Category Archives: Life Sciences

New Edition! Pharmaceutical and Biotech Patent Law (2023)

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PLI Press is proud to announce the publication of the new edition of Pharmaceutical and Biotech Patent Law.

This book provides the legal, scientific, and technical information needed to help clients obtain, defend, and challenge patents in these important business areas. It shows readers how to craft problem-free patent applications and includes detailed checklists that help resolve tricky patent issues in the complex pharmaceutical and biotech fields. It is regularly updated to reflect Federal Circuit rulings and other significant court decisions.

Some of the recent developments reflected in this new edition include:

  • Inter Partes Review: Coverage of the PTO guidance for discretionary denials which clarifies when institutions will not be denied under Fintiv (see Section 1:5.3).
  • Patentability of Stereoisomers and New Salts: Discussion of the Federal Circuit’s decision in Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp. regarding whether Mylan Pharmaceuticals had failed to show that the claims of U.S. Patent No. 7,326,708 were either anticipated or rendered obvious by the asserted prior art (see Sections 7:2.4[A][2] and 7:2.6[C][1]).
  • Cell and Gene Therapy Products: New chapter exploring the patent landscape for cell and gene therapy products and the current disputes related to these products (see Chapter 15).
  • ITC Litigation: New chapter providing recent trends and practice tips on ITC Litigation (see Chapter 16).

Order a print copy today.

PLI PLUS subscribers can access this title through their subscription.

Treatise Update – FDA Deskbook: A Compliance and Enforcement Guide

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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]).
  • FDA Inspections: New discussion covers the effect of the COVID-19 pandemic, and related emergency declarations, on FDA inspections, both domestically and internationally (see section 21:1.2). For related information on how the pandemic has impacted the drug approval process, read the PLI Chronicle article, Expediting the Drug Approval Process: Formulating Regulatory Responses to Critical Societal Health Issues While Preserving Scientific Standards.

Order a print copy today.

PLI PLUS subscribers can access this title through their subscription.