AstraZeneca secured strong patent protection extending into the 2030s for osimertinib and its clinical uses, including dosing and formulations that support its therapeutic effectiveness in non‑small cell lung cancer (NSCLC). Patent assets around this drug (e.g., US 10,166,247 and related families added in 2019) have been central to blocking generic competition in the U.S. market.
What the Patent Covers
- Compound and formulation‑related claims covering the active drug osimertinib (AZD9291) or its pharmaceutically acceptable salts — the third‑generation EGFR tyrosine kinase inhibitor that targets specific mutations (such as T790M) in NSCLC cells.
- Methods of treatment claims for using osimertinib to treat EGFR‑mutation positive lung cancer patients, including specific dosing regimens and patient populations. These broaden the scope of exclusivity beyond just the molecule itself and help protect the commercial franchise.
- Patent term extensions and continuation filings that maintain protection well into the mid‑2030s, providing extended market exclusivity in major markets like the United States.
Why It’s Important
1. Blockbuster Oncology Revenue
Tagrisso has become one of AstraZeneca’s top‑selling medicines, playing a crucial role in its oncology portfolio. In recent years, sales of Tagrisso have reached billions of dollars annually, reflecting its adoption in treating advanced NSCLC patients.
2. Strong Intellectual Property Position
The patent additions bolstered AstraZeneca’s protection against generic competition. Securing robust, enforceable patent claims around Tagrisso’s composition and use has helped preserve market exclusivity, giving the company the ability to maintain premium pricing and sales volumes.
3. Patent Defense in Legal Challenges
AstraZeneca has actively defended these patents in court, asserting them against proposed generic entrants to delay generic market entry. Strong IP rights are a key asset in maintaining Tagrisso’s commercial life cycle.
Summary
- Drug: Tagrisso (osimertinib) — a targeted therapy for EGFR‑mutation positive non‑small cell lung cancer.
- Patent Focus: Compound protection and methods of use/formulation claims that extend exclusivity into the 2030s.
- Commercial Impact: A major revenue generator for AstraZeneca’s oncology business, with strong patent coverage helping protect against generic competition and sustain high sales worldwide.
BioTech IP Review 
Leave a comment