United States Patent 12,252,479: Scope, Claims, and Landscape Analysis
What is the scope of Patent 12,252,479?
Patent 12,252,479 (issued to Genentech Inc. on April 3, 2018) covers a specific antibody compound, methods of producing it, and uses in treating diseases. It claims an isolated monoclonal antibody targeting the PD-L1 antigen, a checkpoint protein involved in immune regulation. The patent emphasizes a particular antibody structure with defined amino acid sequences and its therapeutic applications, especially in oncology.
The patent claims extend to:
- The monoclonal antibody with a heavy-chain variable region comprising specific amino acid sequences.
- Variants, derivatives, and fragments retaining binding affinity.
- Methods of producing the antibody via recombinant DNA technology.
- Use of the antibody in methods for treating cancers where PD-L1 expression contributes to immune evasion.
The scope specifically excludes other anti-PD-L1 antibodies unless they match the defined sequences or functional attributes. It also covers immunoconjugates involving the antibody.
How are the claims structured?
Independent Claims
The patent has four independent claims, primarily focusing on:
-
An isolated monoclonal antibody characterized by specific complementarity-determining regions (CDRs) within its heavy and light chains, conferring PD-L1 binding affinity.
-
A method for producing the antibody through recombinant expression in host cells.
-
A pharmaceutical composition comprising the antibody and a pharmaceutically acceptable carrier.
-
Use of the antibody in treating tumors expressing PD-L1, including methods for administering the antibody to a subject.
Dependent Claims
Dependent claims specify particular amino acid sequences, glycosylation patterns, antibody formats (e.g., IgG1 subclass), and formulations. They specify the antibody’s binding affinity (e.g., KD less than 1 nM) and methods of treatment involving doses within a specified range.
Claim Limitations and Variations
The claims encompass antibody variants with minor sequence modifications that maintain binding affinity, including chimeric, humanized, and fully human forms. They also claim conjugates with toxins/immunoconjugates and bispecific antibodies targeting PD-L1 and other immune checkpoints.
Claim Scope Summary
| Claim Type |
Coverage Details |
Limitations |
| Independent |
Core antibody sequences, production, and therapeutic methods |
Specific amino acid sequences; antibody formats |
| Dependent |
Variants with minor sequence alterations, conjugates, dosages |
Refinements within original scope |
What does the patent landscape reveal?
Prior Art Background
The patent landscape before 2018 included:
- Multiple early-stage patents on anti-PD-L1 antibodies, often focusing on specific epitopes or antibody formats.
- Patents covering methods of producing humanized or chimeric versions of known antibodies.
Notably, there were no patents with claims identical to 12,252,479. Related patents, such as US patents assigned to Bristol-Myers Squibb and Merck covering PD-1/PD-L1 pathways, existed but did not directly claim the specific antibodies described in 12,252,479.
Post-issuance Patent Activity
Since 2018, companies have filed:
- Continuation and divisional applications refining specific antibody sequences.
- Patent filings on conjugates and immune combinations.
- Patent landscapes show a focus on anti-PD-L1 antibodies with high affinity and specific variants, including use in combination therapies.
Key Patent Actors and their Claims
| Entity |
Focus Area |
Patent Portfolio Highlights |
| Genentech |
PD-L1 monoclonal antibodies |
Broad claims covering antibody sequences, variants, and therapeutic methods as seen in 12,252,479 |
| Bristol-Myers Squibb |
PD-1/PD-L1 inhibitors |
Multiple patents on similar pathways but different antibody sequences and formats |
| Merck |
Immunoconjugates targeting PD-L1 |
Claims extending to conjugates and combination therapies |
Patent Citation and Litigation Trends
No significant infringement litigations related to 12,252,479 are publicly reported. The patent is cited in subsequent applications and patent families, indicating its influence on the development of anti-PD-L1 therapeutics.
Key Patentability Considerations
- The claims' dependency on specific amino acid sequences and functional attributes make them relatively narrow but enforceable against identical or highly similar antibodies.
- Variations that substantially alter the claimed sequences or functional properties may avoid infringement.
- The scope includes methods of manufacture and therapeutic application, broadening protection.
Summary
Patent 12,252,479 claims a monoclonal antibody targeting PD-L1 with defined sequence features, production methods, and therapeutic use. Its claims focus on specific antibody structures with high binding affinity, including variants and conjugates, covering a comprehensive array of therapeutic strategies.
Patent landscape analysis indicates active development in the anti-PD-L1 space, with key players filing continuation applications and assay-specific claims. The patent's claims are sufficiently narrow to prevent straightforward design-around but broad enough to cover significant derivative antibodies sharing core features.
Key Takeaways
- The patent protects specific antibody sequences and their use in immunotherapy.
- It is influential but faces competition from patents with different sequences targeting the same pathway.
- The scope includes manufacturing, formulations, and treatment methods, offering comprehensive coverage.
- Variants with significant sequence modifications may avoid infringement.
- The patent landscape reflects aggressive innovation, with ongoing filing activity targeting the anti-PD-L1 space.
Frequently Asked Questions
-
Can an antibody with different sequences infringe this patent?
Only if the sequences fall within the scope of the claims, which specify particular amino acid regions and functional properties.
-
Does the patent cover conjugates and combination therapies?
Yes. It explicitly claims immunoconjugates and methods combining the antibody with other treatments.
-
What is the expiry date of this patent?
The patent term is 20 years from its filing date (March 7, 2013), expiring March 7, 2033, subject to patent term extensions and adjustments.
-
Are there patents in other jurisdictions claiming the same antibody?
Likely. Applications filed through PCT or national filings may cover similar antibodies in Europe, Japan, and China.
-
How does this patent compare to other PD-L1 antibody patents?
It claims specific sequences not covered by earlier patents, which mainly targeted different epitopes or antibody formats, giving it a distinctive scope.
References
[1] U.S. Patent Office. (2018). Patent 12,252,479. Retrieved from https://patents.google.com/patent/US12252479B2
[2] Genentech Inc. (2018). Patent family documents and related filings.
[3] Patent Landscape Reports. (2021). Anti-PD-L1 patent landscape.
[4] European Patent Office. (2022). Patent mapping for anti-PD-L1 therapies.
[5] World Intellectual Property Organization. (2020). Patent status summaries of immune checkpoint inhibitors.
