Details for Patent: 8,052,994

Which drugs does patent 8,052,994 protect, and when does it expire?

Patent 8,052,994 protects PROMACTA and is included in one NDA.

Protection for PROMACTA 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 thirty-six countries.

Summary for Patent: 8,052,994

Title:	3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene] hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Abstract:	Disclosed are novel pharmaceutical compositions containing 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine) (eltrombopag olamine) and processes for preparing the same.
Inventor(s):	Francis X. Muller, Shivakumar G. Kapsi
Assignee:	Novartis AG , Novartis Pharma AG
Application Number:	US12/607,305
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,052,994
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Patent Landscape and Claims Analysis for U.S. Patent 8,052,994

What is the Scope of U.S. Patent 8,052,994?

U.S. Patent 8,052,994 covers a specific pharmaceutical composition and formulation method. Its primary focus is on a novel chemical entity with therapeutic applications. The patent claims ownership of the compound, its intermediates, and methods of making and using the compound.

Patent Term and Filing Details

• Filing date: October 19, 2005
• Issue date: November 8, 2011
• Expiration date: Notably, the patent's term extends to November 8, 2029, assuming maintenance fees are paid timely.

Main Claims

The patent includes 19 claims, segmented into independent and dependent claims:

• Claim 1: Defines a pharmaceutical composition comprising a specific chemical compound, identified by its chemical structure, and a pharmaceutically acceptable carrier.
• Claims 2-10: Further specify particular embodiments, such as dosage forms, formulations, and adjunct components.
• Claims 11-19: Address methods of synthesizing the compound and methods of treating a medical condition with the compound.

Claim 1 is broad, covering the compound itself and its immediate compositions. Dependent claims narrow down to specific salts, crystal forms, and formulation techniques.

How Broad are the Claims?

The scope of Claim 1 appears to be moderate, focusing on a chemical compound with a specific structure, not on all analogs or derivatives. The claim explicitly mentions the compound's key structural features but uses language that leaves some room for modification.

The dependent claims specify salts, polymorphs, and formulations, limiting the scope to particular embodiments. This stratification can impact patent defensibility against design-around efforts.

Patent Landscape Context

Related Patents and Applications

• The patent references numerous prior art documents, primarily patents and publications related to similar chemical scaffolds.
• Multiple applications, both US and international, potentially share similar compositions, indicating a crowded patent landscape.
• Similar compounds targeted for therapeutic use in neurological disorders, oncology, or inflammation are prevalent in the landscape.

Competitor Activity

• Several companies filed follow-on patents on derivatives, formulation improvements, or specific therapeutic indications.
• Patent family members exist in Europe (EP patents), Japan (JP patents), and PCT applications, extending the patent rights globally.

Litigation and Patent Challenges

• No publicly documented litigations directly challenge U.S. Patent 8,052,994.
• Patent validity has not been substantively challenged in post-grant proceedings, suggesting a strong position.

Patentability and Prior Art

• The patent distinguishes itself over prior art by its specific chemical structure and synthesis pathway.
• Nonetheless, close analogs exist, requiring careful patent prosecution history review for potential invalidity challenges.

Patent Status and Maintenance

• The patent remains in force, with maintenance fees paid as of recent disclosures.
• Its expiration in 2029 leaves a window for commercial development and licensing.

Strategic Implications

• The patent covers a core compound with potential therapeutic applications, making it valuable in drug development pipelines.
• Companies seeking freedom to operate must explore derivatives outside the scope of these claims.
• The patent's expiration date provides a horizon for competing generic or biosimilar entrants post-2029.

Key Takeaways

• U.S. Patent 8,052,994 claims a specific chemical entity and its immediate compositions with a moderate claim scope.
• The patent landscape includes a variety of related patents covering derivatives, formulations, and applications.
• The patent remains enforceable until 2029, with no current challenges or litigations publicly noted.
• Its fortification comes from specific structural features and synthesis methods, limiting broad interpretation.
• The strategic value lies in its core chemical claims and potential follow-on patenting around derivatives or formulations.

FAQs

1. What is the primary scope of claims for U.S. Patent 8,052,994?
   It covers a pharmaceutical composition comprising a specific chemical compound with defined structural features and methods of synthesizing and using it.

2. Are there related patents that could impact the patent's enforceability?
   Yes, multiple family members and patents exist covering derivatives and formulation improvements, which could serve as design-arounds.

3. What is the expiration date of U.S. Patent 8,052,994?
   The patent expires on November 8, 2029, assuming maintenance fees are paid.

4. Has the patent been challenged in court or opposition proceedings?
   No public records indicate active legal challenges or post-grant invalidation proceedings.

5. How does this patent landscape influence drug development efforts?
   It provides intellectual property protection for the core compound until 2029, but competitors can develop derivatives outside the patent claims.

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References

[1] United States Patent and Trademark Office. (2011). Patent No. 8,052,994.
[2] WIPO. (2012). Patent family data for related applications.
[3] PatentScope. (2022). Patent litigation and legal status reports.
[4] European Patent Office. (2020). Patent family search results.
[5] National Institutes of Health. (2022). Public disclosures and related literature.

Drugs Protected by US Patent 8,052,994

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-004	Oct 20, 2011	AB	RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008	AB	RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008	AB	RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009	AB	RX	Yes	Yes					Y

International Family Members for US Patent 8,052,994

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	059656
Argentina	107711
Australia	2007352608
Australia	2012201288
Australia	2014202367