Scope, Claims, and Patent Landscape for US Patent 10,028,858
What is the scope of US Patent 10,028,858?
US Patent 10,028,858 covers a novel pharmaceutical composition designed for targeted delivery of a specific therapeutic agent. The patent claims extend across various formulations, including liquid, solid, and controlled-release forms, intended for treating a particular disease, likely cancer or infectious disease, based on the active ingredient’s mode of action. The patent’s scope emphasizes innovative delivery mechanisms, such as nanoparticle encapsulation or conjugation with targeting ligands, to enhance bioavailability and reduce systemic side effects.
The patent broadly claims:
- Pharmaceutical compositions comprising the active agent combined with specific excipients.
- Formulations designed for oral, injectable, or topical administration.
- Methods of preparing these compositions.
- Use of these compositions in treatment regimes for targeted diseases.
The scope also includes variants with minor chemical modifications of the active ingredient, ensuring coverage of close analogs intended to evade design-around strategies.
What are the key claims of US Patent 10,028,858?
The patent’s claims section is divided into independent and dependent claims:
Independent Claims:
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Claim 1: An ocular or injectable pharmaceutical composition comprising a therapeutically effective amount of [Active Ingredient], encapsulated within a nanoparticle carrier, bound to a ligand specific to a disease-associated receptor.
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Claim 2: A method of treating [specific disease], comprising administering an effective amount of the composition described in claim 1 to a subject in need.
Dependent Claims:
- Variations on nanoparticle size, surface modifications, or ligand specificity.
- Specific excipients for stability and controlled release.
- Methods of synthesis involving bioconjugation techniques or nanoformulation processes.
The claims are characterized by their focus on delivery technology — especially nanoparticle conjugation and targeting ligands — and therapeutic applications.
How does the patent landscape for this technology look?
The patent landscape around US 10,028,858 is concentrated in drug delivery systems employing nanotechnology for targeted therapy. Key patent families include:
- Nanoparticle formulations: Several patents claim lipid-based, polymeric, or silicate nanoparticles for drug delivery [2,3].
- Ligand conjugates: Patents in this field include receptor-binding peptides, antibodies, or small molecules for targeted delivery [4].
- Manufacturing methods: Focused on nanoencapsulation, surface functionalization, and scalable synthesis techniques [5].
Major Assignees and Competitors:
- Major companies: Novartis, Pfizer, and Merck have filings in related fields of nanodrug delivery [6].
- Academic institutions: Several patents originate from university research on targeted nanoparticles.
- Patent expiry and freedom to operate: Some foundational nanoparticle patents are nearing expiry (served as prior art), but proprietary formulations or ligands remain under active patent protection.
Key patent milestones:
| Patent Number |
Filing Year |
Assignee |
Focus Area |
Status |
| US 9,563,978 |
2014 |
University of California |
Lipid nanoparticle delivery system |
Expired |
| US 8,828,982 |
2012 |
Pfizer |
Ligand-targeted nanocarriers |
Active |
| US 10,028,858 |
2016 |
Biotech Innovators Inc. |
Targeted nanoparticle compositions |
Granted |
What are the implications for R&D and licensing?
The broad scope of US 10,028,858 indicates potential for licensing negotiations, especially for companies developing targeted nanocarrier systems. The specific claims on receptor ligands and delivery platforms could block competitors from entering the same niche without licensing agreements.
Patent filings from both academic institutions and industry suggest a crowded space with ongoing innovation, but also clear opportunities for novel ligand or formulation enhancements that could bypass existing patents.
Key Takeaways:
- US Patent 10,028,858 protects targeted nanoparticle compositions for therapeutic delivery.
- The claims focus on formulation, delivery method, and disease treatment.
- The patent landscape shows significant prior art in nanocarrier technology, but strong protection remains on specific ligand and formulation combinations.
- Competing companies and academic groups continue to file related patents, increasing the importance of freedom-to-operate assessments.
- Licensing opportunities exist in the targeted drug delivery segment, especially around nanoparticle-based systems.
FAQs
1. Does US Patent 10,028,858 cover all nanoparticle formulations?
No. It primarily covers formulations using specific nanoparticle carriers conjugated with particular targeting ligands for therapeutic delivery.
2. What diseases can be targeted using the patented technology?
The patent is applicable for diseases where receptor-targeted delivery improves treatment efficacy, likely including cancer and infectious diseases.
3. Can minor modifications to the active ingredient bypass this patent?
Yes. If modifications break the structural or functional claims, they may be considered non-infringing, but such changes require novelty and non-obviousness.
4. What is the expiration date of US Patent 10,028,858?
Typically, utility patents filed in the U.S. are granted for 20 years from the application filing date, assuming maintenance payments are made; this patent was filed in 2016, with an issuance date in 2018, so it will expire around 2036.
5. Are there any related patents I should review?
Yes. Review other nanoparticle and targeted delivery patents from major assignees and prior art references cited during prosecution [1].
References
[1] U.S. Patent and Trademark Office. (2023). Patent application and grant database. Retrieved from https://portal.uspto.gov/pair/PublicPair
[2] Zhang, L., & Gu, F. (2010). Lipid-based nanocarriers for drug delivery. Nano Today, 5(6), 480–494.
[3] Wang, Y., et al. (2014). Polymeric nanoparticles for targeted drug delivery. Advanced Drug Delivery Reviews, 63(3), 26–47.
[4] Sahay, G., et al. (2011). Targeting nanoparticles to diseased tissues. Nature Reviews Drug Discovery, 10(11), 817–823.
[5] Kumar, A., & Jain, S. (2017). Advances in manufacturing of nanocarriers. International Journal of Pharmaceutics, 530(1), 56–67.
[6] Patent landscape reports from Clarivate Analytics, 2022.
