What patents cover patisiran, and who owns them?
Patisiran (marketed as Onpattro) is protected by a network of patents covering multiple layers of the product, not just the active ingredient. Those layers typically include:
- The lipid nanoparticle formulation and its specific components and ratios
- The siRNA sequence(s) and chemically modified design used to enable activity and stability
- Manufacturing processes and analytical/quality controls
- Uses in specific therapeutic areas, such as hereditary transthyretin amyloidosis (hATTR amyloidosis)
Ownership is usually split across companies and assignees involved in discovery, formulation, and manufacturing. The practical “patent landscape” for patisiran therefore focuses on identifying assignees across these categories and mapping where their claims overlap or run out first.
When do patisiran key patents expire, and how does exclusivity affect market entry?
A patisiran “patent landscape” is usually assessed in two time dimensions:
1) Patent expiration dates (by jurisdiction), which depend on filing and priority dates plus any adjustments.
2) Additional regulatory exclusivities (for example, data/market exclusivity and pediatric extensions where applicable), which can delay generic or biosimilar-like competition even after some patents expire.
Because the question is about landscape rather than a single patent, the key deliverable is a timeline that identifies the earliest expiring claims that would block entry for a potential competitor in each region (US, EP, UK, Japan, etc.). In many branded biologics/complex drug cases, the “effective” freedom-to-operate date is later than the first nominal expiration because other formulation, method-of-use, or process patents remain in force.
Are there generic or biosimilar pathways for patisiran?
Patisiran is an siRNA therapeutic delivered in lipid nanoparticles. That affects the pathway a challenger would pursue: a “generic” is not straightforward because the product is not a traditional small-molecule drug and the delivery system and manufacturing are central to performance. Competitive entry typically turns on whether a follow-on product is considered sufficiently comparable to obtain approval under the relevant regulatory framework for complex biologic-like therapeutics.
In a patent landscape search, the practical question is less “is it a generic?” and more:
- Which patents are most likely to be infringed by an applicant’s intended formulation and manufacturing process?
- Which patents can be designed around (different lipid composition, different process steps, different siRNA chemistry or targeting while preserving function)?
What parts of the technology do competitors try to design around?
Patent claim sets for patisiran commonly concentrate on details that are hard to replicate exactly, such as:
- Lipid nanoparticle composition (specific lipids and their molar ratios, inclusion/exclusion of helper lipids, and PEG-lipid characteristics)
- siRNA chemical modifications used for stability and activity
- Manufacturing and formulation steps (how nanoparticles are formed, buffer/exchange steps, and process controls)
- Methods of treating hATTR amyloidosis using patisiran dosing schedules and patient populations
A landscape approach typically maps which competitor claim targets (or claim chart elements) would be hardest to avoid without changing product performance.
How do patent challenges usually play out for patisiran?
In complex drug landscapes, freedom-to-operate risks are usually managed through a mix of:
- Patent invalidity or non-infringement arguments (often in the jurisdiction with the strongest patent enforcement or fastest litigation timelines)
- Settlement agreements that can include agreed market-entry dates
- Narrow design changes intended to fall outside claim scope
So the landscape effort often includes not just patents currently listed but also:
- Litigated patents
- Family members filed in multiple jurisdictions
- Pending applications that might mature into enforceable patents
How to build a usable “patisiran patent landscape” for investors or counsel
A search that yields actionability generally includes:
- Patent family mapping across jurisdictions (US, EP, UK, JP, etc.)
- Claim-category tagging (composition, formulation, method of use, manufacturing/process, analytical methods)
- Earliest priority date and earliest expected expiration per family member in each region
- A timeline that flags the “first-to-expire” patents and the “likely blocking” patents
- An assessment of likely infringement exposure based on a hypothetical follow-on product design
This kind of output answers both “when does protection end?” and “what specifically blocks entry?”
What I need from you to produce the actual landscape (dates, numbers, owners)
I can’t list specific patent numbers, assignees, or exact expiration dates without additional inputs. If you tell me:
1) Which country/region(s) you care about (US only? EP/UK too? global?),
2) Whether you want strict patent expiration dates only or also regulatory exclusivity,
3) The audience goal (legal freedom-to-operate vs. market timing vs. academic overview),
I can format the landscape around a region-by-region timeline and the major patent families that typically protect siRNA + lipid nanoparticle therapeutics like patisiran.
Sources
No sources were provided in the prompt, so I did not cite any.