Affordable Prescriptions for Patients Act | ChamberLight
Bills · S 1041
PASSED SENATE· 119TH CONGRESS
Senate BillS 1041Inflation and pricesCivil actions and liability
Affordable Prescriptions for Patients Act
INTRO MAR 13· LAST ACTION JUL 21
READING
4MIN
COSPONSORS
3BIPARTISAN
READER REACTIONS0 TOTAL
NO VOTES YET · BE THE FIRST
Reported, not passed
LEGISLATIVE PROGRESS
STEP 4 / 8
Introduced
In Committee
Reported
Passed Senate
Passed House
Conference
To President
Became Law
WHAT THE BILL DOES
AI-written
The Americans most directly affected would be companies that develop and manufacture expensive biologic drugs, known as 'innovator' companies, and companies that develop 'biosimilar' versions of those drugs. Innovator companies would see an expanded scope for what constitutes patent infringement, potentially strengthening their intellectual property, but also face a new limit on the number of patents they can assert in lawsuits against biosimilar developers.
Biosimilar manufacturers would contend with a wider range of patents that could trigger infringement lawsuits, but they could also benefit from the potential cap on the number of patents an innovator can assert, which might streamline the legal process for getting their lower-cost drugs to market. Ultimately, patients might be indirectly affected, as these changes could influence the speed at which more affordable biosimilar drugs become available and the prices they pay for these medications.
KEY PROVISIONS
5AI-extracted
PROVISION 01
Expands the definition of patent infringement to include any patent claiming the biological product, its method of use, or any method or product used to manufacture it, when a biosimilar application is submitted.
This gives original drug companies more grounds to sue biosimilar manufacturers for patent infringement.
PROVISION 02
Limits the number of patents an original drug company can assert in a lawsuit against a biosimilar company to a maximum of 20 patents, with a sub-limit of 10 patents issued after a specific date.
This aims to streamline patent litigation and potentially speed up the market entry of biosimilar drugs.
PROVISION 03
Allows a court to increase the 20-patent limit if there is good cause, such as the biosimilar company failing to provide necessary information or if there are significant changes to the biosimilar product.
This provides flexibility for original drug companies to protect their intellectual property under specific circumstances that warrant additional claims.
PROVISION 04
The 20-patent limit only applies if the biosimilar company completes all required information-sharing actions under the Public Health Service Act.
This incentivizes biosimilar companies to fully comply with established legal procedures for patent dispute resolution.
PROVISION 05
Excludes patents claiming methods of using the biological product in therapy, diagnosis, or prophylaxis (e.g., specific indications or treatment methods) from the 20-patent cap.
This ensures that specific treatment-related innovations remain fully protected without being subject to the patent lawsuit limit.
The Americans most directly affected would be companies that develop and manufacture expensive biologic drugs, known as 'innovator' companies, and companies that develop 'biosimilar' versions of those drugs. Innovator companies would see an expanded scope for what constitutes patent infringement, potentially strengthening their intellectual property, but also face a new limit on the number of patents they can assert in lawsuits against biosimilar developers.
Biosimilar manufacturers would contend with a wider range of patents that could trigger infringement lawsuits, but they could also benefit from the potential cap on the number of patents an innovator can assert, which might streamline the legal process for getting their lower-cost drugs to market. Ultimately, patients might be indirectly affected, as these changes could influence the speed at which more affordable biosimilar drugs become available and the prices they pay for these medications.
KEY PROVISIONS
AI-extracted
high
Expands the definition of patent infringement to include any patent claiming the biological product, its method of use, or any method or product used to manufacture it, when a biosimilar application is submitted.
This gives original drug companies more grounds to sue biosimilar manufacturers for patent infringement.
high
Limits the number of patents an original drug company can assert in a lawsuit against a biosimilar company to a maximum of 20 patents, with a sub-limit of 10 patents issued after a specific date.
This aims to streamline patent litigation and potentially speed up the market entry of biosimilar drugs.
med
Allows a court to increase the 20-patent limit if there is good cause, such as the biosimilar company failing to provide necessary information or if there are significant changes to the biosimilar product.
This provides flexibility for original drug companies to protect their intellectual property under specific circumstances that warrant additional claims.
med
The 20-patent limit only applies if the biosimilar company completes all required information-sharing actions under the Public Health Service Act.
This incentivizes biosimilar companies to fully comply with established legal procedures for patent dispute resolution.
med
Excludes patents claiming methods of using the biological product in therapy, diagnosis, or prophylaxis (e.g., specific indications or treatment methods) from the 20-patent cap.
This ensures that specific treatment-related innovations remain fully protected without being subject to the patent lawsuit limit.
The amendments apply to applications for biosimilar products submitted on or after the date the Act becomes law.
GLOSSARY
AI-written
Patent Infringement
The unauthorized use, manufacturing, sale, or offer for sale of a patented invention, which is protected by law for a period of time.
Reference Product (Innovator Biologic)
The original, already-approved biological product against which a proposed biosimilar product is compared for approval.
Biosimilar
A biological product that is highly similar to an already approved reference biological product, with no clinically meaningful differences in terms of safety, purity, and potency. They are often referred to as 'generic versions' of biologics.
Subsection (k) applicant
A company seeking approval for a biosimilar product through a specific expedited pathway established by the FDA.
ACTION TIMELINE
15 EVENTS
JUL 21
Passed/agreed to in Senate: Passed Senate with amendments by Unanimous Consent.
FLOOR
JUL 21
Passed Senate with amendments by Unanimous Consent. (consideration: CR S4198-4199; text: CR S4199)