Competitive DRUGS Act of 2019
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Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 or the Competitive DRUGS Act of 2019
This bill authorizes the Federal Trade Commission to initiate a proceeding against parties to an agreement resolving or settling a patent infringement claim in connection with the sale of a drug. Such an agreement is generally presumed to be an unfair method of competition and is a violation of this bill if the filer of the generic drug application receives something of value and agrees to limit or forgo research, development, manufacturing, marketing, or sales of the generic drug.
However, an agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market the generic drug prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on a claim that the generic drug infringes a patent. An agreement if also exempt if the agreement's pro-competitive benefits outweigh its anticompetitive effects.
The bill establishes penalties for violations of the bill.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
- Introduced in House Formatted Text PDF Formatted XML
Cite this page
U.S. Congress. (2026). H.R. 1344: Competitive DRUGS Act of 2019. 116th Congress. Open America. https://openamerica.io/bill/116-HR-1344/
"H.R. 1344: Competitive DRUGS Act of 2019." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-HR-1344/.
H.R. 1344, 116th Cong. (2026), https://openamerica.io/bill/116-HR-1344/.
[H.R. 1344: Competitive DRUGS Act of 2019](https://openamerica.io/bill/116-HR-1344/)