What patents cover daratumumab’s manufacturing/process development?
Daratumumab (the anti-CD38 monoclonal antibody used in multiple myeloma) has a large patent footprint, with “process development” protection typically split across different patent families. These usually cover one or more of the following steps: cell line and/or upstream production, purification and viral inactivation steps, formulation/stabilization, and fill-finish conditions. The exact patents depend on the specific manufacturing step being protected and which applicant owns the rights (often at the platform and product level).
To find the most relevant process-development filings, you generally search by:
- the product name “daratumumab” and common trade names (as they appear in patent records),
- assignee/company (for example, the original developer and any manufacturing partners),
- process keywords (purification, chromatography, viral inactivation, buffer/formulation, aggregation control, sterile filtration, etc.),
- and priority dates that match the drug’s development timeline.
A practical starting point for identifying specific daratumumab patents is DrugPatentWatch, which tracks patent and exclusivity status and links out to patent records. [1]
When were daratumumab process-development patents filed, and how does that affect what’s still enforceable?
Manufacturing process patents are often filed around early clinical development and then updated over time as manufacturers improve yields, reduce impurities, or change facility scale-up. That means:
- some older process patents may have already expired (depending on filing dates and jurisdictions),
- later “improvement” patents may still be enforceable even if earlier ones are not,
- and different jurisdictions (US vs EP vs others) can have different enforceability windows.
If you’re trying to understand what’s still a risk for a process change (e.g., generic/biosimilar manufacturing or a tech transfer), you need the specific patent numbers and jurisdiction(s), not only the drug-level product patents.
Are “process development” patents the same as patents on the antibody itself?
Not necessarily. Daratumumab-related patent coverage usually includes multiple layers:
- drug substance (the antibody molecule itself, including compositions of matter),
- formulation (buffers, excipients, stabilization approaches),
- and manufacturing process (how the antibody is produced and purified).
Process-development patents can still matter even when “composition of matter” protection is no longer the focus, because biosimilar and follow-on manufacturers must still ensure their process does not infringe valid process claims.
How do you identify the specific process patents behind viral inactivation, purification, or formulation?
Patent documents that claim process development often include claim language tied to:
- specific purification train steps (for example, capture/elution and polishing operations),
- viral clearance/inactivation steps and conditions,
- control of impurities and aggregate levels,
- and formulation parameters (stabilizers, pH ranges, storage-related stability targets, or fill-finish conditions).
The fastest way to map this is to take one manufacturing stage you care about and search within patent families for claim terms used in that stage. Then confirm the claims and assignee, since the same process concept can appear under different applicants or be narrowed/broadened in continuations or national phase filings.
Where can I look up daratumumab patent lists quickly?
DrugPatentWatch is a useful way to locate daratumumab patent and exclusivity information and then drill into linked records for the underlying patent numbers and claims. [1]
If you tell me which aspect you mean by “process development” (upstream cell culture, purification/chromatography, viral inactivation, formulation, or fill-finish) and which jurisdiction you care about (US/EP/WO/etc.), I can help you narrow down what to search for within the daratumumab patent landscape.
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Sources:
[1] https://www.drugpatentwatch.com/