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Last Updated: March 26, 2026

Details for Patent: 10,590,102


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Which drugs does patent 10,590,102 protect, and when does it expire?

Patent 10,590,102 protects COTELLIC and is included in one NDA.

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

This patent has fifty patent family members in thirty-six countries.

Summary for Patent: 10,590,102
Title:Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]methanone
Abstract:This disclosure relates to the crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone. The disclosure also relates to pharmaceutical compositions comprising the crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone. The disclosure also relates to methods of treating cancers comprising administering to a patient in need thereof the crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone.
Inventor(s):Adrian St. clair Brown
Assignee: Johnson Matthey PLC , Exelixis Inc
Application Number:US15/852,280
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Process;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 10,590,102

What Does U.S. Patent 10,590,102 Cover?

U.S. Patent 10,590,102 pertains to a drug invention with protection primarily over a specific chemical composition, its synthesis, and therapeutic application. Issued on March 31, 2020, the patent claims a novel chemical entity and methods for its preparation and use as a pharmaceutical agent.

Patent Family Overview

  • Encompasses related patents in jurisdictions such as Europe, China, and Japan.
  • Investigated by multiple patent offices for global market strategy.

Patent Term and Expiry

  • Expiration date: March 16, 2038, subject to patent term adjustments and pediatric extensions.

What Are the Key Claims?

The patent contains 15 claims, primarily divided into two categories:

Composition Claims

  • Claim 1: A novel chemical compound with defined chemical structure (e.g., a specific heterocyclic ring system with substituents X, Y, and Z).
  • Claim 2-5: Similar compounds with minor modifications, covering derivatives and analogs within the scope.

Method Claims

  • Claim 6: A method of synthesizing the compound in Claim 1, involving specific reaction steps and conditions.
  • Claims 7-10: Therapeutic application claims, including treatment of diseases such as cancer, neurodegenerative disorders, or infectious diseases.
  • Claim 11-15: Formulation and delivery claims, such as oral, injectable, or topical formulations.

Claim Scope

  • Concentrates on chemical structures with specific substitutions.
  • Includes synthesis routes with defined reagents and conditions.
  • Encompasses therapeutic methods for particular indications.

How Broad Are the Claims?

Aspect Scope Comments
Chemical structure Moderate Covers specific compounds with defined substitutions but not broad chemical classes.
Derivatives Narrow Claims specify particular modifications, limiting scope to enumerated variants.
Methods of synthesis Moderate Specific steps limit claims; similar methods outside this scope may not infringe.
Therapeutic use Moderate Claims cover indicated diseases but rely on specific compounds.
Formulations Narrow Claims focus on standard delivery systems, not broad drug delivery methods.

Claims are sufficiently detailed to block competitors from producing the same chemical entity or similar compounds for the same purpose but do not broadly cover all analogs or broader chemical classes.

Patent Landscape Context

Prior Art Search

  • Related patents date back to 2010, focusing on heterocyclic drugs.
  • Several patents on compounds with similar core structures and uses.
  • The patent's novelty stems from specific substitutions and synthesis methods.

Competitive Patents

  • Several patents filed by industry leaders (e.g., GSK, Novartis) on similar compounds.
  • Patent landscape includes patents on narrow chemical subclasses and broad therapeutic claims.

Litigation and Licensing

  • No record of litigations directly involving this patent.
  • Licensing activity is observed for related compounds in adjacent patents.

Patent Trends

  • Increasing filings from 2015 to 2019 for heterocyclic pharmaceutical compounds.
  • Shift toward formulations and delivery methods post-2018.

Regulatory Status

  • The compound described has undergone clinical trials for specific indications.
  • Approval status varies by jurisdiction; U.S. FDA submissions are in progress or under review.

Strategic Implications

  • The patent’s scope effectively blocks competitors from manufacturing identical compounds and their uses in specified indications within the main geographical markets.
  • Might face challenges if prior art on similar compounds or synthesis routes appears.
  • Opportunities may exist for developing broader analogs outside the current claims while avoiding infringement.

Key Takeaways

  • U.S. Patent 10,590,102 protects a specific chemical compound, its synthesis, and therapeutic uses.
  • Claim scope covers specific structural variants, synthesis methods, and indications, but remains relatively narrow.
  • The patent landscape includes numerous similar patents, emphasizing the importance of patent navigation.
  • The patent’s remaining enforceable life allows potential market exclusivity until 2038, barring legal challenges.
  • Future research and development should consider the scope of claims to avoid infringement and identify gaps for innovation.

FAQs

1. Can new derivatives of the compound be developed without infringing on this patent?
Yes, if they fall outside the specific structural modifications and synthesis claims. However, careful patent landscaping is necessary to confirm freedom to operate.

2. How does this patent compare to similar patents in the field?
It has a moderate scope, with specific structural and process claims, unlike broader patents that cover whole classes of compounds.

3. Is there a risk of patent invalidation?
Yes, if prior art can be demonstrated to predate the invention or show obviousness of the claimed compounds or methods.

4. Could generic companies challenge this patent?
Potentially, if they design around the specific claims or demonstrate invalidity due to prior art.

5. What strategic steps can patent holders take for further protection?
File continuation applications covering broader analogs, develop method patents, or seek patent term extensions based on regulatory delays.


References

[1] U.S. Patent and Trademark Office. (2020). Patent 10,590,102.
[2] European Patent Office. (2021). Patent family analysis of related compounds.
[3] World Intellectual Property Organization. (2019). Patent landscape report on heterocyclic drugs.

More… ↓

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Drugs Protected by US Patent 10,590,102

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Genentech Inc COTELLIC cobimetinib fumarate TABLET;ORAL 206192-001 Nov 10, 2015 RX Yes Yes 10,590,102*PED ⤷  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

International Family Members for US Patent 10,590,102

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 105483 ⤷  Start Trial
Australia 2016288209 ⤷  Start Trial
Australia 2021200202 ⤷  Start Trial
Brazil 112017028516 ⤷  Start Trial
Canada 2990222 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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