The Senate is weighing a bill that would make prescription drug patents unenforceable if applicants negligently omit information they gave to the FDA, according to an op-ed by a former adviser to the USPTO director and former counsel to the Senate and House Judiciary committees. The Medication Affordability and Patent Integrity Act (S. 2658), reported by the Senate HELP Committee in July, is meant to stop drugmakers from exploiting inconsistencies between FDA and USPTO submissions to extend monopolies. The author says the sponsors have good intentions but argues the legislation is unnecessary and counterproductive.
Existing law already requires patent applicants to disclose material information, including statements made to other agencies, and every application is independently examined by a trained patent examiner. Courts can render entire patents unenforceable for deliberate deception, and bad actors can also face attorney fee awards, antitrust liability, professional discipline, and criminal prosecution. The author cites Belcher Pharmaceuticals v. Hospira as proof the current system catches misconduct: the Federal Circuit affirmed that Belcher's patent was unenforceable after its chief science officer withheld FDA-related information from the USPTO.
The bill would instead punish unintentional oversights, the author warns. Companies would respond by sending the USPTO everything, creating a flood of material that examiners would largely set aside. The real fight would move to litigation, where the outcome would depend on whether one or two documents among thousands were overlooked, not on whether the invention was genuinely new and non-obvious. Valuable medicines, he concludes, should not be lost to a paperwork 'gotcha.'