La Jolla Pharma v. Squires: PTAB Decisions Affirmed in Pharmaceutical Patent Application Dispute
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📋 Case Summary
| Case Name | La Jolla Pharma, LLC v. John A. Squires, Director of the USPTO |
| Case Number | 1:24-cv-00951 |
| Court | Eastern District of Virginia |
| Duration | June 2024 – January 2026 597 days |
| Outcome | Defendant Win – PTAB Rejections Affirmed |
| Patents at Issue | |
| Accused Products | La Jolla Pharma’s Claimed Pharmaceutical Compositions/Methods |
Case Overview
The Parties
⚖️ Plaintiff
A pharmaceutical company seeking patent protection for drug-related inventions, appealing adverse PTAB decisions.
🛡️ Defendant
The statutory defendant in civil actions challenging PTAB final decisions, representing the United States Patent and Trademark Office.
The Patent Applications at Issue
This case involved two U.S. patent applications related to pharmaceutical compositions or methods, which were rejected by the PTAB:
- • U.S. Patent Application No. 16/220,901 (published as US20190183962A1)
- • U.S. Patent Application No. 17/592,943
Both applications were subject to PTAB final decisions affirming rejections based on prior art or other patentability grounds. Sigma-Aldrich products were referenced as relevant prior art in the underlying record.
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The Verdict & Legal Analysis
Outcome
The district court affirmed the PTAB’s final decisions, effectively denying patent protection for both of La Jolla Pharma’s applications. This resulted in the **permanent loss of patent rights** for the claimed subject matter, with no damages awarded as this was a prosecution appeal.
Key Legal Issues
This case, classified as an infringement action but functionally a civil action under 35 U.S.C. § 145, required La Jolla Pharma to demonstrate that the PTAB erred in its final rejections. A critical element was the court’s denial of La Jolla Pharma’s motion to exclude the expert opinions of Dr. Laird Forrest, suggesting his testimony was deemed sound and supported the USPTO’s position. The ultimate grant of summary judgment for the USPTO Director highlights the substantial deference federal courts afford to PTAB determinations, especially when supported by credible expert evidence.
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⚠️ Freedom to Operate (FTO) Analysis
This case highlights critical IP risks in pharmaceutical patent prosecution. Choose your next step:
📋 Understand This Case’s Impact
Learn about the specific risks and implications from this litigation for pharmaceutical IP.
- Review specific prior art cited in this case
- Identify active companies in related pharmaceutical spaces
- Analyze PTAB appeal trends for similar rejections
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High Risk Area
Pharmaceutical compositions/methods from rejected applications
Prior Art Cited
Sigma-Aldrich products referenced
Strategic Prosecution Options
Consider continuations or claim redrafting
✅ Key Takeaways
For Patent Attorneys
§ 145 district court appeals face significant deference to PTAB technical findings, especially with expert support.
Search related case law →Failed expert exclusion motions can accelerate adverse summary judgment outcomes for applicants.
Explore precedents on expert testimony →For R&D Teams
Monitor rejected competitor applications as signals for potential freedom-to-operate opportunities.
Start FTO analysis for my product →Conduct thorough prior art searches and FTO analysis incorporating the rejected applications (16/220,901 and 17/592,943).
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