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Patent Protection: How AbbVie Builds Patent Fences to Extend Brand Life and Safeguard HUMIRA and Its Immunology Franchise

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25 Info Graphics

10 Data Graphics

130+ Metrics

6 Narratives

Pages: 45

Published: 2020

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STUDY OVERVIEW
BENCHMARK CLASS
STUDY SNAPSHOT
KEY FINDINGS
VIEW TOC AND LIST OF EXHIBITS

When Abbott received US FDA approval for marketing D2E7 (renamed HUMIRA) for the treatment of rheumatoid arthritis in 2002, it adopted an integrated patent strategy to maximize its period of market exclusivity and add exceptional value to its immunology franchise.

While AbbVie’s initial patent strategy protected HUMIRA’s core standing in rheumatoid arthritis, the company also added 200+ patents to extend and defend market exclusivity against competitors - ultimately generating some $78 billion in additional sales value.

Video Brief:

This Best Practices, LLC case study examines how HUMIRA used patent innovations as a source of competitive advantage to add value to its clinical assets and commercial operations. The case study highlights the lessons learned and winning strategies revealed in HUMIRA’s journey to achieving legendary blockbuster status.

Industries Profiled:
Pharmaceutical

Companies Profiled:
Abbott Laboratories; AbbVie; BASF Pharma; Knoll AG

Study Snapshot

Best Practices, LLC conducted extensive secondary research to review how HUMIRA used patent innovations as a source of competitive advantage to add value to its clinical assets and commercial operations.

Key Findings

Select key insights uncovered from this report are noted below. Detailed findings are available in the full report.

Extending Brand Life: Systematic use of patents has extended HUMIRA’s exclusivity period in the US market by more than 50%.

Patent Trees: AbbVie’s initial patent strategy protected HUMIRA’s core standing in RA; then it added +200 patents to extend, defend and block other competitors.

Table of Contents

Sr. No.	Topic	Slide No.
I.	Executive Summary: How HUMIRA Forged a Powerful New Source of Value	Pg. 3
II.	HUMIRA: History of a Blockbuster that Used Legal Innovations to Add Exceptional Value to the Franchise	Pg. 5
III.	Patent Objectives: How Patents Incent Innovation Through Protection from Competition	Pg. 9
IV.	Patent Skills, Tactics and Strategies: How HUMIRA Extended Franchise Life and Added $78 Billion in Additional Sales Value	Pg. 16
V.	HUMIRA’s Success has Also Become a Lightning Rod for Criticism	Pg. 33
VI.	HUMIRA Compared to Competitors in Use of Patent Thickets	Pg. 40
VII.	Lessons Learned and Winning Strategies	Pg. 43
VIII.	About Best Practices LLC	Pg. 45

List of Charts & Exhibits

I. Executive Summary: How HUMIRA Forged a Powerful New Source of Value

Summary of key insights

II. HUMIRA: History of a Blockbuster that Used Legal Innovations to Add Exceptional Value to the Franchise

Revenue generated by HUMIRA ($ million) from launch till date and its blockbuster journey
Start of HUMIRA’s birth story as rheumatoid arthritis treatment
HUMIRA’s creative patents and strategies

III. Patent Objectives: How Patents Incent Innovation Through Protection from Competition

HUMIRA’s patent focus areas, and U.S. patent laws specification
Patent evolution from 1421 to 1980
Categories of patents
Patent requirements
Patentable and non-patentable ideas
HUMIRA’s patent trees

IV. Patent Skills, Tactics and Strategies: How HUMIRA Extended Franchise Life and Added $78 Billion in Additional Sales Value

Summary themes and lessons learned from HUMIRA’s agile patent strategies
HUMIRA’s indications in the US market
HUMIRA’s patent scenario
AbbVie’s long-term strategy
HUMIRA’s patent clusters
Cornerstone strategy to block competitors entering HUMIRA’s micro markets
Process and purification patents
HUMIRA’s FDA approved TA-treatment patents across all fronts to defend and extend market leadership
AbbVie’s series of patents for its ‘anti-TNF� antibody formulations’
Defending delivery IP
AbbVie’s offensive and defensive patent tactics
AbbVie’s innovative patent extension strategies
AbbVie’s coopetition strategy
AbbVie’s IP feathering to safeguard HUMIRA’s market leadership
Cost of obtaining patents and generated return of investment
HUMIRA’s success formula for creating a winning dynasty in immunology

V. HUMIRA’s Success has Also Become a Lightning Rod for Criticism

Summary themes and lessons learned from HUMIRA’s agile patent strategies
Controversy surrounding AbbVie’s innovative use of patent defenses
Patent thickets
Region-wise revenue generated by HUMIRA (USD billion)
AbbVie’s US vs. EU patent applications
US public burden due to increase in HUMIRA’s pricing

VI. HUMIRA Compared to Competitors in Use of Patent Thickets

Drugs with 100+ patent applications and HUMIRA’s comparison
Drugs with more than 50% increase in prices and HUMIRA’s comparison

VII. Lessons Learned and Winning Strategies

Take aways from HUMIRA’s IP patent successes

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