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A Review of Patent Regimes on Health Biotechnology Innovation in India Biotechnol. Law Rep. (IF 0.2) Pub Date : 2023-02-03 By AZAMAT ALI, KUNAL SINHA
Patents can significantly contribute to technical advancement and improved economic performance. Patents can be used to protect both innovations and scientific research produced by businesses and research institutions. There is a close relationship among contemporary developments in patent systems, the economy, and technical innovation processes. New waves of innovation have been created by scientific
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Observation on the R&D Effectiveness and Application of China's Novel Coronavirus Vaccine Biotechnol. Law Rep. (IF 0.2) Pub Date : 2023-02-03 By Xiang Yu, Na Li, Hui Wang
The outbreak of the coronavirus disease (COVID-19) had put vaccine research and development (R&D) on the urgent agenda. China had taken a diversified route in vaccine research and development. It had taken an approach of first producing inactivated vaccines and then tackling mRNA vaccines, and had achieved varying degrees of progress. At present, the scale of production and the number of vaccines in
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Research on the Latest Progress of “Mechanism for Early Resolution of Patent Disputes” for Biological Products in China Biotechnol. Law Rep. (IF 0.2) Pub Date : 2022-12-15 By Wang Xiaofen, Han Weiwei
As biologic drugs are gaining attention worldwide, the biopharmaceutical industry in China has developed rapidly in recent years. The People's Republic of China (PRC) dispute resolution mechanism for drug patents covers chemical drugs, biological products, and traditional Chinese medicines (TCMs). This article delves into the early resolution mechanism for patent disputes of biological products, in
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Patentability Analysis of “Intelligent” Disease Diagnosis Methods in China in the Era of Smart Health Care Biotechnol. Law Rep. (IF 0.2) Pub Date : 2022-12-15 By Shuren Tao, Yichao Chen, Chen Jiajv, Li Wei
In the era of smart health care, artificial intelligence technology has penetrated the medical field, resulting in a number of new inventions with “disease diagnosis methods” as their content and “artificial intelligence algorithm” as their method. These new inventions represent “intelligent” disease diagnosis. In China, patent applications for such inventions have been published and even been granted
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How a Dosage Regimen Patent for RRMS Treatment May Satisfy the Written Description Requirement—A Lesson from Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. Biotechnol. Law Rep. (IF 0.2) Pub Date : 2022-10-11 By PING-HSUN CHEN
This article discusses how a treatment claim with a dosage regimen limitation may meet the written description requirement under Novartis I, 21 F.4th 1362 (Fed. Cir. 2022), and Novartis II, No. 2021-1070, 2022 WL 2204163 (Fed. Cir. June 21, 2022). The disputed phrase in Novartis was “at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.” Though, the daily dosage limitation
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Generic Drugs and Innovative Drug Incentives: Early Dispute Resolution Mechanism in China Biotechnol. Law Rep. (IF 0.2) Pub Date : 2022-08-05 By Li Jiang, Hong Yang
The early dispute resolution mechanism created a new foundation for pharmaceutical innovation and expanding access to generics in China. This article examines the evolution of pharmaceutical regulation, explores the structure of early dispute resolution provisions, and analyzes the implications for generics and innovators through a comparative approach. It concludes that the early dispute resolution
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Patents Cannot Be Blamed for Inequitable Access to COVID-19 Vaccines Biotechnol. Law Rep. (IF 0.2) Pub Date : 2022-04-12 By Raildo Duarte, Hasan Irfan Khan, Alejandro Luna, Ramadan Amin, Charul Yadav, Ulrich Storz
In view of the inequitable distribution of COVID-19 vaccines, several initiatives have been discussed to waive respective patent rights. This article provides a fact-based multinational study on patent rights protecting BioNTech-Pfizer's vaccine BNT162b2. We conclude that although there actually is a vaccine shortage in many countries, patents cannot be blamed as the scapegoat for said situation.
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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. Biotechnol. Law Rep. (IF 0.2) Pub Date : 2022-04-12 By Ping-Hsun Chen
Pharmacokinetics (PK) data acquired during clinical trials can provide a way to claim a pharmaceutical compound, composition, or medical treatment. While reciting a PK profile is a common practice in claim drafting, the Federal Circuit in Horizon Pharma, Inc. v. Dr. Reddy's Laboratories Inc., 839 F. App'x 500 (Fed. Cir. 2021), has taught that a phrase starting with a dose form followed by a verb “target”
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Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part II Biotechnol. Law Rep. (IF 0.2) Pub Date : 2022-04-01 Christopher M. Holman
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Novartis Pharms. Corp. v. Accord Healthcare, Inc. Biotechnol. Law Rep. (IF 0.2) Pub Date : 2022-04-01 Christopher M. Holman
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Selected Developments in Biotechnology Law and the Biotechnology Industry Biotechnol. Law Rep. (IF 0.2) Pub Date : 2022-04-01 Steven J. Zweig
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AstraZeneca AB v. Mylan Pharms. Inc. Biotechnol. Law Rep. (IF 0.2) Pub Date : 2022-04-01 Christopher M. Holman
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AI (Re)Defining Pharmaceutical Exclusivities Biotechnol. Law Rep. (IF 0.2) Pub Date : 2022-02-01 Jonathan Kimball,Srividhya Ragavan
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The Drawing-Up of Laws on Research Involving Human Embryos in Australia: Lack of an Islamic Voice Biotechnol. Law Rep. (IF 0.2) Pub Date : 2022-02-01 Maryam Hashimi,Patrick Foong
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ModernaTx, Inc. v. Arbutus Biopharma Corp. Biotechnol. Law Rep. (IF 0.2) Pub Date : 2022-02-01 Christopher M. Holman
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ModernaTx, Inc. v. Arbutus Biopharma Corp. Biotechnol. Law Rep. (IF 0.2) Pub Date : 2022-02-01 Christopher M. Holman
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Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part I Biotechnol. Law Rep. (IF 0.2) Pub Date : 2022-02-01 Christopher M. Holman
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Selected Developments in Biotechnology Law and the Biotechnology Industry Biotechnol. Law Rep. (IF 0.2) Pub Date : 2022-02-01 Steven J. Zweig
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14-Day Limit of Human Embryo Research: Moral Issues in the Patent Law in China Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-12-13 By Li Jiang
Conflicting decisions are made regarding the patentability of inventions related to human embryonic stem cells (hESC) in China based on divergent ethical judgments and arguments. Gaps between patent and health law exist, and inconsistent applications of patentability emerge. The amendment to China's Patent Examination Guidelines regulated that isolating or obtaining stem cells using human embryos which
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In Juno v. Kite the Federal Circuit Strikes Down Patent Directed Towards Pioneering Innovation in CAR T-Cell Therapy Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-12-01 Christopher M. Holman
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An Innovation Principle in Gene Technology Law? Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-12-01 Tade Matthias Spranger
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Selected Developments in Biotechnology Law and the Biotechnology Industry Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-12-01 Steven J. Zweig
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Legal and Ethical Challenges in the Construction of China's Biobanks Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-10-12 By Jiajv Chen, Jiayu Huang, Xuekai Xie
China has no special legislation on biobanks, and it regulates these banks by several different laws and regulations. In the past 15 years, China's biobanks have collected a large number of biological samples. The law gives many institutions the right to store and use biological samples; however, due to the absence of government regulation, lack of ethical norms, and unclear legal provisions, the risks
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Observation on the Admission Situation of the Anti-Coronavirus Drug “Remdesivir” in China Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-10-12 By Na Li, Xiang Yu
A novel coronavirus pneumonia broke out in early 2020 in China. In order to find a certain cure, China has turned its attention to Remdesivir, which is produced by Gilead. At the initial stage, China placed high expectations on this drug, and urgently approved phase III clinical trial applications. As the epidemic in China slowed, the development of Remdesivir clinical trials also encountered the problem
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Minerva Surgical, Inc. v. Hologic, Inc. Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-10-01 Christopher M. Holman
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Bio-Rad Lab'ys, Inc. v. Int'l Trade Comm'n Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-10-01 Christopher M. Holman
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Janssen Ortho, LLC v. United States Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-10-01 Christopher M. Holman
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Supplementary Protection Certificates in Europe: Clarity at Last? Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-10-01 Jules Fabre,Sarah Taylor
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Selected Developments in Biotechnology Law and the Biotechnology Industry Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-10-01 Steven J. Zweig
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In Minerva v. Hologic, the U.S. Supreme Court Reins in the Equitable Doctrine of Assignor Estoppel Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-10-01 Christopher M. Holman
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Japanese CRISPR Patent and Biotech Developments in the Early Reiwa Era Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-08-02 John A. Tessensohn By
On February 25, 2020, in the second year of the Reiwa era, the Intellectual Property High Court of Japan (IPHCJ) issued two appellate decisions relating to the groundbreaking, Nobel Prize–winning, genome-editing technology, CRISPR. This article will outline the IPHCJ decisions' interpretative scope of the Japanese patent law novelty bar (secret prior art) where an earlier-filed, but subsequently published
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Review of the UK's R&D Tax Reliefs—A Good News Story for the UK's Life Sciences Sector? Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-08-01 Penny Simmons
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In re Huping Hu: Quantum Entanglement, Medical Innovation, and Patentability on the Scientific “Fringe” Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-08-01 Christopher M. Holman
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Selected Developments in Biotechnology Law and the Biotechnology Industry Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-08-01 Steven J. Zweig
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The EPO Guidelines They Are a-Changin’ Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-06-01 DR. Benjamin Quest,DR. Markus Grammel
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Selected Developments in Biotechnology Law and the Biotechnology Industry Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-06-01 Steven J. Zweig
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The Federal Circuit Continues to Grapple with the Question of Patent Eligibility for Diagnostic Methods Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-06-01 Christopher M. Holman
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Introduction on Biosafety Law of the People's Republic of China and Linkage Thereof with International and Domestic Regulations Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-03-30 By Weiwei Han
Biosafety and technology innovation have been drawing wide attention in the biological and medical fields. With the dramatic development of biotechnology and improved cooperation worldwide, the balance and co-development of biosafety and technology innovation will be influential on human beings and nature. The Chinese Biosafety Law, which will come into effect in the near future, relates to multiple
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The Compulsory Licensing for Exploiting Patented COVID-19 Pharmaceutical Treatment: Legal Approaches of Some Arab Countries Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-03-30 By Tariq Kameel, Ramzi Madi, Kawthar Kayed
This article deals with exploitation of a pharmaceutical patent to treat the novel coronavirus. The laws of several Arab nations, which regulate industrial property rights in regard to the use of compulsory licensing for exploiting patented COVID-19 pharmaceutical treatments, are examined, compared, and contrasted. The cases in which such laws permit use of compulsory licensing are clarified, such
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Selected Developments in Biotechnology Law and the Biotechnology Industry Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-04-01 Steven J. Zweig
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Branded Drug Companies Are Successfully Asserting the Doctrine of Equivalents in Hatch-Waxman Litigation Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-04-01 Christopher M. Holman
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Pharmaceutical Patent Term Compensation System in China—Centered on Article 42(3) of the Amendment to the Patent Law of the People's Republic of China Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-02-01 Peng Feirong,Luo Ningning
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Government Involvement in Pharmaceutical Development Can Come Back to Haunt a Drug Company Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-02-01 Christopher M. Holman
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Legislative Moves on Biosecurity in China Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-02-01 Shihui Qiu,Ming Hu
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Selected Developments in Biotechnology Law and the Biotechnology Industry Biotechnol. Law Rep. (IF 0.2) Pub Date : 2021-02-01 Steven J. Zweig
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Incorrect Translation Causing a Claim to Be Indefinite Under 35 U.S.C. § 112—A Case Study of IBSA Institut Biochimique, S.A. v. Teva Pharmaceuticals USA, Inc. Biotechnol. Law Rep. (IF 0.2) Pub Date : 2020-12-02 By Ping-Hsun Chen
IBSA Institut Biochimique, S.A. v. Teva Pharmaceuticals USA, Inc., 966 F.3d 1374 (Fed. Cir. 2020), shows a case of inaccurate translation leading the court to find the asserted claims invalid. The disputed term “half-liquid” was found unclear in terms of whether pastes and gels should fall within or be excluded from the patentee's construction of “half-liquid.” This article examines the IBSA case and
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GlaxoSmithKline v. Teva: Holding a Generic Liable for an Artificial Act of Inducement Biotechnol. Law Rep. (IF 0.2) Pub Date : 2020-12-01 Christopher M. Holman
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Selected Developments in Biotechnology Law and the Biotechnology Industry Biotechnol. Law Rep. (IF 0.2) Pub Date : 2020-12-01 Steven J. Zweig
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Amendment of China's Biotechnology Laws in Relation to the Prevention and Containment of the COVID-19 Pandemic Biotechnol. Law Rep. (IF 0.2) Pub Date : 2020-12-01 Zi Zhengfa,Wu Wanqiang
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Interrelationship Between Genetic Resources and Traditional Knowledge: An Example from Earthworm Fibrinolytic Enzyme Biotechnol. Law Rep. (IF 0.2) Pub Date : 2020-12-01 Yi-Chia Ke, Jiun-Hong Chen
The interrelationship between genetic resources and traditional knowledge under the Convention on Biological Diversity (CBD) has seldom been discussed. However, this interrelationship affects the a...
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State Universities Push the Limits of Eleventh Amendment Sovereign Immunity at the Federal Circuit Biotechnol. Law Rep. (IF 0.2) Pub Date : 2020-10-01 Christopher M. Holman
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Selected Developments in Biotechnology Law and the Biotechnology Industry Biotechnol. Law Rep. (IF 0.2) Pub Date : 2020-10-01 Steven J. Zweig
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Regulation of Artificial Intelligence in Drug Discovery and Health Care Biotechnol. Law Rep. (IF 0.2) Pub Date : 2020-10-01 Kavita Sharma,Padmavati Manchikanti
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CJEU Installs Another Hurdle for SPCs on Functionally Defined Products and Ends Second Medical Use SPCs Biotechnol. Law Rep. (IF 0.2) Pub Date : 2020-10-01 Franz-Josef Zimmer,Benjamin Quest
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UK Biotech Corporate Finance Trends Post COVID-19 Biotechnol. Law Rep. (IF 0.2) Pub Date : 2020-10-01 Sunjay Malhotra,Julian Stanier
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Exclusions from Patentability with an Emphasis on Biotechnological Inventions: A Comparative Study Biotechnol. Law Rep. (IF 0.2) Pub Date : 2020-08-17 By Ramzi Madi, Majed Abu Saleh, Kawthar Kayed
Through a comparative legal study among United Arab Emirates, Jordan, Egypt, and Syria, in addition to a review of certain international agreements, this article addresses exclusions in inventions. These exclusions are divided into two parts: the traditional exclusions, which cover all types of inventions regardless of their topic, such as discoveries, scientific theories, and mathematical methods;
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Selected Developments in Biotechnology Law and the Biotechnology Industry Biotechnol. Law Rep. (IF 0.2) Pub Date : 2020-08-01 Steven J. Zweig
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Patent Term Adjustment: Recent Developments at the Federal Circuit and PTO Biotechnol. Law Rep. (IF 0.2) Pub Date : 2020-08-01 Christopher M. Holman
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Reflections on the Pharmaceutical Patent Protection in China Biotechnol. Law Rep. (IF 0.2) Pub Date : 2020-08-01 Xuanyu Zheng
In recent years, China has paid much more attention to its pharmaceutical policy than ever, and forecasting policy on pharmaceutical patent protection has become a public concern in China. This art...
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Willowood v. Syngenta Petition for Certiorari Asks Supreme Court to Weigh in on Copyright Protection for Generic Pesticide Labeling Biotechnol. Law Rep. (IF 0.2) Pub Date : 2020-06-01 Christopher M. Holman