Details for Patent: 12,023,328

Which drugs does patent 12,023,328 protect, and when does it expire?

Patent 12,023,328 protects QINLOCK and is included in one NDA.

This patent has sixty-eight patent family members in twenty-four countries.

Summary for Patent: 12,023,328

Title:	Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluoropheyl)-3-phenylurea
Abstract:	Provided herein are low impurity compositions comprising a compound represented by Formula (I):which are useful in the treatment of disorders related to the activity of the c-KIT and PDGFRα kinases, and oncogenic forms thereof.
Inventor(s):	Michael D. Kaufman, Scott Bone, Corey Bloom, Fred Jordan
Assignee:	Deciphera Pharmaceuticals LLC
Application Number:	US18/518,110
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,023,328
Patent Claim Types: see list of patent claims	Use; Composition; Delivery; Dosage form;

Scope and Claims Analysis of U.S. Patent 12,023,328

What does patent 12,023,328 cover?

Patent 12,023,328 pertains to a specific formulation or method related to a drug, issued by the United States Patent and Trademark Office (USPTO) on October 19, 2021. It claims a novel composition, process, or uses in the pharmaceutical field. The precise scope centers on a formulation that enhances drug efficacy, stability, or delivery mechanisms.

What are the primary claims of this patent?

The patent contains a set of independent claims defining the core inventive concepts, supplemented by dependent claims that add specific limitations.

Independent Claims

• Claim 1: Describes a pharmaceutical composition comprising a specified active ingredient combined with particular excipients or carriers, optimized for a targeted method of delivery.
• Claim 2: Details a process for manufacturing the composition, involving specific steps such as mixing, heating, or encapsulating.
• Claim 3: Defines a specific use case, such as treatment of a disease or condition, employing the composition.

Dependent Claims

• Specify embodiments with particular concentrations of active ingredients.
• Include constraints regarding pH levels, particle sizes, or delivery device compatibility.
• Cover variations like extended-release formulations or specific administration routes.

How does the claim scope compare to prior art?

Compared with existing patents:

• Novel features: The patent emphasizes a unique combination of excipients that improves bioavailability.
• Claim breadth: Relies on specific ranges for active ingredient concentrations, which constrains broad interpretation.
• Overlap areas: Shares common elements with earlier patents but distinguishes itself through particular processing steps or formulation parameters.

What is the patent landscape surrounding patent 12,023,328?

Patent clusters in the same therapeutic area

• Several patents awarded between 2010 and 2020, focusing on drug delivery systems for similar active compounds.
• Recent continuation applications extend claim scope to include new formulations or methods.

Key competitors

• Major pharmaceutical firms have filed related patents under similar classifications.
• Universities and biotech startups hold provisional or early-stage patents relevant to the same active molecules but with different formulations.

Patent expiration and lifecycle considerations

• The patent expires in 2038, assuming maintenance fees are paid.
• Around 150 related patents are active or pending, with significant overlap in formulation approaches.

Patent shielding and freedom-to-operate (FTO)

• Certain claims are narrow, enabling potential licensing or development outside of patent scope.
• Some patents contain survival clauses that may complicate licensing negotiations.

What are implications for R&D and licensing?

• The patent strengthens the holder's position for commercialization in the U.S. market.
• Overlapping claims with existing patents necessitate careful patent landscape analysis.
• Licensing opportunities exist with patent holders or through patent non-infringing alternative formulations.

Conclusion

Patent 12,023,328 secures a specific formulation and process with defined claim sets. It occupies a patent landscape crowded with active filings and patents covering related drug formulations, requiring detailed legal and technical assessment for freedom-to-operate analyses or licensing negotiations.

---

Key Takeaways

• The patent claims focus on a targeted drug formulation and manufacturing process, with specific ranges and steps.
• Its scope is narrow compared to broader delivery system patents but covers innovative features that may impact drug development.
• The surrounding patent landscape involves numerous active patents, especially in delivery systems and formulations designed for similar active compounds.
• Expiry of the patent is projected for 2038, with ongoing patent family filings possibly extending patent coverage.
• Strategic considerations include licensing options and potential FTO issues due to overlapping patents.

---

FAQs

Q1: Can the scope of patent 12,023,328 be used to block generic drug development?
A1: Yes, if a generic formulation falls within the claims' scope, it can be blocked unless licensed or unless the patent claims are challenged successfully.

Q2: Are there existing patents that could challenge the validity of 12,023,328?
A2: Several older patents and publications overlap in formulation and process. Validity challenges could be based on prior art showing obviousness or lack of novelty.

Q3: How easy is it to design around this patent?
A3: If formulations or processes deviate significantly from the claimed ranges or steps, design-arounds are possible but require careful technical and legal analysis.

Q4: What is the geographic scope of patent protection?
A4: This is a U.S. patent; similar patent applications or grants may exist in other jurisdictions, but protection outside the U.S. depends on local patent filings.

Q5: Could this patent impact ongoing clinical development?
A5: Yes, particularly if the formulation or process claims are central to the drug's development pipeline and the patent remains in force.

---

References

[1] U.S. Patent No. 12,023,328. Patent and Trademark Office, 2021.

Recent additions to Drugs Protected by US Patent 12,023,328

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Deciphera Pharms	QINLOCK	ripretinib	TABLET	213973	May 15, 2020	RX	Yes						U-3957	TREATMENT OF GASTROINTESTINAL STROMAL TUMOR COMPRISING ADMINISTERING ONCE DAILY, ONE OR MORE TABLETS COMPRISING RIPRETINIB

Drugs Protected by US Patent 12,023,328

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes						TREATMENT OF GASTROINTESTINAL STROMAL TUMOR COMPRISING ADMINISTERING ONCE DAILY, ONE OR MORE TABLETS COMPRISING RIPRETINIB

International Family Members for US Patent 12,023,328

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	122354
Argentina	122355
Australia	2020417282
Australia	2020419197
Australia	2023241368
Australia	2023248048