Claim construction ruling favors Genentech's infringement theory but is not outcome-determinative. Watch for summary judgment motions and trial scheduling. Evrysdi is a key revenue driver for Roche/Genentech — a final ruling blocking generic entry would protect that franchise.
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Executive Summary
A New Jersey federal district court issued a Markman claim construction ruling in Genentech's ANDA litigation against generic manufacturers seeking to market a copy of Evrysdi (risdiplam) for spinal muscular atrophy. The court adopted Genentech's proposed construction of the key term 'crystalline Form A,' rejecting the defendants' attempt to import all specification characteristics into the claim. This is an interlocutory procedural ruling that favors Genentech's infringement case but does not resolve the merits.
Court Ruling Details
Key Facts
- Court adopted Genentech's proposed construction of 'crystalline Form A' as defined in the '789 patent specification
- Rejected defendants' request to require all specification characteristics for infringement
- Ruling is a Markman claim construction order — interlocutory, not a final judgment
- Case involves ANDA filings for generic Evrysdi (risdiplam) by Natco, Sun Pharma, and Zydus
- Evrysdi is an oral treatment for spinal muscular atrophy
Financial Impact
No damages awarded or financial exposure stated in the opinion
Risk Factors
- Defendants may still prevail on non-infringement or invalidity at summary judgment or trial
- Interlocutory ruling — no final resolution of patent validity or infringement
- Generic entry risk remains until final judgment and any appeals are exhausted
Market Snapshot
Documents Analyzed
This report is based on 1 court opinion.
| Document | Accession Number |
|---|---|
| COURT-RULING Data (Synthetic) | court-5575644deb-RHHBY |
Track record builds as more directional reports settle.
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| Type | Now | ||||
|---|---|---|---|---|---|
Oct 23, 2026 4d ago | Court Ruling | — | awaiting T+5 | — | — |
Oct 13, 2026 14d ago | Court Ruling | $55.69 $59.11 | ▲ +6.14% | ▲ +5.69% | $59.98 (+7.70%) |
Aug 14, 2026 10w ago | Court Ruling | $54.61 $57.47 | ▲ +5.24% | ▲ +6.43% | $59.98 (+9.83%) |
Jul 30, 2026 12w ago | Court Ruling | $54.67 $57.26 | ▲ +4.74% | ▲ +1.23% | $59.98 (+9.71%) |
US Market Status
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