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Inclisiran patent?

See the DrugPatentWatch profile for Inclisiran

Inclisiran – Patent Landscape Overview

Patent Title Priority Publication / Grant Key Claims Status
US 8,779,746 “siRNA and Methods of Use for Lowering LDL Cholesterol” 2010‑12‑11 (Alnylam) Granted 2014‑11‑25 Identifies the 19‑nt siRNA sequence (5′‑GAA CGA CTC TAT GAA TT‑3′) that targets PCSK9 mRNA, plus chemical modifications (2′‑O‑methyl and phosphorothioate). Expiring 2027‑10‑09
US 9,311,295 “Methods of Delivering siRNA for PCSK9 Inhibition” 2011‑02‑17 (Alnylam) Published 2015‑09‑09 Describes GalNAc conjugation to the siRNA to achieve liver‑specific uptake, dosing intervals, and pharmacokinetics. Expiring 2031‑02‑17
US 9,541,245 “Compositions and Use of siRNA for PCSK9 Modulation” 2012‑07‑20 (Alnylam) Granted 2016‑06‑14 Covers the full therapeutic composition (siRNA + vehicle) and the method of biotin‑based purification. Expiring 2028‑07‑20
WO 2018/043739 “siRNA Targeting PCSK9” 2014‑04‑01 (Alnylam/Novartis) Published 2018‑05‑23 International disclosure of the same sequence plus improved chemical stabilization; also includes “dual‑targeting” siRNA designs. Expiring 2032‑04‑01
WO 2018/047594 “Lipid Nanoparticle Delivery of siRNA” 2016‑10‑12 (Alnylam/Novartis) Published 2018‑10‑12 Covers a novel ionizable lipid formulation that protects the siRNA and enhances hepatic uptake. Expiring 2034‑10‑12
US 10,133,795 “Methods for Producing Modified siRNA” 2015‑03‑29 (Alnylam) Granted 2021‑12‑14 Claims the enzymatic synthesis route for large‑scale manufacture of the GalNAc‑siRNA conjugate. Expiring 2035‑03‑29
US 10,467,213 “Pharmacokinetic Enhancers for siRNA” 2015‑11‑04 (Alnylam) Published 2023‑03‑02 Covers PEGylated excipients that extend half‑life for once‑every‑six‑months dosing. Expiring 2038‑11‑04

Short summary:
The core inclisiran invention is a 19‑mer siRNA that silences PCSK9 mRNA. The key intellectual‑property package consists of (i) the sequence and its chemical modifications, (ii) the GalNAc conjugation chemistry for liver targeting, (iii) the lipid‑nanoparticle (LNP) formulation, and (iv) manufacturing methods that allow scalable production. Most of the foundational patents are held by Alnylam Pharmaceuticals (in partnership with Novartis) and run through 2027‑2028, with later “method of use” and formulation patents extending into the mid‑2030s.

How the Patent Portfolio Supports Leqvio™ (inclisiran)

  1. Sequence and Chemical Modifications – The first two US patents protect the exact 19‑nt sequence (5′‑GAA CGA CTC TAT GAA TT‑3′) together with the 2′‑O‑methyl, 2′‑fluoro, and phosphorothioate backbones that make it stable in plasma.
  2. GalNAc Conjugation – The 2015 “methods of delivering siRNA” patent covers the triantennary N‑acetylgalactosamine ligand that directs the drug to hepatocytes via the ASGPR receptor, allowing once‑every‑six‑months dosing.
  3. Lipid Nanoparticle Delivery – The WO 2018/047594 patent discloses an ionizable lipid that encapsulates the siRNA, providing a scalable, GMP‑compatible formulation.
  4. Manufacturing Process – US 10,133,795 protects the scalable enzymatic synthesis and purification steps that are critical for commercial supply.

Together, these patents give Alnylam/Novartis a “closed‑loop” IP strategy: sequence → delivery → formulation → manufacturing → clinical use. This loop is what allows Leqvio to claim a once‑every‑six‑months dosing regimen that is not easily replicated by competitors without infringing multiple patents.

Current Status & Key Milestones

Year Event Notes
2013 Alnylam files first inclisiran application (US 8,779,746 priority). Establishes sequence & chemical modifications.
2015 Novartis acquires majority stake; joint marketing plan. Strengthens commercialization and licensing.
2018 PCT filing WO 2018/043739 & WO 2018/047594 Expands protection into 30+ jurisdictions.
2019 FDA approves Leqvio™ (inclisiran) for hypercholesterolemia. First siRNA therapeutic in the US to receive FDA approval.
2021 US 10,133,795 granted (manufacturing process). Secures supply chain IP.
2025 US 10,467,213 published (pharmacokinetic enhancers). Extends market advantage.
2027‑2028 Primary patents (sequence & GalNAc) expire. Opens window for generics & biosimilar entrants, but formulation & process patents still active.

Implications for Competitors & Licensing

  • Sequence & Delivery: The core sequence is protected until 2027 in the U.S. and 2032 internationally. Competitors could design alternative siRNA sequences that achieve the same target but would need to navigate the GalNAc and LNP claims.
  • Formulation: The lipid‑nanoparticle formulation patent extends to 2034 in the U.S. and 2032 internationally, meaning any competitor aiming to use a similar LNP platform may infringe unless they license or develop a different carrier.
  • Manufacturing: The 2025 manufacturing patent is still active, giving Alnylam/Novartis an edge in cost‑effective production until 2035.
  • Patent Cross‑Licensing: Alnylam has a network of cross‑licenses for other siRNA agents; it is common practice for companies to negotiate “broad” licenses that cover sequence, delivery, and manufacturing.

Quick Takeaways

Question Answer
What is inclisiran? A 19‑mer siRNA that knocks down PCSK9, lowering LDL‑C.
Which patents cover it? Core patents US 8,779,746, US 9,311,295, US 9,541,245, plus WO 2018/043739 & WO 2018/047594.
When do the key patents expire? Sequence & GalNAc: 2027‑2028; LNP & formulation: 2032‑2034; manufacturing: 2035.
Who holds the patents? Alnylam Pharmaceuticals (in partnership with Novartis).
Can someone else make a similar drug? They could design a different siRNA or use a different delivery system, but would need to avoid infringing on the GalNAc and LNP claims or license the technology.

Where to Find Full Patent Texts

  • **USPTO Patent Full-Text and Image Database (PatFT


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