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To the U.S. Congress · The FTC · The USPTO

End Patent Monopolies. Restore Fair Access to Metabolic Medications.

Big Pharma is using stacked "junk" patents — not real innovation — to lock generics, biosimilars, and compounding pharmacies out of the GLP-1 market. Add your name and demand that the loophole be closed.

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100+

Improper Orange Book patent listings flagged by the FTC across brand-name drugs.

Dozens

Secondary patents can be stacked on a single molecule — on pen devices, dosing, and formulation tweaks.

Decades

How long layered filings can push back the date a generic or biosimilar may legally enter.

Background & the problem

A patent system built to reward invention is being used to forbid competition.

Millions of Americans rely on metabolic therapies, including GLP-1 and dual and triple-agonist medications like semaglutide, tirzepatide, and investigational drugs such as retatrutide. Rather than relying on the single primary patent for the active molecule, manufacturers are building patent thickets — dozens of overlapping secondary patents on minor formulation tweaks and delivery devices such as auto-injector pens.

This anti-competitive strategy deliberately blocks generic manufacturers, compounding pharmacies, and biosimilars from entering the market, keeping prices artificially high and denying patients affordable access to life-saving treatment. The Federal Trade Commission has already identified hundreds of these "junk" patents listed improperly in the FDA's Orange Book — but stronger legislative and regulatory action is required.

Why one company should not own peptides outright

Peptides are chains of amino acids — chemistry, not invention. When device patents and formulation filings are stacked on top of a molecule, a single manufacturer effectively controls an entire therapeutic class: who may make it, who may prepare it, and what every patient pays. Competition, not exclusivity, is what has always brought American drug prices down.

Our demands

We, the undersigned, call for four immediate actions.

  1. Demand 01

    Pass the ETHIC Act

    Congress must pass the Eliminating Thickets to Increase Competition (ETHIC) Act, strictly limiting the number of related patents a brand-name manufacturer can assert in litigation — neutralizing the thicket strategy used to indefinitely block generic entry.

  2. Demand 02

    Aggressive FTC enforcement

    The FTC must continue issuing warning letters and taking legal action against companies that submit improper or inaccurate secondary patent listings to the FDA's Orange Book. Bogus filings used to stall generic approvals must carry consequences.

  3. Demand 03

    FDA and USPTO coordination

    Congress must grant the FDA authority and resources to evaluate every patent submitted for Orange Book listing, and the FDA and USPTO must jointly reject frivolous secondary patents that offer no new clinical benefit.

  4. Demand 04

    Enforce march-in rights

    Where discoveries benefited from taxpayer-funded research, the federal government must exercise Bayh-Dole march-in rights and license those patents to third-party manufacturers when the innovator refuses a reasonable public price.

The U.S. patent system was designed to reward true innovation — not to grant permanent monopolies through legal loopholes. It is time to prioritize patient health over pharmaceutical profiteering.

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