Methodology
Scoring & analysis
- Patent vulnerability score (0-100) — how we score every Orange Book patent for IPR / paragraph IV / design-around risk
- Editorial policy + sourcing — primary sources, refresh cadences, how we handle conflicts
Data sources
- FDA Orange Book — daily sync. Source of truth for US small-molecule patent listings + use codes.
- FDA Purple Book — weekly sync. BLA biologics with BPCIA 12-year reference exclusivity.
- USPTO Patent Public Search + Google Patents — grounded title, abstract, claim 1 text, assignee.
- INPADOC — international family expansion (EP, JP, CN, CA, AU, GB, KR, BR).
- openFDA drugsfda.json — full BLA / NDA submission history including approval dates.
- PTAB E2E API — real-time IPR + post-grant proceeding filings.
- FDA monthly paragraph IV cert list — first-filer alerts.
- PACER — Hatch-Waxman district court filings.
- EU SPC bulletins — DPMA, UKIPO, EPO supplementary protection certificate extensions.
AI grounding
Every LLM output on the platform — patent summaries, drug briefs, company briefs, landscape reports, claim analyses — uses a strict-grounding prompt: the model receives JSON facts pulled from our database and is forbidden from inventing companies, drugs, indications, or numbers not present in those facts. Outputs are post-validated with a hedge-detection filter that rejects responses containing speculative language ("may", "might", "possibly", "likely", "appears"). We use Groq's Llama 3.1 8B model for cost and latency.
Refresh schedule
- Orange Book: daily 03:00 UTC
- Purple Book: weekly Monday 04:00 UTC
- PTAB IPR filings: hourly
- Paragraph IV certifications: daily 05:00 UTC (FDA publishes ~once/month, we poll daily)
- Patent vulnerability scores: daily 06:00 UTC after Orange Book sync
- AI strategic briefs: regenerated when underlying facts change > 10%
- Patent watch alerts: daily 09:00 UTC
Corrections
If you spot something wrong, email hello@druglandscape.com. We log every correction and re-validate the upstream source.