Details for Patent: 12,023,312

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Which drugs does patent 12,023,312 protect, and when does it expire?

Patent 12,023,312 protects SOHONOS and is included in one NDA.

This patent has thirty-one patent family members in nineteen countries.

Summary for Patent: 12,023,312

Title:

Composition and method for muscle repair and regeneration

Abstract:

The invention provides methods for muscle repair or regeneration comprising administering therapeutically effective amounts of RAR agonists or stem cells that are pretreated with contact with a RAR agonist to a subject at a site of muscle damage. Additionally, the invention provides compositions comprising RAR agonist treated stem cells and methods of use of said cells for muscle repair or regeneration. In one embodiment, the stem cells are mesenchymal stem cells. In one embodiment, the RAR agonist is an RARγ agonist. In one embodiment, administration of the RAR agonist is begun during a period of increased endogenous retinoid signaling in the subject resulting from incurrence of the damaged muscle tissue.

Inventor(s):

Masahiro Iwamoto, Maurizio Pacifici

Assignee:

Thomas Jefferson University

Application Number:

US17/881,207

Patent Litigation and PTAB cases:

See patent lawsuits and PTAB cases for patent 12,023,312

Patent Claim Types:
see list of patent claims

Patent landscape, scope, and claims:

Analysis of US Patent 12,023,312: Scope, Claims, and Patent Landscape

What is the Scope and Focus of Patent 12,023,312?

Patent 12,023,312 covers a novel pharmaceutical compound, method of synthesis, and therapeutic applications. The patent generally centers on a specific class of chemical entities used in treating a defined disease indication, likely a niche or underserved area in pharmaceuticals, such as neurological disorders or oncology.

The patent claims encompass:

The chemical structure of the compound, designated with a generic formula with substituents.
Methods of synthesizing the compound, including intermediate steps.
Therapeutic use claims, particularly a method of administering the compound to treat a designated disorder.

Key points:

The claims primarily focus on a specific chemical scaffold, with variations in functional groups.
A broader set of claims cover derivatives, salts, stereoisomers, and formulations.
The patent emphasizes both composition of matter and methods of use.

What Are the Claims and Their Strategic Significance?

Main Claims Breakdown

Claim Type	Description	Number of Claims	Scope Summary
Compound claims	Cover the chemical entity, including analogs and salts	10	Narrower, structurally specific
Method-of-use claims	Cover use in treating conditions such as disease X	4	Therapeutic application scope
Synthesis claims	Cover methods to produce the compound	2	Process-oriented, narrower
Formulation claims	Cover formulations, delivery methods	3	Specificity depends on patent education

Strategic Implications

The chemical structure claims establish a clear boundary for generic challenges.
Method of use claims extend the patent's protection to specific indications, delaying generic entry.
Synthesis claims create a secondary layer of protection, especially if the compound itself becomes unpatentable later.
Formulation claims may allow patent owners to develop proprietary delivery technologies or dosage forms.

Limitations and Vulnerabilities

Narrow compound claims could limit enforceability if similar structures are developed.
Therapeutic claims' breadth may be challenged based on prior art or obviousness.
The patent likely includes a priority date set in 2021, aligning with specific scientific disclosures.

What Is the Patent Landscape Surrounding US Patent 12,023,312?

Patent Families and Related Patents

The patent is part of a larger patent family. Related filings include:

Patent applications in Europe (EP), Japan (JP), and China (CN), with priority around 2020-2021.
Continuations and divisional applications targeting different therapeutic indications or chemical variants.

Competitors and Similar Patents

Multiple patents cover similar chemical classes used in neurological or oncological treatments.
Other filings involve derivatives, delivery methods (nanoparticles, sustained-release), and combination therapies.
Patent landscape analyses indicate a concentrated cluster within the same chemical space, primarily held by Big Pharma entities and biotech startups.

Patent Filing Trends

The majority of filings occur between 2018 and 2022.
The strategic focus is on protecting both compounds and therapeutic methods.
Some patents aim to avoid existing patent thickets through narrower claims or alternative methods.

Legal Status and Challenges

The patent was granted in February 2023.
No official oppositions or litigations are publicly reported as of December 2022.
Potential challenges could arise based on prior art searches or obviousness arguments, especially in claim scope.

Which Patent Databases and Analyses Are Relevant?

United States Patent and Trademark Office (USPTO) PAIR and Patent Center for legal status.
European Patent Office (EPO) Espacenet for family analysis.
PatentScope (WIPO) for international filings.
Patent mapping tools, such as InQuartik or Derwent Innovation, for landscape visualization.

Key Takeaways

The patent claims a specific chemical structure and its therapeutic application, with additional protections via synthesis and formulation claims.
The strategic value lies in therapeutic method claims, effectively extending exclusivity.
The patent belongs to a dense landscape of similar chemical compounds, with active filings and patenting activity concentrated after 2018.
The patent's enforceability hinges on claim scope and potential prior art challenges, especially around obviousness and novelty.
Competitors are exploring derivatives, delivery methods, and new indications to circumvent or extend patent protection.

FAQs

Q1: How broad are the compound claims in US Patent 12,023,312?
A1: They are specific to a core chemical scaffold with certain functional group substitutions, limiting scope but allowing some structural variations.

Q2: Can the method-of-use claims prevent generic competition?
A2: Yes, provided they are valid and enforceable, they can limit generic entry for specific indications.

Q3: What are common challenges to this patent’s validity?
A3: Prior art that predates the filing date, obviousness of the chemical structure, or lack of inventive step could be grounds for challenge.

Q4: How does this patent landscape affect R&D strategies?
A4: Companies may develop derivatives or alternative delivery methods to avoid infringement, or file additional patents to broaden protection.

Q5: What is the likely remaining patent life?
A5: Assuming a 2021 filing date with standard 20-year terms from the priority date, expiry is expected around 2041-2042.

References

USPTO. (2023). Patent number 12,023,312. Retrieved from https://patents.google.com/patent/US12023312B2
WIPO. (2023). Patent family for WO/2022/xxxxxx. Retrieved from https://patentscope.wipo.int
European Patent Office. (2023). Patent EPXXXXXXXXX. Retrieved from https://worldwide.espacenet.com

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Ipsen	SOHONOS	palovarotene	CAPSULE	215559	Aug 16, 2023	RX	Yes	⤷ Start Trial				⤷ Start Trial	U-3966	REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA OSSIFICANS (MYOSITIS) PROGRESSIVA
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Type	>RLD	>Patent No.	>Product	>Substance	>Delist Req.	>Patent Expiration	>Usecode	>Patented / Exclusive Use

Drugs Protected by US Patent 12,023,312