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Affordable Prescriptions for Patients Act
4/15/2025, 4:23 AM
Summary of Bill S 1041
One of the key provisions of the bill is the requirement for the Secretary of Health and Human Services to establish a public database of patents related to biologics. This database would provide information on the patents held by manufacturers of biologics, as well as any patent disputes or litigation that may be ongoing. This increased transparency is intended to help prevent the infringement of patents on biologics and ensure that manufacturers are held accountable for their intellectual property rights.
Additionally, the bill includes provisions to streamline the patent dispute resolution process for biologics. This includes establishing a process for the timely resolution of patent disputes, as well as mechanisms for the sharing of information between patent holders and potential infringers. By making it easier for patent holders to enforce their rights and for potential infringers to understand their obligations, the bill aims to reduce the likelihood of patent infringement in the biologics industry. Overall, Bill 119 s 1041 is designed to protect the intellectual property rights of manufacturers of biologics and promote innovation in the development of these important medical products. By increasing transparency and accountability in the patent system for biologics, the bill seeks to ensure that patients have access to safe and effective treatments while also respecting the rights of patent holders.
Congressional Summary of S 1041
Affordable Prescriptions for Patients 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.
Read the Full Bill
Current Status of Bill S 1041
Bipartisan Support of Bill S 1041
Total Number of Sponsors
6Democrat Sponsors
0Republican Sponsors
6Unaffiliated Sponsors
0Total Number of Cosponsors
3Democrat Cosponsors
2Republican Cosponsors
1Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill S 1041
Primary Policy Focus
CommercePotential Impact Areas
Alternate Title(s) of Bill S 1041
Comments

Amari Sharma
8 months ago
I think this bill is not good because it may make it harder for people to access important biological products. This could affect me personally because I rely on certain medications that could become more expensive or harder to get if this bill passes. It's important to consider how this bill could impact individuals who depend on these products for their health and well-being.

Fatima Willis
8 months ago
I dunno bout this bill, seems like it could be bad for us patients who need biological products. How does this affect me and others like me? #confused #notsure

Langston Solomon
8 months ago
I'm all for it, sounds good to me!

Maeve Abrams
7 months ago
This bill is so confusing. It's gonna mess everything up for me.


