uniQure v. Pfizer: Federal Circuit Affirms Invalidity of Factor IX Gene Therapy Patent
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📋 Case Summary
| Case Name | uniQure BioPharma BV v. Pfizer, Inc. |
| Case Number | 23-1405 (Fed. Cir.) |
| Court | Federal Circuit, Appeal from PTAB |
| Duration | Jan 2023 – May 2025 2 years 4 months |
| Outcome | Defendant Win – Patent Invalidated |
| Patent at Issue | |
| Accused Products | Pfizer’s Hemophilia B Gene Therapy Pipeline |
Case Overview
The Parties
⚖️ Plaintiff
Dutch biopharmaceutical pioneer in gene therapy, especially for hemophilia B treatment, holding Factor IX-related technology.
🛡️ Defendant
Global pharmaceutical giant with significant investments in gene therapy, competing in the hemophilia B pipeline.
Patent at Issue
This landmark case involved US Patent No. 9,982,248 B2 (Application No. US15/650070) covering a Factor IX polypeptide mutant and its method of production.
- • US9982248B2 — Factor IX polypeptide mutant and its production method
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The Verdict & Legal Analysis
Outcome
The Federal Circuit affirmed the lower tribunal’s finding, declaring US9982248B2 unpatentable. This ruling effectively cancels or invalidates the patent claims, eliminating uniQure’s ability to assert it going forward.
Key Legal Issues
The invalidity finding likely centered on statutory grounds such as anticipation, obviousness (§102/103), or written description/enablement (§112). In biotech, obviousness and written description challenges are common, particularly for polypeptide variants where the specification might lack robust experimental data or breadth of disclosure.
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⚠️ Freedom to Operate (FTO) Analysis
This case highlights critical IP risks in gene therapy development. Choose your next step:
📋 Understand This Case’s Impact
Learn about the specific risks and implications for gene therapy IP strategy.
- View related gene therapy patents in this space
- See key players in Factor IX innovation
- Understand common invalidity challenges
🔍 Check My Gene Therapy Product’s Risk
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High Risk Area
Broad claims for polypeptide variants
Invalidated Patent
US9982248B2 now unpatentable
Expanded FTO
Potential for new design-around options
✅ Key Takeaways
For Patent Attorneys
Broad functional claims in biotech, especially for engineered biologics, are highly vulnerable to written description and enablement challenges.
Search related case law →Appellate courts generally defer to PTAB factual findings on obviousness/written description, making trial-level record development decisive.
Explore PTAB strategies →For R&D Teams
Conduct thorough FTO analysis early in gene therapy R&D to identify and mitigate IP risks, especially for modified biologics.
Start FTO analysis for my product →Ensure robust experimental data and detailed disclosure support for all claimed embodiments in patent applications for new gene therapies.
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