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 2021-08-01 to 2025-08-01.)
ArticleCitations
CareDx, Inc. v. Natera, Inc. United States Court of Appeals of the Federal Circuit, 2022 40 F.4th 137116
The Localization of Drug Patent Linkage System in China: Where Should It Go?4
Patents Cannot Be Blamed for Inequitable Access to COVID-19 Vaccines4
Trade Secret Protection on a Publicly Sold, Patented Spinal Implant Device: Life Spine, Inc. v. Aegis Spine, Inc.3
Legal Governance of Human Gene Editing Technology: From Single Governance to Multiple Governance3
To What Extent Does Mayo v. Prometheus Allow for the Patenting of Diagnostic Methods?3
Supplementary Protection Certificates in Europe: Clarity at Last?2
Selected Developments in Biotechnology Law and the Biotechnology Industry2
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
Selected Developments in Biotechnology Law and the Biotechnology Industry1
In re Entresto1
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
Selected Developments in Biotechnology Law and the Biotechnology Industry1
Bio-Rad Lab'ys, Inc. v. Int'l Trade Comm'n1
Moo-re Gene-edited Animals Get Regulatory Clearance: U.S. FDA Approves Genetically Engineered Cattle for Human Consumption1
ImmunoGen, Inc. v. Stewart1
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
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
ModernaTx, Inc. v. Arbutus Biopharma Corp.1
Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC1
Univ. of S. Fla. Bd. of Trustees v. United States1
14-Day Limit of Human Embryo Research: Moral Issues in the Patent Law in China1
Pac. Biosciences of California, Inc. v. Pers. Genomics Taiwan, Inc1
Research on the Latest Progress of “Mechanism for Early Resolution of Patent Disputes” for Biological Products in China1
Hologic, Inc. v. Minerva Surgical, Inc.1
Astellas Pharma, Inc. v. Sandoz Inc. USA, Inc.1
A 12th Year 101 Update—Diagnostic and DNA Claims Are Patent Eligible, but Pre-Mayo Patents May Continue to Fall1
Univ. of Massachusetts v. L'Oreal S.A.1
Dilemma and Solution of Intellectual Property Protection of Biological Genetic Resources1
Selected Developments in Biotechnology Law and the Biotechnology Industry1
Nippon Shinyaku Co. v. Sarepta Therapeutics, Inc.1
Selected Developments in Biotechnology Law and the Biotechnology Industry1
Generic Drugs and Innovative Drug Incentives: Early Dispute Resolution Mechanism in China1
ChromaDex, Inc. v. Elysium Health, Inc. United States Court of Appeals of the Federal Circuit, 2023 59 F.4th 12801
Legal and Ethical Challenges in the Construction of China's Biobanks1
Selected Developments in Biotechnology Law and the Biotechnology Industry1
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 Review of Patent Regimes on Health Biotechnology Innovation in India1
China's Challenges in Implementing Compulsory Drug Patent Licenses and its Response in the Context of COVID-191
Observation on China's Performance in the Global Supply Chain of COVID-19 Medicine1
Recent Developments in FDA Regulatory Exclusivities1
Tris Pharma, Inc. v. Actavis Lab'ys FL, Inc.1
Sanho Corp. v. Kaijet Tech. Int’l Ltd., Inc1
An Innovation Principle in Gene Technology Law?1
Federal Circuit Reiterates That Drug Safety and Efficacy Are Issues for the FDA, Not the Patent Laws1
Incyte Corp. v. Sun Pharm. Indus., Ltd.0
Review of the UK's R&D Tax Reliefs—A Good News Story for the UK's Life Sciences Sector?0
In Juno v. Kite the Federal Circuit Strikes Down Patent Directed Towards Pioneering Innovation in CAR T-Cell Therapy0
The Enablement and Written Description Requirements Through the Lens of the Federal Circuit's Actions (As Opposed to Its Words)0
In re Huping Hu: Quantum Entanglement, Medical Innovation, and Patentability on the Scientific “Fringe”0
Rosalind Franklin Society Proudly Announces the 2022 Award Recipient for Biotechnology Law Report0
Teva v. Amneal: The Federal Circuit Weighs in on the Listing of Patents Relating to Drug-Device Combinations in the Orange Book0
In re Couvaras0
Recent Developments at the Intersection of Pharma, Patents, and Antitrust Law0
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
Par Pharm., Inc. v. Eagle Pharms., Inc.0
The U.S. Patent and Trademark Office Proposes New Rules Targeting Continuation Practice and Terminal Disclaimers0
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
Patentability Analysis of “Intelligent” Disease Diagnosis Methods in China in the Era of Smart Health Care0
Celanese Int’l Corp. v. Int’l Trade Comm’n0
Genentech, Inc. v. Sandoz, Inc.0
Amarin Pharma, Inc. v. Hikma Pharms. USA, Inc.0
Purdue Pharma L.P. v. Collegium Pharm., Inc0
In Minerva v. Hologic, the U.S. Supreme Court Reins in the Equitable Doctrine of Assignor Estoppel0
Novartis Pharms. Corp. v. Accord Healthcare, Inc.0
The Legal Protection of Gene Private Rights0
Navigating Cross-Border Challenges In Biobanking: Analysing Eu Legislation, ECJ Case Law, and the Role of Private International Law0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
A 2023 Review of Legislation Aimed at Increasing Generic and Biosimilar Competition0
Janssen Pharms., Inc. v. Teva Pharms. USA, Inc0
Research on Intellectual Property Right Protection of Genetic Resources in China Under Benefit-Sharing0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
HIPAA, HIPPA, or HIPPO: What Really Is the Heath Insurance Portability and Accountability Act?0
The U.S. Patent and Trademark Office’s Response to Recent Developments in Artificial Intelligence0
Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. Ltd0
Medytox, Inc. v. Galderma S.A.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
Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part II0
AI (Re)Defining Pharmaceutical Exclusivities0
Regulation of Biomedical Research: Global and Indian Perspective0
Balancing Innovation and Biomedical Ethics within National Institutes of Health: Integrative and Regulatory Reforms for Artificial Intelligence-Driven Biotechnology0
Janssen Ortho, LLC v. United States0
Natera, Inc. v. NeoGenomics Lab’ys, Inc0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
H. Lundbeck A/S v. Lupin Ltd.0
Allergan USA, Inc. v. MSN Lab’ys Priv. Ltd0
The Evolving Grace Period for U.S. Patent Applicants0
A Crisis on Patenting of “Ready-to-Use” Oral Liquid Formulations: Azurity Pharms., Inc. v. Alkem Lab’ys Ltd0
The Drawing-Up of Laws on Research Involving Human Embryos in Australia: Lack of an Islamic Voice0
China Releases Document on Ethics Review of Life Sciences: Comments and Compliance Guidelines0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Navigating Pharmaceutical Patent Term Extension System in China0
Wuhan Healthgen Biotechnology Corp. v. Int’l Trade Comm’n0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part I0
Geopolitical Data Barriers in Biomedicine: Resolving Sino–U.S. Regulatory Conflicts and Compliance Challenges Under Executive Order 141170
ModernaTx, Inc. v. Arbutus Biopharma Corp.0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
The Fate of FTC v. Actavis, Inc. in the Biosimilar Context—Does and Should the FTC v. Actavis Decision Apply to Reverse Patent Settlements Between Brand Drug and Biosimilar Manufacturers0
Correction to: AI (Re)Defining Pharmaceutical Exclusivities, by Jonathan Kimball and Srividhya Ragavan, Biotechnol Law Rep 2022;41(1):23–29; doi: 10.1089/blr.2021.29257.sr0
SawStop Holding LLC v. Vidal United States Court of Appeals of the Federal Circuit, 2022 48 F.4th 13550
UCB, Inc. v. Actavis Lab'ys UT, Inc.0
Regulation of Clinical Trials and Pandemic Research: Upholding Ethical Standards During a COVID-19 Crisis0
Japanese CRISPR Patent and Biotech Developments in the Early Reiwa Era0
Novartis Pharms. Corp. v. Accord Healthcare, Inc.0
Observation on the Admission Situation of the Anti-Coronavirus Drug “Remdesivir” in China0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Pleading Use of Trade Secrets Concerning a Biological Product by Showing Product-Related Similarities: Allergan, Inc. v. Revance Therapeutics, Inc.0
Regulatory Landscape for Generic Drugs in India: Assessing Quality, Safety, and Efficacy Standards0
Regeneron Pharms., Inc. v. Mylan Pharms. Inc.0
A Review of Judicial Opinions Interpreting the Novelty Provisions of the America Invents Act0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Pfizer Inc. v. Sanofi Pasteur Inc0
Galderma Lab’ys, L.P. v. Lupin Inc0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
Unproven Stem Cell Industry in the U.S.: Regulatory Challenges and Enforcement Issues0
Oligonucleotide Therapeutics Patenting: Strategies for Success0
Pac. Biosciences of California, Inc. v. Oxford Nanopore Techs., Inc. United States Court of Appeals of the Federal Circuit, 2021 996 F.3d 1340
Salix Pharms., Ltd. v. Norwich Pharms. Inc.0
Univ. of S. Fla. Bd. of Trustees v. United States and the Federal Government’s Nonexclusive License under the Bayh-Dole Act0
GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.United States Court of Appeals of the Federal Circuit, 20217 F.4th 13200
Selected Developments in Biotechnology Law and the Biotechnology Industry0
AstraZeneca AB v. Mylan Pharms. Inc.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
Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc.0
Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC United States Court of Appeals of the Federal Circuit, 2023 No. 2023-1186, 2023 WL 21986400
Legal Perspective of Genetically Modified Crops and Drowsy Stance of International Actors0
Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC0
Sanofi-Aventis Deutschland GmbH 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
Gilead Scis., Inc. v. United States0
Ethical Boundary of the Development of Human Gene Editing Technology0
Navigating Procedural Challenges in Biotechnological Patenting: A Path Forward for India’s Innovation Landscape0
Challenges in Patenting Human Stem Cell Inventions: A Comparative Perspective in USA, Europe, and India—Is India Lagging?0
Recent Developments in the Listing of Patents in FDA's Orange Book0
Actelion Pharms. LTD v. Mylan Pharms. Inc.0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
A Pharmaceutical Formulation as a Claim Term Cannot “Target” a Plasma Concentration-Time Profile Under 35 U.S.C. § 112: A Lesson from Horizon Pharma, Inc. v. Dr. Reddy's Laboratories Inc.0
Cornell Rsch. Found., Inc. v. Vidal0
The Broad Institute Scores Another Victory in Its Battle with the University of California over the Patenting of CRIPSR0
Arbutus Biopharma Corp. v. ModernaTX, Inc. United States Court of Appeals of the Federal Circuit, 2023 65 F.4th 6560
Juno Therapeutics, Inc. v. Kite Pharma, Inc. United States Court of Appeals of the Federal Circuit, 202110 F.4th 13300
Minerva Surgical, Inc. v. Hologic, Inc. United States Court of Appeals of the Federal Circuit, 2023 59 F.4th 13710
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
A Feasible Pathway for Open Access to Human Embryonic Stem Cell Patents—With China's Open License for Patent as the Entry Point0
Minerva Surgical, Inc. v. Hologic, Inc.0
Innovate, Evaluate, Legislate: U.S. Senators Forge a Path to Assess Artificial Intelligence’s Biosecurity Quandary0
Reflections on Pending Technical and Legal Issues in the R&D of COVID-19 Medical Products0
Rosalind Franklin Society Proudly Announces the 2023 Award Recipient for Biotechnology Law Report0
Observation on the R&D Effectiveness and Application of China's Novel Coronavirus Vaccine0
The Legislative Paradigm of China's Biosafety Law and Its Positive Significance for the SARS-CoV-2 Prevention and Control0
In re Entresto and the Standard of Review for Compliance with the Written Description Requirement0
Selected Developments in Biotechnology Law and the Biotechnology Industry0
GlaxoSmithKline II and Other Recent Developments in Induced and Contributory Patent Infringement0
Cytiva BioProcess R&D AB v. JSR Corp.0
In re Huping Hu United States Court of Appeals of the Federal Circuit, 2021 No. 2019-2104, 2021 WL 1016437 (non-precedential)0
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