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IL HB4822

Bill

Status

Introduced

2/11/2020

Primary Sponsor

Tom Demmer

Click for details

Origin

House of Representatives

101st General Assembly

AI Summary

  • Creates the Preserving Access to Affordable Drugs Act to regulate patent settlement agreements in pharmaceutical transactions between brand-name drug companies and generic/biosimilar manufacturers.

  • Presumes agreements resolving patent infringement claims are anticompetitive violations if a generic/biosimilar filer receives "anything of value" AND agrees to limit or delay research, development, manufacturing, marketing, or sales of its drug product.

  • Establishes safe harbor exceptions for settlements that include: marketing rights before patent expiration, covenants not to sue, documented litigation cost compensation (capped at $7.5 million or 5% of projected revenue), trigger-based entry provisions, regulatory approval assistance, or forgiveness of at-risk launch damages.

  • Imposes civil penalties of up to 3 times the value received by violators (minimum $20 million) or 3 times the value given to other parties (minimum $20 million), recoverable through Attorney General enforcement with a 4-year statute of limitations.

  • Prohibits presumptions that patents are enforceable, that delayed entry is necessary, or that agreements caused no competitive harm without final court adjudication, while presuming the relevant market consists of the brand drug and competing generic/biosimilar versions.

Legislative Description

ACCESS TO AFFORDABLE DRUGS

Last Action

Rule 19(b) / Re-referred to Rules Committee

6/23/2020

Committee Referrals

Rules6/23/2020
Prescription Drug Affordability & Accessibility3/12/2020
Rules2/18/2020

Full Bill Text

No bill text available