS. Methods: This is an ongoing multicenter prospective Phase 1 dose-escalation trial of IBR in combination with AZA in patients with HR-MDS (NCT02553941). Results of the dose escalation phase are reported. Eligibility included World Health Organization or French-American-British classification-defined MDS and Revised International Prognostic Scoring System (IPPS-R) intermediate or higher risk. Any prior therapy was allowed or patients could be untreated if unfit for, or had refused, high intensity chemotherapy. Transfusion-dependent patients were eligible. Patients received AZA 75 mg/m2 IV/SC daily for 7 days and IBR orally daily for 28 days. Cycles repeated every 28 days. Dose-escalation used a 3+3 design with IBR dose levels of 420 mg (Cohort 1) and 560 mg (Cohort 2). The primary objective was to determine the safety and tolerability of IBR in combination with AZA. Adverse events (AEs) were monitored throughout treatment, and dose-limiting toxicities (DLT) were assessed during cycle 1. The secondary objective was to assess preliminary efficacy using modified International Working Group Response Criteria. Exploratory objectives evaluated pharmacodynamic and biological effects of the combination, including BTK occupancy in CD34+ bone marrow mononuclear cells (BMMC). Results: As of June 1, 2017, 9 patients [89% male, median age 80 years (range 64-81)] were enrolled into Cohort 1 (n=3) and Cohort 2 (n=6). MDS subtypes included single lineage dysplasia (n=1), multilineage dysplasia (n=1), excess blasts (EB)-1 (n=2), EB-2 (n=3), refractory anemia with EB in transformation (n=1) and unclassifiable (n=1). IPSS-R scores were intermediate (n=2), high (n=2) and very high (n=5). Three patients were HMA-naive and six had prior HMA therapy [AZA (n=3), decitabine (n=2), both (n=1)]. All patients completed cycle 1. No DLTs were observed. All patients experienced at least one treatment-emergent adverse event (TEAE). Seven patients experienced a grade 3-4 TEAE with neutropenia (n=6), thrombocytopenia (n=3) and febrile neutropenia (n=3) most common. Four patients (three in Cohort 1 and one in Cohort 2) experienced a serious adverse event including febrile neutropenia (n=3) and gastric hemorrhage (n=1). No patients experienced atrial fibrillation. Median time on study was 160 days (range 42-283) with a median of five cycles (range 1-10) received. Six patients remain on IBR plus AZA, and three patients have discontinued study therapy (two disease progression and one withdrawal of consent and subsequent death on hospice). Four patients have reduced AZA to 5 days per cycle per investigator discretion, and four patients have had interruptions of IBR dosing due to febrile neutropenia (n=3) and concurrent azole use (n=1). Three patients (33%) achieved complete remission (CR), one (11%) had a partial remission (PR), and five (55%) had stable disease (SD). All three CRs occurred in patients without prior HMA exposure and included one complete and two partial cytogenetic responses. CR was achieved after 1, 4 and 6 cycles in these patients. One patient (11%) with SD had a hematologic improvement-erythroid response (HI-E). The overall hematologic normalization rate (CR+PR+HI) was 55%. BTK occupancy in CD34+ BMMC after cycle 1 was 42.0% and 51.7% in two patients at IBR 420 mg and 41.5% in one patient at IBR 560 mg. Conclusions: The combination of IBR and AZA demonstrates a tolerable safety profile in patients with HR-MDS. No DLTs were observed at either IBR dose level. The combination shows promising preliminary efficacy, including responses in patients with prior HMA exposure. CD34+ BMMC BTK occupancy was seen. An expansion cohort at the IBR 560 mg dose level in AZA-naive patients is ongoing. Disclosures Jonas: AbbVie, Celgene, Daiichi Sankyo, Pharmacyclics, Genentech/Roche, Glycomimetics, Esanex, Kalobios: Research Funding; Celgene: Membership on an entity9s Board of Directors or advisory committees; Rigel: Consultancy. Logan: Novartis: Consultancy, Research Funding; Incyte: Consultancy; Astellas: Research Funding; Shire: Consultancy; Kite: Research Funding; Amgen: Consultancy; Pharmacyclics: Research Funding; Jazz: Consultancy. Abedi: Takeda: Speakers Bureau; Seattle Genetics: Speakers Bureau; Gilead: Speakers Bureau; BMS: Speakers Bureau; Amgen: Research Funding; Celgene: Membership on an entity9s Board of Directors or advisory committees, Research Funding, Speakers Bureau; California Institute of Regenerative Medicine: Research Funding. Bejar: Celgene: Consultancy, Honoraria, Other: DSMB, Steering Committee, Research Funding; Genoptix: Consultancy, Honoraria, Patents & Royalties; AbbVie/Genetech: Honoraria, Other: Ad-hoc advisory board; Foundation Medicine: Honoraria, Other: Ad-hoc advisory board; Otsuka/Astex: Honoraria, Other: Ad-hoc advisory board; Modus Outcomes: Consultancy, Honoraria. Wieduwilt: Reata Pharmaceuticals: Equity Ownership; Sigma-Tau: Research Funding. Curtin: Amgen, Celgene, Onconova, Pharmacyclics: Research Funding.

Trends in Surgical Patents Held by Surgeons From 1993 to 2018.

This study aims to quantify the number of patent-holding surgeons and determine their specialty demographics. The number of intellectual property filings related to surgery has exponentially increased over the past 40 years, yet surgeon inventor status among these inventions remains poorly defined. A query of the United States Patent and Trademark Office (USPTO) Patent Full-Text and Image Database was performed over the years 1993 to 2018. Patents related to surgery were defined as surgical devices, implantables, dressings, introducers, and sterilization equipment based on Cooperative Patent Classification (CPC) code. Inventor names were cross-indexed with names of active Fellows in the American College of Surgeons (FACS) as of 2019. Surgeon inventors were identified and differences between specialty and sex were evaluated. A total of 275,260 patents related to surgery were issued over the study period. The number of surgical patents has increased by 462% from 4593 per year to 21,241 per year. A total of 9008 patents were held by a total of 2164 surgeons (4% of FACS). This represents 3.3% of all surgical patents with a mean of 5 patents (range 1-346) per patent-holding surgeon. Specialties with the largest number of patent holders include neurosurgery (9%) and orthopedic surgery (8%). Ninety-seven percent of patent-holding surgeons were male. 3.3% of patents related to surgery involve a surgeon inventor, and although the number of surgical patents has shown an exponential increase, surgeon involvement in these inventions has grown minimally. Surgical innovation training may offer an opportunity to reduce these discrepancies and increase surgeon involvement as patent holders.

Pledging Patent Rights for Fighting Against the COVID-19: From the Ethical and Efficiency Perspective.

In response to the great crises of the COVID-19 coronavirus, virtually all new technologies protected by patent rights have been used in practice from diagnostics, therapeutic, medical equipment, and vaccine to prevention, tracking, and containment of COVID-19. However, the moral justification of patent rights is questioned when pharmaceutical patents conflict with public health. This paper proposes a revised approach of deciding on how to address the conflicts between business ethics and patent protections and then compares the different mechanisms of clearing patent thickets. Our findings highlight that patent pledges may not only contribute to achieving the maximized substantive justice of the public but also help patent pledgors fulfill procedural justice. The advantages of patent pledges have attracted many patent holders to make public statements during the COVID-19 pandemic. In contrast, the disadvantages of a free license may make patent pledges not sustainable for a long time without the related supporting measures. Our findings will be helpful for policymakers or company managers to make an appropriate decision on rationally utilizing patent portfolios for fighting against public health crises.

Patents, Governance and Control: Ethics and the Patentability of Novel Beings and Advanced Biotechnologies in Europe.

This article focuses primarily on to what extent novel beings, and particularly, beings which display something akin to human consciousness or agency would be (or should be) patentable under current European patent law. Patents grant the patent holder a right to exclude others from using the patented invention for the period of patent grant (usually 20 years). This allows the patent holder to control how that invention can or cannot be used by others downstream, granting patent holders a governance like function over the patented technology for the duration of the patent. Accordingly, the potential for patentability of novel beings gives rise to a myriad of ethical issues including: to what extent is it appropriate for patent holders to retain and exercise patents over "novel beings"; how issues of "agency" displayed by any "novel beings" would fit within the current patent framework, if at all; and to what extent existing exclusions from patentability might exclude patents on "novel beings" or whether changes within patent law may be needed if patents in relation to "novel beings" are deemed ethically problematic. This article focuses on such issues, and in doing so, also sheds light on the role of ethical issues within the patenting of advanced biotechnologies more generally.