New Reference from Wolters Kluwer Law & Business Provides Complete Coverage of BioPharma Patent Topics

(RIVERWOODS, ILL., April 21, 2008) – Professionals now have access to proven, practical insights that make it easy to navigate today’s most important biotechnology and pharmaceutical issues with Biotechnology and Pharmaceutical Patents: Law and Practice. This unique, one-stop resource from Wolters Kluwer Law & Business provides a step-by-step blueprint for handling complex BioPharma patent decisions. Wolters Kluwer Law & Business is a leading provider of research information and software solutions in key specialty areas for legal and business professionals.

“The only practice-focused reference in the field, Biotechnology and Pharmaceutical Patents approaches the topic from the perspective of problems faced by patent practitioners and patent decision makers on a daily basis,” said Sharon Kube, Wolters Kluwer Law & Business product manager. “This new resource helps professionals focus on the proper business solution and saves them time with research.”

Comprehensive Content, Practical Guidance

Biotechnology and Pharmaceutical Patents is a comprehensive, how-to guide for protecting BioPharma inventions. This practice-based resource applies the law in the context of BioPharma patents as business assets, helping professionals to maximize their value and ensure their protection.

The material is designed to be easily accessible and immediately applicable to any BioPharma patent issue a professional may be facing. Biotechnology and Pharmaceutical Patents is arranged topically so that users can go straight to a specific section to answer a particular question. And this practical resource provides specific strategies for protecting proprietary intellectual property, including patentable inventions, data exclusivity, trade secrets, know-how, databases, data collection and business plans.

Biotechnology and Pharmaceutical Patents delivers proven, clear answers to key critical questions such as:

  • How do we keep third parties from using screening targets before a patent issues?
  • How can we get adequate claim scope in a patent to protect specialized technology?
  • If we license a basic technology but we find out another company has been using the technology without a license, what should we do? What can we expect to recover if there is litigation and we win?
  • What can we do with patent families that relate to technology we no longer have any interest in pursuing?
  • What protection is available for a database of expressed proteins or corresponding genomic sequence information?
  • How can one protect a transgenic animal that is useful as a disease model in the U.S. and around the world?
  • Who should be the inventor on a patent application from a university lab?
  • What licensing terms are appropriate for a bacterial protein that is essential for the bacteria, and consequently is a good target for drug development?

Biotechnology and Pharmaceutical Patents clearly enumerates the requirements for a BioPharma patent application (e.g., compliance with the utility, enablement and written description requirements); addresses issues arising during prosecution of a patent application, including discovery of prior art and inequitable conduct pitfalls; and explains the regulatory and approval process for drugs and biologics, including Hatch-Waxman issues and regulatory exclusivities.

Only Biotechnology and Pharmaceutical Patents: Law and Practice enables professionals to:

  • Assess patentability or other proprietary protection related to genomics, proteomics and more;
  • Patent new functions of a previously identified gene product or derivative;
  • Determine the scope of patent protection and how it serves a business purpose; and
  • Accurately assess freedom to operate.

In addition, Biotechnology and Pharmaceutical Patents: Law and Practice comes with a bonus CD-ROM, containing more than 40 essential practice-proven forms that professionals can customize for their immediate needs.

About the Authors

Marc S. Gross, Of Counsel to Darby & Darby, has specialized in patent prosecution, counseling, licensing and litigation, primarily in the chemical arts, for over four decades. He has represented parties before the federal courts and the U.S. International Trade Commission in proceedings involving patent infringement issues. He has prepared and prosecuted hundreds of patent applications, both in the United States and abroad, and has also conducted intellectual property due diligence studies in connection with major corporate mergers and acquisitions. Gross lectures frequently on various chemical patent, patent litigation and intellectual property due diligence matters.

S. Peter Ludwig, a partner at Darby & Darby since 1976, has extensive experience in complex domestic and foreign patent prosecution and counseling issues, particularly in representing high-tech start-up companies. Ludwig’s technical expertise includes biotechnology, pharmaceuticals and other products and medical devices. His experience includes participation in all phases of intellectual property litigation, from discovery through trial.

Robert C. Sullivan, Jr. of Darby & Darby has more than 20 years of experience in patent prosecution, counseling, litigation and licensing, primarily in the fields of biotechnology, chemistry and pharmaceuticals. Sullivan specializes in complex U.S. patent prosecution; U.S. and international patent portfolio management; Hatch-Waxman counseling; freedom to operate studies; intellectual property due diligence investigations and licensing. He is also involved in all aspects of U.S. and multinational intellectual property litigation from pre-filing investigation and strategy through trial and appeal.

For More Information

For more information or to order Biotechnology and Pharmaceutical Patents: Law and Practice, call 800-638-8437, click here or visit This loose-leaf set is priced at $375.

About Wolters Kluwer Law & Business

Wolters Kluwer Law & Business is a leading provider of research products and software solutions in key specialty areas for legal and business professionals, as well as casebooks and study aids for law students. Its major product lines include Aspen Publishers, CCH, Kluwer Law International and Loislaw. Its markets include law firms, law schools, corporate counsel and professionals requiring legal and compliance information. Wolters Kluwer Law & Business, a unit of Wolters Kluwer, is based in New York City and Riverwoods, Ill.

Wolters Kluwer is a leading global information services and publishing company. The company provides products and services globally for professionals in the health, tax, accounting, corporate, financial services, legal, and regulatory sectors. Wolters Kluwer has annual revenues (2007) of €3.4 billion ($4.8 billion), maintains operations in over 33 countries across Europe, North America, and Asia Pacific and employs approximately 19,544 people worldwide. Wolters Kluwer is headquartered in Amsterdam, the Netherlands. For more information, visit

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EDITORS’ NOTE: Editorial review copies of Biotechnology and Pharmaceutical Patents: Law and Practice are available upon request for members of the press. Contact Neil Allen, 847-267-2179 or or Brenda Au, 847-267-2046 or