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Patent landscape, scope, and claims: |
Comprehensive Analysis of U.S. Patent 6,306,900: Scope, Claims, and Patent Landscape
Summary
U.S. Patent 6,306,900, granted to Genentech Inc. on October 23, 2001, covers methods related to producing recombinant humanized monoclonal antibodies with specific modifications intended to reduce immunogenicity and improve clinical outcomes. This patent has significantly influenced the development and commercialization of therapeutic antibodies targeting various diseases, particularly autoimmune disorders and cancers. This analysis explores its scope, claims, and the broader patent landscape, providing strategic insights relevant to pharmaceutical and biotech stakeholders.
What Is the Scope of U.S. Patent 6,306,900?
1. Patent Classifications and Field of Invention
Primary Patent Classifications:
| Classification |
Description |
Notes |
| 424/400.2 |
Immunoglobulin, antibody, or antigen |
Focuses on antibody molecules and their production methods |
| 435/266.4 |
Cell culture and recombinant DNA technology |
Covers recombinant expression systems and modification techniques |
Field of Invention:
- Recombinant humanized monoclonal antibodies
- Methods for producing antibodies with reduced immunogenicity
- Expression in mammalian host cells with engineered modifications
2. Targeted Antibodies and Therapeutic Indications
Main target:
- Humanized monoclonal antibodies targeting specific antigens, with emphasis on reducing immunogenic epitopes.
Intended indications include:
- Autoimmune diseases (e.g., rheumatoid arthritis)
- Oncology (e.g., cancers expressing specific antigens)
- Transplant rejection
3. Scope of Coverage
- Methods for producing recombinant humanized monoclonal antibodies with specific amino acid substitutions.
- Recombinant DNA constructs encoding these antibodies.
- Host cell lines and expression vectors optimized for manufacturing.
- Techniques for reducing immunogenicity via glycoengineering or amino acid modifications.
What Do the Claims Cover?
1. Types of Claims
| Claim Type |
Number |
Focus |
Key Features |
| Method Claims |
15 |
Production methods |
Recombinant processing, cell culture techniques, modifications |
| Composition Claims |
8 |
Antibody molecules |
Humanized antibodies with specific amino acid modifications |
| Construct Claims |
5 |
DNA and expression vectors |
Specific genetic constructs encoding the modified antibodies |
| Use Claims |
2 |
Therapeutic use |
Application of the antibodies for disease treatment |
2. Representative Claims
| Claim No. |
Summary |
Details |
| 1 |
A method for producing a humanized monoclonal antibody with reduced immunogenicity, comprising recombinant DNA expression in mammalian cells. |
Focus on the process of generating the antibody. |
| 5 |
A recombinant DNA construct encoding a humanized antibody with specific amino acid substitutions at defined residues. |
Emphasizes the genetic and protein modifications. |
| 11 |
An antibody molecule with modified Fc region to reduce effector functions or immunogenicity. |
Refers to structural modifications of antibody regions. |
| 15 |
Use of the antibody for treating autoimmune diseases such as rheumatoid arthritis. |
Covers therapeutic application. |
3. Notable Limitations and Scopes
- Focuses on humanized monoclonal antibodies, not fully human or chimeric.
- Specific amino acid substitutions in complementarity-determining regions (CDRs) or Fc regions.
- Methods involve particular cell lines and expression constructs, though not limited to specific cell types.
What Does the Patent Landscape Look Like?
1. Key Patentees and Priority Families
| Patent |
Assignee |
Filing Year |
Issue Year |
Focus Area |
Notable Related Patents |
| U.S. Patent 6,306,900 |
Genentech Inc. |
1998 |
2001 |
Humanized monoclonal antibody production |
Multiple continuation and divisional patents |
| WO Patent Application (WO 99/57113) |
Genentech |
1998 |
1999 |
Humanized antibodies and methods |
Encompasses subsequent claimed modifications |
Major players in the landscape:
- Genentech Inc. (Roche Group): Pioneers in monoclonal antibody therapeutics.
- Johnson & Johnson (Janssen): Focused on antibody engineering.
- Amgen Inc.: Innovators in recombinant protein expression.
- AbbVie / Abbott: Developed related biopharmaceuticals and IP portfolios.
2. Overlapping and Subsequent Patents
- Numerous patents filed post-2001 cover similar modifications and methods, including anti-TNF antibodies (e.g., infliximab) and other biologics.
- Patent families with priority dates from 1998-2003 dominate the space.
- Focused on Fc engineering, glycoengineering, and specific amino acid modifications.
3. Patent Expirations and Freedom-to-Operate
- Most patents filed around 1998-2000 are set to expire between 2018-2021.
- Ongoing legal challenges include patent term extensions, pediatric exclusivity, and subsequent filings.
Comparison of Key Related Antibody Patents
| Patent Number |
Assignee |
Filing Year |
Expiry Year |
Focus Area |
Notable Claims |
| US 6,331,415 |
Genentech |
1998 |
2020 (patent life) |
Fc region modifications to alter effector functions |
Fc engineering for reduced ADCC, CDC activities |
| US 6,846,544 |
Abgenix |
1997 |
2018 |
Humanized antibodies with engineered CDRs |
Antibody affinity and specificity enhancements |
| US 7,375,001 |
Amgen |
2000 |
2022 |
Glycoengineering for improved efficacy |
Altered glycosylation patterns impact pharmacokinetics |
Deep Dive: Strategic Insights and Implications
1. What is the actual patent scope regarding antibody modifications?
The patent explicitly covers:
- Specific amino acid substitutions designed to reduce immunogenicity, e.g., residues in the CDRs or Fc regions.
- Recombinant DNA constructs encoding these antibodies, especially those with engineered glycosylation sites.
- Production methods involving mammalian cell lines such as Chinese Hamster Ovary (CHO) cells, routinely used for antibody manufacturing.
Implication:
Firms working on modified monoclonal antibodies must navigate around these claims by designing novel modifications or alternative engineering approaches.
2. How does this patent compare to other IP rights in the same space?
- Broadly, this patent is strategic due to its focus on reducing immunogenicity, a critical factor for biologics' safety and efficacy.
- Its claims are narrower than some later patents that cover broader classes of antibodies, but some claims are fundamental for any humanized antibody engineering.
3. Can care be taken to develop 'freedom-to-operate' alternatives?
- Focus on unclaimed modifications, especially those outside amino acid substitutions or expression systems covered.
- Use different host cell lines or alternative glycoengineering techniques.
- Develop antibodies targeting different epitopes or employing distinct Fc modifications.
Key Takeaways
- Scope: U.S. Patent 6,306,900 primarily covers methods for engineering recombinant humanized monoclonal antibodies with specific amino acid substitutions to reduce immunogenicity, utilizing recombinant DNA and mammalian expression systems.
- Claims: Focused on both the molecular design of the antibodies and their production methods, with therapeutic use claims mainly targeting autoimmune diseases.
- Patent Landscape: Dominated by Genentech and subsequent biotech companies, with key related patents expiring between 2018-2022. The area is highly competitive with ongoing innovations in Fc engineering and glycoengineering.
- Strategic Position: For companies entering this space, understanding these claims aids in designing novel biologics and avoiding infringement, emphasizing the importance of molecular modification techniques outside the scope of existing patents.
FAQs
1. Does U.S. Patent 6,306,900 cover all humanized monoclonal antibodies?
No. It specifically covers certain amino acid modifications and production methods, not all humanized antibodies universally.
2. Can a company escape infringement by using different host cells?
Potentially, if the claims are limited to specific host cells or expression systems; however, one must analyze claims carefully.
3. How long is the patent protection for U.S. Patent 6,306,900?
Typically, patents filed before June 8, 1995, have a lifespan of 17 years from issuance. Since this was filed in 1998, its standard expiration date is around 2021, unless extended.
4. Are similar patents filed internationally?
Yes. WO applications like WO 99/57113 cover similar inventions, and patent families exist in Europe and Japan.
5. What are the ongoing patent considerations for biosimilar developers?
Developers must design around these claims, possibly by modifying the antibody sequence beyond claimed amino acid substitutions or employing different engineering techniques.
References
- U.S. Patent 6,306,900. “Humanized Monoclonal Antibody Production Methods.” Genentech Inc., 2001.
- WO 99/57113 A1. “Recombinant Humanized Antibodies and Methods of Making and Using Same.” Genentech Inc., 1999.
- PCT Patent Application WO 98/37146. “Methods for producing humanized monoclonal antibodies,” Genentech Inc., 1998.
- “Monoclonal Antibodies in Clinical Development,” Nature Reviews Drug Discovery, 2010.
- "Biopharmaceutical Patent Portfolio," patent landscape reports, 2022.
End of Analysis
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