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
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?4
CareDx, Inc. v. Natera, Inc. United States Court of Appeals of the Federal Circuit, 2022 40 F.4th 13713
To What Extent Does Mayo v. Prometheus Allow for the Patenting of Diagnostic Methods?3
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
Selected Developments in Biotechnology Law and the Biotechnology Industry2
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
Landscape of Genome Editing Technology Patents in the European Patent Office with a Focus on CRISPR-Related Opposition Proceedings1
Dilemma and Solution of Intellectual Property Protection of Biological Genetic Resources1
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
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
Recent Developments in FDA Regulatory Exclusivities1
Regents of the Univ. of California v. Broad Inst., Inc.1
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
Pfizer Inc. v. Sanofi Pasteur Inc0
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
Lab’y Corp. of Am. Holdings v. Qiagen Scis., LLC0
Gilead Scis., Inc. v. United States0
Wuhan Healthgen Biotechnology Corp. v. Int’l Trade Comm’n0
Salix Pharms., Ltd. v. Norwich Pharms. Inc.0
Am. Hosp. Ass’n v. Kennedy0
Seeds of Innovation: Exploring Intellectual Property Rights in the Realm of Genetically Modified Crops in India0
Rosalind Franklin Society Proudly Announces the 2022 Award Recipient for Biotechnology Law Report0
The Evolving Grace Period for U.S. Patent Applicants0
China Releases Document on Ethics Review of Life Sciences: Comments and Compliance Guidelines0
Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc.0
Bayer Pharma Aktiengesellschaft v. Mylan Pharms. Inc0
Novartis Pharms. Corp. v. Accord Healthcare, Inc.0
Navigating Pharmaceutical Patent Term Extension System in China0
Genentech, Inc. v. Sandoz, Inc.0
Teva Pharms. Int’l GmbH v. Lilly0
Janssen Pharms., Inc. v. Teva Pharms. USA, Inc0
Seagen Inc. v. Daiichi Sankyo Co.0
Ethical Boundary of the Development of Human Gene Editing Technology0
Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc.0
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
Oligonucleotide Therapeutics Patenting: Strategies for Success0
REGENXBIO Inc. v. Sarepta Therapeutics, Inc.0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Reflections on Pending Technical and Legal Issues in the R&D of COVID-19 Medical Products0
Glob. Health Sols. LLC v. Selner0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
SawStop Holding LLC v. Vidal United States Court of Appeals of the Federal Circuit, 2022 48 F.4th 13550
Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. Ltd0
Geopolitical Data Barriers in Biomedicine: Resolving Sino–U.S. Regulatory Conflicts and Compliance Challenges Under Executive Order 141170
GlaxoSmithKline II and Other Recent Developments in Induced and Contributory Patent Infringement0
Cornell Rsch. Found., Inc. v. Vidal0
Reshaping Biotechnology Governance: The NSCEB Report, Congressional Testimony, and the Path Forward0
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
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Restem, LLC v. Jadi Cell, LLC0
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
Cytiva BioProcess R&D AB v. JSR Corp.0
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
Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC0
Incyte Corp. v. Sun Pharm. Indus., Ltd.0
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
In re Xencor, Inc.0
Natera, Inc. v. NeoGenomics Lab’ys, Inc0
Preventing Ethical Risks in Cutting-Edge Biotech: China’s Evolving Governance Model0
Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC0
Purdue Pharma L.P. v. Collegium Pharm., Inc0
Guardant Health, Inc. v. Univ. of Washington0
The U.S. Patent and Trademark Office Proposes New Rules Targeting Continuation Practice and Terminal Disclaimers0
Par Pharm., Inc. v. Eagle Pharms., Inc.0
Innovate, Evaluate, Legislate: U.S. Senators Forge a Path to Assess Artificial Intelligence’s Biosecurity Quandary0
Regeneron Pharms., Inc. v. Mylan Pharms. Inc.0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Balancing Innovation and Biomedical Ethics within National Institutes of Health: Integrative and Regulatory Reforms for Artificial Intelligence-Driven Biotechnology0
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
Regulation of Biomedical Research: Global and Indian Perspective0
The U.S. Patent and Trademark Office’s Response to Recent Developments in Artificial Intelligence0
Recent Developments in the Listing of Patents in FDA's Orange Book0
HIPAA, HIPPA, or HIPPO: What Really Is the Heath Insurance Portability and Accountability Act?0
H. Lundbeck A/S v. Lupin Ltd.0
Regeneron Pharms., Inc. v. Mylan Pharms. Inc.0
The U.S. Congress Considers Patent Eligibility Reform0
Pleading Use of Trade Secrets Concerning a Biological Product by Showing Product-Related Similarities: Allergan, Inc. v. Revance Therapeutics, Inc.0
Gilead Prevails Over the United States Government in Litigation Alleging Patent Infringement (by Gilead) and Breach of Contract (by the United States)0
Observation on the R&D Effectiveness and Application of China's Novel Coronavirus Vaccine0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Transforming Blood Management Systems in Developing Countries Through Technological and Artificial Intelligence-Driven Innovations0
Functional Features in Antibody Claims: The UPC vs. the EPO0
A Review of Judicial Opinions Interpreting the Novelty Provisions of the America Invents Act0
Unproven Stem Cell Industry in the U.S.: Regulatory Challenges and Enforcement Issues0
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
Selected Developments in Biotechnology Law and the Biotechnology Industry0
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
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
In re Xencor and the Use of Jepson and Means-Plus-Function Claiming in the Context of Antibody Inventions0
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
Research on the Intellectual Property Protection of Genetically Modified Crops in China0
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
Navigating Procedural Challenges in Biotechnological Patenting: A Path Forward for India’s Innovation Landscape0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Allergan USA, Inc. v. MSN Lab’ys Priv. Ltd0
The Fate of FTC v. Actavis, Inc . in the Biosimilar Context—Does and Should the FTC v. Actavis Decision Ap0
Drafting a Pharmaceutical Composition Claim Covering Later-Developed Combination Drugs Without Losing the Disclosure Requirement Challenge: In re Entresto 0
In re Couvaras0
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
Legal Perspective of Genetically Modified Crops and Drowsy Stance of International Actors0
Amgen Inc. v. Sandoz Inc. United States Court of Appeals of the Federal Circuit, 2023 No. 2022-1147, 2023 WL 29941660
Patent Portfolio Landscape in China’s Orange Book : Size Achievements and Persistent Quality Gaps Between Domestic Firms and Multinational Corporations0
Regulatory Landscape for Generic Drugs in India: Assessing Quality, Safety, and Efficacy Standards0
UCB, Inc. v. Actavis Lab'ys UT, Inc.0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
How a Treatment Claim Without Reciting Safety and Efficacy Requirements May Survive the Disclosure Requirement Challenge: United Therapeutics Corp. v. Liquidia Technologies, Inc0
A Crisis on Patenting of “Ready-to-Use” Oral Liquid Formulations: Azurity Pharms., Inc. v. Alkem Lab’ys Ltd0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
How Science, Technology, and Society Influence Patent Policies: The Choice and Direction of Gene Patent Pathways from the View of Technoscience0
Amarin Pharma, Inc. v. Hikma Pharms. USA, Inc.0
Azurity Pharms., Inc. v. Alkem Lab’ys Ltd.0
Patentability Analysis of “Intelligent” Disease Diagnosis Methods in China in the Era of Smart Health Care0
A Feasible Pathway for Open Access to Human Embryonic Stem Cell Patents — With China's Open License for Patent as the Entry Point0
Medytox, Inc. v. Galderma S.A.0
Shockwave Med., Inc. v. Cardiovascular Sys., Inc0
Research on Intellectual Property Right Protection of Genetic Resources in China Under Benefit-Sharing0
Merck Serono S.A. v. Hopewell Pharma Ventures, Inc.0
From the GRATK Treaty to Chinese Domestic Law: Adapting Patent Disclosure Rules to Protect Genetic Resources and Associated Traditional Knowledge0
Galderma Lab’ys, L.P. v. Lupin Inc0
Actelion Pharms. LTD v. Mylan Pharms. Inc.0
Rosalind Franklin Society Proudly Announces the 2023 Award Recipient for Biotechnology Law Report0
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
Univ. of Massachusetts v. L'Oreal S.A.0
The Legislative Paradigm of China's Biosafety Law and Its Positive Significance for the SARS-CoV-2 Prevention and Control0
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
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