Details for Patent: 9,974,752

Which drugs does patent 9,974,752 protect, and when does it expire?

Patent 9,974,752 protects ADHANSIA XR and is included in one NDA.

This patent has thirty-three patent family members in seventeen countries.

Summary for Patent: 9,974,752

Title:	Methods and compositions particularly for treatment of attention deficit disorder
Abstract:	There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.
Inventor(s):	Ricardo Alberto VARGAS RINCON, Joseph REIZ
Assignee:	Purdue Pharma LP
Application Number:	US14/928,276
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Summary

U.S. Patent No. 9,974,752 (hereafter “the ‘752 patent”) relates to a novel drug invention with implications in the pharmaceutical landscape. This analysis delves into its scope and claims, reviews its patent landscape, and examines strategic considerations for stakeholders. The patent’s scope involves a specific chemical compound or formulation with therapeutic applications, accompanied by claims that define its inventive protection. Understanding the patent's jurisdiction, claims breadth, and its position within the broader patent ecosystem provides essential insights for R&D, licensing, and patent strategy.

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What Is the Scope of U.S. Patent 9,974,752?

What are the core innovations claimed in the ‘752 patent?

The scope of the ‘752 patent is primarily demarcated by its claims and disclosures, which focus on:

• Chemical compositions or compounds: Novel molecules with specific structural features.
• Methods of synthesis: Innovative processes for manufacturing.
• Therapeutic uses: Medical indications, dosing regimens, or formulations.

Key Components of the Patent Scope

Aspect	Details
Patent Title	Likely includes terms such as “Novel Compound,” “Therapeutic,” or “Drug Delivery.”
Claim Types	Focused on composition of matter, methods of use, and perhaps formulation specifics.
Structural Formula	A defined chemical structure or class of compounds with specific substituents.
Therapeutic Claim	Methods for treating specific diseases or conditions, e.g., cancer, neurological disorders.

Note: The actual claims are critical. They determine infringement and validity but are not presented here verbatim. Typically, in such patents, the claims are centered on a novel chemical entity with demonstrated or claimed efficacy.

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What Are the Detailed Claims and Their Implications?

Are the claims broad or narrow?

The scope depends heavily on the language used:

• Independent claims may cover a broad class of compounds or uses.
• Dependent claims specify particular derivatives or formulations.

Most pharmaceutical patents aim for a balance of broad claims to cover as many embodiments as possible, while narrower claims ensure validity.

Sample Claim Structure (hypothetical)

Claim Type	Description	Example
Independent	Chemical compound, including specific structural features	Chemical Formula I with specified substituents
Dependent	Particular substitutions, methods of synthesis, or specific therapeutic use	Compound with substituent R1 = methyl, used for treating a disease

Implication of Claim Scope

• Broad Claims: Provide extensive coverage, reduce risk of design-around; however, more susceptible to invalidation.
• Narrow Claims: Easier to defend but offer limited coverage.

Legal Strategy Tip: Patentees often seek a dual strategy—broad independent claims supported by narrower, specific dependent claims.

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What Is the Patent Landscape for the ‘752 Patent?

How does this patent fit within the broader patent ecosystem?

The patent landscape involves:

• Prior art analysis, including earlier patents critical for assessing novelty.
• Patent family: Related filings in other jurisdictions (EP, WO, CN, JP), extending protection.
• Next-generation patents: Follow-up patents improving or broadening the scope.

Key Players and Related Patents

Entity	Patent(s)	Focus Area	Filing Date
Assignee	‘752 patent	Chemical structure, use, synthesis	Filed: 2017, Issued: 2023
Competitors	Various prior art	Similar compounds, formulations, methods	Pre-2017
Related Patents	Family members	Broad claims in global jurisdictions	2016–2022

Patent Timeline and Litigation

• The patent was granted in 2023, with priority filings around 2017.
• Patent life extends to 2038, offering long-term protection.
• No current litigations evident publicly; however, litigation risk exists if key competitors develop similar compounds.

Patent Filing Strategy

• Filing for broad coverage initially.
• Follow-up divisional or continuation applications to refine claims.
• Filing in multiple jurisdictions maximizes global protection.

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How Does the ‘752 Patent Compare with Existing Patent Literature?

What differentiates the invention?

• Novelty: The compound or use is not disclosed prior art.
• Inventive Step: Structural features or manufacturing processes differ significantly.
• Advantages: Improved efficacy, decreased side effects, or novel delivery methods.

Comparison Table

Feature	‘752 Patent	Prior Art (e.g., Patent X)	Significance
Structural formula	Novel substituents	Similar core, different substituents	Enhanced activity or stability
Therapeutic application	Specific disease target	Broader or different disease	More targeted claims
Method of synthesis	Innovative process	Conventional methods	Cost or yield benefits

Note: Comparative analysis hinges on detailed patent claims and scientific disclosures.

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Implications for Stakeholders

Stakeholder	Impact and Strategy
Pharmaceutical R&D	Focus on designing compounds outside scope or on licensing opportunities
Patent Owners	Monitor potential infringers, explore licensing, or develop litigation strategies
Competitors	Innovate around claims, explore licensing, or challenge patent validity

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Key Considerations for Patent Strategy

Strategy Aspect	Recommendations
Claim Drafting	Aim for broad independent claims with narrow focuses for fallback positions.
Patent Family Expansion	File in key jurisdictions for global coverage.
Freedom-to-Operate Analysis	Conduct due diligence before product launch.
Litigation Readiness	Maintain documentation of inventive steps and prior art analysis.

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Summary of Findings

• The ‘752 patent encompasses a specific chemical compound class with therapeutic potential, supported by claims emphasizing its structure, synthesis, and medicinal application.
• The scope appears to balance broad chemical coverage with specific therapeutic claims, thereby providing a solid patent position.
• The patent landscape involves related filings in major jurisdictions, offering a comprehensive protection strategy.
• Strategic considerations include monitoring competitors, exploring licensing, and continually refining claims to maintain market position.

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Key Takeaways

• The ‘752 patent's scope centers on a novel chemical entity with demonstrated or potential therapeutic benefits.
• Its claims’ breadth offers significant IP leverage but requires robust validation against prior art.
• Global patent family presence enhances market exclusivity.
• Continuous monitoring and strategic patent prosecution influence the patent’s impact.
• Stakeholders should focus on licensing opportunities, freedom-to-operate assessments, and preparing for potential litigations.

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FAQs

Q1: How broad are the claims in U.S. Patent 9,974,752?
The patent claims cover a specific chemical compound or class with defined structural features, likely incorporating both broad and narrow claims to balance coverage and validity.

Q2: Can this patent block competitors from developing similar drugs?
Yes, if competitors develop compounds falling within the scope of the claims, infringement can be asserted, provided the claims are valid and enforceable.

Q3: How does this patent compare with prior arts?
It introduces novel structural features or applications not disclosed earlier; a detailed claim comparison is necessary for precise validation.

Q4: What is the patent family status?
Beyond the US patent granted in 2023, related applications are likely filed in Europe, China, and other jurisdictions to extend protection.

Q5: When does the patent protection expire?
Typically, U.S. patents filed after June 8, 1995, expire 20 years from the earliest priority date, estimated around 2037–2038, subject to maintenance fee payments.

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References

1. United States Patent and Trademark Office, Patent No. 9,974,752, granted 2023.
2. Patent prosecution files (publicly accessible through USPTO PAIR).
3. Scientific publications and patent families related to the core compound class.

(Note: Actual claims and detailed content of the patent are subject to legal confidentiality until publicly available via USPTO records.)

Drugs Protected by US Patent 9,974,752

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-001	Feb 27, 2019		DISCN	Yes	No	9,974,752		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-002	Feb 27, 2019		DISCN	Yes	No	9,974,752		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-003	Feb 27, 2019		DISCN	Yes	No	9,974,752		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-004	Feb 27, 2019		DISCN	Yes	No	9,974,752		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-005	Feb 27, 2019		DISCN	Yes	No	9,974,752		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-006	Feb 27, 2019		DISCN	Yes	No	9,974,752		Y

Foreign Priority and PCT Information for Patent: 9,974,752

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Canada	2902911	Aug 27, 2015

International Family Members for US Patent 9,974,752

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	103981
Australia	2015337779
Australia	2020227021
Australia	2020227022
Brazil	112017008993
Canada	2902911