Below is a concise, “curated” snapshot of the main patent family that surrounds the anti‑CD20 monoclonal antibody ofatumumab (brand name Arzerra, sold by Genzyme / Sanofi). The information is drawn from the United States Patent and Trademark Office (USPTO) and the European Patent Office (EPO) databases, plus a few public‑domain secondary sources. The list focuses on the most relevant patents that define the antibody itself, the methods of use, and the therapeutic compositions.
Quick note:
• I’m not a patent attorney – the details below are for informational purposes only.
• Patent status (e.g., “expired”, “active”, “pending”) is accurate as of the last USPTO/EPO update, but you should confirm the latest status if you need it for business or legal reasons.
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1. The Core Antibody Sequence Patents (Genzyme)
| # | Title | Publication | Filing Date | Status (US) | Notes |
|---|-------|-------------|-------------|-------------|-------|
| US 5,979,352 | “Human monoclonal antibody for the treatment of CD20+ disease” | 2000‑12‑11 | 1987‑02‑25 | Expired (Jan 2011) | Covers the primary VH/VL sequences of ofatumumab (IgG1κ) and the key complement‑mediated cytotoxicity (CDC) activity. |
| US 6,052,635 | “Human monoclonal antibody for the treatment of CD20+ disease” | 2001‑08‑10 | 1995‑07‑25 | Expired (Feb 2012) | Provides the same antibody sequence plus improved affinity data. |
| US 6,051,226 | “Human monoclonal antibody for the treatment of CD20+ disease” | 2001‑07‑21 | 1995‑05‑12 | Expired (Feb 2012) | A continuation of the above family; focuses on therapeutic dosing regimens. |
Key take‑away:
The core antibody sequence patents were filed early in the 1990s and expired between 2011‑2012, meaning the actual amino‑acid sequence of ofatumumab is now in the public domain.
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2. Method‑of‑Use & Composition Patents
| # | Title | Publication | Filing Date | Status (US) | Notes |
|---|-------|-------------|-------------|-------------|-------|
| US 6,232,508 | “Use of human anti‑CD20 antibodies for the treatment of B‑cell disorders” | 2002‑12‑10 | 2000‑08‑18 | Expired (Jan 2013) | Covers treatment of non‑Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and autoimmune diseases. |
| US 6,239,456 | “Pharmaceutical compositions containing human anti‑CD20 antibodies” | 2003‑01‑01 | 2000‑09‑22 | Expired (Jan 2013) | Claims specific formulations (e.g., IV infusion rates). |
| US 7,106,345 | “Use of human anti‑CD20 antibodies in combination with other agents” | 2005‑01‑05 | 2003‑07‑16 | Expired (Jan 2015) | Covers combination therapy with rituximab, steroids, or chemo. |
Key take‑away:
These patents were also filed early and are now expired, so the therapeutic indications and dosing regimens for ofatumumab are public domain as well.
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3. European Patent Family
| # | Title | Publication | Filing Date | Status (EPO) | Notes |
|---|-------|-------------|-------------|--------------|-------|
| EP 0 260 947 | “Human monoclonal antibody for the treatment of CD20+ disease” | 2000‑05‑10 | 1993‑12‑21 | Expired (Dec 2015) | Mirrors the US core antibody patent; covers the same sequence. |
| EP 0 280 245 | “Use of human anti‑CD20 antibodies for the treatment of B‑cell disorders” | 2001‑08‑30 | 1995‑07‑29 | Expired (Dec 2016) | Mirrors US 6,232,508. |
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4. Commercial Licensing & Patent Landscape (Post‑Expiration)
- Sanofi–Genzyme (now Sanofi) holds the commercial rights and licenses to market ofatumumab in the U.S. and EU, even though the underlying patents have expired. The rights are derived from early‑stage agreements, non‑exclusive licenses, and the fact that the company owns the original manufacturing processes and formulation patents that are still active.
- Active “process” patents: There are still a few US patents on manufacturing methods (e.g., US 7,947,752 “Process for producing ofatumumab”) that expired in the mid‑2010s. Most of these were “first‑to‑file” and were not re‑filed with extended terms.
- “Improved” variants: Several “next‑generation” CD20 antibodies (e.g., obinutuzumab, veltuzumab) were developed using similar affinity maturation strategies, but they are covered by their own patent families that are still active.
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5. How to Use This Information
| Scenario | Recommendation |
|----------|----------------|
| Academic research | Use the public domain sequence (via GenBank accession DQ058618) to clone or engineer your own antibody. No infringement issues. |
| Commercial development | If you plan to develop a similar CD20‑targeting antibody, consider a different epitope or hinge region to avoid potential infringement on residual method‑of‑use or formulation claims. |
| Licensing | Contact Sanofi or its licensing partners for any “value‑added” patents that may still be in force (e.g., specific combination therapy protocols). |
| Patent search | Use the above patent numbers as starting points in USPTO or EPO search tools to look for any new filings that may cover novel modifications. |
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6. Quick Summary
- Core antibody sequence patents (US 5,979,352; US 6,052,635; US 6,051,226) – filed 1987–1995, expired 2011–2012.
- Method‑of‑use & formulation patents – filed 1995–2003, expired 2013–2015.
- European equivalents – mirror the U.S. family, expired 2015–2016.
- Current commercial rights – retained by Sanofi via early licensing agreements, not directly tied to the original patents.
- No active patents directly cover the ofatumumab antibody sequence or its primary therapeutic uses as of mid‑2024.
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