Biotechnology Law Report

Papers
(The TQCC 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 2022-08-01 to 2026-08-01.)
ArticleCitations
Legal Governance of Human Gene Editing Technology: From Single Governance to Multiple Governance31
The Localization of Drug Patent Linkage System in China: Where Should It Go?4
Is Cross-Border Transfer of Human Genetic Data an Impossible Mission?4
To What Extent Does Mayo v. Prometheus Allow for the Patenting of Diagnostic Methods?3
CareDx, Inc. v. Natera, Inc. United States Court of Appeals of the Federal Circuit, 2022 40 F.4th 13713
Selected Developments in Biotechnology Law and the Biotechnology Industry2
Trade Secret Protection on a Publicly Sold, Patented Spinal Implant Device: Life Spine, Inc. v. Aegis Spine, Inc.2
Sanho Corp. v. Kaijet Tech. Int’l Ltd., Inc2
Amgen v. Sanofi : The Supreme Court Takes up the Enablement Requirement in the Context of Therapeutic Monoclonal Antibodies2
Pac. Biosciences of California, Inc. v. Pers. Genomics Taiwan, Inc1
Astellas Pharma, Inc. v. Sandoz Inc. USA, Inc.1
Duke Univ. v. Sandoz Inc.1
Federal Circuit Reiterates That Drug Safety and Efficacy Are Issues for the FDA, Not the Patent Laws1
Regents of the Univ. of California v. Broad Inst., Inc.1
Recent Developments in FDA Regulatory Exclusivities1
Incyte Corp. v. Sun Pharm. Indus., Ltd.1
United Therapeutics Corp. v. Liquidia Techs., Inc.1
Selected Developments in Biotechnology Law and the Biotechnology Industry1
Selected Developments in Biotechnology Law and the Biotechnology Industry1
Tris Pharma, Inc. v. Actavis Lab'ys FL, Inc.1
Hologic, Inc. v. Minerva Surgical, Inc.1
Alnylam Pharms., Inc. v. Moderna, Inc.1
Generic Drugs and Innovative Drug Incentives: Early Dispute Resolution Mechanism in China1
Biotechnology and Intellectual Property Law: Theoretical and Practical Reflections on Albanian National Law and Jurisprudence in Comparison with EU Acquis and ECJ Case Law1
A 12th Year 101 Update—Diagnostic and DNA Claims Are Patent Eligible, but Pre- Mayo Patents May Continue to Fall1
Dilemma and Solution of Intellectual Property Protection of Biological Genetic Resources1
Landscape of Genome Editing Technology Patents in the European Patent Office with a Focus on CRISPR-Related Opposition Proceedings1
Agilent Techs., Inc. v. Synthego Corp.1
Selected Developments in Biotechnology Law and the Biotechnology Industry1
Selected Developments in Biotechnology Law and the Biotechnology Industry1
Vanda Pharms., Inc. v. United States Food & Drug Admin1
Janssen Pharms., Inc. v. Teva Pharms. USA, Inc.1
Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC1
Eye Therapies, LLC v. Slayback Pharma, LLC1
A Review of Patent Regimes on Health Biotechnology Innovation in India1
In re Entresto1
ImmunoGen, Inc. v. Stewart1
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
Selected Developments in Biotechnology Law and the Biotechnology Industry1
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
Observation on China's Performance in the Global Supply Chain of COVID-19 Medicine1
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Navigating Procedural Challenges in Biotechnological Patenting: A Path Forward for India’s Innovation Landscape0
Amarin Pharma, Inc. v. Hikma Pharms. USA, Inc.0
Research on the Intellectual Property Protection of Genetically Modified Crops in China0
Azurity Pharms., Inc. v. Alkem Lab’ys Ltd.0
The Fate of FTC v. Actavis, Inc . in the Biosimilar Context—Does and Should the FTC v. Actavis Decision Ap0
A Feasible Pathway for Open Access to Human Embryonic Stem Cell Patents — With China's Open License for Patent as the Entry Point0
In re Couvaras0
Medytox, Inc. v. Galderma S.A.0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Research on Intellectual Property Right Protection of Genetic Resources in China Under Benefit-Sharing0
Amgen Inc. v. Sandoz Inc. United States Court of Appeals of the Federal Circuit, 2023 No. 2022-1147, 2023 WL 29941660
Merck Serono S.A. v. Hopewell Pharma Ventures, Inc.0
UCB, Inc. v. Actavis Lab'ys UT, Inc.0
Galderma Lab’ys, L.P. v. Lupin Inc0
How a Treatment Claim Without Reciting Safety and Efficacy Requirements May Survive the Disclosure Requirement Challenge: United Therapeutics Corp. v. Liquidia Technologies, Inc0
Actelion Pharms. LTD v. Mylan Pharms. Inc.0
Univ. of Massachusetts v. L'Oreal S.A.0
How Science, Technology, and Society Influence Patent Policies: The Choice and Direction of Gene Patent Pathways from the View of Technoscience0
Challenges in Patenting Human Stem Cell Inventions: A Comparative Perspective in USA, Europe, and India—Is India Lagging?0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Patentability Analysis of “Intelligent” Disease Diagnosis Methods in China in the Era of Smart Health Care0
A 2023 Review of Legislation Aimed at Increasing Generic and Biosimilar Competition0
Recent Developments at the Intersection of Pharma, Patents, and Antitrust Law0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
A Recitation of “Clinically Proven Effective” Fails to “Breathe Patentability” Into Method-of-Treatment Claims0
Data Risks and Legal Regulation of Non-Invasive Brain–Computer Interfaces0
Food & Drug Admin. v. R. J. Reynolds Vapor Co.0
Shockwave Med., Inc. v. Cardiovascular Sys., Inc0
Lab’y Corp. of Am. Holdings v. Qiagen Scis., LLC0
Gilead Scis., Inc. v. United States0
Salix Pharms., Ltd. v. Norwich Pharms. Inc.0
From the GRATK Treaty to Chinese Domestic Law: Adapting Patent Disclosure Rules to Protect Genetic Resources and Associated Traditional Knowledge0
Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc.0
Seeds of Innovation: Exploring Intellectual Property Rights in the Realm of Genetically Modified Crops in India0
The Evolving Grace Period for U.S. Patent Applicants0
Rosalind Franklin Society Proudly Announces the 2023 Award Recipient for Biotechnology Law Report0
Teva Pharms. Int’l GmbH v. Lilly0
Bayer Pharma Aktiengesellschaft v. Mylan Pharms. Inc0
Navigating Pharmaceutical Patent Term Extension System in China0
The Legislative Paradigm of China's Biosafety Law and Its Positive Significance for the SARS-CoV-2 Prevention and Control0
Janssen Pharms., Inc. v. Teva Pharms. USA, Inc0
Ethical Boundary of the Development of Human Gene Editing Technology0
Pfizer Inc. v. Sanofi Pasteur Inc0
In re Entresto and the Standard of Review for Compliance with the Written Description Requirement0
Should the United States Join Treaty Mandating Patent Disclosure Requirements for Genetic Resources?0
Wuhan Healthgen Biotechnology Corp. v. Int’l Trade Comm’n0
REGENXBIO Inc. v. Sarepta Therapeutics, Inc.0
Am. Hosp. Ass’n v. Kennedy0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Rosalind Franklin Society Proudly Announces the 2022 Award Recipient for Biotechnology Law Report0
Reflections on Pending Technical and Legal Issues in the R&D of COVID-19 Medical Products0
China Releases Document on Ethics Review of Life Sciences: Comments and Compliance Guidelines0
Glob. Health Sols. LLC v. Selner0
Novartis Pharms. Corp. v. Accord Healthcare, Inc.0
SawStop Holding LLC v. Vidal United States Court of Appeals of the Federal Circuit, 2022 48 F.4th 13550
Genentech, Inc. v. Sandoz, Inc.0
Cornell Rsch. Found., Inc. v. Vidal0
Seagen Inc. v. Daiichi Sankyo Co.0
Geopolitical Data Barriers in Biomedicine: Resolving Sino–U.S. Regulatory Conflicts and Compliance Challenges Under Executive Order 141170
Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc.0
GlaxoSmithKline II and Other Recent Developments in Induced and Contributory Patent Infringement0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Oligonucleotide Therapeutics Patenting: Strategies for Success0
The Legal Protection of Gene Private Rights0
The Enablement and Written Description Requirements Through the Lens of the Federal Circuit's Actions (As Opposed to Its Words)0
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
Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC United States Court of Appeals of the Federal Circuit, 2023 No. 2023-1186, 2023 WL 21986400
ChromaDex, Inc. v. Elysium Health, Inc. United States Court of Appeals of the Federal Circuit, 2023 59 F.4th 12800
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Evaluation of Turkish Legal Regulations Regarding the Production of Transgenic Products in the Light of American Legal Regulations0
Incyte Corp. v. Sun Pharm. Indus., Ltd.0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Do Access and Benefit-Sharing Obligations Apply to Digital Sequence Information?0
Navigating Cross-Border Challenges In Biobanking: Analysing Eu Legislation, ECJ Case Law, and the Role of Private International Law0
Natera, Inc. v. NeoGenomics Lab’ys, Inc0
Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. Ltd0
Par Pharm., Inc. v. Eagle Pharms., Inc.0
Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC0
Guardant Health, Inc. v. Univ. of Washington0
Reshaping Biotechnology Governance: The NSCEB Report, Congressional Testimony, and the Path Forward0
Innovate, Evaluate, Legislate: U.S. Senators Forge a Path to Assess Artificial Intelligence’s Biosecurity Quandary0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Restem, LLC v. Jadi Cell, LLC0
Celanese Int’l Corp. v. Int’l Trade Comm’n0
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
Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC0
The U.S. Patent and Trademark Office’s Response to Recent Developments in Artificial Intelligence0
Cytiva BioProcess R&D AB v. JSR Corp.0
HIPAA, HIPPA, or HIPPO: What Really Is the Heath Insurance Portability and Accountability Act?0
In re Xencor, Inc.0
Regeneron Pharms., Inc. v. Mylan Pharms. Inc.0
Preventing Ethical Risks in Cutting-Edge Biotech: China’s Evolving Governance Model0
The U.S. Congress Considers Patent Eligibility Reform0
Purdue Pharma L.P. v. Collegium Pharm., Inc0
Gilead Prevails Over the United States Government in Litigation Alleging Patent Infringement (by Gilead) and Breach of Contract (by the United States)0
The U.S. Patent and Trademark Office Proposes New Rules Targeting Continuation Practice and Terminal Disclaimers0
Observation on the R&D Effectiveness and Application of China's Novel Coronavirus Vaccine0
Regeneron Pharms., Inc. v. Mylan Pharms. Inc.0
Transforming Blood Management Systems in Developing Countries Through Technological and Artificial Intelligence-Driven Innovations0
Balancing Innovation and Biomedical Ethics within National Institutes of Health: Integrative and Regulatory Reforms for Artificial Intelligence-Driven Biotechnology0
Functional Features in Antibody Claims: The UPC vs. the EPO0
Research on the Latest Progress of “Mechanism for Early Resolution of Patent Disputes” for Biological Products in China0
Regulation of Biomedical Research: Global and Indian Perspective0
Unproven Stem Cell Industry in the U.S.: Regulatory Challenges and Enforcement Issues0
Recent Developments in the Listing of Patents in FDA's Orange Book0
Arbutus Biopharma Corp. v. ModernaTX, Inc. United States Court of Appeals of the Federal Circuit, 2023 65 F.4th 6560
The Redemption of Drug Patent Linkage System: The Dilemma and Improvement in the Qualification System of Market Exclusivity Period for China’s First Generic Drug0
H. Lundbeck A/S v. Lupin Ltd.0
Minerva Surgical, Inc. v. Hologic, Inc. United States Court of Appeals of the Federal Circuit, 2023 59 F.4th 13710
Can Artificial Intelligence-Generated Inventions Be Protected by Patent Law?0
Teva v. Amneal : The Federal Circuit Weighs in on the Listing of Patents Relating to Drug-Device Combinations in the Orange Book0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Univ. of S. Fla. Bd. of Trustees v. United States0
Pleading Use of Trade Secrets Concerning a Biological Product by Showing Product-Related Similarities: Allergan, Inc. v. Revance Therapeutics, Inc.0
Univ. of S. Fla. Bd. of Trustees v. United States and the Federal Government’s Nonexclusive License under the Bayh-Dole Act0
Should the Federal Circuit Lower the Threshold for Article III Standing to Appeal Adverse Decisions in AIA Trial Proceedings?0
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
Allergan USA, Inc. v. MSN Lab’ys Priv. Ltd0
Drafting a Pharmaceutical Composition Claim Covering Later-Developed Combination Drugs Without Losing the Disclosure Requirement Challenge: In re Entresto 0
A Review of Judicial Opinions Interpreting the Novelty Provisions of the America Invents Act0
Patent Portfolio Landscape in China’s Orange Book : Size Achievements and Persistent Quality Gaps Between Domestic Firms and Multinational Corporations0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Legal Perspective of Genetically Modified Crops and Drowsy Stance of International Actors0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Regulatory Landscape for Generic Drugs in India: Assessing Quality, Safety, and Efficacy Standards0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
In re Xencor and the Use of Jepson and Means-Plus-Function Claiming in the Context of Antibody Inventions0
A Crisis on Patenting of “Ready-to-Use” Oral Liquid Formulations: Azurity Pharms., Inc. v. Alkem Lab’ys Ltd0
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