Biotechnology Law Report

Article	Citations
To What Extent Does Mayo v. Prometheus Allow for the Patenting of Diagnostic Methods?	21
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
Trade Secret Protection on a Publicly Sold, Patented Spinal Implant Device: Life Spine, Inc. v. Aegis Spine, Inc.	3
CareDx, Inc. v. Natera, Inc. United States Court of Appeals of the Federal Circuit, 2022 40 F.4th 1371	3
Selected Developments in Biotechnology Law and the Biotechnology Industry	2
Selected Developments in Biotechnology Law and the Biotechnology Industry	2
Legal Governance of Human Gene Editing Technology: From Single Governance to Multiple Governance	2
An Innovation Principle in Gene Technology Law?	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
China's Challenges in Implementing Compulsory Drug Patent Licenses and its Response in the Context of COVID-19	1
Moo-re Gene-edited Animals Get Regulatory Clearance: U.S. FDA Approves Genetically Engineered Cattle for Human Consumption	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
Selected Developments in Biotechnology Law and the Biotechnology Industry	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
Sanho Corp. v. Kaijet Tech. Int’l Ltd., Inc	1
Selected Developments in Biotechnology Law and the Biotechnology Industry	1
Observation on China's Performance in the Global Supply Chain of COVID-19 Medicine	1
In re Entresto	1
14-Day Limit of Human Embryo Research: Moral Issues in the Patent Law in China	1
Univ. of S. Fla. Bd. of Trustees v. United States	1
Hologic, Inc. v. Minerva Surgical, Inc.	1
Landscape of Genome Editing Technology Patents in the European Patent Office with a Focus on CRISPR-Related Opposition Proceedings	1

ImmunoGen, Inc. v. Stewart	1
Astellas Pharma, Inc. v. Sandoz Inc. USA, Inc.	1
Recent Developments in FDA Regulatory Exclusivities	1
United Therapeutics Corp. v. Liquidia Techs., Inc.	1
Dilemma and Solution of Intellectual Property Protection of Biological Genetic Resources	1
Nippon Shinyaku Co. v. Sarepta Therapeutics, Inc.	1
Federal Circuit Reiterates That Drug Safety and Efficacy Are Issues for the FDA, Not the Patent Laws	1
Incyte Corp. v. Sun Pharm. Indus., Ltd.	1
ChromaDex, Inc. v. Elysium Health, Inc. United States Court of Appeals of the Federal Circuit, 2023 59 F.4th 1280	1
Pac. Biosciences of California, Inc. v. Pers. Genomics Taiwan, Inc	1
Univ. of Massachusetts v. L'Oreal S.A.	1
A 12th Year 101 Update—Diagnostic and DNA Claims Are Patent Eligible, but Pre-Mayo Patents May Continue to Fall	1
A Review of Patent Regimes on Health Biotechnology Innovation in India	1
Incyte Corp. v. Sun Pharm. Indus., Ltd.	1
Generic Drugs and Innovative Drug Incentives: Early Dispute Resolution Mechanism in China	1
Regents of the Univ. of California v. Broad Inst., Inc.	1
Tris Pharma, Inc. v. Actavis Lab'ys FL, Inc.	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
Selected Developments in Biotechnology Law and the Biotechnology Industry	1
Selected Developments in Biotechnology Law and the Biotechnology Industry	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
Agilent Techs., Inc. v. Synthego Corp.	1
Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC	1
Patentability Analysis of “Intelligent” Disease Diagnosis Methods in China in the Era of Smart Health Care	0
Cytiva BioProcess R&D AB v. JSR Corp.	0
A Crisis on Patenting of “Ready-to-Use” Oral Liquid Formulations: Azurity Pharms., Inc. v. Alkem Lab’ys Ltd	0
Salix Pharms., Ltd. v. Norwich 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-Aldrich	0
Regulation of Biomedical Research: Global and Indian Perspective	0
The Enablement and Written Description Requirements Through the Lens of the Federal Circuit's Actions (As Opposed to Its Words)	0
Legal Perspective of Genetically Modified Crops and Drowsy Stance of International Actors	0
Par Pharm., Inc. v. Eagle Pharms., Inc.	0
A Review of Judicial Opinions Interpreting the Novelty Provisions of the America Invents Act	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
Navigating Pharmaceutical Patent Term Extension System in China	0
Celanese Int’l Corp. v. Int’l Trade Comm’n	0
Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part II	0
Geopolitical Data Barriers in Biomedicine: Resolving Sino–U.S. Regulatory Conflicts and Compliance Challenges Under Executive Order 14117	0
ModernaTx, Inc. v. Arbutus Biopharma Corp.	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
Restem, LLC v. Jadi Cell, LLC	0
Seeds of Innovation: Exploring Intellectual Property Rights in the Realm of Genetically Modified Crops in India	0
Amarin Pharma, Inc. v. Hikma Pharms. USA, Inc.	0
Balancing Innovation and Biomedical Ethics within National Institutes of Health: Integrative and Regulatory Reforms for Artificial Intelligence-Driven Biotechnology	0
Novartis Pharms. Corp. v. Accord Healthcare, Inc.	0
Recent Developments in the Listing of Patents in FDA's Orange Book	0
Allergan USA, Inc. v. MSN Lab’ys Priv. Ltd	0
Reflections on Pending Technical and Legal Issues in the R&D of COVID-19 Medical Products	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
Janssen Pharms., Inc. v. Teva Pharms. USA, 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
How Science, Technology, and Society Influence Patent Policies: The Choice and Direction of Gene Patent Pathways from the View of Technoscience	0
The U.S. Patent and Trademark Office Proposes New Rules Targeting Continuation Practice and Terminal Disclaimers	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
SawStop Holding LLC v. Vidal United States Court of Appeals of the Federal Circuit, 2022 48 F.4th 1355	0
Novartis Pharms. Corp. v. Accord Healthcare, Inc.	0
H. Lundbeck A/S v. Lupin Ltd.	0
Medytox, Inc. v. Galderma S.A.	0
Purdue Pharma L.P. v. Collegium Pharm., Inc	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
GlaxoSmithKline II and Other Recent Developments in Induced and Contributory Patent Infringement	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
Challenges in Patenting Human Stem Cell Inventions: A Comparative Perspective in USA, Europe, and India—Is India Lagging?	0
Natera, Inc. v. NeoGenomics Lab’ys, 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
Oligonucleotide Therapeutics Patenting: Strategies for Success	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
The Evolving Grace Period for U.S. Patent Applicants	0
Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc.	0
Rosalind Franklin Society Proudly Announces the 2023 Award Recipient for Biotechnology Law Report	0
Gilead Scis., Inc. v. United States	0
Ethical Boundary of the Development of Human Gene Editing Technology	0
The Broad Institute Scores Another Victory in Its Battle with the University of California over the Patenting of CRIPSR	0
The Legislative Paradigm of China's Biosafety Law and Its Positive Significance for the SARS-CoV-2 Prevention and Control	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
The U.S. Patent and Trademark Office’s Response to Recent Developments in Artificial Intelligence	0
Rosalind Franklin Society Proudly Announces the 2022 Award Recipient for Biotechnology Law Report	0
Research on the Intellectual Property Protection of Genetically Modified Crops in China	0
Juno Therapeutics, Inc. v. Kite Pharma, Inc. United States Court of Appeals of the Federal Circuit, 202110 F.4th 1330	0
How a Treatment Claim Without Reciting Safety and Efficacy Requirements May Survive the Disclosure Requirement Challenge: United Therapeutics Corp. v. Liquidia Technologies, Inc.	0
Navigating Cross-Border Challenges In Biobanking: Analysing Eu Legislation, ECJ Case Law, and the Role of Private International Law	0
Cornell Rsch. Found., Inc. v. Vidal	0
In Juno v. Kite the Federal Circuit Strikes Down Patent Directed Towards Pioneering Innovation in CAR T-Cell Therapy	0
Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC	0
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 2994166	0
Regulatory Landscape for Generic Drugs in India: Assessing Quality, Safety, and Efficacy Standards	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
Navigating Procedural Challenges in Biotechnological Patenting: A Path Forward for India’s Innovation Landscape	0
China Releases Document on Ethics Review of Life Sciences: Comments and Compliance Guidelines	0
Azurity Pharms., Inc. v. Alkem Lab’ys Ltd.	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
Genentech, Inc. v. Sandoz, Inc.	0
Unproven Stem Cell Industry in the U.S.: Regulatory Challenges and Enforcement Issues	0
UCB, Inc. v. Actavis Lab'ys UT, Inc.	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 Legal Protection of Gene Private Rights	0
AI (Re)Defining Pharmaceutical Exclusivities	0
Univ. of S. Fla. Bd. of Trustees v. United States and the Federal Government’s Nonexclusive License under the Bayh-Dole Act	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
Regeneron Pharms., Inc. v. Mylan Pharms. Inc.	0
AstraZeneca AB v. Mylan Pharms. Inc.	0
The Drawing-Up of Laws on Research Involving Human Embryos in Australia: Lack of an Islamic Voice	0
GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.United States Court of Appeals of the Federal Circuit, 20217 F.4th 1320	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
In re Xencor and the Use of Jepson and Means-Plus-Function Claiming in the Context of Antibody Inventions	0
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 Industry	0
A 2023 Review of Legislation Aimed at Increasing Generic and Biosimilar Competition	0
Pfizer Inc. v. Sanofi Pasteur Inc	0
Regulation of Clinical Trials and Pandemic Research: Upholding Ethical Standards During a COVID-19 Crisis	0
Actelion Pharms. LTD v. Mylan Pharms. Inc.	0
Wuhan Healthgen Biotechnology Corp. v. Int’l Trade Comm’n	0
Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc.	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	0
Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. Ltd	0
Selected Developments in Biotechnology Law and the Biotechnology Industry	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 I	0
Innovate, Evaluate, Legislate: U.S. Senators Forge a Path to Assess Artificial Intelligence’s Biosecurity Quandary	0
Research on Intellectual Property Right Protection of Genetic Resources in China Under Benefit-Sharing	0
Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC	0
In re Couvaras	0
HIPAA, HIPPA, or HIPPO: What Really Is the Heath Insurance Portability and Accountability Act?	0

Arbutus Biopharma Corp. v. ModernaTX, Inc. United States Court of Appeals of the Federal Circuit, 2023 65 F.4th 656	0
In re Xencor, 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
Pleading Use of Trade Secrets Concerning a Biological Product by Showing Product-Related Similarities: Allergan, Inc. v. Revance Therapeutics, Inc.	0
Galderma Lab’ys, L.P. v. Lupin Inc	0
Recent Developments at the Intersection of Pharma, Patents, and Antitrust Law	0