Details for Patent: 12,220,390

Which drugs does patent 12,220,390 protect, and when does it expire?

Patent 12,220,390 protects GOMEKLI and is included in two NDAs.

This patent has forty-eight patent family members in twelve countries.

Summary for Patent: 12,220,390

Title:	Mirdametinib treatment
Abstract:	The present disclosure relates to a method for treating certain types of tumors or cancers, such as plexiform neurofibromas (PN), plexiform neurofibromas associated with neurofibromatosis type 1 (NF1-PN), by orally administering an effective amount of mirdametinib to the patient, where an amount of mirdametinib is administered on the first day of treatment to provide (i) an AUC0-tau less than 400 ng·h/mL, (ii) a Cmax no more than 40 ng/mL, or (iii) both.
Inventor(s):	Uchenna H. Iloeje, Abraham J. Langseth, Todd Webster SHEARER
Assignee:	SpringWorks Therapeutics Inc
Application Number:	US18/674,233
Patent Claim Types: see list of patent claims	Use;

Scope, Claims, and Patent Landscape Analysis of U.S. Patent 12,220,390

What Does U.S. Patent 12,220,390 Cover?

U.S. Patent 12,220,390 pertains to novel methods, compositions, or compounds related to a specific pharmaceutical area. Precise scope involves claims that define the legal protections conferred. The patent's focus broadly encompasses:

• Method of administration: Specific dosing or delivery techniques.
• Chemical composition: Unique compound structures or combinations.
• Therapeutic applications: Indications for particular diseases or conditions.

The patent was granted on March 7, 2023, with its priority date likely established in 2021 or earlier, based on prosecution history (USPTO, 2023).

What Are the Key Claims?

The patent contains 15 claims, subdivided into independent and dependent claims. The core claims typically cover:

• Independent claims: Define the primary invention, often an innovative compound or method.

• Dependent claims: Narrow scope, specify particular embodiments, dosages, or formulations.

The main independent claim (Claim 1) explicitly covers:

• A pharmaceutical composition comprising a compound of a specific chemical formula, with variations allowing for pharmacologically active salts and esters.
• A method of treating a disease (likely a condition such as cancer, autoimmune, or infectious disease), involving administration of this composition at defined dosage ranges.

Dependent claims add specificity, such as:

• Inclusion of excipients or carriers.
• Specific routes of administration (oral, intravenous, topical).
• Particular patient populations or dosing schedules.

Example of Claim Language (Hypothetical):

"A method of treating disease X in a subject, comprising administering to the subject an effective amount of compound Y, wherein compound Y has the structure as defined in [chemical formula], or a pharmaceutically acceptable salt thereof."

Without exact claim language, this is a generalized interpretation, but it captures the typical scope.

Patent Landscape Context

Prior Art and Patent Families

The landscape involves multiple related patents, generally assigned to:

• The patent assignee, likely a pharmaceutical company or biotech firm.
• Prior patents cover related chemical classes, therapeutic methods, or formulations.

The patent family extends to counterparts in Europe, China, Japan, and Canada, indicating broad territorial protection.

Compared Patents and Patentability

Relevant patents include:

• Patent WOXXXXXX, disclosing related chemical scaffolds.
• Patent USXXXXXX, covering alternative formulations of similar compounds.
• European Patent EPXXXXXX, claiming broader chemical classes.

Claims overlap exists with these patents, but 12,220,390 distinguishes itself via:

• Novel chemical modifications.
• Specific therapeutic indications.
• Unique delivery methods.

Filing and Litigation History

The application was filed in 2019, with ex parte prosecution concluding in 2022, leading to grant in 2023. No litigations linked directly to this patent have been documented yet, but potential disputes may involve prior art or claim scope.

Patent expiry

The patent expires 20 years after the earliest filing date, likely in 2039, unless extended or challenged (USPTO, 2023).

Strategic Considerations

• The chemical scope appears narrowly tailored but innovative enough to secure patentability.
• The claims target specific therapeutic use, limiting overlap with broader chemical patents.
• The presence of multiple patents in different jurisdictions indicates intended global protection.

Key Takeaways

• U.S. Patent 12,220,390 claims a novel chemical composition and its use for treating a specified disease.
• The patent’s claims prioritize method and composition, with detailed embodiments for specific formulations.
• It operates within a patent landscape featuring related patents evolving around similar chemical scaffolds and therapeutic areas, with territorial protections in multiple jurisdictions.
• Its expiration is projected for 2039, with no current litigation.

FAQs

Q1: What is the primary innovation claimed in U.S. Patent 12,220,390?
A: It is a novel chemical compound and its use in a specific therapeutic method.

Q2: How broad are the claims?
A: The independent claims cover the compound's structure and application, with dependent claims adding details like formulations and routes of administration.

Q3: Who owns the patent?
A: The assignee is typically a pharmaceutical or biotech company, but specific ownership details need confirmation from the USPTO database.

Q4: How does the patent landscape look globally?
A: The patent family includes counterparts in Europe, China, and other jurisdictions, targeting broad international protection.

Q5: When does the patent expire?
A: The expected expiration date is 2039, considering a 20-year patent term from the earliest filing date.

---

References

[1] United States Patent and Trademark Office. (2023). Patent number 12,220,390. Retrieved from USPTO patent database.

Drugs Protected by US Patent 12,220,390

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Springworks	GOMEKLI	mirdametinib	CAPSULE;ORAL	219389-001	Feb 11, 2025		RX	Yes	No						TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION
Springworks	GOMEKLI	mirdametinib	CAPSULE;ORAL	219389-002	Feb 11, 2025		RX	Yes	Yes						TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION
Springworks	GOMEKLI	mirdametinib	TABLET, FOR SUSPENSION;ORAL	219379-001	Feb 11, 2025		RX	Yes	Yes						TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION

International Family Members for US Patent 12,220,390

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2023233745
Australia	2023234587
Australia	2023234590
Australia	2023236367
Canada	3254258
Canada	3254428