PIPLI Urges Court to Protect Patients and Restore Rule of Law at the Patent Office

Alex Moss | Friday, June 20, 2025

The Public Interest Patent Law Institute (PIPLI) has filed an amicus brief in In re SAP America, calling on the U.S. Court of Appeals for the Federal Circuit to stop the U.S. Patent and Trademark Office (USPTO) from unlawfully changing the rules for challenging invalid patents after the fact. The USPTO’s decision to apply new rules retroactively doesn’t just violate due process—it threatens to lock in bad patents that keep drug prices high.

The Stakes: A Fair Process or a Rigged Game?

In the case, SAP filed an inter partes review (IPR) petition to challenge a patent after being sued for infringement. At the time, binding agency guidance from the USPTO made clear: if a petitioner agreed not to pursue certain overlapping legal claims in court, the petition would not be denied simply because parallel litigation was underway.

SAP did exactly that. It made litigation concessions it otherwise wouldn’t have—promising not to assert legal defenses that might have strengthened its position in court—in order to avoid discretionary denial of its IPR petition. Months later, control of the USPTO changed hands. After the agency’s current leadership took over, it jettisoned the discretionary denial rules, came up with new ones, and started applying them retroactively to petitions that had already been filed. Like SAP’s.

This isn’t about whether the USPTO should have granted SAP’s petition. It’s about whether the government can promise one set of rules, induce parties to rely on them, and then retroactively switch to another.

Why It Matters for Drug Prices

The USPTO’s shift doesn’t just hurt SAP. It sets a dangerous precedent for anyone trying to challenge weak, invalid patents—including patents that block competition in the drug market.

Patent challenges are powerful tools in efforts to bring down prescription drug prices.. They have helped eliminate patents that never should have issued—patents used by brand-name drug companies to delay generics and maintain monopoly pricing. But if challengers can no longer rely on the USPTO’s rules, they may be forced to choose between protecting their litigation position or risking an IPR denial under new and unpredictable standards.

That uncertainty gives patent holders even more leverage to extract settlements and keep prices high. It guts the reliability of a system Congress created to fix the problem of low-quality patents.

PIPLI’s Position: Agencies Must Play by the Rules Too

In our amicus brief, PIPLI argues that the USPTO’s actions violate fundamental principles of due process and administrative law. Agencies can’t retroactively penalize the public for relying on official, binding guidance—especially when that reliance leads parties to give up legal rights.

If allowed to stand, this policy change would discourage future challenges, empower abusive patent holders, and make it harder to eliminate patents that are unjustly inflating drug prices. It sends a dangerous message: following the USPTO’s own guidance may leave you worse off.

The Bottom Line

Patent review can’t function if the rules change midgame. The USPTO’s retroactive rescission of its policy doesn’t just break trust—it undermines the entire system Congress designed to protect the public from harmful monopolies. The Federal Circuit now has an opportunity—and a responsibility—to step in.

This isn’t just a fight about legal process. It’s a fight for a patent system that works in the public interest. And for patients across the country, it’s a fight that could help determine how soon they get access to affordable medicine.