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Creates a statutory safe harbor in 35 U.S.C. 271 that says certain FDA‑related activities about drugs and biological products — such as filing applications, providing descriptions, and engaging in promotion or marketing tied to regulatory submissions — are not, by themselves, acts of patent infringement for method‑of‑use claims. The safe harbor is limited where labeling, promotion, or marketing explicitly references the patented condition(s) of use. The provision defines key terms and applies to conduct and proceedings before, on, or after enactment (i.e., it operates retroactively).
Redesignate existing subsections (h) and (i) of section 271 of title 35, United States Code, as subsections (k) and (l), respectively.
Add new subsection (h)(1)(A): Submitting or seeking approval of a drug application under section 505(j) or section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act, or submitting or seeking approval of an application described in section 505(b)(2), shall not be an act of direct, induced, or contributory infringement of a method-of-use patent claim included in the lists described in section 505(j)(7) or 512(n)(4), provided the application includes the applicable statement for the method-of-use claims and the proposed labeling.
Add new subsection (h)(1)(B): Promoting or commercially marketing a drug product with the labeling approved in an application described in subsection (h)(1)(A) shall not be an act of infringement of the listed method-of-use patent claims.
Add new subsection (h)(1)(C): Describing a drug product approved under section 505(j), section 512(b)(2), or section 505(b)(2) as a generic of, or therapeutically equivalent to, the listed drug referenced in such application shall not be an act of infringement of the listed method-of-use patent claims.
Add new subsection (h)(2): Subparagraphs (A) through (C) of subsection (h)(1) apply only if the labeling, promotion, or commercial marketing does not reference the condition(s) of use claimed in the patent that was identified by the patent owner or assignee to the Secretary under 21 C.F.R. 314.53 and that was the subject of the required statement under the cited FDCA provisions.
Who is affected and how:
Drug and biologic developers and applicants: Companies preparing and submitting regulatory applications, labeling, and submission‑related materials will have clearer protection from being sued for method‑of‑use infringement solely because of those regulatory activities. This reduces the legal chill on preparing and pursuing FDA approvals and related communications.
Generic and biosimilar manufacturers: These firms often engage in activities (e.g., regulatory filings, descriptions of use) that previously could trigger method‑of‑use infringement claims; the safe harbor may lower their near‑term litigation exposure for routine regulatory conduct, but exposure remains if their labeling or promotion explicitly invokes the patented use.
Patent holders (brand companies owning method‑of‑use patents): May see a narrower scope for asserting infringement based solely on regulatory filings or routine communications; they retain the ability to sue where defendants’ labeling or promotion specifically references a patented use, so enforcement focuses more on commercial messaging and labeling strategy.
Health care providers and patients: Indirect effects could include changes in how companies describe uses in labeling and promotional materials; clearer safe harbors might facilitate communication about regulatory matters, but patient access and prescribing decisions are not directly changed by the statute itself.
Courts and litigants: Patent litigation over method‑of‑use claims will need to consider the new statutory safe harbor, especially when assessing whether challenged conduct was merely regulatory activity or impermissible promotion/labeling targeting a patented use. Retroactive application means pending and past disputes may be revisited in light of the new standard.
Overall effect: The law clarifies and narrows the instances where regulatory interactions are treated as method‑of‑use infringement, likely reducing lawsuits based solely on filing or submission activity while shifting enforcement focus to labeling/promotion that expressly targets patented indications. The change raises strategic considerations for patent owners, innovator firms, and generic/biosimilar manufacturers about how labeling and promotional materials are drafted and used in the marketplace.
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Read twice and referred to the Committee on the Judiciary.
Introduced January 9, 2025 by John Wright Hickenlooper · Last progress January 9, 2025
Read twice and referred to the Committee on the Judiciary.
Introduced in Senate