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Affordable Prescriptions for Patients Act

4/15/2025, 4:23 AM

Summary of Bill S 1041

Bill 119 s 1041, also known as the "Biologics Patent Transparency Act," is a proposed piece of legislation that aims to make changes to title 35 of the United States Code in order to address issues related to the infringement of patents on biological products. The bill seeks to increase transparency and accountability in the patent system for biologics, which are complex drugs made from living organisms.

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.

Current Status of Bill S 1041

Bill S 1041 is currently in the status of Bill Introduced since March 13, 2025. Bill S 1041 was introduced during Congress 119 and was introduced to the Senate on March 13, 2025.  Bill S 1041's most recent activity was Placed on Senate Legislative Calendar under General Orders. Calendar No. 44. as of April 10, 2025

Bipartisan Support of Bill S 1041

Total Number of Sponsors
6
Democrat Sponsors
0
Republican Sponsors
6
Unaffiliated Sponsors
0
Total Number of Cosponsors
3
Democrat Cosponsors
2
Republican Cosponsors
1
Unaffiliated Cosponsors
0

Policy Area and Potential Impact of Bill S 1041

Primary Policy Focus

Commerce

Potential Impact Areas

- Administrative remedies
- Civil actions and liability
- Competition and antitrust
- Consumer affairs
- Drug safety, medical device, and laboratory regulation
- Federal Trade Commission (FTC)
- Health care costs and insurance
- Inflation and prices
- Intellectual property
- Judicial review and appeals
- Manufacturing
- Prescription drugs

Alternate Title(s) of Bill S 1041

A bill to amend title 35, United States Code, to address the infringement of patients that claim biological products, and for other purposes.
A bill to amend title 35, United States Code, to address the infringement of patients that claim biological products, and for other purposes.

Comments

Amari Sharma profile image

Amari Sharma

404

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 profile image

Fatima Willis

497

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 profile image

Langston Solomon

479

8 months ago

I'm all for it, sounds good to me!

Maeve Abrams profile image

Maeve Abrams

398

7 months ago

This bill is so confusing. It's gonna mess everything up for me.