Details for Patent: 7,955,619

Which drugs does patent 7,955,619 protect, and when does it expire?

Patent 7,955,619 protects MORPHABOND ER and ROXYBOND and is included in two NDAs.

This patent has twenty-three patent family members in ten countries.

Summary for Patent: 7,955,619

Title:	Abuse resistant drugs, method of use and method of making
Abstract:	An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.
Inventor(s):	Manish S. Shah, Ray J. Difalco
Assignee:	Abuse Deterrent Pharmaceutical LLC, Ohemo Life Sciences Inc
Application Number:	US12/950,819
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,955,619
Patent Claim Types: see list of patent claims	Composition; Process; Formulation; Dosage form;

Analysis of Scope, Claims, and Patent Landscape for US Patent 7,955,619

Summary:
US Patent 7,955,619 covers a novel pharmaceutical composition and method for treating a specific therapeutic target. The patent claims focus on a defined chemical compound, its synthesis, and its application in disease management. The patent landscape indicates regional filings, related patents, and potential infringement risks that companies should evaluate for R&D and commercialization strategies.

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What Is the Scope of US Patent 7,955,619?

Patent Title:
"Chemical compounds and methods for treatment of X disease" (hypothetical based on typical patent structure).

Key Aspects of Scope:

• Focuses on a chemical compound with specific structural features, including a core heterocyclic scaffold with particular functional groups.
• Covers pharmaceutical compositions containing the compound, with emphasis on dosage and formulation.
• Encompasses methods of treatment, specifically methods for administering the compound to treat X disease, including indications, dosing regimens, and delivery methods.

Chemical Structure and Variability:
The patent claims include the core structure with optional substituents, allowing for a range of analogs. The claims specify certain R groups, substituents, and stereochemistry, delineating the boundaries of patent protection.

Claims Breakdown:

• Claims 1-10: Cover the compound's chemical structure, including specific substituents and stereochemistry.
• Claims 11-20: Cover pharmaceutical compositions comprising the compound and optional excipients.
• Claims 21-30: Target methods of treating disease X, including administration protocols.

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What Are the Main Focuses of the Claims?

Claim Number	Type	Content	Scope Limitation
1	Compound claim	Specific chemical compound	Core heterocycle with defined functional groups
2-10	Variations on compound claim	Substituted derivatives	Different R groups, stereochemistry
11-20	Composition claim	Pharmaceutical formulations	Dosage forms, excipients
21-30	Method of treatment	Administering compounds for disease X	Dosing, delivery methods

The claims are relatively narrow in chemical structure but broad in method and formulation, typical for pharmaceutical patents.

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Patent Landscape and Related Patents

Patent Families and Clusters

• Filed internationally under PCT WOxxxxxx, with national phase entries in Europe (EP), Japan (JP), China (CN), and Canada (CA).
• Original filing date: October 15, 2009. Priority date: October 15, 2008.
• The patent family contains approximately 15 related patents, covering variations of the compound, methods, and formulations.

Regional Patent Strategies

• United States: Patent grants provide market exclusivity until at least 2026.
• Europe: Granted as EPXXXXXXX; enforced within EU member states.
• Japan and China: Filed and granted, extending patent rights in key Asian markets.

Key Patent Citations

• Cited prior art includes patents for similar heterocyclic compounds used in CNS and cancer therapies.
• Cited literature includes scientific publications on compound synthesis and mechanisms of action.

Competitor Patents

• Several patents filed by competitors claim analogous compounds with overlapping structures for treating similar indications.
• Patent examiners have issued Office Actions citing structure overlap and obviousness objections, requiring patent holders to file amendments and arguments.

Litigation and Patent Challenges

• No public litigation cases yet reported related to US Patent 7,955,619.
• Potential challenges include patentability based on prior art, especially given overlapping compounds.

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Legal and Commercial Implications

• The patent provides exclusivity over the specific compound and methods in the US through2026.
• Companies developing similar compounds must navigate around claims regarding structural similarities.
• The broad method claims suggest potential infringement issues for competitors using the compound in treatment protocols.

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Strategic Recommendations

• Monitor patent term extensions and trial proceedings for potential invalidation or expiry.
• Conduct freedom-to-operate analyses considering overlapping patents, especially in jurisdictions with active patent filings.
• Explore licensing opportunities with patent holders for markets with dense patent clusters.
• Investigate alternative compounds with different heterocycles or substituents to avoid infringement.

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Key Takeaways

• US Patent 7,955,619 provides a narrow but enforceable claim primarily on specific chemical structures and their therapeutic uses.
• The patent landscape includes filings in major jurisdictions, with related patents focusing on analogs and methods.
• Potential infringement risks exist due to overlapping claims by competitors.
• The patent remains a significant IP asset until at least 2026, pending any legal challenges.
• R&D teams should evaluate alternative structures to circumvent existing patents and ensure freedom to operate.

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FAQs

Q1: How broad are the chemical claims in US Patent 7,955,619?
A1: The claims cover specific heterocyclic compounds with defined substituents, making them relatively narrow in scope but sufficient to prevent similar compounds with identical core features.

Q2: Are there known patent challenges or litigations associated with this patent?
A2: No public litigations are reported, but prior art cited during prosecution suggests ongoing examination of patentability.

Q3: Which regions have filings related to this patent?
A3: The patent family includes filings in Europe, Japan, China, and Canada, providing international coverage.

Q4: What are the implications for a competitor developing a similar compound?
A4: Potential infringement risks exist if the compound falls within the scope of claims, especially in the US and other jurisdictional territories.

Q5: When does the patent expire?
A5: The patent expires in 2026 unless extended, challenged, or invalidated.

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References

1. U.S. Patent and Trademark Office. (2023). Patent 7,955,619.
2. WIPO. (2023). Patent Family Database.
3. European Patent Office. (2023). EPXXXXXXX Patent family records.
4. Google Patents. (2023). Patent citations and legal status.
5. USPTO Public PAIR. (2023). Patent prosecution history.

[1] United States Patent and Trademark Office. (2023). Patent 7,955,619.

Drugs Protected by US Patent 7,955,619

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ohemo Life	MORPHABOND ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	206544-001	Oct 2, 2015		DISCN	Yes	No	7,955,619		Y
Ohemo Life	MORPHABOND ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	206544-002	Oct 2, 2015		DISCN	Yes	No	7,955,619		Y
Ohemo Life	MORPHABOND ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	206544-003	Oct 2, 2015		DISCN	Yes	No	7,955,619		Y
Ohemo Life	MORPHABOND ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	206544-004	Oct 2, 2015		DISCN	Yes	No	7,955,619		Y
Protega Pharms	ROXYBOND	oxycodone hydrochloride	TABLET;ORAL	209777-001	Apr 20, 2017		RX	No	No	7,955,619		Y
Protega Pharms	ROXYBOND	oxycodone hydrochloride	TABLET;ORAL	209777-004	Sep 5, 2024		RX	No	No	7,955,619		Y
Protega Pharms	ROXYBOND	oxycodone hydrochloride	TABLET;ORAL	209777-002	Apr 20, 2017		RX	No	No	7,955,619		Y

International Family Members for US Patent 7,955,619

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2008286914
Australia	2009282376
Australia	2015200009
Australia	2017200414
Australia	2019200895
Brazil	PI0815387
Canada	2696341