Biotechnology and the Federal Circuit, Second Edition, with 2013 Supplement

This treatise for patent prosecutors, litigators, and in-house counsel discusses major court decisions in chemical, biotechnology, and pharmaceutical cases within the context of the current law. It contains an incomparably thorough subject-matter index, a table of cases, a table of statutes and regulations cited, and text and footnote references updated to include extensive cross-references to major Federal Circuit cases.

Kenneth J. Burchfiel
Main Volume Author
Howard W. Levine
Supplement Author
Cora R. Holt
Supplement Author


Main Volume Information

Biotechnology and the Federal Circuit, Second Edition is the only reference work that provides an in-depth consideration of the entire body of Federal Circuit precedent in the rapidly developing area of biotechnology. This treatise integrates the court’s decisions in chemical, biotechnology and pharmaceutical cases with an analysis of the current law. Unique in its detailed discussion of precedent and critical analysis of jurisprudence, patent prosecutors, litigators and in-house counsel alike can count on this treatise for the guidance to navigate through the labyrinth of Federal Circuit biotechnology patent law.

The Second Edition offers full analysis and incisive, expert commentary on recent en banc Federal Circuit and Supreme Court decisions which have rewritten the law applied to biotechnology inventions and altered the basic legal principles governing patentability and infringement. It includes extensive revisions and updates to the original volume and supplements, and encompasses the most recent Federal Circuit precedent, including comprehensive analysis and discussion of:

  • KSR v. Teleflex, the Federal Circuit’s biotechnology and pharmaceutical decision applying the Supreme Court’s analysis of obviousness and motivation to combine prior art teachings, including the revived “obvious to try” standard
  • Abbott v. Sandoz, the Federal Circuit’s fundamental product-by-process decision and its implications for patentability and infringement of biotechnology process patents
  • In re Bilski, and its implications for patentability of biotechnology inventions involving quantitative analysis and processes involving the application of algorithms, including the Federal Circuit’s decision in Prometheus v. Mayo
  • Written description and the evolution of the requirement leading to the court’s en banc decision in Ariad v. Eli Lilly (including its application in In re Wallach), Capon v. Eshhar, University of Rochester v. Searle, Invitrogen v. Clontech, Carnegie Mellon. v. Hoffman-La Roche, and In re Alonso, as well as the revised 2008 USPTO Guidelines and training materials
  • Utility and the court’s “practical utility” standard for patentability, including its decisions in In re Fischer, Rasmusson v. SKB, and In re ’318 Patent Litigation
  • The Hatch-Waxman Act and Supreme Court and Federal Circuit precedent concerning the safe harbor for medical and pharmaceutical research, including Merck v. Integra, and a Federal Circuit precedent governing generic pharmaceutical infringement litigation under §271(e)(2)
  • Patent term and term extension, including USPTO delays under §154 and FDA regulatory delays under §156, and their interrelationship under the 20-year patent term
  • Infringement and the various standards of claim construction approved in Phillips v. AWH, as well as the application in subsequent biotechnology and pharmaceutical infringement decisions, including Amgen v. Hoechst

Biotechnology and the Federal Circuit, Second Edition also contains incomparable research aids, including the most thorough subject-matter index available; a completely revised table of cases, and a table of statutes and regulations cited; and text and footnote references updated to include extensive cross-references to recent Federal Circuit cases.

Supplement Information

The 2013 Supplement  encompasses full analysis of recent Supreme Court and Federal Circuit decisions. It addresses the metes and bounds of patent-eligible subject matter, including:

  • Bilski, Mayo v. Prometheus and Myriad
  • The often misunderstood doctrine of obviousness-type double patenting
  • The utility requirement under 35 U.S.C. §101 and the amount of experimental data needed before filing a patent application
  • The evolution of the law of written description, including Centocor v. Abbott, Boston Scientific v. Johnson & Johnson and Novozymes v. DuPont

The 2013 Supplement also:

  • Examines the “lead compound” analysis for determining structural obviousness as a way to avoid using impermissible hindsight
  • Reviews the Federal Circuit’s treatment of secondary considerations, and the proper framework and relevant burdens for making an obviousness determination
  • Addresses the Federal Circuit’s en banc decision in Akamai
  • Discusses the Supreme Court’s Caraco decision, permitting the filing of a counterclaim to correct improper use codes in Hatch-Waxman litigation
  • Considers recent Federal Circuit decisions in Classen v. Biogen and Momenta v. Amphastar


Bloomberg BNA authors and editors are practicing professionals with insider perspectives and real-life experience. Learn more about this book’s authors and editors.
Kenneth J. Burchfiel is a partner in Sughrue Mion, PLLC, Washington, D.C.

Howard W. Levine is a partner with Finnegan, Henderson, Farabow, Garrett & Dunner, LLP in Washington, D.C.

Cora R. Holt is an associate with Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, in Washington, D.C.


View full tables of contents and read the book’s preface or introduction.