New ETHIC Act Restricts Drug Patent Lawsuits to One Per 'Patent Group,' Aiming to Speed Up Generic Drug Access

The Eliminating Thickets to Increase Competition Act, or the ETHIC Act, takes direct aim at one of the biggest roadblocks to cheaper drugs: the practice of 'patent thickets.' Essentially, this bill tries to prevent brand-name drug companies from drowning generic and biosimilar competitors in dozens of lawsuits over slightly different patents on the same drug. If passed, this change could mean faster access to cheaper, generic versions of medications.

The One-and-Done Rule for Drug Lawsuits

Here’s the core of the change in Section 2: When a brand-name company sues a generic or biosimilar maker who is trying to get their version approved, the brand-name company can only bring forward one patent per 'Patent Group' in that specific lawsuit. Think of it like this: if a drug company has 15 related patents covering a single medicine—say, one for the pill, one for the coating, one for the manufacturing process—and those patents are all linked in a specific legal way (more on that in a moment), they form a Patent Group. The brand company gets to pick only one of those 15 patents to sue with.

Crucially, once that lawsuit is filed using one patent from a Patent Group against a specific challenger, the brand company can’t file any more lawsuits against that same generic challenger using the other patents from that same group. It’s a 'one strike and you're out' approach for the rest of the patents in that group, at least against that specific competitor. This is a big deal because right now, companies can file multiple, sequential lawsuits that delay generic entry for years, often long after the original drug patent has expired.

Who Benefits from Clearing the Thicket?

This provision is designed to benefit two main groups: consumers and generic drug makers. For consumers, the quicker a generic or biosimilar drug gets to market, the faster prices drop. If the ETHIC Act successfully cuts down on the time spent in litigation, you could see cheaper versions of new drugs hitting pharmacy shelves sooner. For generic and biosimilar makers, this drastically reduces their legal risk and costs. Instead of having to fight 20 separate lawsuits over 20 similar patents, they only have to fight one per group, making the path to market much clearer.

However, this change only applies to applications for new drugs submitted after the ETHIC Act becomes law. For all the drugs already on the market or in the FDA pipeline, the old, complex litigation rules still apply.

Defining the 'Patent Group'—The Legal Fine Print

This is where things get technical, and it’s also where the bill has a medium level of vagueness that could lead to new legal fights. The bill defines a “Patent Group” as two or more commonly owned patents that are related because they were involved in disclaimers used to avoid “obviousness-type double patenting.”

In plain English: Sometimes, a company gets two patents that are so similar they essentially cover the same invention twice. To fix this, they file a 'disclaimer' linking the two patents together, making sure they expire at the same time. The ETHIC Act says if patents are linked this way, they belong to the same Patent Group. The complexity here lies in the fact that patent lawyers might disagree sharply on whether a specific set of patents truly meets this definition, potentially leading to new, albeit narrower, legal battles focused solely on defining the group itself.