ETHIC Act Proposes Limiting Drug Patent Lawsuits to One Claim Per 'Patent Group' to Speed Up Generics

The “Eliminating Thickets to Increase Competition Act”—or the ETHIC Act—is taking aim at a major roadblock in the pharmaceutical industry: the so-called “patent thicket.” This bill specifically changes the rules of engagement when an innovator drug company sues a generic or biosimilar manufacturer over patent infringement. If passed, it would limit the plaintiff (the original patent holder) to asserting a maximum of one patent per defined “Patent Group” in a single lawsuit against a competitor seeking approval for a generic drug or biological product. The goal here is simple: stop companies from burying competitors in dozens of related lawsuits based on a massive pile of slightly different patents, thereby speeding up the arrival of cheaper alternatives to market.

The Patent Thicket Problem

Think of a patent thicket like a complicated, expensive maze built specifically to keep generic competitors—the folks who make the cheaper versions of medications—from reaching the market. Innovator companies often file many related patents on a single drug—covering everything from the manufacturing process to the pill coating—all designed to extend market exclusivity. The ETHIC Act tries to cut through this by focusing on litigation. When a generic manufacturer challenges a drug, the innovator company often sues them over every single patent they hold. This bill says, essentially, you can only pick one patent from a defined “Patent Group” to use in that lawsuit against the generic maker. This restriction only applies to new drug applications submitted after the Act becomes law.

Defining the ‘Patent Group’

This is where the policy gets technical, but the definition is crucial. The bill defines a “Patent Group” as two or more commonly owned patents or applications that are formally linked through a specific legal mechanism called a “disclaimer” under Section 253 of Title 35. A disclaimer is often used when a company wants to clarify that two related patents are not claiming the exact same invention. If Patent A disclaims part of Patent B, and vice versa, or if several patents all point back to the same parent patent via disclaimers, they get lumped into one group. The practical effect is that if a drug company has five patents covering the same core idea, but they are all linked by these disclaimers, they can only sue the generic maker using one of those five patents.

Who Wins and Who Pays?

For generic and biosimilar manufacturers, this is a huge potential win. It means they won't have to defend against dozens of lawsuits simultaneously, dramatically reducing their legal costs and the time it takes to get an affordable drug version approved. This could translate directly into lower drug prices and faster availability for consumers. Imagine a small biosimilar company—they can now focus their legal resources on challenging the single strongest patent, rather than fighting a five-front war. However, for the original innovator companies, this is a significant restriction on their intellectual property rights. They argue they should be able to assert all valid patents they own. By limiting them to one patent per group, the bill forces them to pick their best shot, which could potentially leave other, valid patents undefended against infringement, creating a practical challenge to how they manage their patent portfolios and litigation strategy. The vagueness around the specific definition of the “Patent Group” based on technical disclaimers could also lead to new litigation just to figure out which patents belong in which group, potentially shifting the legal battleground rather than eliminating it entirely.