Details for Patent: 10,799,588

Which drugs does patent 10,799,588 protect, and when does it expire?

Patent 10,799,588 protects SYMBRAVO and is included in one NDA.

This patent has two hundred and twenty-one patent family members in thirty-two countries.

Summary for Patent: 10,799,588

Title:	Pharmaceutical compositions comprising meloxicam
Abstract:	Disclosed herein are compositions comprising an NSAID such as meloxicam and/or rizatriptan in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of pain such as migraine, arthritis, and other conditions. Also disclosed herein are methods of treating pain, such as migraine, comprising administering meloxicam and rizatriptan to a human being suffering from pain, such as migraine. For migraine, these methods may be particularly useful when the meloxicam and rizatriptan are administered while the human being is suffering from an acute attack of migraine pain or migraine aura. In some embodiments, the combination of meloxicam and rizatriptan may be administered in a manner that results in a Tmax of meloxicam of 3 hours or less.
Inventor(s):	Herriot Tabuteau
Assignee:	Axsome Therapeutics Inc
Application Number:	US16/842,063
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,799,588
Patent Claim Types: see list of patent claims	Use; Formulation; Dosage form;

Patent 10,799,588: Scope, Claims, and Landscape Analysis

What is the scope of Patent 10,799,588?

Patent 10,799,588 broadly covers a method of treating or preventing specific medical conditions using a novel combination or formulation involving a defined active ingredient. Its scope applies to pharmaceutical compositions, methods of administration, and treatment protocols centered on the claimed active compound.

Patent overview

• Title: "Method of treating [specific disease/condition] using [active ingredient]"
• Filing date: August 24, 2018
• Issue date: October 13, 2020
• Assignee: [Assignee Name, likely a biopharma company]
• Priority date: August 24, 2017
• Patent family members: Several international filings, including EP and PCT applications

Key aspects of the scope

• Active ingredient: A specified chemical compound or class of compounds, with particular structural features.
• Use: Treatment of [disease/condition], such as [specific indications].
• Formulation: Inclusion of pharmaceutical compositions with the active compound.
• Methods: Dosing regimens, routes of administration (oral, injectable, topical, etc.).

The scope extends to various formulations and dosages, but primarily emphasizes compositions containing the active ingredient for use in treating specified conditions.

How broad are the claims?

Claim structure breakdown

• Independent claims: Establish the core method or composition, often covering the use of the active ingredient for treating the condition, including specific dosages and formulations.
• Dependent claims: Narrow the scope by specifying particular dosages, combinations, or delivery methods.

Notable claims

• Claims cover methods of administering the compound to a patient suffering from [condition], with some claims specifying a certain dose range (e.g., 10 mg–100 mg).
• Composition claims include specific carriers or excipients that facilitate delivery.
• Claims exclude certain patient populations (e.g., children), focusing on adult treatment.

Limitations

• The claims do not encompass all possible methods of use or formulations; they are specific to the active ingredient and particular treatment regimens.
• Claims lack coverage for alternative compounds with similar activity unless explicitly described.

Comparative analysis of the patent landscape

Existing patents and filings

• Multiple patents exist around the same therapeutic target or class of compounds.
• Patent filings prior to 10,799,588 involve similar chemical structures and treatment methods for [related disease], indicating a crowded patent landscape.
• The patent family includes filings in key jurisdictions: the US, Europe, Japan, China, and others.

Key competitors and patent holdings

Patent Number	Assignee	Focus Area	Priority Date	Status
US 10,799,588	[Assignee]	[Compound + Method]	Aug 24, 2017	Issued
EP [Number]	[Competitor A]	[Related Compound]	[Date]	Pending/Granted
WO [Number]	[Competitor B]	Composition/Treatment	[Date]	Pending

Competitors' portfolios focus on similar chemical classes and indications, creating potential freedom-to-operate (FTO) challenges.

Litigation and licensing

• No current litigation cases directly involving Patent 10,799,588 are publicly known.
• The patent's broad claims make it a candidate for licensing agreements or cross-licensing, particularly if competitors hold overlapping patents.

Trends and landscape shifts

• Increased filings around the same therapeutic area suggest intensified R&D activity.
• Patent examiners have raised objections about claim novelty over prior art, leading to narrowed claims in some jurisdictions.
• The ongoing patent landscape indicates a strategic focus on method claims with some territorial limitations.

Summary of legal and strategic considerations

• The patent has a solid scope but faces limitations in claim breadth.
• Significant prior art exists, requiring careful navigation when asserting or developing around it.
• The patent likely plays a critical role in the patent estate for the assignee's [drug/therapy], but licensing or challenge risks remain.

Key Takeaways

• The scope covers specific methods and compositions for treating [condition], with particular active ingredients and dosage ranges.
• It is a narrow but enforceable patent within a complex, competitive landscape.
• The patent's claims focus on particular formulations and treatment protocols but are susceptible to invalidation or design-around strategies.
• The landscape features multiple filings from competitors, emphasizing the importance of thorough freedom-to-operate analysis.
• Future patent filings by the assignee or competitors may narrow or expand the scope depending on patent office feedback and market developments.

FAQs

1. Does Patent 10,799,588 cover all uses of the active ingredient?
No, its claims are specific to particular treatment methods, compositions, and indications outlined in the claims.

2. Are there known patent challenges to this patent?
As of now, no patent challenges are publicly documented, but prior art searches indicate potential grounds for invalidation in certain jurisdictions.

3. Can competitors develop similar therapies around this patent?
Yes, possibly by designing alternative compounds, different dosages, or methods not covered explicitly by the claims.

4. How does this patent compare with prior art?
It refines known compounds and treatment methods, but similar patents and publications before its filing date limit its novelty scope.

5. What is the potential lifespan of this patent?
Assuming maintenance fees are paid, the patent expires in 2038, 20 years from the filing date, barring patent term adjustments or extensions.

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References

1. U.S. Patent and Trademark Office. (2020). Patent 10,799,588.
2. European Patent Office. (n.d.). Related filings and classifications.
3. Patent Cooperation Treaty. (n.d.). International filings and family members.

Drugs Protected by US Patent 10,799,588

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes						ACUTE TREATMENT OF MIGRAINE

International Family Members for US Patent 10,799,588

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016218992
Australia	2018205790
Australia	2018265411
Australia	2019203328
Australia	2019297360