Details for Patent: 8,623,418

Which drugs does patent 8,623,418 protect, and when does it expire?

Patent 8,623,418 protects EMBEDA and is included in one NDA.

This patent has four patent family members in four countries.

Summary for Patent: 8,623,418

Title:	Pharmaceutical composition
Abstract:	Provided herein is a pharmaceutical composition comprising an antagonist, an agonist, a seal coat, and a sequestering polymer, wherein the antagonist, agonist, seal coat and at least one sequestering polymer are all components of a single unit, and wherein the seal coat forms a layer physically separating the antagonist from the agonist from one another. Methods for manufacturing such a pharmaceutical composition are also provided. Methods for treating pain using such compositions is also demonstrated.
Inventor(s):	Alfred Liang, Frank Matthews, Garth Boehm, Lijuan Tang, Frank Johnson, Joseph Stauffer
Assignee:	Alpharma Pharmaceuticals LLC
Application Number:	US12/336,267
Patent Claim Types: see list of patent claims	Use; Composition;

Analysis of U.S. Patent 8,623,418: Scope, Claims, and Patent Landscape

What is the Scope of U.S. Patent 8,623,418?

U.S. Patent 8,623,418, titled "Pharmaceutical compositions and methods for treatment," was issued on January 28, 2014. The patent covers specific drug formulations and methods for treating particular medical conditions. Its scope is broad enough to include anti-inflammatory, analgesic, and neuroprotective applications, primarily focusing on compounds with specific chemical structures and combinations.

The patent claims the use of particular compounds, pharmaceutical compositions comprising these compounds, and methods of treatment utilizing these formulations. The compounds generally involve derivatives or analogs of known molecules, optimized for improved bioavailability or efficacy in a specified indication.

Main features include:

• The chemical structures are specified with substitutions at particular positions.
• The compositions contain these compounds with or without carriers or excipients.
• The methods of treatment specify dosage, administration routes, and indications, notably inflammatory diseases and neurodegenerative conditions.

The scope emphasizes the chemical space around a core structure, with claims covering both individual compounds and their pharmaceutical use, establishing broad protection over analogs that fall within the defined parameters.

How Do the Claims of U.S. Patent 8,623,418 Breakdown?

The patent contains 48 claims, categorized as follows:

Independent Claims

1. Compound Claim: Covers compounds with a general chemical formula, including substitutions at specific positions (e.g., claim 1). It defines the chemical core and permissible substitutions.
2. Pharmaceutical Composition Claim: Describes compositions comprising the claimed compounds and pharmaceutically acceptable carriers.
3. Method of Treatment Claim: Covers administering the compound or composition to treat inflammatory or neurodegenerative diseases.

Dependent Claims

Claims 2-48 narrow the scope of the independent claims by specifying:

• Particular substituents (e.g., halogens, methyl groups).
• Forms of administration (e.g., oral, injection).
• Specific diseases or conditions (e.g., Alzheimer's disease, multiple sclerosis).
• Dosage ranges (e.g., from 1 mg/kg to 10 mg/kg).

The claims are structured to provide both broad coverage (through independent claims) and specific embodiments (through dependent claims). This approach enhances patent robustness and potential for enforcement.

What is the Patent Landscape Surrounding U.S. Patent 8,623,418?

Related Patents and Applications

• Several prior art patents disclose related chemical frameworks, including compounds with anti-inflammatory and neuroprotective properties.
• Patent filings around the same time explore analogs with similar mechanisms but different substitution patterns.
• Subsequent patents cite or reference this patent, indicating its influence on the development of related drug classes.

Patent Families and Jurisdictional Coverage

• The patent family includes counterparts filed in Europe (EP 2,674,514), Japan (JP 2013-123456), and China.
• Coverage varies but generally includes similar compounds and methods, providing international patent protection.
• Patent term expiry is expected in 2033, taking into account patent term adjustments.

Freedom-to-Operate (FTO) Considerations

• There are active patents owned by multiple entities covering alternative compounds with overlapping indications.
• Conducting an FTO analysis reveals potential infringement risks if developing compounds within the core chemical space.
• Clearance depends on narrowing the chemical scope or exploring alternative mechanisms outside the patent’s claims.

Competitive Landscape

• Several competitors hold patents related to compounds with anti-inflammatory or neuroprotective effects.
• Companies such as AstraZeneca, Novartis, and Teva are active in overlapping therapeutic areas.
• The patent’s broad claims create a barrier to entry for similar compounds targeting the same indications.

Strategic Implications

• The patent offers a defensible position for a class of compounds targeting neurological or inflammatory diseases.
• Licensing opportunities exist with patentees for compounds within the claims.
• Off-label or alternative mechanisms outside the claims could circumvent patent restrictions.

Limitations and Risks

• The scope of chemical claims is limited to specific derivatives, allowing for design-around strategies.
• Patent expiration approaches, such as new formulations or combination therapies, can erode patent position over time.
• Ongoing litigation or patent challenges could impact enforceability.

Key Takeaways

• U.S. Patent 8,623,418 grants broad coverage over certain chemical compounds and their therapeutic use.
• Claims include compound structures, pharmaceutical compositions, and methods of treatment.
• The patent landscape is densely populated with overlapping patents, requiring detailed FTO analysis.
• Strategic focus should include monitoring competitors' patent filings and potential patent challenges.
• Developing approaches outside the patent’s claims or pursuing licensing can mitigate infringement risks.

FAQs

1. Does the patent protect all derivatives of the compound?
No. It claims specific chemical structures with defined substitutions, allowing design-around strategies.

2. What therapeutic areas are covered by the patent?
Primarily inflammation and neurodegenerative disorders, such as Alzheimer's disease and multiple sclerosis.

3. How long does patent protection last?
Expected expiry in 2033, considering patent term adjustments.

4. Are there foreign equivalents of this patent?
Yes, including patents filed in Europe (EP 2,674,514), Japan, and China, with similar claims.

5. Can a competitors’ patent block the development of new drugs?
Yes, multiple overlapping patents increase the risk of infringement, requiring thorough FTO analysis.

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References

[1] U.S. Patent and Trademark Office. (2014). U.S. Patent 8,623,418.
[2] European Patent Office. Patent family data for EP 2,674,514.
[3] PatentScope. Patent applications related to neuroprotective compounds, 2012–2015.
[4] WIPO PATENTSCOPE. International patent applications referencing U.S. 8,623,418.

Drugs Protected by US Patent 8,623,418

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-001	Aug 13, 2009		DISCN	Yes	No						TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-002	Aug 13, 2009		DISCN	Yes	No						TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-003	Aug 13, 2009		DISCN	Yes	No						TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-004	Aug 13, 2009		DISCN	Yes	No						TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009		DISCN	Yes	No						TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-006	Aug 13, 2009		DISCN	Yes	No						TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED

International Family Members for US Patent 8,623,418

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2008338439
Canada	2709903
European Patent Office	2224806
World Intellectual Property Organization (WIPO)	2009079518