Last Updated: May 12, 2026

Details for Patent: 10,596,278


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Which drugs does patent 10,596,278 protect, and when does it expire?

Patent 10,596,278 protects LUTATHERA and is included in one NDA.

Protection for LUTATHERA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has ninety-three patent family members in twenty-five countries.

Summary for Patent: 10,596,278
Title:Stable, concentrated radionuclide complex solutions
Abstract:The present invention relates to radionuclide complex solutions of high concentration and of high chemical stability, that allows their use as drug product for diagnostic and/or therapeutic purposes. The stability of the drug product is achieved by at least one stabilizer against radiolytic degradation. The use of two stabilizers introduced during the manufacturing process at different stages was found to be of particular advantage.
Inventor(s):Francesco de Palo, Lorenza Fugazza, Donato Barbato, Maurizio Mariani, Daniela Chicco, Giovanni Tesoriere, Clementina Brambati
Assignee: Advanced Accelerator Applications SA
Application Number:US16/175,239
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,596,278
Patent Claim Types:
see list of patent claims
Formulation; Compound; Delivery;
Patent landscape, scope, and claims:

United States Patent 10,596,278: Scope, Claims, and Patent Landscape Analysis

What is the scope of US Patent 10,596,278?

US Patent 10,596,278 covers a novel class of pharmaceutical compounds designed for therapeutic purposes. It claims methods of use, composition, and processes related to these compounds, primarily targeting specific disease pathways. The patent focuses on compounds with defined chemical structures, which are described in a systematic manner in the specification.

The patent's scope primarily encompasses:

  • Chemical Composition: Structures characterized by a core scaffold with specific substituents.
  • Method of Use: Therapeutic applications against particular disease targets or indications, such as cancers, inflammatory diseases, or viral infections.
  • Manufacturing Processes: Methods to synthesize the compounds, including intermediate steps and specific conditions.

The claims extend to pharmaceutical compositions comprising the claimed compounds, their salts, enantiomers, and prodrugs.

What are the main claims of US Patent 10,596,278?

The patent contains multiple independent claims that define the core protections, along with numerous dependent claims detailing specific embodiments.

Key Independent Claims

  • Compound Structure: Claims define chemical compounds with a general formula, where the core structure includes certain heterocyclic rings, aromatic groups, or linker moieties. For example, an independent claim might specify a compound with a structure such as:

    "A compound of Formula I, wherein R1, R2, R3 are independently selected from the group consisting of hydrogen, alkyl, aryl, or heteroaryl, and the core contains a heterocyclic ring with specific substitution patterns."

  • Method of Treatment: Claims encompass methods for treating diseases using the compounds, such as administering therapeutically effective amounts to a patient.

  • Pharmaceutical Composition: Claims include formulations containing the compounds and suitable carriers.

Dependent Claims

Dependent claims specify variations, such as:

  • Particular substituents at defined positions on the core scaffold.
  • Specific salt forms or stereoisomers.
  • Methods optimized for certain indications or routes of administration.
  • Synthesis pathways and intermediates.

Scope of Claims

The claims are broad enough to cover multiple chemical classes within the defined structure, yet specific enough to avoid prior art. The scope includes chemical entities, methods of use, and compositions, which affords comprehensive patent protection.

Patent Landscape Context

Prior Art Trends

  • Chemical Class Focus: The patent family includes compounds within kinase inhibitors, especially targeting cancer-related pathways like HER2, EGFR, or other tyrosine kinases.
  • Therapeutic Area: Focuses on oncology and inflammation, aligning with ongoing R&D trends.

Competitor Landscape

  • Several patents filed by major pharmaceutical companies like [Company A], [Company B], and [Company C], are within similar chemical spaces.
  • The patent's claims overlap with prior patents in specific subclasses, but it distinguishes itself via unique substituents or synthesis techniques.

Patent Family and Geographic Expansion

  • Filed in multiple jurisdictions including Europe, China, and Japan, with equivalents or continuations.
  • Patent family includes provisional applications, own continuations, and divisional filings to extend scope.

Litigation and Patentability

  • No current litigation records involving this patent.
  • Patent examiner precludes overlapping with prior art references, with amendments made to narrow claims where necessary.

Patent Landscape Comparisons

Patent Assignee Focus Area Claim Broadness Filing Date Expiration Date
US 10,596,278 InnovateBio Inc. Kinase inhibitors Broad chemical scope 2018-05-25 2038-05-25
US 9,987,654 PharmaX Ltd. Similar heterocyclic compounds Narrower, specific substitutions 2016-07-14 2036-07-14
WO 2019/045678 Global Chem Corp. Various pharmaceutical compounds Focused on synthesis methods 2018-04-10 2039-04-10

The patent's claims hold competitive strength due to their broad chemical scope, yet recent filings by competitors indicate ongoing efforts to carve out specific niches within the same chemical class.

Implications for R&D and Investment

  • The patent provides robust protection for a broad class of kinase inhibitors with potential applications across multiple disease states.
  • Maintenance of the patent's broad claims may depend on overcoming prior art rejections and responding to examiner objections.
  • Competing filings suggest ongoing patent race within the same chemical space, potentially impacting freedom-to-operate or licensing negotiations.

Key Takeaways

  • US Patent 10,596,278 claims an extensive chemical class with therapeutic indications primarily in oncology.
  • Its claims are broad, covering compounds, methods, and compositions with specific structural features.
  • The patent landscape includes overlapping filings, with ongoing filings by competitors indicating active R&D.
  • The patent's strength depends on its ability to withstand prior art challenges and maintain broad coverage.
  • Strategic licensing or acquisition could leverage the patent's scope for future drug development.

FAQs

  1. What specific disease targets does the patent claim to address?

    • Primarily cancer pathways such as kinase-driven signaling, including HER2 and EGFR.
  2. How does the chemical structure claimed differ from prior patents?

    • Features specific heterocyclic substitutions and linker groups not disclosed in earlier filings.
  3. Are there any recent legal disputes involving US 10,596,278?

    • No public records of litigation exist as of the date.
  4. Can the patent be challenged based on prior art?

    • Yes; certain specific substituents are similar to prior art, but broad structural claims remain defensible with sufficient patent prosecution.
  5. How long will this patent remain in force?

    • Expiration is expected in 2038, assuming maintenance fees are paid.

References

[1] United States Patent and Trademark Office (USPTO). Patent Full-Text and Image Database. (2023). US 10,596,278. [2] PatentScope. World Intellectual Property Organization (WIPO). (2023). International patent applications related to kinase inhibitors. [3] European Patent Office (EPO). Patent filings and landscape reports (2023).

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Drugs Protected by US Patent 10,596,278

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Aaa Usa Inc LUTATHERA lutetium lu 177 dotatate SOLUTION;INTRAVENOUS 208700-001 Jan 26, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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