About
Learn the fundamentals of protecting valuable life sciences assets!
Pharmaceutical and biotech companies spend billions of dollars to develop new products with the hope that these products will gain FDA and patent approval. Because of the extensive amounts of time and money invested, it is imperative that patents actually protect the product a company plans to market. In order to accomplish this, patent counsel, patent agents, and R&D and business development executives need to ensure that patent claims are correctly drafted, patent filings coordinate with FDA strategies, and purchased patents are truly valid and enforceable.
You cannot afford to be left in the dark regarding the interconnection of IP and FDA regulation in these industries. Get the winning edge - boost your life sciences IP and regulatory IQ.
ACI’s publication from Pharma/Biotech Patent Boot Camp has been designed to give new patent attorneys and patent attorneys who are new to the life sciences industries - as well as business executives in pharma and biotech companies - a strong working knowledge of essential IP and regulatory competencies relative to life sciences patents.
About
Learn the fundamentals of protecting valuable life sciences assets!
Pharmaceutical and biotech companies spend billions of dollars to develop new products with the hope that these products will gain FDA and patent approval. Because of the extensive amounts of time and money invested, it is imperative that patents actually protect the product a company plans to market. In order to accomplish this, patent counsel, patent agents, and R&D and business development executives need to ensure that patent claims are correctly drafted, patent filings coordinate with FDA strategies, and purchased patents are truly valid and enforceable.
You cannot afford to be left in the dark regarding the interconnection of IP and FDA regulation in these industries. Get the winning edge - boost your life sciences IP and regulatory IQ.
ACI’s publication from Pharma/Biotech Patent Boot Camp has been designed to give new patent attorneys and patent attorneys who are new to the life sciences industries - as well as business executives in pharma and biotech companies - a strong working knowledge of essential IP and regulatory competencies relative to life sciences patents.
Contents & Contributors
Food and Drug Administration (FDA)
Donald O. Beers, Arnold & Porter LLP
Understanding the Jurisdiction and Interplay of the FDA and PTO in the Patenting of Drugs and Biologics
Thomas J. Kowalski, Frommer Lawrence & Haug LLP
Life Science Patents What Is Patentable?
Deborah L. Lu, Ph.D., Frommer Lawrence & Haug LLP
Tests for Patentability in the Life Sciences
Bart W. Wise, Ph.D., Five Prime Therapeutics, Inc.
Doctrine of Inherent Anticipation
Matthew W. Siegal, Stroock & Stroock & Lavan LLP
Perfecting Claims in Life Sciences Patent Applications
Richard J. Berman, Arent Fox LLP
Perfecting Claims In Life Science Patent Applications (Part 2)
Len Smith, Novo Nordisk Inc.
Pre-Patent Considerations Relative to Product Development, Commercialization & Life Cycle Management
Jeffrey A. McKinney, Altairnano, Inc.
Pre-Patent Considerations Relative to Product Development, Commercialization and Life Cycle Management
Judy Jarecki-Black, Ph.D., Merial Limited.
Freedom to Operate: Analysis and Opinions for Pharma and Biotech
Teresa Bittenbender, Elan Drug Delivery, Inc.
Finding Safe Harbors for Life Sciences IP: The Hatch-Waxman Act and Pre-Merck V. Integra Interpretation of the “Safe Harbor”
William Leschensky, Alexza Pharmaceuticals
Scope of Privilege Waiver After In Re Echostar and In Re Seagate
John P. Iwanicki, Banner & Witcoff, Ltd.
The Supreme Pronouncement on Pharmaceuticals and Patents: The Aftermath of Merck V. Integra
Raymond S. Parker, III, Ph.D., US Patent Department Operations
sanofi-aventis US L.L.C.
The Federal Circuit Listens to the Supreme Court — Now What?
James F. Haley Jr., Ropes & Gray LLP
The Nature of the Approval Process for Drugs and Biologics What Every Life Sciences Patent Attorney Should Know
Mark Krietzman, Greenberg Traurig, LLP
Hatch-Waxman
Donald O. Beers, Arnold & Porter LLP
Patent and Trademark Considerations During the Preapproval Period
Hans Sauer, Biotechnology Industry Organization
Patent and IP Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress, and More
Eric Marandett, Choate, Hall & Stewart
Publication Details