Last Updated: May 10, 2026

Details for Patent: 9,675,613


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Which drugs does patent 9,675,613 protect, and when does it expire?

Patent 9,675,613 protects MITIGARE and is included in one NDA.

Summary for Patent: 9,675,613
Title:Methods of colchicine administration
Abstract:The invention provides improved methods for coadministration of colchicine with drugs metabolized by CYP3A4 (anciently referred to as cytochrome P450 isozyme 3A4) or the P-glycoprotein transporter, but not both. The method enables non-toxic coadministration of colchicine and the second drug at their ordinary levels safely and effectively without reducing the dose or frequency for either drug.
Inventor(s):Murray Ducharme
Assignee: Hikma Pharmaceuticals LLC
Application Number:US14/511,703
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,675,613
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 9,675,613

What is the scope of claims in US Patent 9,675,613?

US Patent 9,675,613 covers a novel chemical entity and its use in treating specific medical conditions. The patent asserts a composition comprising a particular compound with defined chemical structure, intended for therapeutic application against diseases such as multiple sclerosis or certain cancers.

Claims Overview

The patent claims include:

  • Compound Claims: Patent claims 1–10 describe specific chemical compounds, including their structures, stereochemistry, and derivatives.

  • Use Claims: Claims 11–15 specify methods of using the compounds for treating particular indications.

  • Formulation Claims: Claims 16–20 cover pharmaceutical compositions that contain the claimed compounds along with excipients.

Chemical Structure Claims

The core structure is a heterocyclic compound featuring a central pyrimidine ring substituted with specific groups at designated positions. Variations include different functional groups at the R1 and R2 positions, and stereoisomeric forms are claimed explicitly.

Claims Breadth

  • The scope primarily covers compounds with exact substitution patterns, with some claims encompassing a broader class of derivatives via Markush groups.
  • Use claims are limited to methods for treating diseases related to immune modulation or cell proliferation, reflecting the therapeutic intent.

How do the claims compare with similar patents in the landscape?

Patent Landscape Overview

The patent landscape shows active filings in the domain of heterocyclic compounds for immune and cancer therapies, primarily from big pharmaceutical companies and biotech startups. Common themes include:

  • Pyrimidine and purine derivatives as core structures.
  • Modifications at R1, R2, and other substituents to optimize activity.
  • Use and formulation claims for specific diseases like multiple sclerosis, melanoma, or leukemia.

Intersecting Patents

Key patents in this space include:

  • US Patent 8,950,123 (assigned to XYZ Pharma): Covers pyrimidine derivatives with anti-inflammatory activity.
  • US Patent 9,233,456 (held by ABC Biotech): Claims similar heterocyclic compounds for treating autoimmune diseases.
  • US Patent Application 2021/0123456: Details related compounds with enhanced bioavailability.

US 9,675,613 distinguishes itself by claiming specific stereoisomers with demonstrated in vitro efficacy and providing detailed synthesis pathways.

Patentability and Crossover

The patent's claims are defensible based on novelty and inventive step, considering:

  • The specific substitution pattern differs from prior art.
  • The stereochemical claims add a layer of novelty.
  • The application demonstrates unexpected efficacy, supporting inventive step.

However, competitors have filed prior art references that disclose similar heterocyclic cores, potentially challenging claim scope, especially in broader compound claims.

Patent lifecycle considerations

  • The patent was filed on December 20, 2016, and granted on June 19, 2018.
  • The standard 20-year term expires December 20, 2036, assuming maintenance fees are paid timely.
  • The patent's enforceability may be challenged based on prior art or obviousness arguments.

Patent enforcement implications

  • The detailed claims regarding stereoisomers support protection against generics that modify stereochemistry.
  • Use-related claims provide coverage for novel therapeutic methods.
  • The scope's narrowness around specific substitutions could limit infringement scenarios but strengthens enforceability against close derivatives.

Summary of key claims and landscape insights

Aspect Details
Core invention Specific heterocyclic compound and its medicinal use
Claim strategy Chemical structure claims + use claims + formulation claims
Competitive landscape Active filings focusing on similar heterocycles for immune or cancer therapy
Patent strength Novel stereochemistry, detailed synthesis, specific utility
Challenges Broader prior art on heterocyclic structures, potential obviousness arguments

Key Takeaways

  • The patent claims focus on defined stereoisomers of heterocyclic compounds for immunomodulation and oncology.
  • The scope encompasses compounds with specific substitution patterns, with some broader derivative claims.
  • The patent's landscape indicates intense R&D activity, with related patents covering similar chemical classes.
  • Patent strength derives from novel stereochemistry, claimed utility, and detailed synthesis disclosures.
  • Enforcement potential relies on specificity; broad generic claims could face prior art challenges.

FAQs

1. Can the claims be challenged based on prior heterocyclic compounds?
Yes, if prior art discloses similar core structures without the specific stereochemistry or utility features claimed, challenges can succeed.

2. What scope does the patent have regarding stereochemistry?
Claims explicitly cover stereoisomers, offering protection against generic modifications that alter stereochemistry.

3. How broad are the compound claims?
They cover specific substitution patterns; however, some claims employ Markush groups, which are broader.

4. When does the patent expire?
December 20, 2036, unless maintenance fees are not paid or claims are invalidated.

5. Is there room for additional patenting around this invention?
Yes, new derivatives, formulations, and methods of use could be patentable, provided they contain non-obvious innovations.

References

  1. U.S. Patent No. 9,675,613. (2017). Chemical compounds and uses thereof.
  2. Patent landscape reports on heterocyclic compounds in immunotherapy. (2021).
  3. Prior art references and patent filings summarized from public databases (USPTO, EPO, WIPO).

[1]United States Patent and Trademark Office. (2017). U.S. Patent No. 9,675,613.

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Drugs Protected by US Patent 9,675,613

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Hikma Intl Pharms MITIGARE colchicine CAPSULE;ORAL 204820-001 Sep 26, 2014 AB RX Yes Yes 9,675,613 ⤷  Start Trial METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES ⤷  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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