U.S. Biotechnology Patent Law


Book Description




ANDA Litigation


Book Description

Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation, this comprehensive guide focuses on current and developing law as well as litigation strategies and tactics. This ready roadmap begins with an explanation of the Hatch-Waxman Act, its implementation, and litigation. Other topics include preparing and trying the case, post-trial issues and appeals, remedies, settlement, antitrust implications, and litigation of pharmaceuticals outside the U.S.




Drafting Patents for Litigation and Licensing


Book Description

"This edition explains and emphasizes techniques that produce patents that may have broader interpretations and strengthened validity, which may have more impact in litigation and which may face less resistance by licensing targets"--




Patents as an Incentive for Innovation


Book Description

Patents as an Incentive for Innovation Edited by Rafal Sikorski & Zaneta Zemla-Pacud Patents are a reward for human inventiveness. A well-functioning patent system must provide incentives for innovation, safeguard dynamic competition and protect the public interest – a balancing act fraught with difficulty in the ‘connected’ global world. This ground-breaking book is the first to deeply analyse how patent law today performs its function of stimulating innovation in the crucial sectors of healthcare, agriculture, artificial intelligence and communications technology. Patent specialists, practitioners and scholars from various jurisdictions thoroughly describe how patent rights can be deployed to incentivize investments in researching and developing socially critical innovations without sacrificing the public’s interest in sharing the benefits that are produced. Among the emerging issues of patent rights investigated are the following: protectability and morality of according private rights over material derived from the human body; licensing on fair, reasonable and non-discriminatory (FRAND) terms; the supplementary protection certificate (SPC) manufacturing waiver; patent eligibility of artificial intelligence-related inventions; excessive enforcement of patents by patent assertion entities; enforcement of second medical use innovations; the so-called farmer’s privilege, the farm-save seed exemption, and breeders’ rights; international trade regulations and their influence on patent systems; human enhancement technologies and the consequences of patenting them; specifics of patent protection for biologic medicines; challenges posed by artificial intelligence for the disclosure requirement in patent law; and standard essential patent licensing, particularly in the context of the 5G standard. Perspectives taken into consideration by the authors include protectability criteria, length and scope of the granted protection, mechanisms for dealing with the friction between generalized application and specialized concerns, and rights enforcement. These aspects are analysed on the domestic, international and global levels. The COVID-19 pandemic has highlighted the urgent need to strike the right balance between innovation and access in healthcare and other technologies, a need rooted in patent law. Because the problems discussed – and solutions offered – in this collection of expert essays are of tremendous practical and cultural significance, the book will be of immeasurable value to practitioners, policymakers and researchers in patent law and other fields of intellectual property law.




Model Rules of Professional Conduct


Book Description

The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.




Patent Law


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Aspen Treatise for Patent Law


Book Description

Succinct and timely, the 7th Edition of the best-selling PATENT LAW continues to demystify its subject as it explores and explains important cases, statutes, and policy. Approachably written for law students, attorneys, inventors, and laypersons alike, this acclaimed text stands on its own or may be used alongside any patent or IP casebook to support more in-depth study of patent law. New to the 7th Edition: Supreme Court review of bedrock patentability requirements: o Amgen (the Court’s first examination of enablement in nearly 100 years) Supreme Court clarification of long-standing equitable doctrines in patent litigation: o Minerva (assignor estoppel is valid but limited to instances when assignor’s claim of invalidity contradicts representations made in assigning patent) Ongoing, intensive Supreme Court scrutiny of the America Invents Act (AIA), the most significant change to U.S. patent law in 70 years, including: Thryv (Federal Circuit lacks jurisdiction to review PTAB’s § 315(b) time-bar decisions) Arthrex (PTO Director review of PTAB final decisions remedies Constitutional violation in appointment of PTAB judges. The problematic landscape of patent-eligibility jurisprudence under § 101, including Federal Circuit decisions in: American Axle (methods of manufacturing) CareDx (diagnostic methods) Trinity Info Media, Adasa, Killian, Free Stream Media, Uniloc, Rudy (abstract ideas) The challenging application of the cornerstone non obviousness requirement to the burgeoning field of design patents, including the Federal Circuit’s first en banc consideration of a patent case in 5 years: LKQ ​Confronting new questions of novelty, priority, and prior art under the AIA, including Federal Circuit and PTAB decisions in: SNIPR Techs. (enumerating patentability and priority requirements for “pure pre-AIA,” “pure AIA,” and “mixed” patents and applications) Penumbra (when is a patent relied on as § 102(a)(2) prior art entitled to the earlier filing date of its related parent or provisional application) Fine-tuning the scope of AIA IPR estoppel to prevent petitioners from relitigating the same validity issues in federal court, including Federal Circuit decisions in: Cal. Inst. (interpreting “during the IPR”) Ironburg (“skilled searcher” standard) The limited role of extrinsic evidence in patent claim interpretation: Genuine Enabling (rejecting accused infringer’s expert testimony seeking to narrow claim scope via prosecution disclaimer) Allowing assertions of the equitable defense of prosecution history laches against unreasonable and inexcusable prosecution delays, despite compliance with statutory and regulatory requirements: Hyatt, Personalized Media How the European Union’s new Unitary Patent and Unified Patent Court (2023) are revolutionizing international patenting Professors and students will benefit from: Thorough coverage and clear writing that clarifies principal legal doctrines, key judicial authorities, governing statutes, and policy considerations for obtaining, enforcing, and challenging a U.S. patent In-depth treatment and comparison of pre- and post-America Invents Act regimes for novelty and prior art with numerous hypotheticals Timely statistics on patent trends Succinct analysis of multi-national patent protection regimes Helpful visual aids, such as figures, tables, and timelines A sample patent and breakdown of a prosecution history Boldfaced key terms and a convenient Glossary




Patent Litigation and Strategy


Book Description

This book sets out governing statutes and rules at the beginning of each chapter and includes sample litigation documents where possible. The casebook begins with discussions of who to sue, where to sue, pleading requirements, discovery, and trial strategy. It then moves into substantive legal issues. The Third Edition includes new material on pharmaceutical litigation under the Hatch-Waxman Act and the most developments in the law of invalidity and infringement. The book next addresses issues surrounding remedies, including injunctive relief (with a discussion of the Supreme Court's eBay decision), contempt proceedings, and damages. Also included are post-trial matters including jury instructions, special verdict forms, the preclusive effect of final judgments, judgment as a matter of law, and new trial motions. Finally, the book covers the appeal process and reexamination and reissue proceedings.




Introduction to Intellectual Property


Book Description

Introduction to Intellectual Property provides a clear, effective introduction to patents, copyright, trademarks, and trade secrets. The text may be used by students and instructors in formal courses, as well as those applying intellectual property considerations to entrepreneurship, marketing, law, computer science, engineering, design, or other fields. The luminaries involved with this project represent the forefront of knowledge and experience, and the material offers considerable examples and scenarios, as well as exercises and references.




Patent Law in Nutshell


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