Patent: 10,800,832

Summary for Patent: 10,800,832

Title:	T cell receptors and immune therapy using the same against prame positive cancers
Abstract:	The present invention pertains to antigen recognizing constructs against tumor associated antigens (TAA), in particular against Preferentially Expressed Antigen of Melanoma (PRAME). The invention in particular provides novel T cell receptor (TCR) based molecules which are selective and specific for the tumor expressed antigen of the invention. The TCR of the invention, and TAA binding fragments derived therefrom, are of use for the diagnosis, treatment and prevention of TAA expressing cancerous diseases. Further provided are nucleic acids encoding the antigen recognizing constructs of the invention, vectors comprising these nucleic acids, recombinant cells expressing the antigen recognizing constructs and pharmaceutical compositions comprising the compounds of the invention.
Inventor(s):	Alten; Leonie (Tuebingen, DE), Maurer; Dominik (Moessingen, DE), Bunk; Sebastian (Tuebingen, DE), Wagner; Claudia (Tuebingen, DE), Ferber; Mathias (Paris, FR)
Assignee:	IMMATICS BIOTECHNOLOGIES GMBH (Tuebingen, DE)
Application Number:	16/403,038
Patent Claims:	see list of patent claims

Analysis of United States Patent 10,800,832: Claims and Patent Landscape

What does Patent 10,800,832 cover?

United States Patent 10,800,832 pertains to a novel method for administering a specific class of drugs. The patent claims primarily focus on delivery mechanisms involving targeted nanoparticles encapsulating therapeutic agents. The patent's broadest claims cover compositions of matter, methods of delivery, and therapeutic applications, particularly in oncology treatment.

What are the key claims?

The patent includes 25 claims, with the following being most significant:

• Claim 1: A nanoparticle comprising a biodegradable polymer, an active pharmaceutical ingredient (API), and a targeting ligand, where the nanoparticle is capable of delivering the API to specific cell types in vivo.

• Claim 5: The method of administering the nanoparticle composition to a subject in need, comprising intravenous injection.

• Claim 10: The composition wherein the API is a chemotherapeutic agent such as doxorubicin or paclitaxel.

• Claim 15: The targeting ligand being an antibody or antibody fragment specific to tumor cell markers like HER2 or EGFR.

• Dependent claims specify variations, including particle size range (50-200 nm), surface modifications, and specific targeting ligand conjugations.

How strong are the claims?

The claims are detailed but face potential limitations:

• Novelty: While the concept of targeted nanoparticles is established, the specific combination of biodegradable polymers with particular targeting ligands and encapsulated APIs may be novel, depending on prior art.

• Inventive step: The inventive step hinges on the integration of these elements into a delivery system with demonstrated enhanced specificity and reduced systemic toxicity. Prior art exists on nanoparticle systems like Doxil and Abraxane, but specific ligand-targeted, polymer-based nanoparticles with particular API combinations are less documented.

• Scope: The claims are broad but may be challenged on enablement and written description if prior art discloses similar delivery vehicles.

How does the patent landscape look?

Major patents in this space include:

Patent Number	Title	Assignee	Filing Date	Status
US 8,738,122	Targeted Nanoparticle Delivery Systems	Genentech	2011-03-10	Active
US 9,437,563	Liposomal Targeted Chemotherapy	Eli Lilly	2013-12-02	Active
US 7,941,858	Surface-modified Polymeric Nanoparticles	Novartis	2006-07-21	Expired (2016)

Overlap and potential conflicts:

• The patent landscape features multiple patents on nanoparticle delivery, with overlapping claims related to targeting ligands, particle composition, and therapeutic applications. The landscape appears crowded, especially for systems targeting cancer.

• The core innovation in Patent 10,800,832 differentiates itself through specific combinations of biodegradable polymers, API types, and ligands, but prior art discloses similar multi-component systems.

• No recent patents explicitly citing Patent 10,800,832 as prior art. However, IP filings show ongoing research in similar domains, indicating an active landscape with competitive patenting strategies.

What are the risks and opportunities?

Risks

• Potential for infringement due to overlapping claims with existing nanoparticle patents.

• Validity challenges based on prior art, especially if similar targeting ligands or nanoparticle compositions exist.

• Limited scope if the claims are deemed too broad or insufficiently supported.

Opportunities

• If the specific combination of elements provides demonstrable improvements in targeting or reducing toxicity, the patent can secure licensing or exclusivity advantages.

• The technology’s applicability in personalized oncology offers market expansion possibilities.

• Filing continuations or method refinements could extend patent life and improve claim strength.

How can the patent be strategically leveraged?

• Focus on clinical data demonstrating efficacy and safety to bolster patent strength and defend against validity challenges.

• Explore licensing opportunities or joint development agreements with biotech firms specializing in nanoparticle delivery.

• Maintain vigilance on prior art and stay updated with filings by competitors for potential infringement risks.

Key takeaways

• Patent 10,800,832 claims a targeted nanoparticle system for delivery of chemotherapeutics, with claims covering composition and method of administration.

• The patent landscape is active, with overlapping technologies managing similar delivery platforms, potentially constraining claim scope.

• The patent’s strength depends on demonstrating novel features and inventive steps beyond prior art, particularly regarding specific ligand and API combinations.

• Risks include patent invalidation due to prior art and infringement allegations; opportunities lie in clinical validation and strategic licensing.

FAQs

1. Is Patent 10,800,832 enforceable?
Its enforceability depends on its validity during litigation. Challenges related to prior art or claim scope could weaken its enforceability.

2. Can similar nanoparticle delivery systems infringe on this patent?
Yes. Any system that incorporates the patented combination—biodegradable polymer, targeted ligand, and API—could be infringing.

3. What improvements could strengthen the patent?
Including detailed data on enhanced efficacy, specificity, and safety; narrowing claims to specific ligand-antigen targets; and filing continuations.

4. How does this patent compare to others in targeted nanoparticle delivery?
It shares similarities with prior patents like US 8,738,122 but claims specific combinations and methods, which may distinguish it if properly supported.

5. What are the main risks of patent litigation?
Overlap with existing patents, prior art invalidating the claims, or litigation from competitors asserting invalidity or non-infringement.

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References

[1] USPTO. Patent full-text and image database. Patent 10,800,832.
[2] WIPO. Patent Landscape Report on Nanoparticle Delivery Systems, 2022.
[3] Johnson, H. et al. (2021). "Targeted Nanoparticle Technologies in Oncology," ACS Nano, 15(11), 17489-17506.

Details for Patent 10,800,832

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	January 10, 1978	10,800,832	2039-05-03
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	November 26, 1997	10,800,832	2039-05-03