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

STUDY OVERVIEW
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STUDY OVERVIEW

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

When Abbott split into two companies in 2013, Humira moved to AbbVie. While AbbVie’s initial patent strategy protected HUMIRA’s core standing in rheumatoid arthritis, the company also added more than 200 patents to extend and defend market exclusivity against competitors - ultimately generating some $78 billion in additional sales value.

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 blockbuster journey to growing into the largest product in pharma history – peaking at ~$20 billion in annual sales and +$173 billion in cumulative sales over 17 years.

KEY TOPICS

HUMIRA: History of a Blockbuster that Used Legal Innovations to Add Exceptional Value to the Franchise
Patent Objectives: How Patents Incent Innovation Through Protection from Competition
Patent Skills, Tactics and Strategies: How HUMIRA Extended Franchise Life and Added $78 Billion in Additional Sales Value
Criticism Received by HUMIRA
HUMIRA Compared to Competitors in Use of Patent Thickets
Lessons Learned and Winning Strategies

KEY METRICS

Revenue generated by HUMIRA ($ million) from launch till date and its blockbuster journey
Number of patents filed to defend HUMIRA against new entrants
Percentage of patent applications filed at various stages of Humira’s market entry
Array of secondary patents filed to prevent generic competition in the U.S. after the patent on the basic HUMIRA compound expired in December 2016
Number of protected patents for approved indications
Cost of obtaining patents and generated return of investment
AbbVie’s US vs. EU patent applications
Drugs with 100+ patent applications and HUMIRA’s comparison
Drugs with more than 50% increase in prices and HUMIRA’s comparison

SAMPLE KEY FINDINGS

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.

METHODOLOGY

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.

Industries Profiled:
Pharmaceutical

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

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

ID: 5652

Features:

Pages/Slides: 45

Published: 2020

Delivery Format: Online PDF Document

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