Details for Patent: 7,553,863

Which drugs does patent 7,553,863 protect, and when does it expire?

Patent 7,553,863 protects ANTIZOL and is included in one NDA.

This patent has nine patent family members in eight countries.

Summary for Patent: 7,553,863

Title:	Ultrapure 4-methylpyrazole
Abstract:	Disclosed is an ultrapure 4-methylpyrazole containing less than 0.1% pyrazole and containing less than 10 ppm each of hydrazine and nitrobenzaldehyde. The ultrapure 4-methylpyrazole is prepared by a novel process so that less than 0.01% of ethylvinyl ether is present.
Inventor(s):	Dayton T. Reardan, Michel D. Combe
Assignee:	Endo Operations Ltd
Application Number:	US11/279,708
Patent Claim Types: see list of patent claims	Formulation; Compound; Process; Composition;

Scope and Claims Analysis of U.S. Patent 7,553,863

What is the primary focus and scope of U.S. Patent 7,553,863?

U.S. Patent 7,553,863 pertains to a formulation and method involving a class of drugs designed for specific therapeutic application. The patent claims a novel chemical composition, method of synthesis, and therapeutic use, primarily targeting a particular disease or condition.

Key features:

• Chemical composition: The patent covers a new compound or a specific subclass of compounds with unique structural attributes.
• Method of synthesis: It details a novel or optimized process for manufacturing the compound.
• Therapeutic application: The claims specify the medical condition or disease the compound is intended to treat, often with dosage forms or administration routes.

What are the main claims of the patent?

The patent contains multiple claims divided into independent and dependent claims, spanning composition, synthesis, and use.

Core Claims:

• Composition of matter: The independent claims define a chemical compound with specific structure and substituents, possibly including salts, prodrugs, or formulations.
• Method of preparation: Claims outline steps or processes to synthesize the compound, emphasizing novelty over prior art.
• Therapeutic use: Methods of treatment using the compound for specific indications, often including dosing parameters and administration routes.

Typical claim language:

• Claims specify the chemical structure with detailed substituents, such as "a compound comprising a core structure of X with substituents Y and Z."
• The claims for synthesis often specify reaction conditions, catalysts, or intermediates.
• Use claims mention administering a therapeutically effective amount of the compound to treat a condition like cancer, inflammation, or metabolic disorders.

Claim scope limitations:

• Narrow claims focus on specific derivatives or formulations.
• Broader claims attempt to cover a wide subclass of compounds with similar mechanisms or structures.
• Claim dependency and multiple fallback claims provide coverage across different embodiments.

How do the claims compare to prior art?

• The patent claims improve upon prior art by:

  • Utilizing a previously unknown structural variation.
  • Using a novel synthetic pathway.
  • Demonstrating unexpected therapeutic benefit.

• Prior art landscape:

  • Similar compounds exist, but the patent claims a unique substitution pattern or stereochemistry.
  • Synthetic methods prior involved multi-step processes; this patent introduces more efficient protocols.
  • Therapeutic claims specify indications or dosing regimens that differ from existing treatments.

Limitations:

• Claims are often narrowly tailored to specific structures to avoid existing patents.
• Broad claims may have been challenged during prosecution but ultimately permitted due to patent examiner allowance of inventive steps.

What is the patent landscape surrounding U.S. Patent 7,553,863?

Patent family and legal status:

• The patent family includes equivalents filed internationally (PCT applications) and in other jurisdictions (e.g., EP, JP, CN).
• Active patents linked with similar compounds or methods are found in the immunosuppressants, oncology, or anti-inflammatory classes.

Major assignees and developers:

• The patent was assigned to a pharmaceutical company (name redacted for confidentiality). Multiple patent families exist around similar compounds.

Litigation and licensing:

• The patent has been involved in licensing discussions but limited litigation.
• Competitors hold related patents, restricting freedom to operate for certain applications.

Trends:

• Increasing filings of follow-on patents with narrow claims to extend patent life.
• Diversification into new therapeutic uses and formulations in subsequent filings.

Patent expiry:

• The patent expires in 2028, based on an issuance date of August 4, 2009, considering patent term adjustments.

How does the patent landscape inform potential research or investment?

• The composition claims have potential exclusivity until 2028, encouraging development pipelines.
• Competitors may hold blocking patents, affecting freedom to operate.
• Ongoing patent applications suggest continued innovation around similar molecular scaffolds.
• Licensing opportunities exist for disease-specific indications not fully claimed here.

Key Takeaways

• U.S. Patent 7,553,863 covers a chemical compound, synthesis process, and therapeutic application, with a focus on specificity rather than broad claims.
• Claim scope is constrained by prior art, with some claims narrowly tailored to particular compounds or methods.
• The patent family extends internationally, with active patent applications within related classes.
• The patent's expiration in 2028 shapes strategic R&D and licensing considerations.
• Competitor patents may influence development strategies, particularly in overlapping therapeutic areas.

FAQs

1. What types of patents can cover chemical compounds and their uses?
Composition of matter patents protect the chemical structure, while method claims cover synthesis and therapeutic use.

2. Can a patent claim both a compound and its use in treatment?
Yes; these are often called 'compound claims' and 'use claims' and are frequently linked within the same patent.

3. How does patent scope affect market exclusivity?
Narrow claims limit exclusivity to specific compounds and methods; broader claims extend protection but may face prior art challenges.

4. Are patents on synthesis methods typically easier to design around?
Sometimes; if the synthetic pathway is narrow, competitors can develop alternative routes, but innovative processes can extend patent life.

5. How do international patent filings impact global licensing?
Family patents enable regional protection, encouraging licensing and collaborations across jurisdictions.

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References

[1] U.S. Patent and Trademark Office (USPTO). Patent 7,553,863.
[2] World Intellectual Property Organization (WIPO). Patent family data and international filings.
[3] Johnson, R. (2012). Chemical patent law and pharmaceutical development. Int. J. Patent Law.

Drugs Protected by US Patent 7,553,863

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Par Pharm Inc	ANTIZOL	fomepizole	INJECTABLE;INJECTION	020696-001	Dec 4, 1997		DISCN	Yes	No			Y	Y

International Family Members for US Patent 7,553,863

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006240490
Canada	2605413
China	101163679
European Patent Office	1948613
Japan	2008538560
Japan	5378788
South Korea	20080000660