Forward to: IP & Legal

Patent Expiry &
Generic Monitor Workflows

Ten agent workflows for IP & Legal — patent cliff tracking, generic entry monitoring, biosimilar intelligence, paragraph IV filings, patent litigation tracking, 180-day exclusivity analysis, REMS-based protection, lifecycle management signals, IP strategy benchmarking, and patent dashboard — enabling data-driven IP decisions powered by comprehensive domain intelligence.

1Patent Cliff Monitoring

AI agent monitors pharmaceutical company domains and patent databases to track upcoming patent expirations, LOE dates, and revenue exposure across the industry portfolio.

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Track Patent Expiration Timeline
/investors/press/legalOpenPageRank
PATENT CLIFF INTELLIGENCE — $280B AT RISK (2026-2030) ════════════════════════════════════════════════════════ CRITICAL EXPIRATIONS (2026-2027): merck.com — Keytruda (pembrolizumab) /investors: $25B annual revenue — patent expires 2028 /legal: 100+ patents in thicket — litigation ongoing SIGNAL: Largest patent cliff in pharma history abbvie.com — Humira biosimilar erosion /investors: Revenue declined 38% — 12 biosimilars launched /press: Aggressive biosimilar pricing — ASP down 82% SIGNAL: Humira erosion faster than expected — our biosimilar pricing model bms.com — Eliquis (apixaban) /investors: $12.2B revenue — patent expiry 2026 /legal: Paragraph IV settlement with generics SIGNAL: Eliquis generics expected Q4 2026 — formulary impact imminent

2Generic Entry Intelligence

AI agent monitors generic pharmaceutical company domains to detect ANDA filings, paragraph IV certifications, manufacturing approvals, and launch timing signals.

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Detect Generic Entry Signals
/products/press/investorsIAB Categories
GENERIC ENTRY DETECTION ════════════════════════════════════════════════════════ tevaapi.com — Teva Pharmaceutical /products: 14 new ANDA filings targeting $42B in brand revenue /press: First-to-file on 3 blockbusters — 180-day exclusivity SIGNAL: Teva targeting our Product X — ANDA filed sandoz.com — Novartis spinoff /products: Biosimilar pipeline — 12 programs /investors: Revenue $10.2B — largest biosimilar company /press: Humira biosimilar gaining 22% market share THREATS TO OUR PORTFOLIO: Product X ($4.2B): 3 ANDA filers — generic entry expected 2027 Product Y ($1.8B): 1 paragraph IV filing — litigation pending Product Z ($2.4B): No filings detected — patent strong through 2031

3Biosimilar Competition Tracking

AI agent monitors biosimilar developer domains to track development programs, regulatory approvals, and commercial launch signals for biologic products approaching patent expiry.

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Track Biosimilar Development
/products/press/investorsOpenPageRank
BIOSIMILAR COMPETITIVE LANDSCAPE ════════════════════════════════════════════════════════ Target Biologic Biosimilars Status Revenue Impact Humira (adalimumab) 12 Launched -$18B Stelara (ustekinumab) 6 Phase 3/Filed -$8B by 2028 Keytruda (pembro) 4 Phase 1-3 -$25B by 2030 Eylea (aflibercept) 3 Filed/Approved -$6B by 2027 OUR BIOLOGIC PORTFOLIO EXPOSURE: Products with biosimilar filings: 3 of 8 Revenue at risk (5-year): $12.4B DEFENSE: Patent thicket on Product A — 84 patents through 2034 VULNERABILITY: Product B — only 12 patents — biosimilar expected 2028

4Patent Litigation Intelligence

AI agent monitors court filings, patent trial board proceedings, and law firm domains to track patent litigation outcomes that affect pharmaceutical market exclusivity.

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Track Patent Litigation
/legal/press/investorsOpenPageRank
PATENT LITIGATION TRACKER ════════════════════════════════════════════════════════ ACTIVE LITIGATION: uscourts.gov — District of Delaware Product X v. Teva: Trial date June 2026 Product X v. Mylan: Settlement negotiations ongoing RISK: If Teva prevails, generic entry accelerates 18 months ptab.uspto.gov — Patent Trial Board IPR2026-00142: Product Y composition patent challenged ALERT: PTAB instituted review — 45% chance of invalidation LITIGATION PORTFOLIO: Active cases: 14 | Our patents challenged: 8 Win rate (last 5 years): 72% Settlements executed: 4 (avg 18-month delay of generic entry) STRATEGY: Settle Product X/Mylan — focus resources on Teva trial

5Lifecycle Management Intelligence

AI agent monitors competitor lifecycle strategies — new formulations, delivery systems, line extensions, and authorized generics — to inform defensive and offensive IP strategies.

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Track Lifecycle Strategies
/products/press/investorsIAB Categories
LIFECYCLE MANAGEMENT INTELLIGENCE ════════════════════════════════════════════════════════ abbvie.com — Post-Humira playbook /products: Skyrizi + Rinvoq — $16B combined, replacing Humira /press: Successful lifecycle transition — model to study INSIGHT: AbbVie's succession strategy is industry gold standard novonordisk.com /products: Ozempic → oral semaglutide → CagriSema — continuous innovation /press: Each generation extends market exclusivity by 5+ years SIGNAL: Our GLP-1 lifecycle needs similar multi-generation strategy OUR LIFECYCLE STATUS: Products with succession plans: 4 of 8 Line extensions filed: 6 Authorized generic strategy: Deployed for Product C GAP: Product B has no lifecycle defense — needs immediate attention

6180-Day Exclusivity Analysis

AI agent tracks first-to-file generic applicants and 180-day exclusivity awards to predict generic launch timing and inform commercial preparation strategies.

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Track Exclusivity Awards
/products/press/complianceOpenPageRank
180-DAY EXCLUSIVITY TRACKER ════════════════════════════════════════════════════════ Product First-to-File Exclusivity Generic Launch Product X tevaapi.com Awarded Q3 2027 Product Y sandoz.com Pending Q1 2028 est. Product Z None N/A 2031+ IMPACT ANALYSIS: Product X: Teva 180-day exclusivity = $2.1B revenue loss in Year 1 After exclusivity: Multi-source = 80-90% price erosion STRATEGY: Launch authorized generic Day 1 to capture 15-20% of generic market

7REMS & Market Protection

AI agent monitors REMS programs and distribution restrictions that provide market protection, tracking FDA signals and competitor challenges to REMS-based strategies.

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Track REMS Protection Status
/compliance/docs/pressOpenPageRank
REMS PROTECTION INTELLIGENCE ════════════════════════════════════════════════════════ fda.gov /compliance: Shared REMS rule — eliminates REMS-based blocking /docs: Updated guidance on shared REMS for generic companies ALERT: Our REMS-based protection strategy weakening OUR REMS PRODUCTS: Product D: Full REMS with ETASU — shared REMS requirement pending Product E: Communication plan only — minimal generic impact ACTION: Prepare shared REMS implementation for Product D

8International Patent Intelligence

AI agent monitors patent offices and regulatory agencies globally to track international patent expirations, SPCs, and data exclusivity periods across major markets.

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Track Global Patent Status
/legal/products/complianceCountries
GLOBAL PATENT INTELLIGENCE ════════════════════════════════════════════════════════ Product X — Global Patent Map: US: Expires 2027 | EU (SPC): Expires 2028 Japan: Expires 2027 | China: Expires 2026 Brazil: No patent grant | India: Compulsory license risk GEOGRAPHIC RISK HEAT MAP: Low risk: US, EU, Japan (patent + data exclusivity) Medium: China, South Korea (patent but weak enforcement) High: India, Brazil (limited or no protection) STRATEGY: Maximize revenue in protected markets while exclusivity holds

9IP Strategy Benchmarking

AI agent benchmarks IP strategies across the pharmaceutical industry, tracking patent filing patterns, prosecution success rates, and defensive strategies that inform IP portfolio optimization.

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Benchmark IP Strategies
/legal/investors/pressOpenPageRank
IP STRATEGY BENCHMARKING ════════════════════════════════════════════════════════ Company Patents/Product Thicket Depth Defense Score abbvie.com 132 Deep 9.4/10 bms.com 98 Strong 8.8/10 merck.com 104 Strong 8.5/10 Our Company 56 Medium 6.8/10 GAPS IDENTIFIED: Patent thicket depth: 56 vs industry avg 98 patents per product Formulation patents: Underinvested Method of treatment: Limited — need more indication-specific claims RECOMMENDATION: File 40+ additional patents on top 4 products

10IP Portfolio Dashboard

AI agent synthesizes all patent intelligence into an executive dashboard — providing leadership with real-time visibility into patent cliffs, litigation status, and IP protection strategies.

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Generate IP Intelligence Dashboard
/legal/investors/pressOpenPageRankIAB Categories
IP PORTFOLIO DASHBOARD — FEBRUARY 2026 ════════════════════════════════════════════════════════ PATENT CLIFF EXPOSURE: Revenue at risk (5-year): $12.4B Products with succession plans: 4 of 8 Generic/biosimilar filings detected: 7 LITIGATION: Active cases: 14 | Win rate: 72% Key trial: Product X v. Teva — June 2026 DEFENSE: Patent thicket score: 6.8/10 (below peer avg 8.5) REMS protection: Weakening under new FDA rules
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Generate IP Report

IP & Patent Report — February 2026

EXECUTIVE SUMMARY ──────────────────────────────────────── Generic companies tracked: 48 domains Biosimilar developers: 24 domains Patent databases: 6 jurisdictions Court filings: 14 active cases KEY INSIGHTS $12.4B in revenue at risk over 5 years from patent expirations and generic/biosimilar entries. Patent thicket depth below industry average — immediate filing program needed. Keytruda patent cliff ($25B) reshaping entire industry. Authorized generic strategy should be deployed for Product X. Product B lifecycle defense gap is critical vulnerability.
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