Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Latest action. Ordered to be Reported in the Nature of a Substitute by voice voteA vote decided by which side sounds louder. No individual positions are recorded, so no member can be held to a position afterward.Read the full definition (opens a new tab).
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
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 April 28, 2021. It describes the bill, it is not the legal text.
Ordered to be Reported in the Nature of a Substitute by Voice Vote.
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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 September 30, 2021: Ordered to be Reported in the Nature of a Substitute by Voice Vote.
How likely is it to become law?
Civibrief does not forecast outcomes and this page has no opinion about this one. What the record supports is a base rate, which is a fact about the whole pile, not a prediction about this measure.
In the 117th Congress (2021-22), 362 of the 15,242 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 April 28, 2021, and 2 members have since signed on as cosponsors.
They come from both major parties: 1 Democrat, 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 April 28, 2021, 1961 days ago. The most recent recorded action was 1806 days ago, on September 30, 2021.
Measures do not carry over. Anything the 117th Congress has not finished by January 3, 2023 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 in the Nature of a Substitute by Voice Vote.
- SenateNot stated in the latest action
- PresidentNot stated in the latest action