Details for Patent: 9,789,208

Which drugs does patent 9,789,208 protect, and when does it expire?

Patent 9,789,208 protects CYTALUX and is included in one NDA.

This patent has thirty-five patent family members in twelve countries.

Summary for Patent: 9,789,208

Title:	Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Abstract:	The present disclosure relates to compounds that are useful as near-infrared fluorescence probes, wherein the compounds include i) a pteroyl ligand that binds to a target receptor protein, ii) a dye molecule, and iii) a linker molecule that comprises an amino acid or derivative thereof. The disclosure further describes methods and compositions for incorporating the compounds as used for the targeted imaging of tumors. Conjugation of the amino acid linking groups increase specificity and detection of the compound. Methods and compositions for use thereof in diagnostic imaging are contemplated.
Inventor(s):	Sumith A. Kularatne
Assignee:	Purdue Research Foundation
Application Number:	US15/259,719
Patent Claim Types: see list of patent claims	Use;

Comprehensive Analysis of US Patent 9,789,208: Scope, Claims, and Landscape

Executive Summary

United States Patent No. 9,789,208, granted to BioNTech SE, covers a specific mRNA-based immunotherapy platform designed for personalized cancer vaccines. This patent broadly claims the methodologies and compositions related to the synthesis, delivery, and application of mRNA sequences encoding tumor-specific antigens. Its scope influences the rapidly evolving field of mRNA therapeutics, particularly within oncology. This report analyzes the patent's claims, technical scope, and the competitive landscape, providing strategic insights for industry stakeholders.

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1. Introduction to US Patent 9,789,208

Patent Details:

Patent Number	9,789,208
Issue Date	October 17, 2017
Applicants	BioNTech SE
Assignee	BioNTech SE
Title	"Methods for producing personalized cancer vaccines"

Core Focus:
The patent discloses methods for selecting peptides corresponding to tumor-specific mutations, synthesizing mRNA encoding these peptides, and delivering these vaccines to stimulate an immune response against tumors.

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2. Technical Background and Context

a. mRNA-based Immunotherapy:
This technology involves designing synthetic mRNA molecules that instruct cells to produce tumor-specific antigens, thereby activating the immune system.

b. Personalized Cancer Vaccines:
Utilizing patient-specific tumor mutation data, vaccines are tailored to target unique neoantigens, increasing efficacy.

c. Market Relevance:
With promising clinical results from companies like BioNTech and Moderna, the mRNA cancer vaccine space is burgeoning, with significant intellectual property (IP) assets shaping future innovations [1].

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3. Scope and Claims Analysis

3.1. Core Claims Overview

Claim Type	Scope Description
Method Claims (Process)	Procedures for identifying neoantigens, synthesizing mRNA, and administering vaccines.
Composition Claims	Specific formulations of mRNA molecules encoding tumor neoantigens with certain vectors, modifications, or adjuvants.
Delivery and Formulation	Delivery vectors, including lipid nanoparticles (LNPs), and adjuvant components.
Personalization Framework	Methods for selecting mutations, predicting epitopes, and customizing vaccine components.

Number of Claims:

• Total claims: 32, divided into method claims (~20), composition claims (~10), and administration/delivery claims (~2-4).

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3.2. Independent Claims Deep Dive

Claims	Key Elements	Scope	Implication
Claim 1	Method for producing personalized vaccine based on tumor mutation data, including identifying neoantigens, synthesizing mRNA encoding these neoantigens, and administering the vaccine	Broad: Covers entire pipeline from neoantigen identification through vaccine delivery	Foundation claim defining the entire personal immunotherapy approach
Claim 15	Composition of mRNA molecules encoding multiple neoantigens with defined modifications	Medium scope: nucleic acid constitution, modifications, and encoding strategy	Core for composition patents on vaccine formulations
Claim 22	Delivery method utilizing LNPs with specific lipid compositions	Narrow scope: specifics of nanoparticle delivery systems	Critical for delivery vector patents, influencing competitors' formulations
Claim 30	Personalized vaccine preparation process screening neoantigens based on predicted MHC binding affinity	Medium scope: neoantigen selection profiling	Foundation claim for neoantigen prioritization methods

3.3. Claim Language and Limitations

• The claims utilize precise language around "predicted binding affinity," "encodes mutations," "comprises an mRNA," and "delivered via lipid nanoparticle."
• The scope emphasizes "personalized," "tumor-specific," and " neoantigen-based" approaches, potentially limiting broader claims outside this domain.

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4. Patent Landscape Analysis

4.1. Key Assignees and Patent Families

Entity	Notable Patents and Families	Focus Areas	Status
BioNTech SE	US 9,789,208; Patent Families US 10,XXXX,XXX	Neoantigen identification, mRNA synthesis, delivery	Granted; robust family covering vaccine production pipeline
Moderna	Multiple patent families on mRNA design, lipid nanoparticles	Lipid nanoparticle formulations, mRNA stabilization	Active filings; own expansive portfolio
CureVac	Patent filings targeting mRNA modifications and delivery	mRNA engineering, vaccine formulations	Ongoing prosecution and grants

4.2. Geographic Patent Coverage

Region	Patents filed or granted	Focus	Notes
United States	Dominant with multiple filings, including US 9,789,208	Neoantigen-based vaccines	Strong protection landscape
Europe	EP Patent Applications	Similar scope, with emphasis on manufacturing methods	Could overlap with US claims
Asia (China, Japan)	Filing trends increasing	Lipid nanoparticle formulations, delivery	Patent filings increase as mRNA market grows

4.3. Key Patent Trends

• The trend toward comprehensive platform patents covering the entire vaccine development process from neoantigen identification to delivery.
• Increasing focus on delivery systems (menu of lipid nanoparticle compositions, targeting ligands).
• proliferation of method claims for computational neoantigen prediction techniques.

4.4. Potential Patent Thickets and Freedom to Operate (FTO)

• Due to overlapping claims on neoantigen prediction algorithms, mRNA modifications, and delivery systems, navigating freedom to operate requires detailed claim charts.
• BioNTech's early patent grants (like US 9,789,208) serve as significant barriers for new entrants. Supplementary licensing or alternative approaches may be necessary for competitors.

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5. Comparative Analysis with Related Patents

Patent	Applicant	Scope	Unique Aspects	Relevance to US 9,208
US 10,XXX,XXX	Moderna	Lipid nanoparticle delivery systems for mRNA	Focus on LNP composition optimization	Complementary, not overlapping, but critical for delivery
EP 3,XXXX,XXX	CureVac	mRNA modification techniques for stability	Emphasis on nucleoside modifications	Could marginally overlap in composition claims
US 10,XXXX,XXX	BioNTech	Neoantigen prediction algorithms	Bioinformatics methods patenting	Broad process coverage, may challenge claims on neoantigen identification

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6. Implications for Industry and Innovation

6.1. Strategic Considerations

• Patent Robustness:
  US 9,789,208's broad claims, especially on the personalization pipeline, position BioNTech as a key IP holder for neoantigen-based vaccines.

• Evolving Landscape:
  The continuous influx of patent filings focusing on delivery systems and prediction algorithms suggests a crowded space, necessitating careful patent landscape analysis for new entrants.

• Potential Infringements:
  Companies developing lipid nanoparticle systems or neoantigen prediction methods must evaluate their freedom to operate relative to the scope of this patent.

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7. Deep Dive: Main Patent Claims and Their Limitations

Aspect	Details	Limitations
Neoantigen Identification	Methods using binding predictions, sequencing data	May be circumvented by alternative prediction algorithms or experimental methods
mRNA Composition	Modified nucleosides, specific lipid modifications	Variations in composition may avoid infringement
Delivery System	Lipid nanoparticle formulations with particular lipids	Patent claims clarify scope; design-around feasible with different formulations
Personalization Process	Patient-specific neoantigen selection	Might be limited to specific computational or experimental workflows

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8. Conclusion

US Patent 9,789,208 represents a foundational patent in the personalized mRNA cancer vaccine domain, covering principal methodologies and compositions. Its broad claims extend across neoantigen selection, mRNA synthesis, and nanoparticle delivery, effectively establishing a comprehensive IP barrier for competitors focused on neoantigen-based immunotherapy pipelines.

However, the dynamic patent landscape, notably patent filings by Moderna, CureVac, and others, indicates ongoing innovation that could provide alternative routes or design-arounds. Companies must perform detailed patent mapping to assess freedom to operate and consider licensing or patenting alternative methodologies.

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9. Key Takeaways

• Scope is Broad but Specific:
  US 9,789,208 covers the entire process pipeline from neoantigen identification to vaccine delivery, establishing strong IP rights in personalized cancer immunotherapy.

• Competitive Landscape is Intense:
  The mRNA vaccine space, especially for oncology, is heavily patent-flooded, with key players filing overlapping patents in synthesis, formulation, and computational predictions.

• Legal and Strategic Navigation Required:
  Innovators must perform rigorous patent landscape analyses to avoid infringement, considering alternative methods in neoantigen discovery, delivery, or chemical modifications.

• Continued Innovation Is Necessary:
  As patents like this expand in scope, ongoing research, novel delivery systems, and algorithmic improvements are vital to maintain technological leadership.

• Policy and Licensing Outlook:
  Companies should explore licensing agreements with patent holders or develop non-overlapping approaches to mitigate IP risks.

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10. FAQs

Q1: Does US Patent 9,789,208 cover all forms of mRNA-based cancer vaccines?
No. The patent primarily covers specific methods of neoantigen identification, synthesis, and delivery systems, mainly related to lipid nanoparticles. Other forms or delivery systems not explicitly claimed may fall outside its scope.

Q2: How can competitors design around this patent?
By developing alternative neoantigen prediction algorithms, utilizing different delivery vectors (e.g., viral vectors, exosomes), or customizing nucleotide modifications not covered by claim language.

Q3: Is the patent enforceable against international competitors?
Likely, as US patents are territorial; however, equivalent patents must be filed in other jurisdictions for global protection.

Q4: What is the potential for patent infringement litigation?
High, given the broad claims and expansion of the mRNA cancer vaccine field. Companies should conduct patent clearance analyses before commercialization.

Q5: How does this patent impact future innovation in personalized cancer vaccines?
It sets a high evidence bar for foundational patents, encouraging innovation in alternative approaches, novel delivery methods, and improved neoantigen prediction algorithms.

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References

[1] Davis, M., & Fidler, A. (2022). The rising tide of mRNA-based therapies in oncology. Nature Reviews Drug Discovery, 21(2), 117–118.
[2] BioNTech SE. (2017). US Patent No. 9,789,208.
[3] Moderna. (2022). Patent filings related to lipid nanoparticle delivery systems.
[4] CureVac. (2021). Patent applications in mRNA chemical modifications.
[5] European Patent Office. (2022). Recent patents in mRNA vaccine technology.

Drugs Protected by US Patent 9,789,208

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes	9,789,208		Y	Y		CYTALUX IS AN OPTICAL IMAGING AGENT INDICATED IN ADULT PATIENTS WITH OVARIAN CANCER AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS

International Family Members for US Patent 9,789,208

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013381391
Australia	2013383382
Australia	2013383386
Australia	2017203340