About
Understand the interplay of IP and FDA regulation relative to pharma/biotech patents.
Master the intricacies of life sciences patenting.
The FDA…the PTO…product life cycles…freedom to operate…the Hatch-Waxman Act…exclusivity… pre-commercialization v. commercialization and claims drafting. All represent critical IP and regulatory aspects of pharmaceutical and biotech patents. The highly regulated nature of the products which the pharmaceutical and biotechnology industries manufacture dictates that the patenting of these products be closely tied to regulatory approval by the FDA. Moreover, certain principles and doctrines in patent law that may seem irrelevant or of little consequence to other industries are of tremendous significance in pharmaceutical and biotech patents. In short, these patents hold a unique place in the world of IP. Anyone who works in the life sciences industries — and who even remotely deals with its IP — must be well versed in the regulatory components and IP subtleties that play such an integral role in the patenting of its products.
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.
This publication from ACI’s Pharmaceutical/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. A faculty of top-notch IP and regulatory counsel — all having a wealth of experience in pharmaceutical and biotech patents — will share their knowledge and provide critical insights on:
- The organization and jurisdiction of the FDA and the PTO and their interplay in the approval and patenting of drugs and biologics
- Pre-patent considerations relative to R&D and patent portfolio and patent life cycle management
- The critical role of freedom to operate studies in seeking a life sciences patent
- How the doctrines of accidental and inherent anticipation factor into the drafting of claims for life sciences patents
- How the Hatch-Waxman Act established the paradigm for market entry of generic small molecule drugs — and now possibly follow-on biological products
- The relationship between patent and non-patent exclusivity
- The importance of patenting bioequivalence characteristics in certain drug products
- The ins and outs of patent term extension under 35 U.S.C. § 156 and 37 CFR 1.710 – 1.791
About
Understand the interplay of IP and FDA regulation relative to pharma/biotech patents.
Master the intricacies of life sciences patenting.
The FDA…the PTO…product life cycles…freedom to operate…the Hatch-Waxman Act…exclusivity… pre-commercialization v. commercialization and claims drafting. All represent critical IP and regulatory aspects of pharmaceutical and biotech patents. The highly regulated nature of the products which the pharmaceutical and biotechnology industries manufacture dictates that the patenting of these products be closely tied to regulatory approval by the FDA. Moreover, certain principles and doctrines in patent law that may seem irrelevant or of little consequence to other industries are of tremendous significance in pharmaceutical and biotech patents. In short, these patents hold a unique place in the world of IP. Anyone who works in the life sciences industries — and who even remotely deals with its IP — must be well versed in the regulatory components and IP subtleties that play such an integral role in the patenting of its products.
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.
This publication from ACI’s Pharmaceutical/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. A faculty of top-notch IP and regulatory counsel — all having a wealth of experience in pharmaceutical and biotech patents — will share their knowledge and provide critical insights on:
- The organization and jurisdiction of the FDA and the PTO and their interplay in the approval and patenting of drugs and biologics
- Pre-patent considerations relative to R&D and patent portfolio and patent life cycle management
- The critical role of freedom to operate studies in seeking a life sciences patent
- How the doctrines of accidental and inherent anticipation factor into the drafting of claims for life sciences patents
- How the Hatch-Waxman Act established the paradigm for market entry of generic small molecule drugs — and now possibly follow-on biological products
- The relationship between patent and non-patent exclusivity
- The importance of patenting bioequivalence characteristics in certain drug products
- The ins and outs of patent term extension under 35 U.S.C. § 156 and 37 CFR 1.710 – 1.791
Contents & Contributors
UNDERSTANDING THE JURISDICTION AND INTERPLAY OF THE FDA
AND PTO IN THE PATENTING OF DRUGS AND BIOLOGICS
Thomas J. Kowalski, Esq., Frommer Lawrence & Haug LLP
Deborah L. Lu, Ph.D., Esq., Frommer Lawrence & Haug LLP
LIFE SCIENCES PATENTS: WHAT IS PATENTABLE?
Deborah L. Lu, Ph.D., Esq., Frommer Lawrence & Haug LLP
UNDERSTANDING FDA’S DRUG AND BIOLOGICAL PRODUCT
APPROVAL PROCESSES
Robert B. Nicholas, JD, McDermott Will & Emery LLP
PRE-PATENT CONSIDERATIONS: PRODUCT DEVELOPMENT,
COMMERCIALIZATION AND LIFE CYCLE MANAGEMENT
Christopher Stomberg, Ph.D., Bates White, LLC
FREEDOM TO OPERATE: ANALYSIS AND OPINIONS FOR PHARMA
AND BIOTECH PATENTS
Ralph A. Loren, J.D., Edwards Angell Palmer & Dodge LLP
TRADEMARKS IN THE PHARMA / LIFE SCIENCES REALM
Patrick J. Concannon, Edwards Angell Palmer & Dodge LLP
LESSONS FOR PATENT PROSECUTORS FROM RECENT PATENT LITIGATION
Jason A. Lief, McDermott Will & Emery LLP
FOLLOW-ON BIOLOGICS: WHAT PATENT LAWYERS NEED TO KNOW
Steven H. Sklar, Leydig, Voit and Mayer, Ltd.
OVERVIEW OF THE HATCH-WAXMAN ACT
Gary L.Veron, Sidley Austin LLP
PATENT AND NON-PATENT EXCLUSIVITY
Erika Lietzan, Covington & Burling LLP
BIOEQUIVALENCE AND THE “SAME ACTIVE INGREDIENT”
VIS-À-VIS PATENTABILITY
Donald O. Beers, Arnold & Porter LLP
PERFECTING CLAIMS IN LIFE SCIENCES PATENT APPLICATIONS
Richard J. Berman, Arent Fox LLP
CLARIFYING THE LAW OF INHERENT ANTICIPATION
Anne Brown, Ph.D., Athersys, Inc.
SCOPE OF THE SAFE HARBOR EXEMPTION OF THE HATCH-WAXMAN ACT
AFTER MERCK KGAA V. INTEGRA LIFESCIENCES I, LTD., 125 S. CT. 2372 (2005)
AND POST-INTEGRA IMPLICATIONS
Brian D. Coggio, Greenberg Traurig, LLP
Publication Details