S-2658 — Medication Affordability and Patent Integrity Act

YourVoice.Now 摘要

企业利益透明度与问责制

Drug firms would have to tell the FDA and the patent office the same facts — or risk losing patent suits.

企业利益

Drug patent owners' lawsuits — can fail if required facts were hidden

A new rule in patent law would give a company sued over a drug patent a way to fight back. It would work if the patent owner, or a past owner, failed to share the facts it had to. That failure can be careless or on purpose.

Firms tied to China, Russia, Iran — barred from new patent defense

The committee added a limit. Firms tied to six named nations could not use the new defense. They are China, Russia, Iran, North Korea, Cuba, and Venezuela under Maduro. A U.S. security law already lists which firms count.

透明度与问责制

Drugmakers' patent claims — must match what they tell the FDA

A company that wants FDA approval would have to state that, as far as it knows, its patent facts match what it told the patent office. It would also tell the patent office its filing there is full and matches what the FDA saw.

Drugmakers' patent facts given to FDA — shared with patent office

Facts that bear on whether a drug deserves a patent, and that a company gives the FDA, would also go to the patent office. So would the FDA's answers. This covers lab data on how a drug is made and claims about earlier inventions.

Skipping the FDA patent statement — becomes a drug law violation

Failing to file the statement to the FDA would be added to the list of banned acts in federal drug law. The bill does not make the patent-office statement part of that list.

Public view of drug patents — patent office may release some data

Data sent to the patent office would stay as secret as it is at the FDA. The committee added one catch. The patent office may share facts the public needs to see what a patent covers.

关于本法案的更多内容

Drug companies would have to tell the patent office and the FDA the same facts about their medicines. Right now, federal drug law does not require those two accounts to match. The rule covers brand-name drugs and biological products (medicines made from living cells). Companies would also have to send the patent office what they tell the FDA about a patent, plus the FDA's replies. It applies to new drug applications filed after the law takes effect. For drugs already in the pipeline, it covers only new patents and new filings after that date. Most people would see no direct change in what they pay. The bill's name points to drug prices, but the text sets no price limit or cost rule. A company that skips its FDA patent statement would break federal drug law. A company sued for copying a patented drug could also fight back in court. It could argue the patent owner carelessly or on purpose held back facts it had to share. Firms tied to China, Russia, Iran, North Korea, Cuba, or Maduro's Venezuela could not use that defense. Shared data would stay protected as trade secrets. The patent office could still release facts the public needs to understand what a patent covers.

国会摘要

Medication Affordability and Patent Integrity Act This bill requires applicants seeking approval of a drug or licensure of a biological product to submit certain information about relevant patents to both the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO). Specifically, the bill requires applicants to make certifications and disclosures related to each applicable patent on a proposed drug or biological product. An applicable patent is a patent or patent application held or sought by the applicant for the drug or biological product (including a formulation or composition, method of use, or method of manufacturing). For each applicable patent, an applicant must submit to the USPTO any information material to patentability that the applicant submitted to the FDA and any information provided by the FDA in response. The applicant must certify that this submission is complete and consistent with the information the applicant provided to the FDA. Further, for each applicable patent, an applicant must certify that certain information submitted to the FDA is consistent with information the applicant provided to the USPTO. This is specific to statements or characterizations that are material to patentability and related to (1) an applicable patent (including a statement or characterization of relevant publicly known information), or (2) analytical data included in a new drug or biological product application. The bill establishes a defense to a patent infringement action if the owner of an applicable patent negligently or intentionally failed to make the disclosures required by these provisions.

立法主题

Drug safety, medical device, and laboratory regulation通货膨胀与价格知识产权制造业处方药

详细信息

国会届次: 119th
议院: SENATE
状态: 全院审议中
行动: Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.
行动日期: 2026-07-28
添加日期: 2026-10-20
来源: Congress.gov →

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