Optimal Licensing Strategy of Green Technology With Corporate Social Responsibility (CSR)

This paper develops a duopoly model to investigate a firm’s green technology licensing strategy with corporate social responsibility (CSR). In our model, licensing is conducted by an inside innovator and the patent holder may take CSR activities under a time-consistent emission tax. The result shows that fixed-fee licensing is always the optimal strategy of the patent holder when there is no CSR. In the CSR case, when the reduction degree of abatement cost coefficient is large, the optimal licensing strategy of the patent holder changes from pure royalty licensing to fixed-fee licensing as the degree of CSR decreases. Furthermore, we find that neither conflict nor consistency always exists between social welfare and firm payoff goals. When the degree of CSR is relatively low, fixed-fee licensing is preferred both by the patent holder and the government. Otherwise, when the degree of CSR is relatively high, the government prefers fixed-fee licensing, while the patent holder prefers royalty licensing. Finally, we analyze the effects of CSR behaviors on environment and social welfare. We show that CSR is beneficial for environment, while it is not always beneficial for social welfare.JEL Classifications: D42; M14; I13

Patents, access to health and COVID-19 – the role of compulsory and government-use licensing in Ireland

As the race for effective vaccines and treatments for COVID-19 continues, attention must turn to how such health-technologies will be accessed globally once developed. Patents play a significant role in this context because they give the patent-holder the right to stop others using patented inventions. Patents are available on diagnostics, medicines and vaccines and could form significant access obstacles for COVID-19. Moreover, whilst many patent-holders may be willing to license health-technologies reasonably, others may not. Therefore, it is imperative that national governments ensure effective avenues exist to intervene with patent-holder discretion via compulsory licensing. This article focuses on the legal framework applicable in Ireland for such compulsory licensing interventions, interrogating the effectiveness of the current framework in alleviating access issues posed by patents for COVID-19. It demonstrates how the current framework could be reformed to make it more effective in tempering patent-holder control, where needed, whilst remaining in compliance with Ireland’s international obligations.

Pre-Clinical Characterization of a Novel Fusion Protein (AT-03), with Pan-Amyloid Binding and Removal

Background: Amyloidosis is characterized by extracellular deposition of protein fibrils that can involve any organ or tissue in the body. It is a severe, progressive and often lethal disorder. There are approximately seventeen different systemic amyloid diseases, each associated with the deposition of a specific precursor protein. Toxic amyloid deposits result in significant organ dysfunction and increased morbidity and mortality. Reduction and removal of tissue amyloid deposits could restore organ function, improve quality of life and increase life expectancy for patients. We have developed and characterized a fusion protein consisting of serum amyloid protein (SAP) linked to a single chain human IgG1 Fc domain, designated AT-03. SAP is a pentameric serum protein that is ubiquitously associated with amyloid deposits. The high affinity and specificity for amyloid resulted in the use of radio-iodinated SAP as an imaging agent for the non-invasive detection of systemic amyloid. The SAP domain of the fusion protein targets the amyloid deposits delivering Fc domains to stimulate amyloid removal via macrophage mediated phagocytosis. Methods: Binding of AT-03 to ATTR and AL fibrils and extracts was assessed by ELISA. Ex vivo phagocytosis of amyloid substrates was studied using activated human THP-1 cells. The biodistribution of AT-03 in murine models of AA, AApoA2 and AL amyloidosis was evaluated immunohistochemically or by SPECT imaging and microautoradiography. Clearance of AA amyloidosis in response to AT-03 therapy was accessed in a mouse model using histological scoring of amyloid burden. Results: AT-03 bound amyloid AL and ATTR substrates with sub nanomolar EC50 values. Systemic administration of AT-03 resulted in specific binding to diverse forms of amyloid in the heart, kidney, liver and/or spleen in multiple animal models. Opsonization of amyloid deposits with AT-03 in vitro resulted in a dose dependent phagocytosis by activated THP-1 cells. A single IV dose of AT-03 resulted in significant reduction of splenic AA amyloid within 14 days post-injection. Conclusions: We have developed a novel fusion protein with sub nanomolar pan amyloid reactivity that specifically binds diverse forms of amyloid in multiple organs and tissues in vivo and can effectuate amyloid removal. The data indicates that AT-03 may serve as a novel therapeutic for the removal of systemic amyloid deposits of diverse types. AT-03 is currently being developed for clinical evaluation. Disclosures Sirac: Attralus, Inc: Patents & Royalties, Research Funding. Jaccard: Janssen: Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria; Abbvie: Honoraria. Bridoux: AstraZeneca: Consultancy, Speakers Bureau; Janssen: Consultancy. Bell: Attralus Inc: Current Employment. Guthrie: Attralus Inc: Current Employment. Selvarajah: Attralus Inc: Current Employment. Kennel: Attralus Inc: Current holder of stock options in a privately-held company, Patents & Royalties: Inventor and patent holder. Wall: Attralus Inc: Current holder of stock options in a privately-held company, Patents & Royalties: Inventor and patent holder, Research Funding.

Detection of Systemic AL Amyloidosis By 124I-p5+14 PET/CT Imaging - Providing the Complete Picture for Diagnosis

Background: Immunoglobulin light chain-associated (AL) amyloidosis is associated with the deposition of fibrils in abdominothoracic organs, notably the heart, liver, spleen and kidneys, resulting in organ dysfunction and significant morbidity. The heterogeneous organ presentation of amyloid and the variable amounts of amyloid burden make accurate and rapid diagnosis challenging. At present, organ biopsy and inferences based on anatomic imaging or changes in serum and urine biomarkers are commonly used to assess organ involvement. Currently, there are no approved radiotracers in the US for the non-invasive detection of AL amyloid load in major organs. To address this, we have developed a synthetic peptide radiotracer, designated 124I-p5+14 (AT-01), suitable for PET/CT imaging. This peptide binds many forms of amyloid through multivalent electrostatic interactions with the amyloid-associated glycosaminoglycans and fibrils. Preclinical studies demonstrated the specific reactivity of the peptide with diverse forms of amyloid (Wall, J.S. et al. (2015) Molecules, 20, 7657). Based on these observations, peptide p5+14 was labeled with iodine-124 and evaluated in a Phase 1/2 PET/CT imaging trial of patients with systemic amyloidosis (NCT 03678259). Herein we describe 23 patients with systemic AL amyloidosis and 5 healthy subjects that have completed the study. Efficacy endpoints include patient- and organ-based sensitivity of 124I-p5+14 uptake in the heart, liver, spleen and kidney. Methods: Subjects, >18 years of age, with a confirmed diagnosis of AL amyloidosis based on organ or abdominal fat pad biopsy findings, with organ-related biomarker changes. Patients taking heparin therapy were excluded. Subjects received an IV infusion of <2 mg of 124I-p5+14 (<2 mCi) and images were acquired at 5-6 h post injection using a Biograph PET/CT with a low dose CT. Prior to imaging, the organ-based distribution of amyloid was determined based on review of the medical record. PET/CT images were evaluated for visual uptake of radiotracer by a reader blinded to patient-related clinical data. Patient and organ-specific sensitivity were determined based on comparison of visual interpretation of the images by a reader blinded to organ involvement and the organ involvement based on the clinical record. Results: Twenty-three patients with systemic amyloidosis and five healthy subjects completed the study. No subjects discontinued or were lost to follow-up. In healthy subjects, radioactivity was observed in the parotid, salivary and thyroid glands, saliva, stomach lumen and urine in the ureters and bladder, consistent with the biodistribution of free radioiodide. No uptake in abdominothoracic organs was observed. In contrast, patients with AL amyloidosis exhibited uptake in the heart (71% of patients), kidneys (61%), spleen (43%), liver (30%), pancreas, lung, bone marrow and other sites. The patient-based sensitivity (patients with visual uptake in at least one anatomic site) was 96% (22/23). The organ-based sensitivity (i.e., clinically positive heart, liver, spleen or kidney that exhibited visual uptake of 124I-p5+14) was 86% (13/14 heart; 3/3 liver; 1/1 spleen; 7/10 kidney). Of note, the one patient without cardiac uptake was 8 years post diagnosis and 7 years post successful stem cell transplant therapy. The percent of abdominothoracic organs detected by PET/CT imaging was 68% higher (47 vs 28) than was noted clinically (16/14 heart; 7/3 liver; 10/1 spleen; 14/10 kidney) Conclusion: PET/CT imaging of amyloidosis using 124I-p5+14 provides accurate detection of AL amyloid deposits in multiple organ systems. Clinically undetected amyloid was observed in numerous anatomic sites with amyloid visualized by 124I-p5+14 in 68% more abdominothoracic organs as compared to that documented in the clinical record. Non-invasive PET/CT imaging with 124I-p5+14 can improve detection of amyloid throughout the body providing a more comprehensive picture of the disease and may provide a method to monitor changes in disease progression. Acknowledgments: This study was supported in part by the National Heart Lung and Blood Institute, National Institutes of Health, through the Science Moving Towards Research Translation and Therapy (SMARTT) program and by contributions to the ACTP Gift Fund at the UTGSM. Disclosures Wall: Attralus Inc: Current holder of stock options in a privately-held company, Patents & Royalties: Inventor and patent holder, Research Funding. Martin: Attrlaus Inc: Current holder of stock options in a privately-held company. Stuckey: Attralus Inc: Current holder of stock options in a privately-held company. Guthrie: Attralus Inc: Current Employment, Current holder of stock options in a privately-held company. Kennel: Attralus Inc: Current holder of stock options in a privately-held company, Patents & Royalties: Inventor and patent holder.

NARCOMS and Other Registries in Multiple Sclerosis

CE Information Activity Available Online: To access the article, post-test, and evaluation online, go to https://www.highmarksce.com/mscare. Target Audience: The target audience for this activity is physicians, physician assistants, nursing professionals, and other health care providers involved in the management of patients with multiple sclerosis (MS). Learning Objectives: 1) Describe what constitutes a registry. 2) Discuss the difference(s) between clinician-driven and patient-driven registries, including potential advantages of patient-driven registries. Accreditation Statement: In support of improving patient care, this activity has been planned and implemented by the Consortium of Multiple Sclerosis Centers (CMSC) and Delaware Media Group. The CMSC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Physician Credit: The CMSC designates this journal-based activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse Credit: The CMSC designates this enduring material for 1.0 contact hour of nursing continuing professional development (NCPD) (none in the area of pharmacology). Disclosures: Francois Bethoux, MD, Editor in Chief of the International Journal of MS Care (IJMSC), has served as Physician Planner for this activity. He has disclosed relationships with Springer Publishing (royalty); Qr8 (receipt of intellectual property rights/patent holder); Biogen (receipt of intellectual property rights/patent holder, speakers’ bureau); MedRhythms (consulting fee, contracted research); GW Pharmaceuticals, Genentech, Helius Medical Technologies, Osmotica, Ipsen (consulting fee); and Adamas Pharmaceuticals (contracted research). Ruth Ann Marrie, MD, PhD, has disclosed being a co-investigator on a study funded by Biogen and Roche. Gary R. Cutter, PhD, has disclosed serving on the data/safety monitoring committees for AstraZeneca, Avexis Pharmaceuticals, BioLineRx, BrainStorm Cell Therapeutics, Bristol Myers Squibb/Celgene, CSL Behring, Galmed, Green Valley Pharma, Mapi Pharmaceuticals, Merck, Merck/Pfizer, Mitsubishi Tanabe, OPKO Biologics, Neurim, Novartis, Orphazyme, Sanofi, Reata, Teva, Viela Bio, the National Heart, Lung, and Blood Institute (Protocol Review Committee), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (Obstetric-Fetal Pharmacology Research Unit Oversight Committee); serving on consulting/advisory boards for Alexion, Antisense Therapeutics, Biodelivery Sciences International, Biogen, Clinical Trial Solutions LLC, Genzyme, Genentech, GW Pharmaceuticals, Immunic, Klein Buendel, MedImmune/Viela Bio, MedDay, Merck/Serono, Neurogenesis Ltd, Novartis, Osmotica, Perception Neuroscience, Protolix Biotherapeutics, Recursion/Cerexis Pharmaceuticals, Regeneron, Reckover Pharmaceuticals, Roche, SAB Biotherapeutics, and TG Therapeutics; and being president of Pythagoras, Inc, a private consulting company. Robert J. Fox, MD, MSc, has disclosed receiving consulting fees from AB Science, Biogen, Celgene, EMD Serono, Genentech, Genzyme, Immunic, Janssen, Novartis, Sanofi, and TG Therapeutics; research funding from Biogen, Novartis, and Sanofi; and royalties from Demos Publishing. Timothy Vollmer, MD, has disclosed receiving compensation for lectures and consultancy from Biogen, Genentech/Roche, Viela Bio, Celgene, EMD Serono, and Novartis; and research support from Rocky Mountain Multiple Sclerosis Center, Celgene, Biogen, Anokion, Genentech, F. Hoffmann-La Roche Ltd, GW Pharmaceuticals, and TG Therapeutics Inc. Tuula Tyry, PhD, has disclosed no relevant financial relationships. Amber Salter, PhD, has disclosed serving as a statistical editor for Circulation: Cardiovascular Imaging. The staff at IJMSC, CMSC, and Delaware Media Group who are in a position to influence content have disclosed no relevant financial relationships. Laurie Scudder, DNP, NP, Continuing Education Director CMSC, has served as Reviewer for this activity. She has disclosed no relevant financial relationships. One peer reviewer for IJMSC has disclosed relationships with Alexion (consulting fee, speakers’ bureau); Biogen, Bristol Myers Squibb, EMD Serono, Genentech (consulting fee, speakers’ bureau, contracted research); Celgene, Novartis, Sanofi Genzyme (consulting fee, contracted research); Viela Bio (consulting fee); National MS Society, PCORI, Atara Biotherapeutics, Roche (contracted research); and Taro Pharmaceuticals, AstraZeneca, Pfizer, Johnson & Johnson, Inovio, GlaxoSmithKline, Viatris, Gilead, Altimmune Inc, CytoDyn Inc (ownership interest [common stocks]). The other peer reviewer has disclosed relationships with Celgene (speakers’ bureau, contracted research); and Merck, EMD Serono, Roche, AbbVie (contracted research). Note: Financial relationships may have changed in the interval between listing these disclosures and publication of the article. Method of Participation: Release Date: December 1, 2021 Valid for Credit Through: December 1, 2022 In order to receive CME/NCPD/CPE credit, participants must: 1) Review the continuing education information, including learning objectives and author disclosures.2) Study the educational content.3) Complete the post-test and evaluation, which are available at https://www.highmarksce.com/mscare. Statements of Credit are awarded upon successful completion of the evaluation and the post-test with a passing score of >70%. The post-test may be retaken if necessary. There is no fee to participate in this activity. Disclosure of Unlabeled Use: This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the FDA. The CMSC and Delaware Media Group do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the CMSC or Delaware Media Group. Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any medications, diagnostic procedures, or treatments discussed in this publication should not be used by clinicians or other health care professionals without first evaluating their patients’ conditions, considering possible contraindications or risks, reviewing any applicable manufacturer’s product information, and comparing any therapeutic approach with the recommendations of other authorities.

GOOD FAITH IN TRIPS COMPULSORY LICENSING OF PHARMACEUTICAL PATENTS: LESSONS FROM PREVIOUS PANDEMIC CASES

The COVID-19 pandemic impacts the world of patents as countries prepare their legal framework to ease the process of compulsory licensing. Some like India and South Africa even went further by proposing a suspension for patents needed to combat COVID-19 which is still under discussion. It is a real possibility that a patented drug that is effective against COVID-19 would potentially see compulsory licensing in many countries its patent holder is doing business. This article discusses why compulsory licensing is an essential issue by examining its legitimacy, previous cases of compulsory licensing, and the conduct of states in cases of compulsory licensing issuance, particularly in examples of Thailand, Brazil, and India. The article will examine ways of remedy against compulsory licensing, including a theoretical possibility for constitutional review of treaties. The remedies discussed shall include international and domestic remedies, both litigation and alternative measures. The research shall use qualitative research methods with the use of primary and secondary legal sources. The result of this article found that a combination of soft law power of the Doha Declaration and the invocation of subsequent compulsory licensing cases be the support pillars of compulsory licensing practice. However, the practice of compulsory licensing both by the patent holder and the state actors is still not performed entirely in good faith according to the Vienna Convention of the Law of Treaties (VCLT) 1969 and the TRIPS Agreement. Hence, such patent holders need to be familiar with both international and domestic remedies, especially the possibility for constitutional review of treaties remedies.

Evaluation of Treatment Practices for Urinalyses and Urine Cultures at an Outpatient Multiple Sclerosis Clinic

CE Information Activity Available Online: To access the article, post-test, and evaluation online, go to https://www.highmarksce.com/mscare. Target Audience: The target audience for this activity is physicians, physician assistants, nursing professionals, pharmacists, and other health care providers involved in the management of patients with multiple sclerosis (MS). Learning Objectives: 1) Describe the characteristic factors of MS disease that can confound the identification of symptomatic urinary tract infection (UTI). 2) Distinguish appropriate, potentially appropriate, and inappropriate testing and treatment practices for the diagnosis and treatment of UTIs in patients with MS. Accreditation Statement: In support of improving patient care, this activity has been planned and implemented by the Consortium of Multiple Sclerosis Centers (CMSC) and Delaware Media Group. The CMSC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Physician Credit: The CMSC designates this journal-based activity for a maximum of 0.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse Credit: The CMSC designates this enduring material for 0.5 contact hour of nursing continuing professional development (NCPD) (none in the area of pharmacology). Pharmacist Credit: This knowledge-based activity (UAN # JA4008165-9999-21-021-H01-P) qualifies for 0.5 contact hour (0.05 CEUs) of continuing pharmacy education credit. Disclosures: Francois Bethoux, MD, Editor in Chief of the International Journal of MS Care (IJMSC), has served as Physician Planner for this activity. He has disclosed relationships with Springer Publishing (royalty); Qr8 (receipt of intellectual property rights/patent holder); Biogen (receipt of intellectual property rights/patent holder, speakers' bureau); MedRhythms (consulting fee, contracted research); GW Pharmaceuticals, Genentech, Helius Medical Technologies, Osmotica, Ipsen (consulting fee); and Adamas Pharmaceuticals (contracted research). Alissa Mary Willis, MD, Associate Editor of IJMSC, has disclosed relationships with Greenwich Biosciences (consulting fee); Alexion (consulting fee, speakers' bureau, contracted research); Genentech (consulting fee, speakers' bureau); and Biogen, Bristol Myers Squibb (speakers' bureau). Nicole C. Griffith, PharmD, has disclosed no relevant financial relationships. Brandon K. Hill, PharmD, has disclosed no relevant financial relationships. Myla D. Goldman, MD, has disclosed relationships with Adamas Pharmaceuticals, Biogen, Brainstorm Cell Therapeutics Ltd, EMD Serono, Genentech, Greenwich Biosciences, Immunic, MedDay, and Sanofi Genzyme (consulting fees). S. Ross Tingen, PharmD, has disclosed a relationship with Novartis (advisory board). The staff at IJMSC, CMSC, and Delaware Media Group who are in a position to influence content have disclosed no relevant financial relationships. Laurie Scudder, DNP, NP, Continuing Education Director CMSC, has served as Reviewer for this activity. She has disclosed no relevant financial relationships. One peer reviewer for IJMSC has disclosed relationships with EMD Serono, Novartis, Bristol Myers Squibb, and Genentech (consulting fees). The other peer reviewer has disclosed no relevant financial relationships. Note: Financial relationships may have changed in the interval between listing these disclosures and publication of the article. Method of Participation: Release Date: October 1, 2021 Valid for Credit Through: October 1, 2022 In order to receive CME/NCPD/CPE credit, participants must: 1) Review the continuing education information, including learning objectives and author disclosures.2) Study the educational content.3) Complete the post-test and evaluation, which are available at https://www.highmarksce.com/mscare. Statements of Credit are awarded upon successful completion of the evaluation and the post-test with a passing score of >70%. The post-test may be retaken if necessary. There is no fee to participate in this activity. Disclosure of Unlabeled Use: This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the FDA. The CMSC and Delaware Media Group do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the CMSC or Delaware Media Group. Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any medications, diagnostic procedures, or treatments discussed in this publication should not be used by clinicians or other health care professionals without first evaluating their patients' conditions, considering possible contraindications or risks, reviewing any applicable manufacturer's product information, and comparing any therapeutic approach with the recommendations of other authorities.

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.

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.

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.