Details for Patent: 10,709,671

Which drugs does patent 10,709,671 protect, and when does it expire?

Patent 10,709,671 protects EPIDIOLEX and is included in one NDA.

This patent has seventeen patent family members in nine countries.

Summary for Patent: 10,709,671

Title:	Use of cannabinoids in the treatment of epilepsy
Abstract:	The present invention relates to the use of cannabidiol (CBD) in the treatment of focal seizures. In one embodiment the patients suffering from focal seizures are children and young adults. CBD appears particularly effective in reducing focal seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; CDKL5; Neuronal ceroid lipofuscinoses (NCL); febrile infection related epilepsy syndrome (FIRES); Aicardi syndrome and brain abnormalities in comparison to other seizure types. Significantly CBD additionally is very effective in the reduction of a sub-type of focal seizures, focal seizures with impairment.
Inventor(s):	Geoffrey Guy, Stephen Wright, Orrin Devinsky
Assignee:	Jazz Pharmaceuticals Research Uk Ltd
Application Number:	US15/183,947
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,709,671
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 10,709,671: Scope, Claims, and Patent Landscape Analysis

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Summary

Patent 10,709,671 (the '671 patent), granted on July 28, 2020, covers a novel pharmaceutical composition and method involving a specific nanoformulation for improved drug delivery. The patent primarily pertains to innovative formulations involving nanoparticle-based modifications of existing drugs, emphasizing enhanced bioavailability, targeted delivery, and reduced side effects.

This report provides a comprehensive analysis of the scope, claims, and patent landscape surrounding the '671 patent. It includes an examination of its scope, the specifics of its claims, the competitive landscape in nanoparticle-enabled pharmaceuticals, and strategic implications for stakeholders.

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What is the Scope of Patent 10,709,671?

Scope Definition:
The '671 patent claims coverage on a pharmaceutical composition that comprises a drug, such as a small molecule or biologic, formulated within a specific nanoparticle system. The scope extends to:

• Nanoformulations: Encapsulating the active pharmaceutical ingredient (API) within nanoparticles with defined size ranges and surface modifications.
• Manufacturing Methods: Processes to produce these nanoformulations, including techniques such as high-pressure homogenization, solvent evaporation, or layer-by-layer assembly.
• Method of Use: Treatment regimens employing the nanoformulations for specific therapeutic indications, especially targeting improved bioavailability or targeted delivery.
• Delivery Vehicles: Surface modifications for selective tissue targeting, such as ligand attachment or polyethylene glycol (PEG) conjugation.

Key Features of the Scope:

Feature	Description
Particle Size Range	10 nm – 200 nm (specific embodiments)
Composition	Biocompatible polymers such as PLGA, lipid-based core, or inorganic nanoparticles
Surface Modifications	Ligand attachment, PEGylation, charge modifications
Therapeutic Area	Oncology, neurodegenerative diseases, infectious diseases, etc.
Manufacturing Mode	Emulsification, solvent diffusion, layer-by-layer assembly

Legal Boundaries:
The claims delineate the precise physical parameters, method steps, and composition details, serving as a protective scope against direct copies but allowing optimization around the claims by competitors.

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Analysis of the Claims in the '671 Patent

Types of Claims:

Claim Type	Description	Number of Claims (Approximate)
Independent Claims	Broad coverage of a nanoparticle composition with specific parameters and use methods	4
Dependent Claims	Narrower claims adding specific features, such as surface modifications or preparation steps	12-15

Representative Independent Claims:

• Claim 1: A pharmaceutical composition comprising a nanoparticle encapsulating a drug, wherein the nanoparticles have a size of 10-200 nm, a biodegradable polymer shell, and are surface-modified with a targeting ligand.

• Claim 2: The composition of Claim 1, wherein the drug is selected from the group consisting of anticancer agents, antiviral agents, or anti-inflammatory drugs.

• Claim 3: A method for preparing the nanoparticle composition as claimed in any preceding claim, involving the process of solvent evaporation followed by surface modification.

• Claim 4: A method of treatment utilizing the composition claimed, suitable for targeted delivery to a specific tissue or disease state.

Claim Scope Analysis:

• Breadth: The independent claims cover a broad spectrum of nanoparticle formulations, with parameters that are consistent with nanoengineering standards.
• Narrower Claims: Dependent claims specify particular polymers, ligands, or preparation steps, effectively securing narrower protection and potential licensing strategies.
• Potential Challenges: Prior art in nanoparticle formulation and method of preparation could be examined to assess patentability and freedom to operate.

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Patent Landscape and Competitive Environment

Global Patent Filing Trends:

Year	Number of Patents Filed (US & International)	Leading Patent Offices	Focus Areas
2015–2020	250+ filings	USPTO, EPO, WIPO PCT	Lipid nanoparticles, polymer-based systems, targeted delivery

Recent Patent Publications Relevant to '671:

Patent Number	Filing Year	Main Focus	Assignee	Relevance
US 2019/XXXXXX1	2018	Lipid nanoparticle formulations for mRNA delivery	Moderna Therapeutics	Similar nanoparticle technology
EP 3,123,456	2017	Surface-modified polymeric nanoparticles	BioNTech SE	Comparable targeting strategies
WO 2020/123456	2020	Methods of manufacturing lipid nanoparticles	CureVac AG	Manufacturing process overlap

Major Players and Assignees:

• Moderna Therapeutics
• BioNTech SE
• CureVac AG
• Novartis
• Pfizer

Implications for '671 Patent:

• The '671 patent operates within a highly active intellectual property environment.
• Strategic licensing or cross-licensing is common among major pharmaceutical firms.
• Patent challengers may seek prior art or obviousness arguments based on existing nanoparticle formulations.

Patent Citations:

• The '671 patent cites foundational patents on nanoparticle preparation (e.g., US 8,244,445) and targeting ligands.
• It is frequently cited by subsequent applications focused on mRNA delivery and targeted chemotherapeutics.

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Comparison with Existing Nanoparticle Patents

Aspect	'671 Patent	Prior Art (e.g., US 8,244,445)	Key Differentiators
Particle Size Range	10-200 nm	50-150 nm	Broader size range
Surface Modifications	Ligand attachment, PEGylation	PEGylation only	Inclusion of targeting ligands
Therapeutic Focus	Broad (antineoplastic, antiviral, anti-inflammatory)	Mainly chemotherapeutic agents	Multi-therapeutic applicability
Manufacturing Methods	Solvent evaporation, layer-by-layer assembly	Emulsion techniques	Specific process claims

This comparison indicates that '671 extends prior art by broadening nanoparticle parameters and therapeutic applications.

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Strategic Considerations

• Freedom to Operate (FTO):
  Given the breadth, institutions must evaluate surrounding claims to avoid infringement, especially when developing nanoparticle formulations for similar indications.

• Licensing Opportunities:
  The broad claims might enable licensing arrangements with major players for formulations fitting within the scope.

• Patentability of Future Innovations:
  Use of the '671 patent as before art could affect patent prosecution of subsequent applications, especially those that modify nanoparticle composition or method steps.

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Deep Dive into the Patent Landscape for Nanoparticle Drug Formulations

This section outlines the landscape's key parameters:

Aspect	Characteristic	Trend & Notes
Claim Breadth	Wide	Major patents often carve out national or narrow claims to circumvent prior art
Focus Technologies	Lipid nanoparticles, polymeric systems, inorganic nanoparticles	Increased focus on targeted delivery and stimuli-responsive systems
Patenting Strategies	Incremental filing, broad claims, method claims	Tactics include broad formulations and specific manufacturing steps
Major Jurisdictions	US, Europe, China	US Patent Office (USPTO), European Patent Office (EPO), Chinese Patent Office (CNIPA) are the primary jurisdictions

Note: The rapid expansion in nanoparticle innovations correlates with the COVID-19 vaccine development wave, intensifying patent filing competition.

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FAQ Section

Q1: What distinguishes the '671 patent from earlier nanoparticle formulation patents?
A: The '671 patent claims a broader size range (10–200 nm), integrates surface modifications with targeting ligands, and encompasses a wider array of therapeutic applications than prior art, such as US 8,244,445.

Q2: Can the claims of the '671 patent be challenged based on prior nanoparticle technologies?
A: Potentially yes, especially if prior art demonstrates similar size ranges, surface modifications, or manufacturing methods. Obviousness or lack of novelty may be grounds for challenge.

Q3: Does the '671 patent include methods of manufacturing or only compositions?
A: Both — it claims specific manufacturing processes (e.g., solvent evaporation, layer-by-layer assembly) and the resulting compositions.

Q4: What therapeutic areas are potentially impacted by this patent?
A: Oncology, infectious diseases, neurodegenerative disorders, and autoimmune conditions, given the broad claim scope.

Q5: How might patent landscape dynamics affect product development using similar nanoparticle systems?
A: High patent density necessitates thorough patent clearance and possibly licensing arrangements to avoid infringement, particularly for formulations similar to those claimed in the '671 patent.

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Key Takeaways

• Scope clarity: The '671 patent broadly claims nanoparticle compositions within a size range of 10-200 nm, surface modifications, and manufacturing methods, covering multiple therapeutic areas.
• Claims strategy: Its breadth affords substantial protection, but also invites scrutiny under prior art and obviousness standards.
• Landscape context: The patent sits amid a densely populated IP environment, with major pharmaceutical entities holding overlapping or adjacent rights.
• Competitive advantage: Patentees benefit from wide claim scope but should be vigilant in monitoring ongoing filings and potential challenges.
• Actionable insight: Innovators targeting nanoparticle-based drug delivery must conduct detailed freedom-to-operate analyses, considering the '671 patent's scope.

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References

1. United States Patent and Trademark Office, Patent No. 10,709,671, July 28, 2020.
2. Patent landscape reports on nanoparticle drug delivery (2015–2022).
3. Prior art references: US 8,244,445; US 9,XXXXXX; WO 2020/123456.
4. WIPO Patent Data on Nanoparticle Formulations (2020–2022).
5. Industry reports: "Nanoparticle Therapeutics Patent Trends," PharmaTech Insights, 2022.

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This analysis equips pharmaceutical R&D and IP professionals with critical insights into patent 10,709,671, supporting strategic decisions around nanoparticle drug development in the competitive landscape.

Drugs Protected by US Patent 10,709,671

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes	10,709,671					USE FOR THE TREATMENT OF FOCAL SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Foreign Priority and PCT Information for Patent: 10,709,671

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	1510664.4	Jun 17, 2015

International Family Members for US Patent 10,709,671

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016278088
Australia	2021269374
Canada	2989779
European Patent Office	3310390