U.S. Biotechnology Patent Law, 2022 ed., authored by Director Jorge A. Goldstein, Ph.D., is now in its seventh edition.

U.S. Biotechnology Patent Law is a highly readable and well-organized desktop companion for practicing attorneys, and patent agents, seeking effortless entry into U.S. case law dealing with patents in modern biotechnology. Using the book’s descriptive subtitles, experienced or novice prosecutors, litigators, inside counsel or academicians can readily access any sub-area of the law, understand the legal background, and then find clear descriptions of the most important cases. The book’s focus is on biotechnology cases decided by the Court of Appeals for the Federal Circuit, its predecessor, the Court of Customs and Patent Appeals, the U.S. Supreme Court, and – when relevant – the U.S. Patent & Trademark Office Appeal Boards.

U.S. Biotechnology Patent Law features a contemporary format and feel, in both print and electronic formats. Each important biotech case is prominently highlighted and includes, in order:

  1. A summary and relevance of the holding;
  2. Separate patent claims (Since the holdings in patent law can only be understood in reference to the claims – Are they methods? Products? What are the exact words and limitations? – the author has separated the involved claims for immediate access.);
  3. Technology drawings or other facts needed for a clearer understanding; and
  4. Verbatim citations and quotes from the tribunal.

Throughout the publication, there are comments contained in shaded boxes, allowing the reader to easily distinguish the discussions in the cases from the opinions of the author. These comments include trends in the case law, critiques of outlier cases, and attempts to provide unifying themes to the historical and thematic development of the case law. Also included are diagrams that, at a glance, provide understanding of a body of case law, such as, for example, the development of a drug from early research to a time after approval by the FDA, or a summary of enablement and written description.

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