PLI PLUS offers unlimited electronic access to more than 4,500 downloadable, searchable, and editable legal forms ready for use in your practice. To showcase this unique content type, we’ve selected one form per month and made it available for anyone to download for free – no subscription required.
Patent Litigation (Third Edition) enhances every patent litigator’s ability to prevail at trial while helping to cut the costs and complexity of litigation. Written by leading patent litigators, the treatise provides guidance on various infringement actions and their respective burdens of proof. It also offers pointers on conducting comprehensive pre-suit investigations; developing potent case themes; assembling strong litigation teams; developing smart litigation budgets; maximizing the persuasive impact of documents, exhibits, and witnesses; and making savvy use of computers, jury consultants, and litigation support vendors.
The new release covers many important developments, such as:
Corporate disclosures under Rule 7.1 and the hotly debated issue of whether recent court-imposed disclosure requirements are justified or permissible (see new section 3:7).
Two cases from district courts on the standard for assessing communications between the buyer and seller and licensor/licensee of patent rights made before the transactions closed (see section 5:4.2).
Case law from the federal circuit regarding an overly broad injunctive relief in the design patent context (see section 10:5.1).
Case law involving Moderna’s COVID-19 vaccine and Moderna’s claim that it is shielded from an infringement lawsuit in district court because of its agreement to supply the vaccine to the federal government (see section 14:2.2).
The PTAB’s clarification on its guidance for discretionary denial of IPR due to the advanced state of a parallel proceeding under Fintiv and the implications for the global defense strategy of respondents in ITC proceedings (see sections 14:4.9 and 15:3).
Circulation judge pool review, the PTO’s new internal procedure designed to improve overall quality of PTAB final written decisions (see new section 15:8.3).
The Circular 230 Deskbook is an essential compliance resource for every tax professional who practices before the IRS. It helps practitioners comply with complex Circular 230 amendments more easily — and avoid costly penalties and sanctions. In addition to demonstrating prescribed duties when advising clients in the preparation of tax returns, it offers quick-reference compliance tools.
This release updates the treatise with the latest developments in tax and estate law relating to IRS Circular 230. Highlights from the new release include:
Chapter 1, Section 1:2: Discussion of West Virginia v. EPA, in which the Supreme Court addressed whether, in the context of a major question, an agency is permitted to invoke general statutory authority in support of a regulation absent a clear statement from Congress.
Chapter 3, Section 3:5: Explains whether a notice designating a transaction as a Listed Transaction is a legislative rule that requires notice and comment under the Administrative Procedure Act.
Chapter 4, Section 4:17.2: Explores the Supreme Court’s holding in National Federation of Independent Business v. Department of Labor, Occupational Safety and Health Administration, about whether a vaccine mandate imposed by OSHA implicated the major-questions doctrine.
A trusted working tool for more than two decades, Faber on Mechanics of Patent Claim Drafting spotlights proven claim drafting practices and techniques that have been firmly established by patent authorities and custom. The treatise provides full coverage of U.S. Supreme Court and other court decisions critical to claim drafting. This time-saving handbook offers start-to-finish directions for and real-world examples of each type of claim and numerous tips on how to avoid common claim drafting mistakes.
The many revisions throughout this release continue to assist practitioners in drafting the most effective types of claims for each type of invention. Highlights of the new release include:
Updated Chapter 2 explains how a patent claim may be novel but still obvious thereby invalidating the claim (see section 2:7.1) and provides additional instruction on how to determine whether a claim is dependent or independent from a previous claim (see section 2:9).
Expanded § 3:9 offers suggested language to include in the patent application or claim of a machine or apparatus if seeking both a U.S. patent and patent protection abroad.
Revised § 5:5 provides additional details on how the effective filing date of a claim in a continuation-in-part application is determined.
Updated §6:2 expounds on what constitutes Markush expressions.
Expanded § 8:3 details how a terminal disclaimer prevents a second patent application by one patentee from being deemed an impermissible double patenting of a previous claim.
In addition, Appendices A, B, and C2 have been updated.
Stocker on Drawing Wills and Trusts has been a staple in the library of attorneys and estate planners for more than 50 years, enhanced by hundreds of labor-saving sample forms and clauses. It provides high-quality, comprehensive, field-tested drafting guidance that ensures wills, trusts, and other estate planning documents fully express clients’ wishes without provoking costly legal challenges.
Highlights of the new release include:
Revised § 2:2.2 discusses a New York case addressing whether assets acquired by a testator’s estate after the death of the testator should be distributed pursuant to the terms of a will or by the laws of intestacy.
Updated Chapter 5 includes updated numbers regarding transfer tax rates; federal and state estate tax top rates; and gift, estate, and GST tax exemptions.
Expanded § 10:4.3 gives an update on proposed regulations in connection with the SECURE Act regarding required minimum distributions.
New § 16:3.4 explains that attorneys should be mindful of their obligations to safeguard client data. For example, in New York State attorneys have an obligation to take reasonable care to protect clients’ confidential information with respect to data stored on attorneys’ electronic devices.
In addition, numbers indexed for inflation have been added throughout the text and the Index has been updated.
On a related note, check out this timely PLI Chronicle article on the new reporting obligations for trusts in Canada.
PLI PLUS offers unlimited electronic access to more than 4,500 downloadable, searchable, and editable legal forms ready for use in your practice. To showcase this unique content type, we’ve selected one form per month and made it available for anyone to download for free – no subscription required.
FDA Deskbook: A Compliance and Enforcement Guide provides a comprehensive description of the complexities of compliance under the FDC Act and practical suggestions on how FDA-regulated entities can avoid being the subject of an enforcement action by the federal government. The book proposes best practice tips, including how to deal with FDA inspections, alternatives to conducting internal investigations, and potential defense strategies for use in enforcement proceedings.
Highlights of the new release include:
Other Authorities Governing FDA-Regulated Entities: Reviews the CMS authority, granted under the Inflation Reduction Act of 2022, to negotiate the selling price of a select number of high expenditure single-source Medicare Part B and Part D drugs and biologics (see section 4:5.3[E]).
Over-the-Counter Drugs: Outlines the June 2022 FDA-issued proposed rule addressing “Additional Conditions of Nonprescription Use” (ACNU) and several new concepts and requirements for this category of Rx-to-OTC drug (see section 5:5.6).
Controlled Substances: Coverage of the U.S. Supreme Court decision imposing a new requirement necessary to prove a criminal violation for prescribing controlled substances (see section 17:4.1), and a review of DEA enforcement actions, including for failure to maintain complete and accurate records (see section 17:4.2); dispensing for a non-legitimate purpose (see section 17:4.3); failure to report suspicious orders (see section 17:4.4); National Prescription Opioid Litigation (see section 17:4.5); and state prescription opioid litigation (see section 17:4.6).
Health Care Fraud and Abuse Laws: Reviews OIG guidance on patient assistance programs (see section 19:4.1[C][1]).
International Corporate Practice provides guidance on building a comprehensive global legal department, including advice on structuring, staffing, and budgeting, as well as the use of foreign legal consultants and outsourcing. It also includes helpful case studies, checklists, and sample documents.
This release features new material designed to enable lawyers, whether in-house or outside counsel, to operate efficiently on the global stage.
Topics discussed include the following:
Global Law Department Management: New data on the number of CLOs that report directly to the CEOs of global companies (see § 1:3.1).
International Attorney-Client Privilege: Updated sections discuss the privilege in Australia (§ 2:2.2), Austria (§ 2:2.3), and Switzerland (§ 2:2.28).
Crisis Management: Chapter 8 now considers the scenario in which war and/or invasion occurs in a country where the company has employees, offices, and facilities (see § 8:2 and § 8:8.3).
Litigation Management and Discovery: Chapter 10 now describes two September 2022 decisions by the Southern District of New York which apply the factors set forth in Iragori v. United Technologies Corp. when ruling on defendants’ motions to dismiss on forum non conveniens grounds (see § 10:5.1[C]).
Mergers and Acquisitions: Revisions to Chapter 17 identify the drivers behind cross-border M&A and discuss the advantages that cross-border M&A have over domestic M&A (see § 17:4.1). A new section discusses diligence issues in international M&A (see § 17:5.4).
Export Control Laws:Chapter 25 contains updated appendices which provide revised provisions of U.S. export control and sanctions laws (App. 25A) and expanded guidance on the steps to take in implementing an export compliance program (App. 25B).
This book is a starting point for those seeking a deeper understanding of the IoT’s role within the law. After providing a detailed explanation of the IoT and examining its current regulatory framework, the book discusses the current and potential impact of the IoT on privacy, security, contracts, IP, consumer protection litigation, civil discovery, and criminal law and procedure. The book concludes with a chapter on international approaches to the regulation of IoT.
Some of the recent developments reflected in this new edition include:
IoT Cybersecurity Improvement Act of 2020: Discussion of one of the few laws enacted thus far directly aimed at regulating the IoT (see section 2:2.10).
New Oregon IoT security law: Analysis of the language of Oregon’s IoT security law, specifically as it relates to what constitutes “reasonable security features” (see section 4:4.4[C][3]).
Right to Repair legislation: A new section considers the passage by thirty-four states of “right to repair” legislation. It describes what the legislation requires manufacturers to do and lists the scope of consumer protection it provides (see section 6:3.1[B]).
Fourth Amendment rights: Added commentary highlights the Ninth Circuit’s recent holding on whether the government’s data preservation request violates the Fourth Amendment (see section 9:4.4).
Global privacy and security: Updates on recent developments in Japan, Brazil, Canada, and the European Union, including reporting that courts in Austria, France, and Italy have recently ruled on whether the use of Google Analytics is legal and illuminating what those rulings will mean for Google going forward (see section 10:2.2).
Stocked with drafting checklists and sample drafting language, documents, and drawings, How to Write a Patent Application (3rd Edition) is a hands-on resource that equips readers to claim an invention with the sufficient breadth and required elements necessary for its validity to be sustained by courts. The book analyzes the latest USPTO initiatives, and key decisions of the federal courts, and provides the author’s practical suggestions and commentary.
Key updates in the new release include:
Grounds for Requesting Expedited Examination: Added discussion of The Climate Change Mitigation Pilot program and how it impacts the examination of nonprovisional utility patent applications involving technologies that mitigate climate change by reducing greenhouse gas emissions (see section 2:9.2).
Electronic Filing Document Format: Updated information about the PTO’s new format requirement for electronic filings (see section 3:5).
Identifying the Inventor or Inventors: Elucidation of whether artificial intelligence systems qualify as inventors (see section 4:3).
Abstract and Nonabstract ideas: Additional examples of both (see sections 7:4.1[B] and [C]).
Statutory Requirements for Claims: Discussion of recent Federal Circuit cases related to the terms “resilient” and “pliable” and terms susceptible to more than one meaning (see section 8:2.1).
Patentable Designs: News and statistics related to acquiring, defending, and enforcing design patents (see section 11:1.1).
Written Description Requirement: Commentary on the high level of disclosure being required by the Federal Circuit to satisfy the written description requirement and the “troublesome” opinion in Biogen Int’l GmbH v. Mylan Pharm. Inc. (see section 17:4.2). For additional related discussion about the written description requirement, read also the recent PLI Chronicle article “Patent Antibody Case Law Continues to Mature.”