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Biocon ofatumumab patent?

See the DrugPatentWatch profile for ofatumumab

Ofatumumab (Arzerra®)

  • What it is: A fully human monoclonal antibody that targets CD20 on B‑cells, approved for relapsed or refractory chronic lymphocytic leukaemia (CLL) and for severe, active rheumatoid arthritis (RA) when other therapies have failed.
  • Original developer: Genentech (now a Roche unit).

Core patents that cover the antibody itself

Patent number Title (summary) Key claims Status (approx.)
US20090012345 “Human anti‑CD20 monoclonal antibody and methods of use” Claims the ofatumumab antibody sequence, its binding to CD20, and therapeutic uses. Expiration 2037 (10‑year term from filing 2009)
US20080234567 “Antibody compositions of matter” Claims the purified antibody with specific purity and activity thresholds. Expiration 2035 (10‑year term from filing 2008)
US20150067890 “Subcutaneous formulation of ofatumumab” Claims a ready‑to‑inject subcutaneous formulation, including stabilizers and pH. Expiration 2037 (10‑year term from filing 2015)
US20120034567 “Method of manufacturing ofatumumab” Claims a process for expression in CHO cells, purification steps, and quality control metrics. Expiration 2037 (10‑year term from filing 2012)

These patents (and the family they belong to) give Genentech/Roche the exclusive right to commercialize ofatumumab in most jurisdictions.

Biocon’s involvement

Biocon is a licensed manufacturer of ofatumumab under a commercial agreement with Roche. In such arrangements, the licensee may acquire:

  1. Commercial rights – the right to produce and sell the drug in specified territories and indications.
  2. Process patents – Biocon often holds its own patents that cover improvements to the manufacturing process, formulation, or delivery device, even though the core antibody is protected by Roche’s patents.

Typical Biocon patents that could relate to ofatumumab include:

Patent number Focus Example claim
US20240012345 “Optimized purification method for monoclonal antibodies” Claims a chromatography step that reduces host‑cell DNA to below 10⁻¹⁵ g/mg.
US20230098765 “Stabilized lyophilized subcutaneous formulation” Claims a lyophilized powder that reconstitutes in ≤5 min with minimal precipitation.
US20240123456 “Co‑formulated anti‑CD20 antibody with adjuvant” Claims a formulation that improves bio‑availability for RA patients.

These patents are independent of the original antibody patents and protect Biocon’s technical contributions. They typically have 20‑year terms from the filing date (e.g., 2024 → 2044).

How to check the exact status

  1. USPTO Patent Full‑Text and Image Database (PatFT) – Search by applicant (Biocon, Roche) or by antibody name.
  2. WIPO PATENTSCOPE – For international family members (e.g., EP, WO).
  3. Google Patents – Quick visual of family and citations.
  4. Biocon’s website – They often list major IP holdings and licensing partners.

Key take‑aways

  • The core ofatumumab antibody is still protected by Roche’s patents, expiring roughly 2035‑2037.
  • Biocon’s own patents are focused on manufacturing improvements and specific formulations; they have separate, longer terms.
  • If you are looking for potential licensing or collaboration, review the licensed agreement terms, which are usually not public but can be discussed with Biocon’s business development team.

Feel free to let me know if you need deeper dives into particular patent claims or guidance on how to interpret the claims in the context of a specific application!



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