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HR 3991 116th Congress House Commerce Competition and antitrust Health care costs and insurance Inflation and prices Intellectual property Judicial review and appeals Prescription drugs

Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019

Introduced: July 25, 2019 Introduced by: Johnson, Henry C. "Hank" Democratic · Georgia See on congress.gov
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 Everywhere this bill has been 6 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Nov 21, 2019
Ordered to be Reported (Amended).
Nov 21, 2019
Committee Consideration and Mark-up Session Held.
Nov 19, 2019
Subcommittee on Courts, Intellectual Property, and the Internet Discharged.
Aug 28, 2019
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
Jul 25, 2019
Referred to the House Committee on the Judiciary.
Jul 25, 2019
Introduced in House
 Plain-English summary Congressional Research Service

Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019

This bill limits in certain instances the number of patents that the manufacturer of a biologic drug can assert in a lawsuit against a company seeking to sell a biosimilar version of that drug. (A biologic drug is produced through natural processes or isolated from natural sources. A biosimilar version is substantially similar to the original biologic, which is the reference product, and is often marketed as a less expensive alternative.)

The bill's provisions apply to an existing framework that gives the biosimilar manufacturer an abbreviated path to Food and Drug Administration approval to sell the biosimilar. Specifically, if the biosimilar manufacturer completes certain actions under the framework, such as sharing certain information about its product with the reference product manufacturer, the bill limits the number of certain patents that the reference product manufacturer may assert in a lawsuit, such as patents that were filed more than four years after the reference product received market approval. The limit shall not apply to patents claiming certain methods for using the biologic drug.

The court in which the infringement lawsuit is filed may increase the limit if justice so requires or if there is good cause for the increase.

What's happening now November 21, 2019

Ordered to be Reported (Amended).

 Committees of jurisdiction 2