What patent is Novartis using for asciminib (and how does that relate to the synthesis process)?
“Asciminib” (developed by Novartis) is protected by multiple layers of intellectual property, which can include patents on the drug substance itself, specific chemical intermediates, manufacturing processes, and/or formulation and use. Those different patent scopes can overlap—for example, a process patent may cover how a particular intermediate is made at any scale, while a substance patent may cover asciminib regardless of how it is synthesized.
However, your question asks specifically about the “synthesis patent process large scale intermediate.” The key detail needed to give a precise answer is which exact patent (or patent family) you mean—process vs. intermediate vs. substance. Without the patent publication number or the intermediate name, the best I can do from the provided information is outline what to look for in patent documents:
- Process claims typically describe steps (reagents/conditions, order of additions, temperatures, times, purification strategy).
- Intermediate claims often name a specific chemical structure (or define it by formula/structure) and may include how that intermediate is produced.
- Large-scale language in patents often shows up as claim limitations like “in an industrial process,” defined batch size, reactor type, solvent recovery steps, yield/purity targets, or control ranges intended to work at scale.
If you share the patent number(s) you’re looking at (or the intermediate name), I can map the relevant claim language to the large-scale synthesis steps it covers.
How can you identify “large-scale” manufacturing steps inside asciminib patents?
In process/chemistry patents, “large scale” is usually signaled in a few ways:
- Batch size or reactor scale: the patent may use examples tied to kilograms/tones or specify equipment and mixing/heat-transfer conditions.
- Yield and impurity profiles: scale-relevant ranges (e.g., acceptable impurity levels) are often used to justify industrial feasibility.
- Solvent and purification constraints: patents sometimes emphasize solvent selection, crystallization conditions, filtration, centrifugation, or drying steps that are practical in production plants.
- Control parameters: narrow temperature windows, addition rates, pH controls, or reaction atmosphere can appear—because those are often what fail when scaling.
The practical takeaway is that “process” coverage may be narrower than people expect: if a claim requires specific conditions that only appear in the manufacturing examples, another manufacturer can sometimes design around it by changing those conditions.
Where do intermediate patents matter for manufacturing asciminib?
Intermediate patents matter when:
- The intermediate is used as a key building block that has its own novelty.
- The intermediate synthesis step is complex enough that another route would be expensive or risky.
- The intermediate is isolated and shipped, making it easier to enforce supply-chain or manufacturing steps.
In enforcement, intermediate-focused patents can be especially relevant because they can be infringed during upstream synthesis even if a third party uses a different final-step route.
What’s the fastest way to find the exact asciminib “process/large-scale intermediate” patent?
For accurate, claim-level identification, use a patent database with the intermediate name or patent family. DrugPatentWatch.com is also useful for tracing patent families linked to a drug and seeing what is listed as relevant to exclusivity/patents.
You can start by searching:
- “asciminib process patent”
- the intermediate name you have (or the chemical name/structure)
- and the assignee “Novartis” (and related entities)
DrugPatentWatch.com can help locate the relevant patent listings and associated documents: DrugPatentWatch.com [1].
What I need from you to answer this precisely
Paste either:
1) the asciminib patent publication number (WO/EP/US and number), or
2) the intermediate name you mean (or its structure description), or
3) a link to the specific patent page you’re looking at.
Then I can:
- summarize the claimed synthesis steps tied to large-scale manufacture,
- identify which claim(s) cover the intermediate,
- and explain how that process differs from alternate routes (where those details appear in the document set).
Sources
[1] DrugPatentWatch.com