Limiting Patent Lawsuits to Lower Costs of Biological Prescription Drugs.
This Act aims to speed up access to cheaper versions of complex biological drugs (biosimilars) by limiting the ability of brand-name companies to delay competition through patent litigation. It generally caps the total number of patents that can be asserted in a lawsuit against a biosimilar manufacturer at 20. Furthermore, the bill allocates $1.8 billion to the Medicare Improvement Fund to enhance healthcare services for seniors.
Key points
Caps the total number of patents a reference product sponsor can assert in litigation against a biosimilar applicant to 20, promoting faster market entry for cheaper alternatives.
The change is intended to curb tactics that delay competition, potentially leading to lower drug costs for consumers and healthcare systems.
Allocates $1.8 billion to the Medicare Improvement Fund, aimed at improving the administration and delivery of Medicare benefits for the elderly.
Expired
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