Loss of exclusivity tracking that recomputes every generic entry date when a patent, court or settlement changes
Every patent, court and settlement change becomes a decided, cited generic entry date for each market within hours.
See one case, screen by screen ↓A product’s real loss-of-exclusivity date is rarely one patent. It is the compound patent with its term extension, the method-of-use and formulation patents, pediatric exclusivity, the SPCs country by country — and, often, a settlement whose licensed entry date accelerates only if a specific set of patents falls. Any one PTAB decision, Paragraph IV letter or register entry can move it.
In most legal departments that map lives in a spreadsheet. Someone has to notice the docket entry, read the decision, re-read every settlement for its acceleration clause, redo the arithmetic market by market and get counsel to agree before Finance hears about it. Meanwhile a 45-day suit window is already running from the day the notice letter arrived.
Estimated split for one source event that touches a product’s dates, by spreadsheet and with the solution.
Six specialist agents watch the sources, read every decision, recompute entry dates and keep the legal clocks; the chief patent counsel decides.
On Oct 2 the PTAB institutes inter partes review of Corventa’s ’418 formulation patent. Here is what happens next, screen by screen, in the working solution.
Omar opens the exclusivity horizon for Northwind Bio: 4 products, 8 markets, 212 patents, 41 exclusivities and 13 settlements watched. 32 dates of record, $12.7B a year under exclusivity, 5 decisions open — 2 of them his — and the next clock, a 45-day suit deadline, 43 days out.
“Revenue at risk across all 32 product-markets: $28.8B.”
The monitor sweeps every watched source every 6 hours, and anyone can run it on demand: USPTO status and term extensions, the PTAB docket, court dockets, the Orange Book, Purple Book and Paragraph IV list, the EPO Register and SPC registers, and the JPO and CNIPA gazettes. This run finds a scheduling order in IPR2026-01187, the Halvard trial date confirmed for Jan 11, 2027, and the October Orange Book update showing 9 Corventa filers.
“Sweep complete. No new change; one docket entry added to CHG-2611. Dates of record unchanged.”
The PTAB has instituted review of all 14 claims of the ’418, finding a reasonable likelihood that at least one is unpatentable; a final written decision is due by Oct 2, 2027. The reader logs the patent owner response due Jan 4, 2027. The settlement reader goes back through all six Corventa settlements: §3.3 acceleration needs final decisions against both the ’418 and the ’772.
The source passage — “ORDERED that inter partes review of claims 1–14 … is instituted on all grounds” — sits highlighted beside the change.
The US date of record stays at Mar 1, 2036, the settled filers’ licensed entry date. But the downside — entry on Sep 15, 2033, when the ’207 compound patent and its pediatric exclusivity end — now needs only the ’772 trial to go against Northwind. The proposal: keep the date, raise the downside likelihood from 20% to 40%.
“Decides: Omar Haddad, Chief Patent Counsel · an agent proposes, a person decides.”
Omar could keep the downside at 20% or ask Dana Okafor for the litigation view. He accepts and sends it to Finance. The date of record and the 40% downside go to the long-range plan feed, Sam Patel in Finance is notified, and both steps land on the audit trail. Undo is one click away.
The Corventa US map lays out every barrier a challenger faces: the ’207 compound patent with its PTE capped at 14 years, NCE exclusivity ended Mar 2024, the ’772 method-of-use patent in litigation, the ’418 formulation patent under IPR, the ’903 process patent not asserted, and the six settled filers’ licensed entry — the barrier that binds. Each layer opens its source.
“Expected entry is the earlier of the two: Mar 1, 2036.”
Switch on “’418 claims cancelled in the IPR” and “’772 held invalid at trial” and the date recomputes: Sep 15, 2033, 2 years 6 months earlier, set by the ’207 compound patent with PTE and pediatric exclusivity. The settled filers’ acceleration clause triggers. The case can be saved as a scenario or sent to Finance.
Brightwell Pharma’s notice letter is dated Oct 2 and arrived Oct 5. It challenges the ’772 and ’418 and certifies paragraph III on the ’207. The suit window ends Nov 19, 2026; a timely suit stays approval to Apr 5, 2029. The proposal: sue on both patents and join the Halvard and Ivel action set for trial on Jan 11, 2027.
The Clock Keeper counts from the received date, never the letter date.
Eight changes have landed since the Q3 summary. The Q4 draft brings them in: Veltrimab in Japan moved from Dec 2030 to Oct 2032 after the term extension was granted, and the Corventa US downside is now carried at 40%. Every figure is cited. Omar signs as counsel, and it goes to commercial leadership for sign-off.
The dashboard shows changes caught, the median time from source event to recomputed date, the share decided the same day and statutory clocks met — beside revenue under exclusivity by year, years of exclusivity left per product and market, and challengers by product: settled, litigating or new.
The same portfolio, seen by the four people who carry it — what their quarter looked like, and what it looks like now.
Six specialist agents watch the sources, read every decision, recompute entry dates and keep the legal clocks; the chief patent counsel decides.
Watches patent offices, PTAB and court dockets, the FDA Orange and Purple Book, the Paragraph IV list and SPC registers, and opens a change for anything that touches a product.
Reads decisions, certificates, letters and listings and extracts claim type, expiry, PTA/PTE/SPC and paediatric terms — applying the 14-year PTE cap and the 15-year SPC cap, with the arithmetic shown.
Reads settlement and licence agreements for licensed entry dates, acceleration triggers, volume limits and territories, and re-checks the triggers when a change touches a licensed patent.
Recomputes expected entry per product and market — the earlier of the settled licensed date and the end of the last barrier a non-settled challenger faces — and records the binding barrier and the downside case.
Computes statutory clocks — the 45-day suit window, the 30-month stay, IPR responses, the patent dance, PTE and SPC filing windows — and assigns each an owner.
Drafts the quarterly loss-of-exclusivity summary from the dates of record, the changes and the clocks, in plain words for leadership.
Decides the date of record. The agents propose; a named person decides.
Ask what sets a date, what could move it or which clocks are running — or tell it to add a rule. Every answer is cited.
Why is Corventa’s US entry March 2036?
Because six challengers settled for a licensed entry date of Mar 1, 2036, and the three that did not settle are blocked longer — by the ’772 method-of-use patent to May 2036 and the ’418 formulation patent to Feb 2038, both with pediatric exclusivity. The date moves only if both patents fall in final decisions; then the settled filers accelerate and entry becomes Sep 15, 2033.
What happens if the IPR cancels the ’418?
Cancelling the ’418 alone does not move the date: the ’772 still blocks unlicensed filers to May 2036, later than the settled Mar 1, 2036. It matters together with the ’772 trial. A final decision is due by Oct 2, 2027, and our response by Jan 4, 2027.
Show the Veltrimab downside in the US
In the downside, biosimilars clear the ’880 process, ’613 treatment and ’036 formulation patents; the last barrier is then the antibody patent with its capped extension — Jul 14, 2031 — instead of the settled Jan 31, 2033. Kestrel and Marlowe would accelerate too.
Add a rule: alert me if any settlement acceleration could trigger
Done. The monitor now watches every decision on a licensed patent and every third-party launch, and alerts you the same hour if a settled filer’s acceleration clause could trigger. The rule is on in Settings and on the audit trail.
13 screens from the working solution, on its sample data. Pick one to see it large.
How dates are computed, who decides and when people are warned are settings, not a project.
| Setting | Default | Choose from |
|---|---|---|
| Count pediatric exclusivity | Once granted | Once granted · Once the written request is accepted |
| Generic launch assumption | On the day the last barrier ends | On the day the last barrier ends · 30 days after · 90 days after |
| Downside case | Every open challenge decided against us | Every open challenge decided against us · Only challenges already instituted or tried |
| Revenue at risk uses | LRP v3 · Sep 26, 2026 | LRP v3 · Sep 26, 2026 · LRP v2 · Jun 2026 |
| Who decides the date of record | Omar Haddad | Omar Haddad · Dana Okafor · Priya Raman · Sam Patel · Lena Ortiz · Dr. Maya Chen |
| Who owns suits and statutory clocks | Dana Okafor | Omar Haddad · Dana Okafor · Priya Raman · Sam Patel · Lena Ortiz · Dr. Maya Chen |
| Finance feed recipient | Sam Patel | Omar Haddad · Dana Okafor · Priya Raman · Sam Patel · Lena Ortiz · Dr. Maya Chen |
| Alert rules | 6 rules, 5 on | Each on or off: new Paragraph IV notice or biosimilar application · IPR, opposition or invalidation filed · a date moving by three months or more · clock reminders at 30, 14 and 7 days · patent lapse risk · Orange Book listing questioned |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample portfolio · “target” = the design goal, measured in the live solution · “estimated” = team estimate · “typical” = published statute (21 USC 355(j): the 45-day suit window and 30-month stay; also 35 USC 156 and EU Regulation 469/2009). People and companies named on this page are characters in the working solution.
Keeping, for each product and country, the date generics or biosimilars can enter and what sets it: patents with their extensions, regulatory exclusivities, SPCs, pediatric terms, challenges and settlements. Exclusivity Cliff Monitor keeps that map live, recomputes it when a source changes, and cites every value to its source document.
The Entry Date Calculator takes the earlier of the settled licensed entry date and the end of the last barrier a non-settled challenger faces, including term extensions and pediatric exclusivity. It records which barrier binds, runs the downside case, and shows the chain of reasoning with citations. It proposes; counsel decides the date of record.
Yes. The Settlement Terms Reader extracts licensed entry dates, acceleration triggers, volume limits and territories, and quotes the clause rather than paraphrasing it. When a change touches a licensed patent, it re-checks which triggers the change could satisfy. Settlement terms are visible to Legal roles only.
USPTO patent status and term extensions, the PTAB and court dockets, the FDA Orange Book, Purple Book and Paragraph IV list, the EPO Register, national SPC registers, the JPO and CNIPA gazettes, and the legal mailbox for notice letters. It also reads your IP management system and contract system.
Yes. The Clock Keeper computes the 45-day suit window, the 30-month stay, IPR response dates, the patent dance and PTE and SPC filing windows from the received date in the source, assigns each an owner, and sends reminders at 30, 14 and 7 days, escalating to the Chief Patent Counsel at 7.
Yes. Agents propose a date and a downside with the binding barrier and citations. Only the Chief Patent Counsel can move a date of record, Finance receives only decided dates, and every agent step and human decision is on the audit trail.
Yes. When pediatric exclusivity counts, the generic launch assumption, what the downside case assumes, which long-range plan prices the revenue at risk, who decides and the alert rules are all settings.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your patent estate, listings, settlements and planning assumptions — and it goes live once every quality gate has passed. We will walk you through it on one of your own products first.
Every generic or biosimilar challenge gets its clocks set and a cited response pack the same day, with weeks left to decide.
1-min filmThird-Party ContractsEvery contract on their paper redlined against your playbook and back in under two days.
1-min filmAlliance ObligationsEvery licence and collaboration becomes a live register of obligations, with each milestone caught within a day of its trigger.
1-min filmWe’ll run Exclusivity Cliff Monitor on one of your own products and its patent estate.