Do Not Let a Paperwork ‘Gotcha’ Sink Valuable Medicines

Congress is considering a bill that would let patents on prescription drugs be rendered unenforceable over an honest paperwork error, even when the underlying invention is genuinely new, non-obvious, and valuable to patients.

Supporters of the Medication Affordability and Patent Integrity Act (S. 2658), which the Senate Health, Education, Labor, and Pensions Committee reported in July, say it will lower drug prices by closing what they describe as a loophole that drugmakers use to extend their monopolies. They worry that companies tell the Food and Drug Administration (FDA) one thing about a medicine and the U.S. Patent and Trademark Office (USPTO) another, or withhold from patent examiners information given to regulators, to secure additional patents that delay generic competition.

The Bill Would Cause a Counterproductive Shift

The bill would require drugmakers to submit to the USPTO any information material to patentability that they provide to the FDA, and to certify that their submissions to both agencies are complete and consistent. If a company, or even a prior owner of the patent, negligently fails to submit everything required, the bill would allow accused infringers to raise that omission as an invalidity defense—effectively rendering otherwise valid patent claims unenforceable.

Companies would respond predictably. None can afford to wait years to learn which FDA filings a court will deem material when a wrong guess costs the patent, so they would send the USPTO everything. Examiners would largely set that mass of material aside, and the real contest would shift to litigation, where the question would be not whether an invention is new and non-obvious, but whether one or two documents out of thousands were overlooked.

As a former adviser to the director of the USPTO and former counsel to both the Senate and House Judiciary committees, I understand the importance of protecting the integrity of the patent system. The bill’s sponsors have good intentions, but the legislation is unnecessary and counterproductive. Existing law already requires disclosure, already subjects every application to independent examination, and punishes deliberate deception. The bill would turn both examination and litigation into sideshows, letting valuable inventions be lost to a paperwork “gotcha” rather than judged on their merits.

We Already Have Mechanisms to Deter Abuse

Start with existing law. Federal regulations already require patent applicants, and others substantively involved in prosecution, to disclose to the USPTO all information they know to be material to patentability. In 2022, the USPTO issued guidance confirming that this duty covers statements made to other agencies, including the FDA.

But an applicant’s duty to disclose is only one safeguard in patent prosecution, and not necessarily the most important. Every application goes to an examiner trained in the relevant technology, who independently searches prior patents and the scientific literature and rejects any claim the prior art shows is not new or would have been obvious. Researchers have found that examiners rely overwhelmingly on prior art they find themselves rather than on references applicants submit.

The duty to disclose is nonetheless important and deserves meaningful enforcement, because deliberate deception should be deterred. The law has responded appropriately, treating those who deliberately deceive the USPTO harshly. Courts can, and do, find inequitable conduct in such cases, rendering the entire patent unenforceable—a sanction the Federal Circuit has called the “atomic bomb” of patent law. The same misconduct can bring attorney fee awards (in Therasense, nearly $6 million), antitrust liability with treble damages, professional discipline, and criminal prosecution for false statements. And bad actors get caught: generic manufacturers have every incentive to challenge drug patents, and in litigation they obtain discovery into the patent owner’s files, FDA submissions included.

Belcher Pharmaceuticals v. Hospira—a case often cited as an example of the very problem this legislation targets—actually shows the system working as intended. Belcher obtained a patent on an epinephrine formulation with a specific pH range, even though it had already told the FDA about existing products in that range and described the range itself as “old.” Yet its chief science officer, who handled both the FDA process and the patent prosecution, withheld that information from the USPTO and argued that the range was “critical” and produced “unexpected” results. When Belcher sued Hospira, a federal district court agreed that this was inequitable conduct, even without direct evidence of intent, and in 2021 the Federal Circuit affirmed.

In other words, the conduct the bill’s supporters describe is already prohibited, detectable, and severely punished. The bill adds no harsher penalty for intentional abuse. What it adds instead is a penalty for unintentional oversights. A patent becomes unenforceable if its owner, or even a previous owner, made a mistake: negligently failing to satisfy the bill’s disclosure requirements.

The Unintended Consequences

The flood of filings the bill would prompt would do little for examination. The FDA asks whether a medicine is safe and effective; the USPTO asks whether an invention is new, non-obvious, and useful. A new drug application can run to thousands of pages of clinical, manufacturing, and stability data organized for regulators, not for comparison against patent claims. The submissions would be a sideshow in prosecution, and processing them would slow examination just as the agency works to reduce a backlog of roughly three-quarters of a million unexamined applications.

In litigation, what would matter is what was left out. An accused infringer would no longer need to prove that a medicine was old or obvious, or that anyone intended to deceive. It would need only to find one or two documents that were never transmitted, through a clerical slip or a reasonable judgment that they did not matter, and call the omission negligent and the documents material. That makes litigation a sideshow, too: a “gotcha” rather than a judgment on the merits.

The Federal Circuit confronted exactly this problem in its landmark 2011 en banc decision in Therasense, Inc. v. Becton, Dickinson & Co., which requires clear and convincing evidence that an applicant intended to deceive the USPTO. The court raised the bar because inequitable conduct charges had become a routine litigation tactic that distracted from the merits. The bill would invite that problem back. Supporters may respond that intent is too hard to prove, but Belcher shows that courts can infer it from circumstantial evidence. A negligence standard would add not more accountability for bad actors, but liability for honest ones.

Don’t Undermine Medical Innovation

That distinction matters. Deliberate deception corrupts the patent bargain; an honest omission does not. A patent should be judged on whether the invention is new, non-obvious, and useful, and inventions that often take more than a decade and enormous investment to reach patients are too valuable to be forfeited over a paperwork error. Investors accept scientific risk as inherent in drug development, but a legal risk unrelated to the science means less investment at the margin. The answer to a flawed patent is a validity challenge; the answer to deception is the array of sanctions already on the books.

Despite its supporters’ good intentions, the Medication Affordability and Patent Integrity Act stands to undermine the medical innovation patients depend on in pursuit of lower drug prices it is unlikely to deliver. Congress should reject it.

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Copyright: stuartmiles