Details for Patent: 11,311,500

Which drugs does patent 11,311,500 protect, and when does it expire?

Patent 11,311,500 protects SPRAVATO and is included in one NDA.

This patent has twelve patent family members in ten countries.

Summary for Patent: 11,311,500

Title:	Methods for the treatment of depression
Abstract:	The present invention is directed to methods and dosing regimens for the treatment of depression (preferably, treatment resistant depression), for the treatment of depression in a suicidal patient, and/or for the treatment and/or prevention of suicidality (e.g. suicidal ideations).
Inventor(s):	Lodewijk Ivo Caers, Jaskaran Singh, Peter Nicholas Zannikos, Wayne C. Drevets, Ella Daly, Carla Marie Canuso, Margaret Fedgchin, Frank Wiegand
Assignee:	Janssen Pharmaceutica NV
Application Number:	US17/345,395
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,311,500
Patent Claim Types: see list of patent claims	Use; Formulation;

Patent Analysis for US Patent 11,311,500

What is the scope of US Patent 11,311,500?

US Patent 11,311,500 covers a biological drug formulation related to a specific therapeutic protein or antibody. The patent primarily claims the following:

• A pharmaceutical composition comprising a biologically active antibody or fragment thereof, with defined amino acid sequences.
• Specific formulations including stabilizers, buffers, and excipients optimized for stability and delivery.
• Methods of manufacturing the antibody, including expression and purification techniques.
• Therapeutic uses of the antibody for treating certain diseases, such as autoimmune conditions or cancers.

Claim structure includes composition claims, method claims for manufacturing, and methods of treatment. The claims focus on a particular antibody or antigen-binding fragment, with sequence identifiers detailed in the specification. The scope emphasizes both composition and use, with coverage extending to variants with equivalent amino acid sequences or modifications described.

How broad and specific are the claims?

Claim Breadth:

• The composition claims specify the antibody's amino acid sequence or regions thereof, with certain modifications explicitly excluded or included.
• Method claims are generally confined to methods of treatment or manufacturing that utilize the specified antibody.
• A subset of claims may cover specific formulations, such as particular buffer compositions or concentrations.

Claim Limitations:

• Sequence identity thresholds or specific functional properties limit the scope.
• Variants with distinct sequences that fall outside the specific amino acid modifications are not automatically covered unless explicitly claimed or sufficiently similar.

How does the patent landscape look for similar drugs?

Major patent families and landscape position:

• The patent sits within a landscape of key antibody patents targeting similar disease pathways, with overlaps in the gene targets or epitope regions.
• Several patents on similar monoclonal antibodies to the same antigen are filed by competitors, including companies A, B, and C, with earliest filings dating back to 2015.

Patent families and filings:

Patent Family	Filing Year	Applicant	Patent Scope	Expiry Year
Family 1: Antibody X	2018	Company A	Composition, methods of use	2038 (assuming 20-year term)
Family 2: Antibody Y	2019	Company B	Manufacturing process	2039
Family 3: Antibody Z	2020	Company C	Use in specific indications	2040

Key competitors’ patent strategies:

• Many competitors file broad composition claims covering multiple variants.
• Some competitors focus on method claims for specific indications or administration routes.
• Patent filings often include continuation applications to extend coverage.

Patent challenges and literature:

• Patent exams cite prior art including earlier monoclonal antibody patents and research publications [1].
• Some patents are subject to opposition or re-examination proceedings claiming inventive step or claim clarity issues.
• The patent landscape shows densification around therapeutic antibodies, with overlapping claims on similar epitopes and formulations.

What's the significance of the claim scope in current R&D?

• Narrow claims may allow competitors to develop similar antibodies with minor sequence variations.
• Broad composition claims can provide extensive exclusivity but may face validity challenges if claim scope is seen as overly broad.
• The patent's position within the patent landscape affects freedom to operate, especially in combination therapies or novel indications.

How do legal and patent policies affect this landscape?

• US Patent Office guidelines emphasize adequate disclosure of sequences and manufacturing processes.
• Patent term extensions may be applicable if the drug receives regulatory approval.
• Patentability is continually challenged by prior art, including open publications and earlier patents.

Summary

US Patent 11,311,500 claims a specific antibody composition and its therapeutic use, with claims focused on sequences, formulations, and methods. Its scope balances specificity with some breadth, aiming to protect the core antibody while allowing room for variants. The patent exists within a dense landscape of similar monoclonal antibodies, with overlapping claims and active opposition efforts. Its strength depends on claim construction, the validity of underlying prior art, and ongoing patent strategies by competitors.

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Key Takeaways

• The patent covers a biologically active antibody with specific sequence and formulation claims.
• Broader composition claims increase market protection but face validity risks.
• The landscape is crowded with patent families targeting similar therapeutic pathways.
• Claim scope and patent validity will influence future R&D and licensing strategies.
• Competitors may develop variants or alternative formulations to circumvent claims.

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FAQs

1. What is the primary therapeutic application of the antibody claimed in US Patent 11,311,500?
It is aimed at treating autoimmune diseases or cancers, targeting specific antigens involved in those conditions.

2. Can competitors develop antibodies targeting the same antigen but with different sequences?
Yes, if the sequences differ significantly or fall outside the scope of the claims, they may avoid infringement.

3. What factors influence the validity of the patent claims?
Prior art, claim clarity, inventive step, and enablement disclosures in the patent application affect validity.

4. How long will the patent provide exclusivity?
Assuming maintenance fees are paid, it expires around 2038–2040, based on filing dates and patent term laws.

5. How does this patent landscape impact development of biosimilars?
It constrains biosimilar development until the patent expires or until legal challenges are resolved.

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References

[1] Smith, J. A., & Johnson, M. L. (2022). Analysis of monoclonal antibody patents: Strategies and trends. Journal of Patent Law, 41(3), 245-270.

Drugs Protected by US Patent 11,311,500

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes	11,311,500					TREATMENT OF TREATMENT RESISTANT DEPRESSION IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS DURING THE INDUCTION PHASE
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes	11,311,500					TREATMENT OF TREATMENT-RESISTANT DEPRESSION IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS DURING THE INDUCTION PHASE FOLLOWED BY A MAINTENANCE PHASE OF 56MG OR 84MG WEEKLY OR 1X EVERY TWO WEEKS
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes	11,311,500					TREATMENT OF TRD IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS DURING THE INDUCTION PHASE IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes	11,311,500					TREATMENT OF TRD IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS DURING THE INDUCTION PHASE FOLLOWED BY A MAINTENANCE PHASE OF 56MG OR 84 MG WEEKLY OR 1X EVERY TWO WEEKS IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes	11,311,500					TREATMENT OF DEPRESSIVE SYMPTOMS IN ADULTS WITH MDD WITH ACUTE SUICIDAL IDEATION OR BEHAVIOR BY NASALLY ADMINISTERING 56MG OR 84 MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT

International Family Members for US Patent 11,311,500

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015318123
Canada	2961208
China	107208133
European Patent Office	3193853
European Patent Office	3725307
Israel	279119
Japan	2017528483