Biotechnology Law Report

Papers
(The median citation count of Biotechnology Law Report is 0. The table below lists those papers that are above that threshold based on CrossRef citation counts [max. 250 papers]. The publications cover those that have been published in the past four years, i.e., from 2022-05-01 to 2026-05-01.)
ArticleCitations
Legal Governance of Human Gene Editing Technology: From Single Governance to Multiple Governance28
Is Cross-Border Transfer of Human Genetic Data an Impossible Mission?4
The Localization of Drug Patent Linkage System in China: Where Should It Go?3
CareDx, Inc. v. Natera, Inc. United States Court of Appeals of the Federal Circuit, 2022 40 F.4th 13713
Amgen v. Sanofi : The Supreme Court Takes up the Enablement Requirement in the Context of Therapeutic Monoclonal Antibodies2
Selected Developments in Biotechnology Law and the Biotechnology Industry2
To What Extent Does Mayo v. Prometheus Allow for the Patenting of Diagnostic Methods?2
Trade Secret Protection on a Publicly Sold, Patented Spinal Implant Device: Life Spine, Inc. v. Aegis Spine, Inc.2
Alnylam Pharms., Inc. v. Moderna, Inc.1
Pac. Biosciences of California, Inc. v. Pers. Genomics Taiwan, Inc1
Vanda Pharms., Inc. v. United States Food & Drug Admin1
Duke Univ. v. Sandoz Inc.1
In re Entresto1
Biotechnology and Intellectual Property Law: Theoretical and Practical Reflections on Albanian National Law and Jurisprudence in Comparison with EU Acquis and ECJ Case Law1
Regents of the Univ. of California v. Broad Inst., Inc.1
Landscape of Genome Editing Technology Patents in the European Patent Office with a Focus on CRISPR-Related Opposition Proceedings1
United Therapeutics Corp. v. Liquidia Techs., Inc.1
Selected Developments in Biotechnology Law and the Biotechnology Industry1
Mylan Pharms. Inc. v. Merck Sharp & Dohme Corp. United States Court of Appeals of the Federal Circuit, 2022 50 F.4th 1471
Sanho Corp. v. Kaijet Tech. Int’l Ltd., Inc1
Nippon Shinyaku Co. v. Sarepta Therapeutics, Inc.1
Astellas Pharma, Inc. v. Sandoz Inc. USA, Inc.1
The Redemption of Drug Patent Linkage System: The Dilemma and Improvement in the Qualification System of Market Exclusivity Period for China’s First Generic Drug1
A Review of Patent Regimes on Health Biotechnology Innovation in India1
Observation on China's Performance in the Global Supply Chain of COVID-19 Medicine1
China's Challenges in Implementing Compulsory Drug Patent Licenses and its Response in the Context of COVID-191
Hologic, Inc. v. Minerva Surgical, Inc.1
Incyte Corp. v. Sun Pharm. Indus., Ltd.1
Selected Developments in Biotechnology Law and the Biotechnology Industry1
Tris Pharma, Inc. v. Actavis Lab'ys FL, Inc.1
Selected Developments in Biotechnology Law and the Biotechnology Industry1
Selected Developments in Biotechnology Law and the Biotechnology Industry1
Selected Developments in Biotechnology Law and the Biotechnology Industry1
ImmunoGen, Inc. v. Stewart1
Generic Drugs and Innovative Drug Incentives: Early Dispute Resolution Mechanism in China1
Eye Therapies, LLC v. Slayback Pharma, LLC1
Moo-re Gene-edited Animals Get Regulatory Clearance: U.S. FDA Approves Genetically Engineered Cattle for Human Consumption1
Federal Circuit Reiterates That Drug Safety and Efficacy Are Issues for the FDA, Not the Patent Laws1
A 12th Year 101 Update—Diagnostic and DNA Claims Are Patent Eligible, but Pre- Mayo Patents May Continue to Fall1
Recent Developments in FDA Regulatory Exclusivities1
Agilent Techs., Inc. v. Synthego Corp.1
Dilemma and Solution of Intellectual Property Protection of Biological Genetic Resources1
Assessing Legal and Ethical Considerations for Processing Digital Medical Data in China: Framework, Issues, and Policy Recommendations1
Selected Developments in Biotechnology Law and the Biotechnology Industry1
Janssen Pharms., Inc. v. Teva Pharms. USA, Inc.1
Amarin Pharma, Inc. v. Hikma Pharms. USA, Inc.0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Janssen Pharms., Inc. v. Teva Pharms. USA, Inc0
Cornell Rsch. Found., Inc. v. Vidal0
Cytiva BioProcess R&D AB v. JSR Corp.0
How a Dosage Regimen Patent for RRMS Treatment May Satisfy the Written Description Requirement—A Lesson from Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc.0
The Broad Institute Scores Another Victory in Its Battle with the University of California over the Patenting of CRIPSR0
China Releases Document on Ethics Review of Life Sciences: Comments and Compliance Guidelines0
Galderma Lab’ys, L.P. v. Lupin Inc0
In re Xencor, Inc.0
Reflections on Pending Technical and Legal Issues in the R&D of COVID-19 Medical Products0
Medytox, Inc. v. Galderma S.A.0
Wuhan Healthgen Biotechnology Corp. v. Int’l Trade Comm’n0
Unproven Stem Cell Industry in the U.S.: Regulatory Challenges and Enforcement Issues0
The U.S. Patent and Trademark Office Proposes New Rules Targeting Continuation Practice and Terminal Disclaimers0
GlaxoSmithKline II and Other Recent Developments in Induced and Contributory Patent Infringement0
Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC0
Purdue Pharma L.P. v. Collegium Pharm., Inc0
The Legal Protection of Gene Private Rights0
Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc.0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Univ. of Massachusetts v. L'Oreal S.A.0
Patent Portfolio Landscape in China’s Orange Book : Size Achievements and Persistent Quality Gaps Between Domestic Firms and Multinational Corporations0
A Look at the Current Status of the CRISPR Patent Interferences Involving Broad Institute, University of California and University of Vienna, ToolGen, and Sigma-Aldrich0
Evaluation of Turkish Legal Regulations Regarding the Production of Transgenic Products in the Light of American Legal Regulations0
Food & Drug Admin. v. R. J. Reynolds Vapor Co.0
Regulation of Biomedical Research: Global and Indian Perspective0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Should the Federal Circuit Lower the Threshold for Article III Standing to Appeal Adverse Decisions in AIA Trial Proceedings?0
Salix Pharms., Ltd. v. Norwich Pharms. Inc.0
Pleading Use of Trade Secrets Concerning a Biological Product by Showing Product-Related Similarities: Allergan, Inc. v. Revance Therapeutics, Inc.0
Lab’y Corp. of Am. Holdings v. Qiagen Scis., LLC0
Navigating Pharmaceutical Patent Term Extension System in China0
Reshaping Biotechnology Governance: The NSCEB Report, Congressional Testimony, and the Path Forward0
Par Pharm., Inc. v. Eagle Pharms., Inc.0
Navigating Cross-Border Challenges In Biobanking: Analysing Eu Legislation, ECJ Case Law, and the Role of Private International Law0
The Evolving Grace Period for U.S. Patent Applicants0
A Review of Judicial Opinions Interpreting the Novelty Provisions of the America Invents Act0
The Fate of FTC v. Actavis, Inc . in the Biosimilar Context—Does and Should the FTC v. Actavis Decision Ap0
Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC0
Ethical Boundary of the Development of Human Gene Editing Technology0
Restem, LLC v. Jadi Cell, LLC0
Should the United States Join Treaty Mandating Patent Disclosure Requirements for Genetic Resources?0
Research on Intellectual Property Right Protection of Genetic Resources in China Under Benefit-Sharing0
How a Treatment Claim Without Reciting Safety and Efficacy Requirements May Survive the Disclosure Requirement Challenge: United Therapeutics Corp. v. Liquidia Technologies, Inc0
HIPAA, HIPPA, or HIPPO: What Really Is the Heath Insurance Portability and Accountability Act?0
In re Couvaras0
Azurity Pharms., Inc. v. Alkem Lab’ys Ltd.0
How Science, Technology, and Society Influence Patent Policies: The Choice and Direction of Gene Patent Pathways from the View of Technoscience0
A Feasible Pathway for Open Access to Human Embryonic Stem Cell Patents With China's Open License for Patent as the Entry Point0
Preventing Ethical Risks in Cutting-Edge Biotech: China’s Evolving Governance Model0
In re Entresto and the Standard of Review for Compliance with the Written Description Requirement0
Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC0
Gilead Prevails Over the United States Government in Litigation Alleging Patent Infringement (by Gilead) and Breach of Contract (by the United States)0
Can Artificial Intelligence-Generated Inventions Be Protected by Patent Law?0
Novartis Pharms. Corp. v. Accord Healthcare, Inc.0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Recent Developments in the Listing of Patents in FDA's Orange Book0
Guardant Health, Inc. v. Univ. of Washington0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Regeneron Pharms., Inc. v. Mylan Pharms. Inc.0
Minerva Surgical, Inc. v. Hologic, Inc. United States Court of Appeals of the Federal Circuit, 2023 59 F.4th 13710
Balancing Innovation and Biomedical Ethics within National Institutes of Health: Integrative and Regulatory Reforms for Artificial Intelligence-Driven Biotechnology0
The Enablement and Written Description Requirements Through the Lens of the Federal Circuit's Actions (As Opposed to Its Words)0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
A Crisis on Patenting of “Ready-to-Use” Oral Liquid Formulations: Azurity Pharms., Inc. v. Alkem Lab’ys Ltd0
Teva v. Amneal : The Federal Circuit Weighs in on the Listing of Patents Relating to Drug-Device Combinations in the Orange Book0
Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC United States Court of Appeals of the Federal Circuit, 2023 No. 2023-1186, 2023 WL 21986400
Univ. of S. Fla. Bd. of Trustees v. United States0
Patentability Analysis of “Intelligent” Disease Diagnosis Methods in China in the Era of Smart Health Care0
Univ. of S. Fla. Bd. of Trustees v. United States and the Federal Government’s Nonexclusive License under the Bayh-Dole Act0
Gilead Scis., Inc. v. United States0
Natera, Inc. v. NeoGenomics Lab’ys, Inc0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Do Access and Benefit-Sharing Obligations Apply to Digital Sequence Information?0
Merck Serono S.A. v. Hopewell Pharma Ventures, Inc.0
In re Xencor and the Use of Jepson and Means-Plus-Function Claiming in the Context of Antibody Inventions0
Challenges in Patenting Human Stem Cell Inventions: A Comparative Perspective in USA, Europe, and India—Is India Lagging?0
Actelion Pharms. LTD v. Mylan Pharms. Inc.0
Transforming Blood Management Systems in Developing Countries Through Technological and Artificial Intelligence-Driven Innovations0
Rosalind Franklin Society Proudly Announces the 2023 Award Recipient for Biotechnology Law Report0
Rosalind Franklin Society Proudly Announces the 2022 Award Recipient for Biotechnology Law Report0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
The U.S. Patent and Trademark Office’s Response to Recent Developments in Artificial Intelligence0
Research on the Intellectual Property Protection of Genetically Modified Crops in China0
Regulatory Landscape for Generic Drugs in India: Assessing Quality, Safety, and Efficacy Standards0
SawStop Holding LLC v. Vidal United States Court of Appeals of the Federal Circuit, 2022 48 F.4th 13550
Pfizer Inc. v. Sanofi Pasteur Inc0
Innovate, Evaluate, Legislate: U.S. Senators Forge a Path to Assess Artificial Intelligence’s Biosecurity Quandary0
Oligonucleotide Therapeutics Patenting: Strategies for Success0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Observation on the R&D Effectiveness and Application of China's Novel Coronavirus Vaccine0
Regeneron Pharms., Inc. v. Mylan Pharms. Inc.0
Amgen Inc. v. Sandoz Inc. United States Court of Appeals of the Federal Circuit, 2023 No. 2022-1147, 2023 WL 29941660
Glob. Health Sols. LLC v. Selner0
Navigating Procedural Challenges in Biotechnological Patenting: A Path Forward for India’s Innovation Landscape0
Legal Perspective of Genetically Modified Crops and Drowsy Stance of International Actors0
UCB, Inc. v. Actavis Lab'ys UT, Inc.0
Allergan USA, Inc. v. MSN Lab’ys Priv. Ltd0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Shockwave Med., Inc. v. Cardiovascular Sys., Inc0
Genentech, Inc. v. Sandoz, Inc.0
Arbutus Biopharma Corp. v. ModernaTX, Inc. United States Court of Appeals of the Federal Circuit, 2023 65 F.4th 6560
Research on the Latest Progress of “Mechanism for Early Resolution of Patent Disputes” for Biological Products in China0
Celanese Int’l Corp. v. Int’l Trade Comm’n0
A 2023 Review of Legislation Aimed at Increasing Generic and Biosimilar Competition0
Recent Developments at the Intersection of Pharma, Patents, and Antitrust Law0
ChromaDex, Inc. v. Elysium Health, Inc. United States Court of Appeals of the Federal Circuit, 2023 59 F.4th 12800
H. Lundbeck A/S v. Lupin Ltd.0
A Recitation of “Clinically Proven Effective” Fails to “Breathe Patentability” Into Method-of-Treatment Claims0
Geopolitical Data Barriers in Biomedicine: Resolving Sino–U.S. Regulatory Conflicts and Compliance Challenges Under Executive Order 141170
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Incyte Corp. v. Sun Pharm. Indus., Ltd.0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc.0
Regulation of Clinical Trials and Pandemic Research: Upholding Ethical Standards During a COVID-19 Crisis0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. Ltd0
Seagen Inc. v. Daiichi Sankyo Co.0
Seeds of Innovation: Exploring Intellectual Property Rights in the Realm of Genetically Modified Crops in India0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
The Legislative Paradigm of China's Biosafety Law and Its Positive Significance for the SARS-CoV-2 Prevention and Control0
Bayer Pharma Aktiengesellschaft v. Mylan Pharms. Inc0
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