Patent Practice Research Articles

Balancing act: Navigating the tensions between patenting practices and open science in Chilean academic research

This study aims to understand the relationship between academic patenting and secrecy in three key areas: the delay in publishing patentable results, the refusal of requests for research outcomes, and the perception of patent clarity drafting. Based on a dataset of Chilean university researchers, we conduct logistic regression models to understand the propensity to delay the publishing of patentable results, the probability of denying requests for research outcomes, and the likelihood of researchers perceiving their patents as clearly drafted. Controls used relate to the seniority of the researcher, the scientific field, whether the university is private or public, and whether the researcher previously worked with industry. Additionally, some constructs reflecting the researcher's perception regarding the patenting system within academic research were obtained through exploratory factor analysis and then incorporated as controls. The analysis reveals a positive correlation between prior patenting experience and publication delay. However, we found no correlation between previous patenting and the propensity to reject requests for research results. Both behaviors were negatively correlated to researcher seniority, gauged by the h-index, and positively correlated to forestry and agricultural technology sciences activity. Researchers who experienced denial of their requests were more likely to reciprocate refusal. Notably, a negative perception of the patent system within academic research was associated with a belief in drafting clearer patents. These findings suggest an environment of selective openness in academic networks, with researchers balancing full disclosure and secrecy. The paper studies three dimensions of secrecy in academic patenting through the novel data set. This study deepens our understanding of academic patenting practices, uncovering some complex dynamics shaping knowledge diffusion within universities.

Medical research without patents: It’s preferable, it’s profitable, and it’s practicable

ABSTRACT This article addresses the question of the possibility of medical research without patents, a major issue in healthcare research and policy. We discuss and evaluate the relevant scientific, economic, societal, and moral aspects of our system of funding and organizing the research, development, manufacture and sale of prescription drugs. The focus is on the patent practices of big pharmaceutical companies. We analyze and critically assess the main features and impacts of these practices. In a positive sense, we propose an approach to organizing and funding drug research that prioritizes its public interest rather than its privatization through patenting. For these purposes, we first demonstrate that producing prescription drugs through patenting has serious drawbacks. Second, we develop a concrete alternative (medical research without patents) that is shown to be scientifically, socially and morally preferable, economically and financially profitable, and socio-politically and organizationally practicable.

The Myriad Decision at 10.

A decade ago, the US Supreme Court decided Association for Molecular Pathology v. Myriad Genetics, Inc., concluding that isolated genes were not patentable subject matter. Beyond being a mere patent dispute, the case was a political and cultural phenomenon, viewed as a harbinger for the health of the biotechnology industry. With a decade of perspective, though, Myriad's impact seems much narrower. The law surrounding patentable subject matter-while greatly transformed-only centered on Myriad in small part. The case had only a modest impact on patenting practices both in and outside the United States. And persistent efforts to legislatively overturn the decision have not borne fruit. The significance of Myriad thus remains, even a decade later, hidden by larger developments in science and law that have occurred since the case was decided. Expected final online publication date for the Annual Review of Genomics and Human Genetics, Volume 25 is August 2024. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

IoT devices with data analytics capabilities Using machine learning algorithms for intelligent decision making: a review of patents and the cited academic literature

Innovation in IoT data analytics is essential for social and economic advancement as well as for opening up new business prospects. IoT data analytics applications have garnered a lot of attention lately for information mining, knowledge extraction, and prediction/inference making. Another field of study that has been effectively used to address a variety of networking issues, including resource allocation, routing, traffic engineering, and security, is machine learning. The use of machine learning (ML)-based techniques to enhance different Internet of Things applications has increased recently. Despite a wealth of research on machine learning and IoT data analytics, there is a dearth of studies that only address the development of ML-based methods for IoT data analysis. The present study examines the patenting practices of various international jurisdictions in the domain of IoT data analytics, in addition to the academically cited literature. Between 2000 and 2023, we gathered 24,931 patent applications, and 13,432 scholarly works were cited by the patents. Our research details the trends in the development of IoT data analytics technologies and the relationship between patenting activity and the referenced scientific literature. Additionally, it examines and displays the social networks found in scientific publications and patents. As a result, it discloses the patenting practices of international jurisdictions concerning IoT data analytics technologies, the degree to which different agents such as Lens Id and Applicants interact within social networks, and the connection between patents and science. According to this study, information retrieval, database structures, and file system structures make up the majority of the IPC categories for filed IoT data analytics patent applications. Chinese businesses and individuals make up the bulk of the patent Lens Id and Applicants. Computer science and medicine are scientific fields that are more strongly connected within the network of co-fields. The relationship between scientific works and inventions is not very strong.

India's Decision to Deny an Extension of Patent for Bedaquiline: A Public Health Imperative.

Tuberculosis (TB) remains a major global public health concern, which has become worse in low- and middle-income nations due to the rise of drug-resistant strains of the disease. Bedaquiline, a groundbreaking anti-TB drug, shows great promise for addressing multidrug-resistant TB (MDR-TB). However, the recent decision by India to reject the application for a patent extension on bedaquiline raises crucial questions regarding access to essential medicines and public health requirements. This article examines the significance of India's rejection of the patent extension for bedaquiline, outlining the global implications of this decision and its impact on intellectual property rights, access to medicines, and the future of drug development. India's stance serves as a model for other countries to prioritize public health in their patent-related decisions, underlining the need for a balanced approach to intellectual property rights, innovation, and affordability in the pharmaceutical sector. In the context of the ongoing battle against drug-resistant TB, India's decision on bedaquiline signifies the evolving landscape of pharmaceutical patent practices in the service of global public health.

Intellectual Property of Psychedelics for Addiction Treatment: Enabling Access and Protecting Innovation Opportunities Through Preserving the Public Domain.

Recent research has shown potential for psychedelic therapeutics as addiction treatments; however, some academic institutions, commercial entities, and individuals are attempting to monopolize psychedelic compounds through exploiting the patent process. This Perspective article describes efforts that have been devised to mitigate exclusionary patent practices pertinent to psychedelic therapeutics for addiction. The nonprofit Porta Sophia has identified 170 patent documents focused on treating addiction through psychedelics, and many of these patents could threaten to privatize public domain knowledge and severely limit or increase the cost of research if granted. Patent examiners who determine if a patent application should be granted must negate false claims to innovation. Yet, given the unique history of psychedelics, prior knowledge can be difficult to find. As a result, overreaching patents may be granted, causing dramatic shifts in access to addiction-focused psychedelic research, treatments, and funding. As the field of psychedelics approaches this crucial inflection point of U.S. Food and Drug Administration decisions, it is imperative for all stakeholders--including university investigators, academic and commercial patent seekers, and policymakers--to use available tools for determining prior knowledge. Maintaining an informed awareness of legal patent eligibility and limitations is crucial for establishing an ethical patent landscape and ensuring subsequent access to these potential life-altering psychedelic therapeutics for addiction.

ABUSE OF PATENTABILITY CRITERIA WHEN PATENTING INVENTIONS RELATED TO MEDICINES

It is well known that intellectual property monopolies for medicines reduce physical and economic availability. Main purpose of the study is to conduct brief review of foreign scholarly views on evergreening patenting practice in the field of pharmaceuticals, to demonstrate implications of such abusive practice and to exemplify good practices used in several countries to address the problem. Evergreening practice poses a serious challenge for healthcare system of Ukraine, but there are promising examples in several countries (e.g. Argentina, Brazil, India) of limiting evergreening.

A Singular Disclosure Requirement Is Necessary For Patent Law

The Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112 has selectively and severely curtailed innovation in the fields of pharmaceuticals and biotechnology. Specifically, the Federal Circuit’s shifting position on 35 U.S.C. § 112 and their evolving jurisprudence to combine expanding the application and scope of the written description requirement with a separate, heightened standard for enabling claims directed to innovation in a genus of therapeutic antibodies, or a genus of compounds having functional limitations, has caused havoc in the biopharmaceutical industry. Federal Circuit jurisprudence on how to interpret the disclosure requirements of the 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by mandating two separate disclosure requirements in place of one, namely that patent applications not only “enable” but also separately “describe” inventions. This recently developed and reactively evolving judge made approach raises the bar exceedingly high for obtaining any meaningful patent protection for new biomedical discoveries, goes against many decades of patent practice, and is proving to be a powerful impediment to the investment necessary for developing new and lifesaving medicines. This article examines patent law’s current disclosure requirements to highlight a failing judicial trajectory and proposes a return to a single 35 U.S.C. § 112(a) standard. By doing so, the great shock that has singled out and disrupted the biopharmaceutical industry will be removed and the law can once again encourage, in a technology-neutral manner, the private sector to innovate in all fields of endeavor, including encouraging the biopharmaceutical industry to develop new lifesaving medicines and treatments.

Empowerment or warfare? dark skin, AI camera, and Transsion’s patent narratives

ABSTRACT Through document analysis and interviews, this paper examines the patent narratives of Transsion, a Chinese company dominating Africa’s smartphone market and a leading innovator in facial recognition technologies (FRTs) optimized for darker skin tones. We identify two major narratives concerning Transsion’s FRT patenting practice. First is ‘empowerment’, through which Transsion argues that there are ‘blind spots’ in conventional AI technologies and presents its AI camera as a remedy and an empowerment tool for dark-skinned users by ‘seeing’ their beauty. Second is the ‘warfare’ narrative, which is shaped by the heightening market competition and accelerating patent races among Chinese phone makers. As the battle for tech supremacy intensifies in Africa, Transsion expresses a strong sense of crisis and considers its FRT patents as ‘weapons of competition’ in preparation for a future smartphone warfare in Africa. This study makes two contributions. Empirically, through analyzing patents, we examine a relatively less-known Chinese tech company that has tremendous impact in the Global South. Theoretically, we interrogate the possibility of algorithmic empowerment against racist AI and technological independence through patents, although developing AI as weaponry, in the China-Africa context, also hampers the politics of decolonization.

How Half-Causation can enlighten the drafting of patent claims

The author’s 2019 article ‘If You Wish to Invent Then Follow the Half-Causation Method’ presented ‘Half-Causation’, which is a philosophical model for the systemization of the invention process. It consists of five phases of reasoning, each terminating with taking a ‘logical branch’. This paper has two objectives. The first (and preliminary) objective is to introduce a readership in patent practices (and theory) to Half-Causation. The second (and primary) objective is to highlight how Half-Causation can be practically useful to patent practitioners (and perhaps ultimately theorists), specifically in terms of enlightening the drafting of patent claims. In order to do this effectively, the reader is presented with a case which they can engage with to see for themselves how Half-Causation can help, step by step. The presented case was the subject of the USPTO’s 2019 patent drafting competition. It consists of rather convoluted instructions received from an ‘imaginary’ client about their ‘imaginary’ invention. The case is an excellent opportunity to illustrate how Half-Causation as a philosophical model can be practically useful. Two Half-Causation tools are implemented. The first is Half-Causation Branching, which allows the logical mapping of the inventing space, within which the imaginary invention is located. Implementing this tool reveals two alternative nearby inventions, which if left out of the sought patent protection would render any eventually granted patent practically worthless. Following that, Half-Causation Encapsulation comes to the rescue by allowing the encapsulation of the original imaginary invention, plus the two alternative nearby ones, all in a manner that provides the all-important unity of invention On the one hand, patent agents are not supposed to contribute to their client’s inventive concept to the extent that they become co-inventors. On the other hand, scientists and engineers are not supposed to dedicate so much time and effort to learning about complex patent laws as to become patent agents. Arguably, each should aim to excel in their discipline. However, a structured dialogue should be considerably helpful to each and to the patent process as a whole. It is proposed that Half-Causation, with its logical structure, can provide a basis for such a dialogue. Besides targeting a readership in patent practices and theory, this paper should be of interest to multiple readerships, for example in engineering design, medical discovery and philosophy of technology.

SEPs licensing across the supply chain: an antitrust perspective

The rise of the Internet of Things (IoT) and the development of 5G are set to add a new layer of complexity to the current practice of standard essential patents (SEPs) licensing. While, until recently, the debate has centred on the nature of fair, reasonable and non-discriminatory (FRAND) commitments and the mechanisms to avoid hold-up and reverse hold-up problems between licensors and licensees, a new hotly-debated issue has now emerged. At its core is the question of whether SEP holders should be required to grant a FRAND licence to any implementer seeking a licence, including component makers (the so-called ‘licence-to-all’ approach), or if they should be allowed freely to target the supply-chain level at which the licence is to be granted (the so-called ‘access-for-all’ approach). After providing an up-to-date overview of the current legal and economic debate, this article focuses on the most recent antitrust case law dealing with the matter on both sides of the Atlantic and argues that no sound economic and legal bases which favour licence-to-all solutions can be identified. * The authors would like to thank the anonymous referees, Luigi Federico Signorini and the participants in the 2021 Annual Conference of European Policy for Intellectual Property (EPIP), in the 38th Annual Conference of the European Law and Economics Association (EALE), in the TILTing Perspectives 2021 (Tilburg University), and in the 16th Annual Conference of the Academic Society for Competition Law (ASCOLA). The study was conducted as part of the research activities promoted by the DEEP-IN (Digital Ecosystem, Economic Policy and Innovation) Research Network. The author is grateful for the financial support received. Any opinions expressed in this paper are personal and are not to be attributed to the Bank of Italy. The first is Half-Causation Branching, which allows the logical mapping of the inventing space, within which the imaginary invention is located. Implementing this tool reveals two alternative nearby inventions, which if left out of the sought patent protection would render any eventually granted patent practically worthless. Following that, Half-Causation Encapsulation comes to the rescue by allowing the encapsulation of the original imaginary invention, plus the two alternative nearby ones, all in a manner that provides the all-important unity of invention On the one hand, patent agents are not supposed to contribute to their client’s inventive concept to the extent that they become co-inventors. On the other hand, scientists and engineers are not supposed to dedicate so much time and effort to learning about complex patent laws as to become patent agents. Arguably, each should aim to excel in their discipline. However, a structured dialogue should be considerably helpful to each and to the patent process as a whole. It is proposed that Half-Causation, with its logical structure, can provide a basis for such a dialogue. Besides targeting a readership in patent practices and theory, this paper should be of interest to multiple readerships, for example in engineering design, medical discovery and philosophy of technology.

Supplemental experimental data in Chinese pharmaceutical patent practice: acceptable or not?

Experimental data is of great importance for pharmaceutical patents. The examination and acceptability of supplemental experimental data in China are analyzed in this article, based on recent judicial interpretation issued by the Supreme People’s Court, the Guidelines for Patent Examination issued by the China National Intellectual Property Administration, as well as influential cases in recent years. It is found that both the CNIPA and the courts hold that supplemental experimental data should be examined and can be accepted if the data meet the requirement of ‘obtainable from the original disclosure’. It is suggested that the acceptability of supplemental experimental data be determined on a factual and factor basis in patent prosecution and judicial review. And it is envisioned that reasonable acceptance of supplemental experimental data would enhance the patent protection of pharmaceuticals and promote innovations in the health industry.

РЕФОРМА ПАТЕНТНОГО ЗАКОНОДАВСТВА (2020): ОСНОВНІ НОВАЦІЇ ЩОДО ВИНАХОДІВ (КОРИСНИХ МОДЕЛЕЙ)

The article considers the main innovations of current legislation concerning inventions and utility models. The conditions for granting legal protection of an invention (utility model), the procedure for filing and considering an application for an invention and a utility model, the application of «pre grant opposition» and «post grant opposition» procedures, and ways to protect patent rights are studied and analyzed. The author proves the importance of creating a national patent office (NIPO) in Ukraine. The article substantiates the need to adopt a separate law on NIPO instead of duplicating the rules on the legal status of NIPO, its structure, competence, etc. in several legislative acts. The author determines that the law eliminated the inaccuracy in the definition of a patent that certifies intellectual property rights to an invention and utility model, rather than ownership of them. This is fully consistent with the application of the theory of exclusive rights in the legislation of Ukraine on intellectual property. The article states that the law provides for only two types of patents (excluding secret and official inventions, utility models): a patent for an invention granted for 20 years based on the results of a qualifying examination, and a patent for a utility model granted for 10 years based on the results of a formal examination. The author notes that this patent by its legal nature remains declaratory, and it is granted under the responsibility of the applicant. The researcher proves the importance of legislative innovations, which eliminated the possibility of granting so-called «evergreen patents» (by improving the content of the inventive step as a condition of patentability). The article substantiates the need for a legislative solution to the issue of ownership of property patent rights to an official invention (utility model). The author notes that the reform of patent legislation (2020) bypassed the improvement of legal regulation on the use of inventions (utility models) taking into account digitalization (in particular, the legal regime «computer implemented inventions» is not defined). The researcher proves that the publication of information about the application for the invention is important, because from that moment the application becomes public, and an indefinite number of people have the opportunity to read its contents, and may see the technical essence of the invention. The author justifies the need to transfer the authority to decide on the issuance of compulsory licenses to the National Intellectual Property Office (or a specialized court after its creation). The article finds that instead of invalidating a patent for an invention (utility model), it was introduced that the rights to an invention (utility model) might be recognized as invalid, which is not currently accepted by case law. The article proves that an important innovation of the patent law reform (2020) is the introduction of a procedure for declaring inventions (utility model) invalid out of court («post-grant opposition») in order to curb the practice of patenting by unscrupulous applicants of well-known technical solutions.

Overqualified and Under-Represented: Gender Inequality in the Pharmaceutical Patent Field

Pharmaceutical patents represent some of the most valuable intellectual property assets for drug companies. These patents can be worth billions of dollars if found valid and infringed. Correspondingly, if invalidated, generic drug manufacturers can get to market earlier, generating billions of dollars of added revenue. Accordingly, drug patents are associated with high-value, high-cost, bet-the-company type prosecution and litigation. Women, however, are noticeably absent from pharmaceutical patent practice. Women represent only 30% of pharmaceutical patent litigators, and only 33% of pharmaceutical patent prosecutors. Some commentators argue that this lack of representation is due to a “pipeline” problem: we don’t see. women in STEM-focused legal careers because women are underrepresented in STEM undergraduate and graduate programs. Proponents of the pipeline argument contend that the solution to gender and racial homogeneity in patent practice is to simply graduate more women from STEM programs or to adopt more flexible requirements for entering patent practice. This study focuses on pharmaceutical patent litigation from 2009-2021. Specifically, this study reviews: (1) the patent prosecutors who obtained these valuable drug patents; (2) the USPTO patent examiners who reviewed these patents; and (3) both the generic and brand pharmaceutical patent litigators. We find significant gender disparities in the private sector lawyers at both the prosecution and litigation levels. The empirical study presented in this article refutes the pipeline argument when it comes to women in pharmaceutical patent prosecution and litigation. It shows that, for over a decade, women have consistently obtained undergraduate, masters, and doctorate degrees in the biological sciences at higher rates than men for over a decade.6 Furthermore, the study finds that women make up over two-thirds of law students with a health professions degree and over half with a natural sciences degree. Yet, despite having more education in the sciences, women are still underrepresented in private sector pharmaceutical patent prosecution and pharmaceutical litigation. Interestingly, however, this gender disparity does not carry over to public sector work in patent law. The study finds the U.S. Patent and Trademark Office (USPTO) is the one place where we see near parity between men and women in the pharmaceutical patent field: 45% women versus 55% men. Women at the USPTO Solicitor’s Office argue about the same number of cases at the Federal Circuit. Further, women make up nearly half of the Court of Appeals for the Federal Circuit. Finally, unlike the private sector, women at the USPTO are paid at the same rate and stay for the same amount of time as their male counterparts at the USPTO. Drug companies and law firms all state that diversity is an important aspect of their business models. But, as this study shows, there is a disconnect between rhetoric and action. The problem does not seem to stem from a lack of education or a lack of participation in the legal system. The problem may be a lack of opportunity given to women to participate in this type of valuable litigation. The solution may have to come from within the industry, specifically those who have control over hiring outside counsel. Law firm clients may have to use the power of the purse to help encourage greater diversity.

Drug Prices, Patents and Access to Life-Saving Medicines: Changes Are Urgently Needed in the COVID-19 Era

When patented life-saving drugs are inaccessible to patients due to high prices it is evident that the system does not perform its intended function and urgently requires reforming. The paper discusses the evidence recently revealed by the US House Committee on Oversight and Reform that directly contradicts pharmaceutical companies’ traditional argument justifying strong patent protection as a vehicle for recouping their R&D investments. It further suggests that structural and comprehensive changes are necessary, including a rigorous investigation into pharmaceutical pricing and patenting practices, ensuring adequate access to the drugs developed with public funds, and assuming the responsibility for public health by governments.

Gender Inequality in Patent Litigation

This article presents an empirical study of gender diversity—or, more precisely, the lack thereof—among the lawyers who handle patent cases in the federal courts, focusing on appellate litigation at the Federal Circuit and the Supreme Court. Drawing on two original datasets, the article finds that, over the past decade, 87.4% of oral arguments in patent appeals at the Federal Circuit have been presented by men. The numbers are similar at the Supreme Court: over the past thirty years, more than 90% of arguments in Supreme Court patent cases have been delivered by male attorneys. The typical explanation for these sorts of gender gaps is that men are disproportionality represented in the science and technology fields that underlie patent practice. But a closer look at the numbers shows that gender parity exists in specific areas of patent litigation. For starters, five of the Federal Circuit’s eleven active judges are women, and those women had more pre-appointment experience in patent law than their male counterparts. In addition, the data collected for this study demonstrate that, when the government becomes involved in patent litigation (usually because a case involves the Patent and Trademark Office), women present oral argument at the Federal Circuit 48.5% of the time—more than five times as frequently as the rate for private-sector litigants. Thus, the story this article tells—of women being largely absent from high-level patent litigation—is actually a story about gender inequality among the lawyers hired by large corporations such as Apple, Amazon, Google, and Samsung, all of which have been represented by women in less than 15% of their Federal Circuit arguments over the past decade. Figuring out why women rarely litigate patent appeals for private-sector clients is challenging, but this study suggests that it stems from persistent inequalities in law firm practice generally. To that end, the article suggests both small steps that would increase gender balance among the lawyers arguing patent cases and broader structural reforms that would improve diversity across the bar.

Analysis of the standard for accepting supplementary experimental data in China’s patent practice

Balancing the interests of the applicants and the public, China has imposed strict restrictions on the examination of supplementary experimental data.

Research Handbook on Patent Law and Practice (Table of Content and Preface)

This significantly updated second edition of the Research Handbook on Patent Law and Practice provides comprehensive coverage of new research for patent protection in three major jurisdictions: the United States, Europe and Japan. Leading patent scholars and practitioners provide an innovative comparative analysis of fundamental issues such as patentability, examination procedure and the scope of patent protection, with current issues such as patent protection for industry standards, computer software and business methods. Updates to this second edition reflect on the dramatic changes that have taken place in the US Patent System since the first edition, including the America Invents Act that has introduced the first-inventor-to-file policy and post issuance proceedings to challenge validity. Current topics, such as the Unified Patent Court, patent litigation updates reform in the US, design patents and patent inventions in medical science, are also addressed.

Evidence-based obviousness for use in patent prosecution and review.

A process for the non-arbitrary determination of obviousness based on examining actual patenting practices of large groups could improve outcomes.

RRI and Patenting: a Study of European Patent Governance

This paper addresses the topic of patenting related to the notion of Responsible Research and Innovation (RRI). Focusing on patents in the field of biotechnology, we assess to what extent current patenting practices of the European Patent Organization, and more specifically of its executive body, the European Patent Office (EPO) align with RRI principles. We first argue for including patenting as a relevant topic in the context of RRI and then provide an operationalisation of RRI principles that functions as an analytic tool in the article. We find that the dimensions of RRI currently do not have a strong position in the EPO. Subsequently, we discuss the potential for improving the alignment of the EPO with RRI principles. We conclude the article with some final reflections on the applicability of RRI to the policies and practices of the European Patent Organization.