Alnylam details Texas patent suit, two Cipla patent cases and a U.S. Attorney subpoena

Alnylam Pharmaceuticals (Nasdaq: ALNY) updated three legal matters in its 10-Q filed October 29, 2026. The Board of Regents of the University of Texas System sued Alnylam over U.S. Patent No. 8,895,717, alleging that its making, use and sale of Onpattro in the U.S. infringes it. The defendant is Alnylam Pharmaceuticals, Inc. The suit was filed on December 12, 2024 in the Western District of Texas. The 10-Q gives no case number.

In the other two patent cases Alnylam is the plaintiff. It sued Cipla USA Inc. and Cipla Ltd, which the filing calls Cipla, in the District of Delaware on March 13, 2026, over a generic version of Leqvio, and on September 16, 2026, over a generic version of Amvuttra. Separately, Alnylam received a subpoena in October 2025 from the U.S. Attorney's Office for the District of Massachusetts. No individual is named in the subpoena, and no lawsuit has been filed on it.

The Texas case

Alnylam moved on February 5, 2025 to dismiss the Texas case for improper venue, or alternatively to transfer it to Massachusetts. The 10-Q says the court transferred the case to the District of Massachusetts on December 15, 2025, and that trial is scheduled for August 2027.

The filings do not agree on how that order came out. Alnylam's second-quarter 10-Q says the court granted the motion to dismiss in part and denied it in part, found venue improper in the Western District of Texas and ordered the case moved. The latest 10-Q describes the same order as denying the motion to dismiss and granting the motion to transfer. Either way, the case left Texas. The case is now in Massachusetts, where a claim construction hearing was held in July 2026.

The Cipla cases

Alnylam filed the Leqvio suit with its collaborators Novartis Pharmaceuticals Corp., Novartis Technology LLC and The Medicines Company. Each Cipla suit rests on an abbreviated new drug application that seeks FDA approval to market a generic. The filing reports no ruling yet in either Cipla case and no trial dates.

The subpoena

The subpoena seeks documents on government price reporting for Amvuttra, Onpattro, Oxlumo and Givlaari, including certain fee and discount arrangements with distributors, plus related communications. Alnylam says it has produced records responsive to the subpoena and continues to engage with the U.S. Attorney's Office. The 10-Q describes no charge or finding.

Defendants at a glance

• Texas patent case: Alnylam Pharmaceuticals, Inc. is the defendant. The plaintiff is the Board of Regents of the University of Texas System.
• Leqvio case: Alnylam is the plaintiff against Cipla USA Inc. and Cipla Ltd.
• Amvuttra case: Alnylam is the plaintiff against Cipla USA Inc. and Cipla Ltd.
• Subpoena: no lawsuit has been filed and no individual is named.

What it means for shareholders

Alnylam says it has no material loss contingencies accrued at September 30, 2026 or December 31, 2025. It says litigation is costly and may divert management's attention, and that losing such proceedings could have a materially adverse effect on its business, results, liquidity and financial condition.

Alnylam has agreed to indemnify its officers and directors for expenses, judgments, fines and settlement amounts tied to proceedings in which they are involved because of their roles, subject to limits.

The products in these cases carry Alnylam's growth. Net product revenues were $1,291,946 thousand in the third quarter of 2026, against $851,082 thousand a year earlier, and total revenues were $1,458,086 thousand. Amvuttra, the subject of the second Cipla suit, is also one of the four drugs named in the pricing subpoena. Cash, cash equivalents and restricted cash stood at $1,755,817 thousand at the end of the period.

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