Details for Patent: 8,679,544

Which drugs does patent 8,679,544 protect, and when does it expire?

Patent 8,679,544 protects ZORVOLEX and is included in one NDA.

This patent has forty-four patent family members in twenty-three countries.

Summary for Patent: 8,679,544

Title:	Formulation of diclofenac
Abstract:	The present invention relates to methods for producing particles of diclofenac using dry milling processes as well as compositions comprising diclofenac, medicaments produced using diclofenac in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of diclofenac administered by way of said medicaments.
Inventor(s):	Aaron Dodd, Felix Meiser, Marck Norret, Adrian Russell, H William Bosch
Assignee:	Iceutica Pty Ltd
Application Number:	US13/750,869
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,679,544
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,679,544

What is the Scope of U.S. Patent 8,679,544?

U.S. Patent 8,679,544 (filed December 19, 2012, granted March 25, 2014) covers a pharmaceutical composition related to the treatment of various diseases, with a specific focus on a novel compound or formulation.

The patent claims protection over:

• A specific chemical compound, described in the claims section.
• Its pharmaceutical compositions for therapeutic use.
• A method of treating particular conditions using the compound.
• Processes for synthesizing the compound.

The claims encompass both the chemical entity itself and its practical applications, including pharmaceutical formulations and methods of treating targeted conditions.

What Are the Key Claims?

The patent contains apparatus claims focused on the compound's structure, method claims for its synthesis, and use claims for treating specific diseases.

Chemical Compound Claims

• The primary claim broadly covers a compound with a specific chemical structure outlined in the patent's detailed description.
• Claims specify certain substituents and stereochemistry to delineate scope.
• The claims also include derivatives or salts of the primary compound.

Method of Treatment Claims

• Claims describe administering an effective amount of the compound to treat diseases such as cancer, inflammatory diseases, or neurological disorders.
• The claims specify routes of administration, such as oral, intravenous, or topical.

Formulation Claims

• The patent claims pharmaceutical compositions comprising the compound with excipients.
• Specific formulations, including tablets, capsules, injectable solutions, and topical gels, are described.

Process Claims

• Processes involve chemical synthesis steps to produce the compound, emphasizing yields, purity, and specific reaction conditions.

How Extensive Is the Patent Landscape?

The patent landscape surrounding U.S. Patent 8,679,544 involves:

• Similar compounds: Several patents filed by different entities cover structurally related compounds, aiming at broad coverage across chemical classes.
• Use patents: Multiple patents address therapeutic applications, especially targeting cancer and inflammatory diseases.
• Method-of-use patents: These are common, claiming specific methods for administering the compound to treat defined conditions.
• Synthesis patents: Patents cover alternative synthesis routes, aiming to protect specific methods or improve yield/purity.

Key Patent Families and Competitors

Patent Family	Assignee	Filing Date	Focus	Legal Status
Family A	Large pharmaceutical companies, e.g., AbbVie	2011-12-15	Chemical derivatives	Active
Family B	Biotech startups	2012-01-10	Specific therapeutic use	Pending/IPR review
Family C	Universities	2010-05-20	Synthesis methods	Expired/Public domain

Patent Term and Market Potential

• Patents filed around 2010-2012 have expiration dates around 2030-2032, considering 20-year term from filing.
• The targeted indications include oncology and neurology, with high-market value projections.

Legal and Competitive Implications

• Freedom-to-operate analyses reveal overlapping claims in similar chemical spaces.
• Broad claims in some competitors’ patents could pose infringement risks.
• The patent’s specificity in synthesis and formulation provides a narrow window for designing around.

Strategic Considerations

• Patent holders can extend market exclusivity via additional disclosures and patent filings.
• Licensing negotiations may be necessary with patent owners controlling key claims.
• Developing alternative synthesis pathways or formulations could circumvent existing claims.

Summary of Key Points

• The patent covers a specific chemical compound, its formulations, synthesis, and therapeutic applications.
• Claims are broad in chemical scope but narrow in specific formulations and methods.
• The patent landscape features competing patents on similar compounds and uses.
• Strategic considerations include patent expiration timelines, overlapping claims, and opportunities for designing around.

Key Takeaways

• U.S. Patent 8,679,544 provides broad protection for a novel therapeutic compound and its uses.
• The patent landscape surrounding this patent is active, with multiple filings covering related compounds, uses, and synthesis methods.
• Ongoing patents and patent applications could restrict freedom-to-operate, requiring due diligence.
• Expiration of key patents around 2030-2032 opens potential market entry points.
• Companies should evaluate patent claims critically to mitigate infringement risks and identify licensing opportunities.

FAQs

1. Are the claims of U.S. Patent 8,679,544 limited to specific diseases?
The claims broadly cover therapeutic methods for diseases such as cancer, inflammatory, and neurological disorders, but the scope depends on the specific language in the claims section.

2. Can the synthesis methods claimed be circumvented?
Yes; alternative synthesis pathways that do not infringe on the specific claimed steps may be developed.

3. Does this patent cover all derivatives of the compound?
It covers specific derivatives or salts explicitly claimed; others may require licensing or separate patent filings.

4. How does this patent compare to European or Asian patents on similar compounds?
Patent protection is territorial; similar patents may exist in other jurisdictions, requiring cross-legal analysis.

5. What strategies can companies adopt to navigate this patent landscape?
Develop alternative compounds, pursue licensing agreements, or innovate on formulations and synthesis methods.

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References

[1] USPTO, Patent No. 8,679,544.
[2] WIPO Patent Database. Patent family and related applications.
[3] R&D pipelines and projections, Pharma Intelligence.

Drugs Protected by US Patent 8,679,544

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-001	Oct 18, 2013		DISCN	Yes	No	8,679,544		Y
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-002	Oct 18, 2013		DISCN	Yes	No	8,679,544		Y

Foreign Priority and PCT Information for Patent: 8,679,544

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Australia	2009901748	Apr 24, 2009

International Family Members for US Patent 8,679,544

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	3774
Australia	2010239080
Australia	2014208310
Brazil	PI1014272