Paragraph IV Notice Management demo
Each notice letter on one clock: the 45-day suit window and the 30-month stay drawn from the courier receipt, every argument mapped to the claim it attacks, and the arguments that are new since the last challenger flagged in red. 1:14
What the demo shows
A patent litigation solution for IP counsel that handles Paragraph IV and biosimilar notices.
The hour a notice letter is signed for, the Notice Reader checks it is a valid notice under 21 CFR 314.95 and the Clock Keeper sets the 45-day suit date (moved to the business day before when day 45 falls on a weekend), the 30-month stay and the internal targets, on the docket with alerts. The Contention Mapper links every argument in the detailed statement to the claims and ground it attacks, and the Prior Positions Finder compares each one with every earlier challenge to the same patents: answered before, answered by our own record, or new. The Response Pack Drafter drafts the hold, the outside-counsel briefing and the decision-memo inputs, every statement cited. Counsel reviews; the Chief Patent Counsel signs the suit decision.
Transcript
- Paragraph IV Notice Management handles generic and biosimilar patent challenges for Pharma IP Counsel.
- A notice gives you 45 days to sue or the 30-month stay is lost.
- A notice from Juniper Generics was signed for at 841.
- Dana clicks read the notice.
- 8 of 8 checks pass, and the clock starts.
- Day 45 is a Saturday, so the complaint is due Friday, November 20th.
- Nine arguments are mapped to the eight claims they attack.
- Each is compared with three earlier challengers.
- Seven are answered on file, two are new.
- The release rate argument is still open, so dissolution data is requested.
- Counsel opens the claim chart and response pack the same day, not in two weeks.
- Build on Botminds, agents, data, screens, and governance on on one platform.
Transcribed from the film’s narration. Captions are on the player.