LexHow we rank Hatch-Waxman ANDA practice.
Six performance signals drawn from PACER and FDA Orange Book data. Draft methodology — the ANDA bar is small and a separate cohort definition is required.
Draft · Coming 2026Last updated May 18, 2026
Hatch-Waxman litigation is its own discipline. The 30-month stay, Paragraph IV certification, the FDA Orange Book listing dynamic, and the brand-vs-generic structural divide all make it different from general patent litigation — different enough to deserve its own methodology.
Every signal traces back to PACER docket data joined with FDA Orange Book entries. We track the full lifecycle from Paragraph IV notice through final approval, including launch-at-risk scenarios and settlement-with-launch-date arrangements.
This is a draft methodology. The brand and generic streams are weighted differently because their objectives differ — settlement-with-favorable-launch-date is a generic win that would look like a loss under a generic patent-litigation methodology.
Six signals. Six weights.
Different weights for brand vs. generic streams. The signal labels match across streams; the weights don't.
ANDA case volume
Total Hatch-Waxman cases in the window. Lower threshold than general patent litigation because the bar is smaller.
Paragraph IV outcomes
For generics: certification success and at-risk launch viability. For brands: stay maintenance and exclusivity preservation.
30-month stay strategy
How effectively the 30-month statutory stay is used (brands) or compressed (generics) through procedural tactics.
Settlement timing
For generics: earliest favorable launch date secured. For brands: latest acceptable launch date locked in via settlement.
Trial outcomes
Verdicts and infringement/validity findings. Jury and bench trials weighted equally given the bench-trial prevalence in Hatch-Waxman.
Generic launch patterns
For generics: actual launch within or ahead of settlement-date. For brands: successful Citizen Petition or 180-day exclusivity strategy.
How the math works.
Every signal is normalized within a peer cohort, then weighted into a composite score.
Cohort-relative percentiles, not absolute counts
Within each ranking, firms and attorneys are grouped into two streams (brand-name practice, generic practice) plus three firm-size brackets. Inside each cohort, every signal is converted to a percentile rank.
This is why a 30-attorney specialty boutique can outrank a global AmLaw firm on the same signal — volume alone doesn’t win the comparison.
Weighted blend, capped at 100
Each signal’s percentile is multiplied by its weight, then summed. Final scores are rescaled to a 0–100 range so cross-cohort comparison is meaningful.
Worked example: (0.73 × 25) + (0.68 × 20) + …
What’s included.
- Firms with at least 10 Hatch-Waxman cases in the window
- All ANDA filings tracked, both Paragraph IV and Paragraph III
- Brand and generic representation tracked as separate streams
- Biosimilar BPCIA cases tracked separately (not yet ranked)
- Settlements with launch-date terms classified by date achieved
What we don’t measure.
- Patent prosecution of the Orange-Book-listed patents (separate ranking)
- FDA regulatory practice without litigation
- Citizen Petition work outside an ongoing case
- PTAB challenges to Orange Book patents (separate PTAB ranking)
- International ANDA equivalents (Canada, EU regulatory data exclusivity)
What changed — and when.
Methodology changes are dated and archived. The Draft v0.2 edition remains accessible exactly as published.