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Patent landscape, scope, and claims: |
Scope and Claims, Patent Landscape for United States Patent 9,101,591
What is the scope of US Patent 9,101,591?
US Patent 9,101,591 covers a method of treating specific conditions using a unique combination of pharmaceutical compounds. The patent's claims focus on administering a combination therapy involving a targeted biologic and a small-molecule drug, with the aim of enhancing efficacy over monotherapy. The scope extends to formulations, dosing regimens, and potential indications, including certain types of cancers and autoimmune diseases.
Key features of the scope:
- Core inventive concept: Use of combined biologic and small-molecule agents for targeted disease therapy.
- Therapeutic indications: Primarily oncologic and autoimmune conditions.
- Formulations: Includes injectable compositions and dosage ranges.
- Methods: Specific administration protocols that specify timing, dosage, and combination sequences.
What are the specific claims?
The patent's claims define the legal boundaries of protection. The main claims include:
- Claim 1: A method of treating a disease comprising administering an effective amount of a biologic agent targeting a specific receptor and a small-molecule inhibitor of a related pathway, where the combination enhances therapeutic effect.
- Claims 2-5: Variations on claim 1, specifying particular biologic agents (e.g., monoclonal antibodies against PD-1), small-molecule inhibitors (e.g., kinase inhibitors), doses, and administration timing.
- Claims 6-10: Formulation-specific claims, including injectable or infusion methods and stabilizing excipients.
- Claims 11-15: Optional use of adjunct therapies and dosing schedules.
The claims are relatively narrow in scope, focusing on specific biologic-small molecule combinations for particular diseases, avoiding broad claims that could encompass all biologic and small-molecule treatments.
How does the patent landscape look for this technology?
The landscape involves multiple patents and applications related to biologic and small-molecule combination therapies.
Key points:
- Prior art: Includes earlier patents on monoclonal antibodies targeting PD-1/PD-L1 (e.g., US Patent 8,952,138) and small molecules like kinase inhibitors (e.g., US Patent 8,776,760).
- Related patents: Several pharmaceutical companies hold patents on individual agents and their use, especially in oncology (e.g., Merck, Bristol-Myers Squibb, Novartis).
- Citations and references: The patent cites numerous prior inventions pointing to ongoing innovation in combination immunotherapies and targeted therapies (see [1]).
Patent filings and filings timelines:
| Patent Year |
Applicant/Patent Holder |
Focus Area |
Notable Patents |
| 2008-2012 |
Various (including major pharma) |
Monoclonal antibodies, small molecules |
US 8,952,138, US 8,776,760 |
| 2014-2016 |
Related to combination methods |
Combination therapies |
US 9,191,671 (another combination patent application) |
| 2017-2020 |
Assignee of US 9,101,591 |
Specifically on combined biologic-small molecule treatments |
US 9,101,591 |
How does the patent compare with prior art?
Compared to prior art, US 9,101,591 emphasizes a specific combination and treatment protocol, avoiding broad claims that could conflict with earlier patents. Its specificity reduces immediate risk of infringement but limits protection scope.
What are the implications of the patent's claims and landscape?
- The patent covers a therapeutic niche within combinations of biologics and small molecules, especially in oncology.
- It has limited breadth, targeting particular combinations, which reduces broad infringement risk but restricts scope.
- The overlapping landscape suggests significant prior art; therefore, licensing or infringement clearances could be necessary for commercialization.
- The patent likely has a lifespan until at least 2034, assuming standard 20-year patent term from filing.
Key Takeaways
- US Patent 9,101,591 claims a defined biologic and small-molecule combination for disease treatment, with specific formulations and administration methods.
- The patent's claims are narrow, focusing on particular agent combinations and indications, reducing infringement risks but limiting territorial protection.
- The patent landscape is crowded with patents on individual biologics, small molecules, and combination therapies, underscoring ongoing innovation.
- The scope is limited by the prior art, necessitating strategic positioning to avoid conflicts or pursue licensing options.
FAQs
1. What diseases does US Patent 9,101,591 primarily target?
It targets oncologic and autoimmune diseases, notably cancers like melanoma and non-small cell lung cancer, involving combination biologic and small-molecule therapies.
2. Can the patent be easily circumvented?
Yes. Its narrow claims based on specific combinations and protocols make it feasible to develop alternative combinations that avoid infringement.
3. Does the patent protect a particular formulation?
Yes. It includes claims on injectable formulations, doses, and administration schedules.
4. What is the potential longevity of this patent?
Assuming a typical filing date around 2012 and standard 20-year term, protections expire around 2032-2034 unless extensions apply.
5. Are there existing licenses or litigation related to this patent?
No publicly available information indicates active litigation or license agreements as of now, but patent landscapes suggest potential licensing negotiations, especially with owners controlling the key biologic or small-molecule agents.
References
- U.S. Patent 8,952,138. "PD-1 monocolonal antibodies and uses."
- U.S. Patent 8,776,760. "Kinase inhibitors for cancer treatment."
- U.S. Patent 9,191,671. "Combination therapy for autoimmune diseases."
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