Biotechnology Law Report

Article	Citations
CareDx, Inc. v. Natera, Inc. United States Court of Appeals of the Federal Circuit, 2022 40 F.4th 1371	17
Patents Cannot Be Blamed for Inequitable Access to COVID-19 Vaccines	4
The Localization of Drug Patent Linkage System in China: Where Should It Go?	4
Legal Governance of Human Gene Editing Technology: From Single Governance to Multiple Governance	3
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.	3
Selected Developments in Biotechnology Law and the Biotechnology Industry	2
Amgen v. Sanofi: The Supreme Court Takes up the Enablement Requirement in the Context of Therapeutic Monoclonal Antibodies	2
Selected Developments in Biotechnology Law and the Biotechnology Industry	2
Supplementary Protection Certificates in Europe: Clarity at Last?	2
14-Day Limit of Human Embryo Research: Moral Issues in the Patent Law in China	1
Pac. Biosciences of California, Inc. v. Pers. Genomics Taiwan, Inc	1
Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC	1
Bio-Rad Lab'ys, Inc. v. Int'l Trade Comm'n	1
Astellas Pharma, Inc. v. Sandoz Inc. USA, Inc.	1
ImmunoGen, Inc. v. Stewart	1
Selected Developments in Biotechnology Law and the Biotechnology Industry	1
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 147	1
Selected Developments in Biotechnology Law and the Biotechnology Industry	1
ModernaTx, Inc. v. Arbutus Biopharma Corp.	1
Research on the Latest Progress of “Mechanism for Early Resolution of Patent Disputes” for Biological Products in China	1
ChromaDex, Inc. v. Elysium Health, Inc. United States Court of Appeals of the Federal Circuit, 2023 59 F.4th 1280	1
Legal and Ethical Challenges in the Construction of China's Biobanks	1
Univ. of Massachusetts v. L'Oreal S.A.	1

A Review of Patent Regimes on Health Biotechnology Innovation in India	1
Hologic, Inc. v. Minerva Surgical, Inc.	1
Observation on China's Performance in the Global Supply Chain of COVID-19 Medicine	1
A 12th Year 101 Update—Diagnostic and DNA Claims Are Patent Eligible, but Pre-Mayo Patents May Continue to Fall	1
Dilemma and Solution of Intellectual Property Protection of Biological Genetic Resources	1
Selected Developments in Biotechnology Law and the Biotechnology Industry	1
Nippon Shinyaku Co. v. Sarepta Therapeutics, Inc.	1
Selected Developments in Biotechnology Law and the Biotechnology Industry	1
Generic Drugs and Innovative Drug Incentives: Early Dispute Resolution Mechanism in China	1
In re Entresto	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 Drug	1
Selected Developments in Biotechnology Law and the Biotechnology Industry	1
Biotechnology and Intellectual Property Law: Theoretical and Practical Reflections on Albanian National Law and Jurisprudence in Comparison with EU Acquis and ECJ Case Law	1
Moo-re Gene-edited Animals Get Regulatory Clearance: U.S. FDA Approves Genetically Engineered Cattle for Human Consumption	1
China's Challenges in Implementing Compulsory Drug Patent Licenses and its Response in the Context of COVID-19	1
Landscape of Genome Editing Technology Patents in the European Patent Office with a Focus on CRISPR-Related Opposition Proceedings	1
Recent Developments in FDA Regulatory Exclusivities	1
Tris Pharma, Inc. v. Actavis Lab'ys FL, Inc.	1
Sanho Corp. v. Kaijet Tech. Int’l Ltd., Inc	1
An Innovation Principle in Gene Technology Law?	1
Federal Circuit Reiterates That Drug Safety and Efficacy Are Issues for the FDA, Not the Patent Laws	1
Univ. of S. Fla. Bd. of Trustees v. United States	1
The Broad Institute Scores Another Victory in Its Battle with the University of California over the Patenting of CRIPSR	0
H. Lundbeck A/S v. Lupin Ltd.	0
Galderma Lab’ys, L.P. v. Lupin Inc	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC	0
In re Couvaras	0
Unproven Stem Cell Industry in the U.S.: Regulatory Challenges and Enforcement Issues	0
Regulation of Biomedical Research: Global and Indian Perspective	0
Navigating Procedural Challenges in Biotechnological Patenting: A Path Forward for India’s Innovation Landscape	0
Recent Developments in the Listing of Patents in FDA's Orange Book	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	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-Aldrich	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
Janssen Ortho, LLC v. United States	0
Natera, Inc. v. NeoGenomics Lab’ys, Inc	0
Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc.	0
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 Manufacturers	0
Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC United States Court of Appeals of the Federal Circuit, 2023 No. 2023-1186, 2023 WL 2198640	0
Legal Perspective of Genetically Modified Crops and Drowsy Stance of International Actors	0
Celanese Int’l Corp. v. Int’l Trade Comm’n	0
A 2023 Review of Legislation Aimed at Increasing Generic and Biosimilar Competition	0
Gilead Scis., Inc. v. United States	0
Ethical Boundary of the Development of Human Gene Editing Technology	0
ModernaTx, Inc. v. Arbutus Biopharma Corp.	0
Minerva Surgical, Inc. v. Hologic, Inc.	0
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. Vidal	0
Rosalind Franklin Society Proudly Announces the 2023 Award Recipient for Biotechnology Law Report	0

Selected Developments in Biotechnology Law and the Biotechnology Industry	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
The Legislative Paradigm of China's Biosafety Law and Its Positive Significance for the SARS-CoV-2 Prevention and Control	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
Regeneron Pharms., Inc. v. Mylan Pharms. Inc.	0
Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc.	0
Innovate, Evaluate, Legislate: U.S. Senators Forge a Path to Assess Artificial Intelligence’s Biosecurity Quandary	0
Amarin Pharma, Inc. v. Hikma Pharms. USA, Inc.	0
Minerva Surgical, Inc. v. Hologic, Inc. United States Court of Appeals of the Federal Circuit, 2023 59 F.4th 1371	0
Observation on the R&D Effectiveness and Application of China's Novel Coronavirus Vaccine	0
Rosalind Franklin Society Proudly Announces the 2022 Award Recipient for Biotechnology Law Report	0
The U.S. Patent and Trademark Office Proposes New Rules Targeting Continuation Practice and Terminal Disclaimers	0
In re Entresto and the Standard of Review for Compliance with the Written Description Requirement	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
How Science, Technology, and Society Influence Patent Policies: The Choice and Direction of Gene Patent Pathways from the View of Technoscience	0
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.sr	0
Arbutus Biopharma Corp. v. ModernaTX, Inc. United States Court of Appeals of the Federal Circuit, 2023 65 F.4th 656	0
Univ. of S. Fla. Bd. of Trustees v. United States and the Federal Government’s Nonexclusive License under the Bayh-Dole Act	0
Novartis Pharms. Corp. v. Accord Healthcare, Inc.	0
Amgen Inc. v. Sandoz Inc. United States Court of Appeals of the Federal Circuit, 2023 No. 2022-1147, 2023 WL 2994166	0
Salix Pharms., Ltd. v. Norwich Pharms. Inc.	0
Teva v. Amneal: The Federal Circuit Weighs in on the Listing of Patents Relating to Drug-Device Combinations in the Orange Book	0
Purdue Pharma L.P. v. Collegium Pharm., Inc	0
The Enablement and Written Description Requirements Through the Lens of the Federal Circuit's Actions (As Opposed to Its Words)	0
AstraZeneca AB v. Mylan Pharms. Inc.	0
Par Pharm., Inc. v. Eagle Pharms., Inc.	0
Challenges in Patenting Human Stem Cell Inventions: A Comparative Perspective in USA, Europe, and India—Is India Lagging?	0
Recent Developments at the Intersection of Pharma, Patents, and Antitrust Law	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
The Legal Protection of Gene Private Rights	0
Geopolitical Data Barriers in Biomedicine: Resolving Sino–U.S. Regulatory Conflicts and Compliance Challenges Under Executive Order 14117	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
The U.S. Patent and Trademark Office’s Response to Recent Developments in Artificial Intelligence	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
In Minerva v. Hologic, the U.S. Supreme Court Reins in the Equitable Doctrine of Assignor Estoppel	0
Novartis Pharms. Corp. v. Accord Healthcare, Inc.	0
Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. Ltd	0
Navigating Cross-Border Challenges In Biobanking: Analysing Eu Legislation, ECJ Case Law, and the Role of Private International Law	0
A Feasible Pathway for Open Access to Human Embryonic Stem Cell Patents—With China's Open License for Patent as the Entry Point	0
Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part II	0
Janssen Pharms., Inc. v. Teva Pharms. USA, Inc	0
Reflections on Pending Technical and Legal Issues in the R&D of COVID-19 Medical Products	0
GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.United States Court of Appeals of the Federal Circuit, 20217 F.4th 1320	0
HIPAA, HIPPA, or HIPPO: What Really Is the Heath Insurance Portability and Accountability Act?	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
Oligonucleotide Therapeutics Patenting: Strategies for Success	0
In Juno v. Kite the Federal Circuit Strikes Down Patent Directed Towards Pioneering Innovation in CAR T-Cell Therapy	0
Medytox, Inc. v. Galderma S.A.	0
A Crisis on Patenting of “Ready-to-Use” Oral Liquid Formulations: Azurity Pharms., Inc. v. Alkem Lab’ys Ltd	0
China Releases Document on Ethics Review of Life Sciences: Comments and Compliance Guidelines	0
Seeds of Innovation: Exploring Intellectual Property Rights in the Realm of Genetically Modified Crops in India	0
Cytiva BioProcess R&D AB v. JSR Corp.	0
Wuhan Healthgen Biotechnology Corp. v. Int’l Trade Comm’n	0
Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part I	0
Actelion Pharms. LTD v. Mylan Pharms. Inc.	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
Patentability Analysis of “Intelligent” Disease Diagnosis Methods in China in the Era of Smart Health Care	0
Incyte Corp. v. Sun Pharm. Indus., Ltd.	0
The Drawing-Up of Laws on Research Involving Human Embryos in Australia: Lack of an Islamic Voice	0
UCB, Inc. v. Actavis Lab'ys UT, Inc.	0
Allergan USA, Inc. v. MSN Lab’ys Priv. Ltd	0
The Evolving Grace Period for U.S. Patent Applicants	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
Navigating Pharmaceutical Patent Term Extension System in China	0
Should the Federal Circuit Lower the Threshold for Article III Standing to Appeal Adverse Decisions in AIA Trial Proceedings?	0
GlaxoSmithKline II and Other Recent Developments in Induced and Contributory Patent Infringement	0
Pleading Use of Trade Secrets Concerning a Biological Product by Showing Product-Related Similarities: Allergan, Inc. v. Revance Therapeutics, Inc.	0
SawStop Holding LLC v. Vidal United States Court of Appeals of the Federal Circuit, 2022 48 F.4th 1355	0
A Review of Judicial Opinions Interpreting the Novelty Provisions of the America Invents Act	0
Regulation of Clinical Trials and Pandemic Research: Upholding Ethical Standards During a COVID-19 Crisis	0
Juno Therapeutics, Inc. v. Kite Pharma, Inc. United States Court of Appeals of the Federal Circuit, 202110 F.4th 1330	0
Pfizer Inc. v. Sanofi Pasteur Inc	0
Observation on the Admission Situation of the Anti-Coronavirus Drug “Remdesivir” in China	0
Research on Intellectual Property Right Protection of Genetic Resources in China Under Benefit-Sharing	0
Balancing Innovation and Biomedical Ethics within National Institutes of Health: Integrative and Regulatory Reforms for Artificial Intelligence-Driven Biotechnology	0
Regulatory Landscape for Generic Drugs in India: Assessing Quality, Safety, and Efficacy Standards	0
AI (Re)Defining Pharmaceutical Exclusivities	0
Genentech, Inc. v. Sandoz, Inc.	0

Selected Developments in Biotechnology Law and the Biotechnology Industry

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