John Manchester
Director, IP Policy, Global Innovation Policy Center (GIPC), U.S. Chamber of Commerce
Published
June 16, 2026
The big picture: The U.S. Chamber of Commerce strongly opposes S. 2658, the Medication Affordability and Patent Integrity Act, because it would weaken the patent system that helps make the United States the global leader in biopharmaceutical innovation.
Why it matters: Strong intellectual property rights give innovators the certainty needed to make the long-term, high-risk investments required to develop new medicines and treatments. But S. 2658 is a solution in search of a problem.
There is no evidence that inconsistent disclosures between the FDA and USPTO are a systemic issue. Existing law already provides a powerful deterrent: patents can be rendered unenforceable when material information is intentionally withheld from the USPTO.
The problem: Instead of improving patent quality, the bill would push large volumes of FDA submission data into an already overburdened USPTO—even when that information may not be useful for patent examination.
More paperwork does not mean better patents. It could slow examination, create uncertainty, and delay new treatments from reaching patients.
The risk: Companies share extensive confidential information with the FDA, including trade secrets, with the expectation that it will be protected. S. 2658 risks moving sensitive regulatory information into a patent-review process that is not designed to handle FDA data the same way.
Even with confidentiality provisions, the bill could increase the risk of public exposure and give foreign competitors, including China, an advantage.
What else: S. 2658 would create a new patent infringement defense based on procedural noncompliance rather than the merits of the patent. That would invite costly litigation, increase complexity, and weaken confidence in the patent system without helping patients or innovators.
It would also depart from the long-standing principle of technology neutrality by creating special patent rules for one industry. That is the wrong approach, especially in biopharmaceutical innovation, where strong and predictable patents are essential.
Bottom line: Congress should reject S. 2658 and focus instead on preserving the strong IP framework that supports American medical breakthroughs, patient access, and U.S. competitiveness.
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