8-KOther Events

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Corporate Update (Dec 10, 2018)

Filed December 10, 2018For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) announced on December 9, 2018, a significant resolution to its ongoing legal disputes with Silence Therapeutics PLC. The Settlement and License Agreement resolves all worldwide claims, administrative proceedings, and regulatory proceedings concerning patent infringement, invalidity, and breach of contract between the two companies. This agreement is highly favorable for Alnylam as it grants them a fully paid-up, global, irrevocable license to all relevant patents for all current and future products, including ONPATTRO and its entire pipeline. This license allows Alnylam to sublicense and commercialize its therapies without further milestone or royalty obligations, except for a limited, tiered royalty on ONPATTRO sales in the European Union through 2023. The absence of admitted liability and the broad, unrestricted license significantly de-risks Alnylam's intellectual property position and future commercialization efforts.

Key Highlights

  • 1Alnylam resolves all ongoing legal disputes with Silence Therapeutics globally.
  • 2A comprehensive Settlement and License Agreement has been executed.
  • 3Alnylam receives a global, irrevocable, and fully paid-up license to Silence's relevant patents for all current and future Alnylam products.
  • 4The license includes rights to sublicense for commercialization by Alnylam, its collaborators, or distributors.
  • 5Exception: Alnylam will pay a low, tiered royalty (0.33%-1.0%) on ONPATTRO net sales in the European Union only, through 2023.
  • 6No admission of liability or wrongdoing by any party.
  • 7This agreement significantly strengthens Alnylam's IP portfolio and future commercialization prospects for its entire pipeline.

Frequently Asked Questions

The main financial impact is highly positive. Alnylam secures a broad, fully paid-up license to Silence's patents for all its products, eliminating future royalty or milestone payments on most of its pipeline. The only financial obligation is a limited, tiered royalty on ONPATTRO sales in the EU through 2023, which is a small percentage and time-bound.

No, this settlement clarifies and strengthens Alnylam's ability to commercialize ONPATTRO globally. While a limited royalty will be paid on EU sales, the agreement provides Alnylam with the necessary patent rights to ensure unimpeded commercialization.

It means Alnylam has secured the rights to use Silence's relevant patents for all its current and future therapies (including those in development like vutrisiran, givosiran, etc.) across the entire world without any further payments, milestones, or royalties, except for the specific ONPATTRO EU royalty. This significantly de-risks the development and commercialization of its pipeline.

No, the agreement resolves all ongoing claims, administrative, and regulatory proceedings worldwide between Alnylam and Silence. The parties have mutually released each other, and all claims are dismissed with prejudice, meaning these specific disputes are permanently settled.