Click to Enlarge

Intellectual Property in Molecular Medicine

Book Series:  A Cold Spring Harbor Perspectives in Medicine Collection
Subject Area(s):  BiotechnologyBiology in Society

Edited by Salim Mamajiwalla, In(sci)te IP Inc.; Rochelle Seide, RKS Consulting

Download a Free Excerpt from Intellectual Property in Molecular Medicine:

Preface and Contents

© 2015 • 304 pages, illustrated (17 color, 1 B&W), index
Hardcover •
ISBN  978-1-621820-83-3

Buy the print book on Amazon.

Some of our books are temporarily unavailable to order in print format directly from CSHL Press. In the meantime we invite you to order these titles on Amazon. Please contact us with any questions.

  •     Description    
  •     Contents    
  •     Related Titles    


Patents are an important way of protecting inventions in the pharmaceutical and biotechnology industries. However, intellectual property law reforms have not kept pace with the rapid advances in genomics, synthetic biology, and stem cell research. Meanwhile, universities are increasingly spinning off companies that use these technologies, requiring the academic scientists involved to gain an understanding of intellectual property law and the patent system as it applies to biomedical innovations.

This collection from Cold Spring Harbor Perspectives in Medicine aims to provide a clear, current, and comprehensive understanding of biomedical intellectual property and the laws that protect it. The contributors describe patent laws and practices in the United States, Canada, Australia, and the European Union. They explain the roles of regulatory agencies in intellectual property, various opinions on the patentability of biological materials (e.g., DNA and stem cells), and the implications of recent court decisions (e.g., the Myriad case). Practical issues related to licensing agreements and patent applications are also discussed. The authors offer guidance on the criteria for patent eligibility (e.g., utility, nonobviousness, and novelty), issues related to timing and possession, and rules for determining inventorship.

Other topics include trade secrets, research exemptions, and the protection of traditional knowledge related to biological resources. This volume will serve as an essential reference for all scientists, physicians, and technology transfer professionals seeking to navigate the complex rules, regulations, and procedures concerning intellectual property in biotech and pharma.


Introduction to Intellectual Property: A U.S. Perspective
Amanda Murphy, Michael Stramiello, Stacy Lewis, and Tom Irving
Impact of America Invents Act on Biotech Intellectual Property
Amanda Murphy, Michael Stramiello, Jonathan Stroud, Stacy Lewis, and Tom Irving
Patenting the Life Sciences at the European Patent Office
Christina Gates
The Role of Regulatory Agencies and Intellectual Property: Part I
Kevin E. Noonan
The Role of Regulatory Agencies and Intellectual Property: Part II
Kevin E. Noonan
Canada’s Patented Medicines (Notice of Compliance) Proceedings and Intellectual Property
Henry Bian and Conor McCourt
Inventorship and Authorship
Antoinette F. Konski and Linda X. Wu
Must an Inventor “Possess” an Invention to Patent It?
Warren D. Woessner and Robin A. Chadwick
What is Your Reasonable Expectation of Success in Obtaining Pharmaceutical or Biotechnology Patents Having Nonobvious Claimed Inventions That the Courts Will Uphold? An Overview of Obviousness Court Decisions
Daniel J. Pereira and Stephen G. Kunin
Inherent Anticipation in the Pharmaceutical and Biotechnology Industries
Michael Goldman, Georgia Evans, and Andrew Zappia
Baseball Bats and Chocolate Chip Cookies: The Judicial Treatment of DNA in the Myriad Genetics Litigation
Ian Binnie and Vanessa Park-Thompson
Patentability of Genes: A European Union Perspective
Paul Cole
Decoding Gene Patents in Australia
Adam Denley and James Cherry
The Impact of Myriad and Mayo: Will Advancements in the Biological Sciences Be Spurred or Disincentivized? (Or Was Biotech Patenting Not Complicated Enough?)
Jennifer Gordon
The Impact of Myriad on the Future Development and Commercialization of DNA-Based Therapies and Diagnostics
Michele Wales and Eddie Cartier
Research Use Exemptions to Patent Infringement for Drug Discovery and Development in the United States
Alicia A. Russo and Jason Johnson
Research Exemption/Experimental Use in the European Union: Patents Do Not Block the Progress of Science
Hans-Rainer Jaenichen and Johann Pitz
Patentability of Stem Cells in the United States
Sarah E. Fendrick and Donald L. Zuhn, Jr.
Patenting Stem Cell Technologies in Europe
Andrew Sheard
The Patentability of Stem Cells in Australia
Jenny Petering and Prue Cowin
Patentability of Self-Replicating Technologies
Richard H. Shear
Protecting Traditional Knowledge Related to Biological Resources: Is Scientific Research Going to Become More Bureaucratized?
Prashant Reddy and Malathi Lakshmikumaran
Licensing Biotech Intellectual Property in University – Industry Partnerships
Vladimir Drozdoff and Daryl Fairbairn
Trade Secrets in Life Science and Pharmaceutical Companies
Tara Nealey, Ronald M. Daignault, and Yu Cai
Protecting Trade Secrets in Canada
Noel Courage and Janice Calzavara

Related Titles

You may be interested in these related titles:

Connecting with Companies: A Guide to Consulting Agreements for Biomedical Scientists
$39 $31.20