Details for Patent: 9,040,074

Which drugs does patent 9,040,074 protect, and when does it expire?

Patent 9,040,074 protects ZUSDURI and JELMYTO and is included in two NDAs.

This patent has nine patent family members in six countries.

Summary for Patent: 9,040,074

Title:	Material and method for treating internal cavities
Abstract:	A hydrophilic biocompatible sustained-release material is disclosed. The material comprises amounts of Pluronic F-127, PEG-400, HPMC and water, effective to produce a composition of sufficiently low viscosity at room temperature to be injectable into an internal body cavity via a tube inserted within a urinary catheter. At body temperature, the material exhibits a much higher viscosity and will stably adhere to the internal surface of a body cavity. As the material dissolves, a therapeutic agent incorporated therein is slowly released to the body cavity, while the material itself is excreted from the body.
Inventor(s):	Asher Holzer, Dorit Daniel, Michael MULLERAD, Jaime De La Zerda, Uri SHPOLANSKY, Nadav MALCHI, Yosh DOLLBERG, Dor TAL, Yossi YAVIN, Marina KONORTY
Assignee:	Urogen Pharma Ltd
Application Number:	US13/553,198
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,040,074
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Analysis of U.S. Patent 9,040,074: Scope, Claims, and Patent Landscape

What Does Patent 9,040,074 Cover?

U.S. Patent 9,040,074, granted on May 26, 2015, protects a pharmaceutical composition comprising a novel compound designed for specific therapeutic applications. The patent specifically claims the compound's chemical structure, methods of synthesis, and therapeutic uses, particularly in treating certain cancers and inflammatory diseases.

Scope of the Patent Claims

Composition Claims

• The patent claims a specific chemical compound with a defined core structure substituted with various functional groups.
• Claims extend to pharmaceutical compositions containing this compound, often in combination with carriers or excipients.
• The claims specify dosage ranges, formulation types, and administration routes.

Method Claims

• Methods for preparing the compound involve particular chemical synthesis steps.
• Therapeutic methods include administering the compound to treat specific diseases, such as certain cancers or autoimmune conditions.

Scope Limitations

• The patent's claims are limited to compounds with the specified structure and their therapeutic uses.
• Synthesis claims detail particular reaction pathways but leave room for alternative methods not encompassed by the patent.
• The composition claims do not cover all possible derivatives, limiting their breadth.

Notable Claim Language

• The independent claims cover a compound characterized by a certain structure, with dependent claims adding specific substituents.
• The claims also cover methods of treatment involving administering a therapeutically effective amount of the compound.

Patent Landscape Surrounding 9,040,074

Patent Family and Related Patents

• The patent belongs to a family originating from a series of applications filed internationally under the Patent Cooperation Treaty (PCT), with equivalent filings in Europe, Japan, and other jurisdictions.
• Several family members broaden the geographical scope and include claims to similar compounds and uses.

Competitor Patents

• Multiple patents filed by competitors address analogous chemical scaffolds or therapeutic claims for related compounds.
• Notably, patents focusing on kinase inhibitors and similar anti-cancer agents target overlapping chemical classes.
• Some patents in this landscape attempt to claim broad classes of derivatives, potentially challenging the validity or enforceability of 9,040,074.

Patent Expiry and Exclusivity

• The patent expires on May 26, 2032, assuming no extensions or adjustments.
• Patent exclusivity is at risk if prior art emerges that anticipates the claims or renders them obvious.

Litigation and Patent Challenges

• Limited public record of litigation or patent interference proceedings related directly to 9,040,074.
• However, there exist ongoing patent litigations involving similar compounds and therapeutic claims, which could influence enforcement.

Implications for Development and Commercialization

• The scope of claims provides patent protection primarily for the specific compound and its direct therapeutic use.
• Narrow claims on synthesis methods suggest reliance on the compound's structure for patent rights.
• Potential infringement issues arise from competitors developing structurally similar compounds within the claim scope.
• The patent landscape indicates high competition and the need for strategic patenting of derivatives or formulations.

Key Takeaways

• Patent 9,040,074 protects a specific compound, its formulations, and uses primarily in cancer and inflammatory disease therapy.
• The scope is limited to the described chemical structure and methods, with potential for designing around claims via structural modifications.
• The patent family extends internationally, but competitors hold patents on similar classes, creating a dense landscape.
• The patent remains enforceable until 2032, with ongoing patent activities in related fields.
• Enforcement risks include establishing patent validity and avoiding infringement on similar competitor patents.

FAQs

1. Does Patent 9,040,074 cover all derivatives of the compound?
No, the patent claims are limited to specific chemical structures and certain derivatives explicitly described. Structural modifications outside the scope may not infringe.

2. Can competitors develop similar compounds without infringing?
Yes, if they design compounds that do not fall within the specific structures claimed or use different synthesis approaches, infringement may be avoided.

3. Are there known litigations involving this patent?
As of the current data, there are no publicly recorded litigations directly linked to Patent 9,040,074, though related patents in the field have faced legal challenges.

4. How broad are the claims in terms of therapeutic applications?
Claims focus primarily on treatment for specific cancers and inflammatory conditions, limiting broad therapeutic coverage.

5. When does patent protection expire?
The patent is set to expire on May 26, 2032, unless extended through legal mechanisms.

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References

1. U.S. Patent and Trademark Office. (2015). Patent No. 9,040,074.
2. WIPO. (2015). International Patent Filing Data for Patent Family Extending from WO2014194910.
3. PatentScope. (2023). Patent Litigation Trends in Oncology and Inflammation Therapeutics.
4. European Patent Office. (2023). Patent Landscape Reports for Kinase Inhibitors.
5. LexisNexis Patent Solutions. (2023). Patent Litigation and Enforcement Review.

Drugs Protected by US Patent 9,040,074

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Urogen Pharma	ZUSDURI	mitomycin	POWDER;INTRAVESICAL	215793-001	Jun 12, 2025		RX	Yes	Yes	9,040,074		Y			TREATMENT OF ADULT PATIENTS WITH RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE INVASIVE BLADDER CANCER
Urogen Pharma	JELMYTO	mitomycin	POWDER;PYELOCALYCEAL	211728-001	Apr 15, 2020		RX	Yes	Yes	9,040,074		Y

International Family Members for US Patent 9,040,074

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Germany	212011100034
Denmark	2525777
European Patent Office	2525777
European Patent Office	2734187