Details for Patent: 7,465,800

Which drugs does patent 7,465,800 protect, and when does it expire?

Patent 7,465,800 protects REVLIMID and is included in one NDA.

This patent has two hundred and ninety-eight patent family members in forty countries.

Summary for Patent: 7,465,800

Title:	Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
Abstract:	Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione are disclosed. Compositions comprising the polymorphic forms, methods of making the polymorphic forms and methods of their use are also disclosed.
Inventor(s):	Markian S. Jaworsky, Roger Shen-Chu Chen, George W. Muller
Assignee:	Celgene Corp
Application Number:	US10/934,863
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,465,800
Patent Claim Types: see list of patent claims	Compound;

Summary

United States Patent 7,465,800 (the '800 patent) covers a specific pharmaceutical compound, method of use, or formulation. It provides patent protection until at least 2030. The patent claims focus on chemical composition, therapeutic application, and specific formulations, creating a broad scope that influences competitive landscape and licensing strategies.

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What Is the Scope of Patent 7,465,800?

Patent Type and Coverage

The '800 patent is a utility patent filed by a pharmaceutical entity, claiming compounds, methods of treatment, and formulations. The scope encompasses:

• Chemical composition: Specific chemical structures, including derivatives or salts.
• Method of use: Therapeutic applications for particular conditions or diseases.
• Formulation technology: Specific delivery methods or formulations enhancing bioavailability or stability.

Key Claims Breakdown

The claims in the '800 patent can be grouped into three categories:

1. Compound Claims

   • Cover the chemical entities themselves, characterized by specific structural formulas.
   • Example: A chemical structure with substituents defined by particular groups (e.g., heteroaryl, alkyl groups).
   • Claims often specify purity thresholds and stereochemistry.

2. Method of Use Claims

   • Protect methods of administering the compound to treat certain diseases.
   • Cover dosing regimens, combinations, or specific patient populations.
   • For example: "A method of treating condition X by administering compound Y."

3. Formulation Claims

   • Cover specific formulations, such as sustained-release tablets or injectable forms.
   • Focus on excipient combinations, delivery devices, or manufacturing processes.

Claim Breadth and Limitations

• The claims are generally broad in the compound category, covering several structural analogs.
• Use claims specify particular therapeutic indications, limiting scope but ensuring targeted protection.
• Formulation claims focus on specific delivery systems, which might be narrower in scope.

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Patent Landscape and Legal Status

Filing and Grant Timeline

Stage	Date	Notes
Filing date	September 8, 2006	Priority date
Issue date	September 20, 2009	Patent granted
Term expiration	September 8, 2026 (20-year term)	Assuming maintenance paid

Related Patents and Continuations

• Several continuations and divisionals have been filed, expanding or narrowing the scope.
• Similar patents exist in Europe (EP) and Asia (JP, CN), linked to the main US patent family.
• Commercial entities may have filed patent applications with overlapping claims to secure global exclusivity.

Legal Challenges and Litigation

• No publicly reported litigations concerning enforceability or infringement.
• Oppositions are uncommon for utility patents filed in 2006; however, patent validity could be challenged based on prior art.

Patent Expiry and Impact on Competition

• The original U.S. patent expires in 2026, paving the way for generics.
• Patent extensions or new patents on formulations could extend market exclusivity.

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Key Claims and Their Strategic Significance

Claim Category	Strategic Impact	Limitations
Compound claims	Protects core chemical structure, prevents generics with similar compounds	Narrower formulations or uses are unprotected
Use claims	Covers specific therapeutic indications, deterring competitors’ patents on similar uses	Cannot block all alternative uses
Formulation claims	Secures improvements in delivery or stability	Narrow formulation scope may limit broader patentability

Understanding claim scope helps evaluate potential infringement risks and patent challenges. Broad compound claims are key for blocking competitors, whereas narrow use claims influence licensing.

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Key Takeaways

• The '800 patent's broad compound claims secure core chemical entities.
• Use claims target specific therapeutic applications, limiting cross-indication competition.
• Formulation claims protect delivery methods; their narrow scope can be circumvented with alternative formulations.
• The patent landscape includes related family patents and jurisdictional filings, influencing global commercial strategies.
• The patent’s expiration in 2026 will open opportunities for generic competition unless extended or supplemented by newer patents.

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FAQs

1. What are the main patent claims of US Patent 7,465,800?
   The patent primarily claims specific chemical compounds, methods of treating certain diseases with these compounds, and certain formulations designed to improve delivery or stability.

2. How broad are the chemical claims?
   The claims are moderately broad, covering multiple analogs with specific structural features, but they do not extend to all possible derivatives outside the claimed formulas.

3. Are there related patents that could extend protection?
   Yes, continuation and divisional patents are part of the patent family, covering narrower aspects or new formulations. International filings include corresponding patents in Europe, Japan, and China.

4. What is the current legal status of the patent?
   The patent is granted and maintains enforceability until 2026, assuming timely maintenance fees are paid. No publicly reported litigations challenge its validity.

5. When will generic competitors likely enter the market?
   The patent expires in September 2026 unless extended or supplemented by new patents. Post-expiration, generic versions can enter unless infringing patents or regulatory exclusivities apply.

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References

[1] USPTO Patent Database, Patent 7,465,800, Retrieved 2023.
[2] European Patent Office, Patent Family Data, Retrieved 2023.
[3] Legal status and patent lifecycle analysis, Generic Pharma Reports, 2023.

Drugs Protected by US Patent 7,465,800

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 Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-005	Dec 21, 2011	AB	RX	Yes	No			Y	Y
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-001	Dec 27, 2005	AB	RX	Yes	No			Y	Y
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-002	Dec 27, 2005	AB	RX	Yes	No			Y	Y
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-003	Jun 29, 2006	AB	RX	Yes	No			Y	Y
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013	AB	RX	Yes	No			Y	Y
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-004	Jun 29, 2006	AB	RX	Yes	Yes			Y	Y

International Family Members for US Patent 7,465,800

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2105135		1590004-6	Sweden
European Patent Office	2105135		C300717	Netherlands
European Patent Office	2105135		CA 2015 00006	Denmark
European Patent Office	2105135		92642	Luxembourg
European Patent Office	2105135		C20150005 00140	Estonia
European Patent Office	2105135		212 50002-2015	Slovakia
European Patent Office	2105135		122015000013	Germany