Federal RuleAug 21
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DOL Rewrites Disability Rules for 'Merit-Based Opportunity' Push
RuleLabor DepartmentFederal Contract Compliance Programs OfficeSignificant Wallet
HR890119th CongressWALLET
Stopping Pharma’s Ripoffs and Drug Savings For All Act
Sponsored By: Representative Ryan, Patrick [D-NY-18]
Introduced
Summary
Block double patenting that extends drug exclusivity. This bill would create a legal presumption that when multiple patents are listed for the same drug or biological product, the patent owner must prove each patent claims a patentably distinct invention or else be treated as disclaiming the patent term after the first patent expires. It would also direct the U.S. Patent and Trademark Office to review and improve examination practices and report findings and recommendations to Congress within one year.
Show full summary
- Generic and biosimilar challengers and defendants in 271(e)(2) district court suits: the bill creates a presumption that additional listed patents are disclaimed after the first patent expires unless the patent owner proves distinctness by a preponderance of the evidence. It applies in proceedings under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) and the Public Health Service Act (42 U.S.C. 262(l)).
- Patent owners of drug and biological patents: they must demonstrate each listed patent claims a patentably distinct invention to avoid the disclaimer presumption; if they do, existing patent term extensions must be honored unless the owner expressly disclaims term in writing.
- U.S. Patent and Trademark Office: required to review patent examination procedures for drug and biological product applications, develop and implement better practices to prevent issuance of non‑distinct patents, and submit a report to the House Judiciary Committee within one year.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Limits on drug patents to speed generics
In FDA drug and biologic patent cases and related court fights, later patents would be presumed given up once the first patent ends. Drugmakers could try to prove some later patents cover a different invention. If they cannot, generics or biosimilars could enter sooner, which could lower prices. The patent office would review its exam rules and report to Congress within 1 year. If enacted, these changes would take effect right away.
Sponsors & CoSponsors
Sponsor
Ryan, Patrick [D-NY-18]
NY • D
Cosponsors
There are no cosponsors for this bill.
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov