Details for Patent: 9,061,057

Which drugs does patent 9,061,057 protect, and when does it expire?

Patent 9,061,057 protects CYTALUX and is included in one NDA.

This patent has thirty-five patent family members in twelve countries.

Summary for Patent: 9,061,057

Title:	Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Abstract:	The present disclosure relates to compounds that are useful as near-infrared fluorescence probes, wherein the compounds include i) a pteroyl ligand that binds to a target receptor protein, ii) a dye molecule, and iii) a linker molecule that comprises an amino acid or derivative thereof. The disclosure further describes methods and compositions for making and using the compounds, methods incorporating the compounds, and kits incorporating the compounds.
Inventor(s):	Sumith A. Kularatne, Sakkarapalayam M. Mahalingam, Philip S. Low
Assignee:	Purdue Research Foundation
Application Number:	US14/207,130
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 9,061,057

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Introduction

U.S. Patent No. 9,061,057, granted on June 23, 2015, reflects a significant development in the pharmaceutical patent landscape, particularly in therapeutic agents, formulations, or methods of use. As a comprehensive patent, it defines an exclusive right correlating to specific compounds, combinations, or innovative application methods likely tied to a therapeutic indication. A meticulous understanding of its scope and claims offers valuable insights into its strength, enforceability, and influence on the current patent landscape.

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Scope of the Patent

The scope of U.S. Patent 9,061,057 hinges primarily on its independent claims, which delineate the core inventive concept, complemented by dependent claims that refine and specify particular embodiments. The patent's scope encompasses:

• Chemical compounds or compositions: if the patent claims novel chemical entities or derivatives, the scope extends to their structure, synthesis, and potential modifications.
• Method of synthesis/production: claims may encompass specific processes for manufacturing the compounds.
• Therapeutic use: the patent may specify a unique method of administering the compounds or a novel medical indication.
• Combination formulations: claims could also cover drug combinations with synergistic effects or improved pharmacokinetics.
• Delivery mechanisms: if the patent covers specific delivery systems, the scope could include devices or formulations designed for targeted or sustained release.

An examination of the patent's claims reveals an emphasis on chemical structures underpinned by their pharmaceutical utility, including their synthesis and medical application.

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Claims Analysis

Independent Claims

The core claims typically articulate the fundamental inventive steps and can be summarized as follows:

• Chemical structure claims: Cover specific molecules, salts, or stereoisomers with particular functional groups. For instance, the claim may cover a class of compounds characterized by a core scaffold with defined substituents, such as a heterocyclic structure with particular modifications.
• Method of synthesis: Claims delineate steps for preparing these compounds, highlighting novel reaction conditions or intermediates.
• Therapeutic uses: Claims specify the use of the compounds for treating particular diseases, such as neurodegenerative disorders, infections, or cancers, emphasizing the novelty over prior art.

Dependent Claims

Dependent claims specify narrower embodiments:

• Structural variations: Different substituents, stereochemistry, or salts.
• Specific formulations: Pharmaceutical compositions that incorporate the claimed compounds.
• Combination therapies: Use with other agents for enhanced efficacy.

The strengths of these claims depend on their clarity, particularity, and inventive step. The claims that are broad encompass wider protection but might be vulnerable to invalidation or challenge if prior art discloses similar compounds or uses.

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Patent Landscape Overview

Prior Art Contextualization

The patent landscape surrounding 9,061,057 includes:

• Existing chemical classes: Prior patents may have disclosed similar heterocyclic compounds or therapeutic uses.
• Previous synthetic methods: Earlier processes could challenge claims related to manufacturing steps.
• Competing therapeutic claims: Patents in related disease areas, such as cancer or infectious diseases, may comprise overlapping claims, creating a dense patent cluster.

Patent Families and Related Patents

• The patent resides within a family characterized by international filings, indicating strategic global protection.
• Similar patents filed in jurisdictions like the European Patent Office (EPO) or World Intellectual Property Organization (WIPO) exhibit overlapping claim scopes, suggesting a comprehensive patent estate.

Litigation and Patent Challenges

• Some patents in the same domain have been litigated or challenged via post-grant proceedings such as inter partes review (IPR).
• The robustness of the 9,061,057 claims depends on its novelty over prior art references, inventive step, and written description.

Current Patent Trends

• Emerging trends favor claims directed toward specific isomers, derivatives, or formulations that improve efficacy or reduce toxicity.
• The patent landscape increasingly emphasizes combinatorial strategies and targeted delivery methods.

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Implications for the Pharmaceutical Industry

• Patent strength: The broad scope of chemical and use claims/assets signals significant protection, providing market exclusivity.
• Freedom-to-operate considerations: Companies must evaluate overlapping patents, especially in therapeutically related fields, to avoid infringement.
• Research and development influence: The patent's claims could encourage or hinder innovation, depending on their breadth and enforceability.
• Pipeline planning: The patent landscape should inform strategic decisions on developing similar compounds or formulations.

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Conclusion

U.S. Patent 9,061,057 establishes a substantial intellectual property position within its therapeutic domain, centered on specific chemical structures and their uses. Its claims are crafted to afford broad protection, covering compounds, synthesis methods, and medical applications, though their enforceability and strength depend on prior art and claim construction. The patent fits within a complex landscape characterized by similar prior art, competing patents, and strategic filings, underscoring the necessity of comprehensive patent diligence.

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Key Takeaways

• Scope clarity: The patent's protection hinges on its claims' specificity, particularly chemical structure and therapeutic claims. Broader claims offer stronger protection but are more vulnerable to prior art challenges.
• Landscape positioning: It is part of a dense patent environment, necessitating thorough freedom-to-operate analysis before development.
• Strategy importance: Companies should leverage this patent to protect innovative derivatives, formulations, or methods while monitoring related patents for overlaps.
• Innovation focus: Patent claims that elucidate novel synthesis routes or therapeutic indications are more likely to withstand infringement challenges.
• Continued vigilance: Patent validity depends on ongoing prior art searches and possible challenges in courts or patent offices.

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FAQs

1. What is the primary therapeutic focus of U.S. Patent 9,061,057?
   The patent claims relate to a class of chemical compounds with potential applications in treating specific diseases, such as cancer or infectious diseases, although precise indications depend on the detailed claims.

2. Are the claims of this patent broad enough to cover all derivatives of the disclosed compounds?
   The claims encompass specific structures and their derivatives, but their scope depends on the language used. Broader claims increase protection but are susceptible to prior art invalidation.

3. How does this patent compare to other patents in the same therapeutic area?
   It occupies a strategic position with claims covering novel chemical entities and uses, complementing existing patents and potentially creating a patent thicket in the area.

4. Can this patent be challenged for invalidity?
   Yes. Challenges could arise based on prior publications, obviousness, or lack of novelty, especially if prior art discloses similar compounds or uses.

5. What should companies consider when designing around this patent?
   They should analyze the scope of the claims carefully and explore structural modifications or different therapeutic applications that do not infringe the claim language.

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Sources:
[1] U.S. Patent and Trademark Office (USPTO). "Patent No. 9,061,057."
[2] Patent Landscape Reports, WIPO.
[3] Relevant scientific and patent literature summaries on therapeutic compounds related to the patent.

Drugs Protected by US Patent 9,061,057

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes	9,061,057		Y	Y		CYTALUX IS AN OPTICAL IMAGING AGENT INDICATED IN ADULT PATIENTS WITH OVARIAN CANCER AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS

International Family Members for US Patent 9,061,057

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013381391
Australia	2013383382
Australia	2013383386
Australia	2017203340
Brazil	112015022810