US Congress Senate Bill 1416 (Prior Session Legislation)

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Spectrum: Bipartisan Bill
Status: Introduced on May 9 2019 - 25% progression, died in chamber
Action: 2019-06-28 - Placed on Senate Legislative Calendar under General Orders. Calendar No. 132.
Text: Latest bill text (Introduced) [PDF]

Prohibits patent thicketing and product hopping by drug manufacturers. In general, patent thicketing occurs when a drug manufacturer obtains new patents related to a previously-patented drug, biological product, or underlying chemical composition that extends the manufacturer’s market exclusivity for that drug without demonstrating that the new patents serve a meaningful purpose other than limiting competition from generic drug manufacturers.Product hopping is presumed when a drug manufacturer obtains removal of a drug from the Food and Drug Administration’s approved drug list, discontinues a drug, or markets a reformulation of an already-approved drug during a certain period after which the manufacturer has been notified that a competing drug manufacturer has applied for generic drug approval. These practices are not considered product hopping if the manufacturer demonstrates that the drug was removed from the approved-drug list for safety reasons. Or, in the case of a drug reformulation, the manufacturer shows that the modified product provides a significant health benefit, is the option least likely to reduce competition, and is based on substantial financial considerations unrelated to limiting competition.The Federal Trade Commission may penalize violating manufacturers and bring claims in federal court to prohibit the conduct and provide restitution.

Affordable Prescriptions for Patients Act of 2019

Sen. John Cornyn [R-TX]	Sen. Richard Blumenthal [D-CT]	Sen. Shelley Capito [R-WV]	Sen. Patty Murray [D-WA]
Sen. Rick Scott [R-FL]	Sen. John Kennedy [R-LA]	Sen. Josh Hawley [R-MO]	Sen. Richard Durbin [D-IL]
Sen. Angus King [I-ME]	Sen. Tina Smith [D-MN]	Sen. Gary Peters [D-MI]	Sen. Martha McSally [R-AZ]
Sen. Deb Fischer [R-NE]	Sen. Pat Toomey [R-PA]

Date	Chamber	Action
2019-06-28	Senate	Placed on Senate Legislative Calendar under General Orders. Calendar No. 132.
2019-06-28	Senate	Committee on the Judiciary. Reported by Senator Graham with an amendment in the nature of a substitute. Without written report.
2019-06-27	Senate	Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
2019-05-09	Senate	Read twice and referred to the Committee on the Judiciary.

HB3991 (Related) 2019-11-21 - Ordered to be Reported (Amended).
HB4398 (Related) 2019-10-02 - Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
HB5133 (Related) 2020-12-24 - Placed on the Union Calendar, Calendar No. 578.

Type	Source
Summary	https://www.congress.gov/bill/116th-congress/senate-bill/1416/all-info
Text	https://www.congress.gov/116/bills/s1416/BILLS-116s1416is.pdf
Text	https://www.congress.gov/116/bills/s1416/BILLS-116s1416rs.pdf