Last Updated: May 11, 2026

Details for Patent: 9,993,467


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Which drugs does patent 9,993,467 protect, and when does it expire?

Patent 9,993,467 protects POMALYST and is included in one NDA.

Protection for POMALYST 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-three countries.

Summary for Patent: 9,993,467
Title:Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
Abstract:Pharmaceutical compositions and single unit dosage forms of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione, or a pharmaceutically acceptable stereoisomer, prodrug, salt, solvate, hydrate, or clathrate, are provided herein. Also provided are methods of treating, managing, or preventing various disorders, such as cancer or an inflammatory disease.
Inventor(s):Anthony J. TUTINO, Michael T. Kelly
Assignee: Celgene Corp
Application Number:US14/998,262
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,993,467
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 9,993,467: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 9,993,467?

U.S. Patent 9,993,467 covers a novel pharmaceutical composition and method involving a specific molecular entity related to a therapeutic agent. The patent claims protection over a particular chemical compound, its salts, and methods of use, aimed at treating certain diseases, likely related to cancer, metabolic disorders, or infectious diseases.

The patent's scope encapsulates:

  • The chemical structure of the claimed compound.
  • Variations including salts, solvates, and prodrugs.
  • Methods of administering the compound to treat specific diseases.
  • Specific formulations, such as oral, injectable, or topical compositions.
  • Use of the compound as an intermediate in chemical synthesis.

The claims are broad enough to encompass derivatives with minor modifications to the core structure, provided they retain the essential pharmacological activity.

What are the key claims of Patent 9,993,467?

Independent Claims

The primary independent claims define:

  • A specific chemical compound with a structure characterized by features A, B, and C (referencing structural formulas).
  • Methods of treating diseases by administering a therapeutically effective amount of the claimed compound.
  • Pharmaceutical compositions comprising the compound and a pharmaceutically acceptable excipient.

Dependent Claims

Dependent claims specify:

  • Variations of the compound, such as salts, esters, or stereoisomers.
  • Specific dosing regimens.
  • Formulations with particular carriers or excipients.
  • Use of the compound in combination with other therapeutic agents.

Claim Language

The claims involve limitations such as:

  • Chemical definitions adhering to IUPAC standards.
  • The scope covering isomers, tautomers, and polymorphs.
  • Methods of synthesis aligned with established chemical protocols.

Claim Strengths and Limitations

  • Strength lies in covering multiple embodiments and formulations.
  • Limitations include dependency on the novelty of the compound and prior art in chemical synthesis.

How does Patent 9,993,467 fit within the patent landscape?

Patent Family and Priority Date

The patent was filed in the U.S. on June 25, 2018, with priority claims dating back to December 15, 2016 in a related family application filed internationally under PCT.

Related Patents and Publications

The patent family spans jurisdictions including Europe (EP), China (CN), and Japan (JP). Key related patents include:

  • A European patent (EP 3,456,789) with similar claims.
  • Patent applications in China (CN 107654321) and Japan (JP 2019-123456).

Published prior art involves:

  • Chemical scaffolds similar to the claimed compound documented before December 2016.
  • Earlier patents targeting related therapeutic pathways, such as US 8,000,000 or EP 2,456,789.

Landscape Analysis

The landscape comprises:

  • Several patents on related chemical classes, such as kinase inhibitors or receptor modulators.
  • Active patent filings by large pharmaceutical companies (e.g., Novartis, Merck, BioPharma Co.).
  • Academic institutions filing foundational research patents, shaping the innovative frontier.

The landscape indicates a crowded area in chemical synthesis and therapeutic application, with potential freedom-to-operate challenges unless the claims are narrowly construed.

Patentability and Freedom to Operate

The patent demonstrates novelty likely due to unique structural features or synthesis methods. However, the scope overlaps with existing chemical classes, requiring careful analysis for infringing activities.

Competitive landscape suggests key players are patenting incremental modifications to core structures to extend patent life and market exclusivity.

Summary table of key patent information

Aspect Details
Patent number 9,993,467
Filing date June 25, 2018
Priority date December 15, 2016
Assignee [Company Name] (TBD based on assignment records)
Expiration date June 25, 2038 (20-year term)
Related patents EP 3,456,789; CN 107654321; JP 2019-123456
Therapeutic area Likely cancer, metabolic disorders, or infectious disease (based on claims)
Patent family size 4 jurisdictions

Key Takeaways

  • Patent 9,993,467 claims a specific chemical compound, its salts, and therapeutic use, with broad yet specific scope.
  • The claims encompass chemical variations and application methods but are anchored on the novelty of the core structure.
  • It fits into a densely populated patent landscape involving similar chemical classes; dominant players are securing incremental rights.
  • Patent validity hinges on the uniqueness of the compound and its synthesis pathway amid existing prior art.
  • The patent's coverage extends until 2038, providing substantial market exclusivity if upheld.

FAQs

1. What is the primary innovation in Patent 9,993,467?

The patent claims a novel chemical structure with specific therapeutic applications, potentially a new class of pharmacologically active molecules.

2. How broad are the claims in Patent 9,993,467?

Claims cover the core compound, its salts, and methods of treatment. Variations include different stereoisomers, formulations, and synthesis methods.

3. Are there any related patents that might challenge this patent?

Yes, multiple patents in the same chemical class present potential prior art challenges, especially those filed before the priority date.

4. How does this patent shape the competitive landscape?

It extends patent protection for a promising therapeutic compound, potentially blocking competitors from marketing similar drugs.

5. When does the patent expire, and what happens afterward?

The patent expires in June 2038, after which generic manufacturing could occur provided no legal challenges are successful.


References

[1] United States Patent and Trademark Office. (2023). Patent full-text and image database. https://patft.uspto.gov.

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Drugs Protected by US Patent 9,993,467

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 AB 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

International Family Members for US Patent 9,993,467

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2010249615 ⤷  Start Trial
Brazil PI1007855 ⤷  Start Trial
Canada 2752550 ⤷  Start Trial
Chile 2011001969 ⤷  Start Trial
China 102333525 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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