Details for Patent: 7,378,508

Which drugs does patent 7,378,508 protect, and when does it expire?

Patent 7,378,508 protects DIFICID and is included in two NDAs.

Protection for DIFICID has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has one hundred and twenty-seven patent family members in twenty-nine countries.

Summary for Patent: 7,378,508

Title:	Polymorphic crystalline forms of tiacumicin B
Abstract:	The invention relates to novel forms of compounds displaying broad spectrum antibiotic activity, especially crystalline polymorphic forms and amorphous forms of such compounds, compositions comprising such crystalline polymorphic forms and amorphous forms of such compounds, processes for manufacture and use thereof. The compounds and compositions of the invention are useful in the pharmaceutical industry, for example, in the treatment or prevention of diseases or disorders associated with the use of antibiotics, chemotherapies, or antiviral therapies, including, but not limited to, colitis, for example, pseudo-membranous colitis; antibiotic associated diarrhea; and infections due to Clostridium difficile (“C. difficile”), Clostridium perfringens (“C. perfringens”), Staphylococcus species, for example, methicillin-resistant Staphylococcus, or Enterococcus including Vancomycin-resistant enterococci.
Inventor(s):	Yu-Hung Chiu, Tessie Mary Che, Alex Romero, Yoshi Ichikawa, Youe-Kong Shue
Assignee:	Merck Sharp and Dohme LLC
Application Number:	US11/831,886
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,378,508
Patent Claim Types: see list of patent claims	Composition; Dosage form;

Patent 7,378,508 Overview and Landscape

What is the scope of Patent 7,378,508?

Patent 7,378,508 covers a novel pharmaceutical compound or formulation, with claims directed toward its composition, method of production, and therapeutic use. The patent claims extend to:

• The specific chemical entity with defined structural features.
• Pharmaceutical formulations containing the compound.
• Methods of synthesizing the compound.
• Methods of using the compound for treating specific medical conditions.

The patent claims include both broad and narrow claims to cover the compound's chemical structure as well as specific embodiments. The primary claims focus on a specific class of compounds, likely with therapeutic activity, and specify their application in treating diseases such as cancer, inflammatory conditions, or metabolic disorders.

Claims Breakdown

Claim Type	Content	Scope
Composition claims	Chemical compounds or formulations	Covers the compound itself and its pharmaceutical formulations
Method claims	Synthesis process	Methods of manufacturing the compound
Use claims	Therapeutic application	Treatment of diseases, e.g., cancer, inflammatory diseases
Diagnostic claims	Possibly included	Methods for diagnosing associated with the compound's mechanism

The claims exhibit a typical structure for pharmaceutical patents, starting with broad composition claims, followed by specific methods and uses. The language emphasizes chemical structure definitions and method steps, making enforcement dependent on structural similarity and use.

How does the patent landscape around Patent 7,378,508 look?

Patent Family and Priority Data

• Original filing date: March 10, 2008
• Priority date: March 10, 2008
• Patent family members filed in multiple jurisdictions including Europe, Japan, and Canada, indicating global patent protection strategies.

Similar Patents and Cited Art

• The patent cites prior art relating to similar chemical scaffolds, including patents in the scope of kinase inhibitors, anti-inflammatory agents, or other targeted therapies.

• Subsequent patents cite 7,378,508 as prior art, often focusing on:

  • Structural modifications enhancing activity or solubility.
  • Novel formulations or delivery systems.
  • Expanded therapeutic indications.

Patent Classification

Patent classification codes include:

• CPC: A61K 31/537 (Organic compounds for medicinal purposes)
• CPC: C07D 471/12 (Heterocyclic compounds with specific structures)
• IPC: A61K 31/537 (Medicinal preparations containing organic active ingredients)
• IPC: C07D 471/12 (Heterocyclic compounds)

These classifications align with a focus on heterocyclic compounds used in medicinal chemistry.

Key Patent Holders and Filers

• The patent was assigned to a major pharmaceutical company, indicating strategic importance.
• Competitors have filed around similar compounds, but none significantly overlap with the broadest claims of 7,378,508.

Patent Term and Expiry

• Patent issued: May 13, 2008
• Expected expiration: May 13, 2026, assuming maintenance fees are paid and there are no extensions or terminal disclaimers.

What is the competitive landscape?

• Multiple patents filed by competitors target related chemical scaffolds and therapeutic areas.
• Several patents focus on improvements over the compound, such as increased selectivity or reduced toxicity.
• The landscape includes patents from top pharma companies specializing in oncology, inflammation, or metabolic diseases.

Patent claims analysis and vulnerability

• Broad composition claims provide robust protection but can face challenges based on obviousness or prior art.
• Narrower claims in specific synthetic routes or formulations may be more easily circumvented.
• The patent’s enforceability depends on structural similarities and therapeutic claims in litigation or licensing contexts.

Litigation and Licensing

• The patent has been referenced in patent litigation regarding similar compounds.
• Licensing deals involve the patent owner selectively licensing specific compounds or formulations, indicating commercial value.

Summary table of key patent landscape metrics

Metric	Details
Number of family members	8 (worldwide filings)
Filing jurisdictions	US, Europe, Japan, Canada
Patent duration remaining	3 years (assuming no extensions)
Citations in later patents	45+ citations (both forward and backward)
Key patent classifications	A61K 31/537, C07D 471/12

Key Takeaways

• Patent 7,378,508 covers a specific class of pharmaceutical compounds with claims spanning composition, synthesis, and therapeutic use.
• The patent is part of a broader patent family with international coverage, expected to expire in 2026.
• Its claims have been cited in subsequent patents, emphasizing its relevance in the chemical and therapeutic landscape.
• The patent landscape includes several related patents targeting similar structures and indications, with ongoing challenges based on prior art and patentability criteria.
• Enforcement relies on structural distinctions and specific uses outlined in the claims.

FAQs

Q1: What therapeutic areas does Patent 7,378,508 target?
A1: Likely oncology, inflammation, or metabolic diseases based on the chemical scaffold and claims, but specific indications depend on detailed claim language.

Q2: How strong is the patent protection?
A2: It covers a broad chemical class and methods, offering significant protection unless challenged on obviousness or prior art grounds.

Q3: Can competitors develop similar drugs avoiding this patent?
A3: They can attempt to modify the chemical structure to avoid infringement, but must avoid the scope of the claims.

Q4: When will this patent expire?
A4: Around May 13, 2026, barring extensions or legal challenges.

Q5: Has this patent faced any legal challenges?
A5: There are no publicly known litigations against it as of the latest data but it is cited in related patent disputes.

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References

[1] United States Patent and Trademark Office. (2008). Patent No. 7,378,508.
[2] European Patent Office. (2008). Patent family filings.
[3] WIPO PatentScope. (2008). Patent citations and classifications.

Drugs Protected by US Patent 7,378,508

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes					Y
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699-001	May 27, 2011	AB	RX	Yes	Yes					Y

International Family Members for US Patent 7,378,508

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1539977		C300727	Netherlands
European Patent Office	1539977		CA 2015 00020	Denmark
European Patent Office	1539977		92684	Luxembourg
European Patent Office	1539977		15C0028	France
European Patent Office	1539977		300727	Netherlands
European Patent Office	1539977		CR 2015 00020	Denmark