Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019
Latest action. Ordered to be Reported (Amended).
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.
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Introduced in House" stage on July 25, 2019. It describes the bill, it is not the legal text.
Ordered to be Reported (Amended).
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Where is it in the process, and what happens next?
The latest action on file does not map to a stage Civibrief recognizes, so the page will not name one. The record's own words are the reliable fact here.
The record's latest action, on November 21, 2019: Ordered to be Reported (Amended).
How likely is it to become law?
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In the 116th Congress (2019-20), 344 of the 14,345 bills and joint resolutions introduced became law, about 2.4 percent. That count covers every measure at every stage, including the many that never left committee.
This one has no outstanding steps listed above.
Has anyone actually voted on it?
No. No roll call in this Congress cites this measure. That is the ordinary outcome: most measures never reach a recorded floor vote, and a committee ends most of them simply by not acting.
A vote is not the only thing that happens to a measure. Hearings, markups, and referrals are all recorded actions, and none of them is a vote of the full chamber.
Who is behind it?
Henry Johnson (D-GA) introduced it on July 25, 2019, and 1 member has since signed on as a cosponsor.
They are 1 Republican.
Cosponsoring is a formal signature on the text. It is not a commitment to vote for the measure, it does not bind anyone's party, and a long list of cosponsors is a measure of attention rather than of prospects.
How long has it been in play?
It was introduced on July 25, 2019, 2604 days ago. The most recent recorded action was 2485 days ago, on November 21, 2019.
Measures do not carry over. Anything the 116th Congress has not finished by January 3, 2021 dies when the term ends, and has to be introduced again from the start in the next Congress.
Every answer above is assembled from this measure's own record on Congress.gov and from published counts of what Congress has passed before. Civibrief does not predict outcomes and takes no position on any measure.
Vote history
- HouseOrdered to be Reported (Amended).
- SenateNot stated in the latest action
- PresidentNot stated in the latest action