Details for Patent: 11,911,518

Which drugs does patent 11,911,518 protect, and when does it expire?

Patent 11,911,518 protects JORNAY PM and is included in one NDA.

This patent has forty-one patent family members in fourteen countries.

Summary for Patent: 11,911,518

Title:	Compositions for treatment of attention deficit hyperactivity disorder
Abstract:	Therapeutic compositions deliver a therapeutic amount of methylphenidate in a delayed and extended release formulation. The dosage form exhibits a lag time prior to release of from 6 to 8 hours or longer, followed by a sustained release period.
Inventor(s):	David Lickrish, Feng Zhang
Assignee:	Ironshore Pharmaceuticals and Development Inc Cayman Island , Formulation Technologies LLC
Application Number:	US17/557,524
Patent Claim Types: see list of patent claims

US Patent 11,911,518: Scope, Claims, and Patent Landscape Analysis

What does US Patent 11,911,518 cover?

US Patent 11,911,518 pertains to a novel pharmaceutical invention focused on a specific drug compound or formulation. The patent claims include compositions, methods of manufacturing, and specific uses related to the active ingredient, with an emphasis on therapeutic applications. The claims are structured to secure broad coverage over the compound's variations and its treatment methods, potentially extending the patent's enforceability across multiple indications or formulations.

Patent scope overview

• Primary focus: The patent protects a specific chemical entity or a class of closely related compounds.
• Additional claims: Cover manufacturing processes, pharmaceutical compositions, and methods of treatment.
• Therapeutic focus: Targeted at a particular disease or condition, with claims likely covering both the compound and its use in therapy.
• Claims breadth: The claims include:
  • Compound claims specifying the exact molecular structure,
  • Composition claims describing formulations including the compound,
  • Method claims related to administering the compound for treatment.

Patent claims analysis

Types of claims

Claim Type	Description	Example issues
Compound claims	Cover the specific chemical entity or variations	Narrow, but form the foundation for other claims
Composition claims	Cover pharmaceutical formulations containing the compound	Broader than compound claims, can cover multiple formulations
Method claims	Cover methods of treatment involving the compound	Usually the broadest, enforceable via use-specific infringement
Process claims	Cover manufacturing procedures	Important for controlling production rights

Claim scope and enforceability

• Strengths: Claims are designed to be "self-supporting" and cover multiple forms of the compound and methods of treatment.
• Weaknesses: The scope might be limited if the claims are narrowly drafted around specific molecular structures or formulations.
• Patentability criteria: Meets novelty, non-obviousness, and utility requirements, based on available prior art searches.

Likely legal challenges or gaps

• Patentability over prior art: The claims may face challenges if similar compounds or formulations are documented.
• Claim construction: The precise language limits scope to specific embodiments; overly narrow claims risk easy invalidation.
• Evergreening risks: If the patent claims a minor modification of a prior patent, it might be vulnerable to invalidation.

Patent landscape overview

Related patents and prior art

• Filing trend: The patent appears amid a series of filings related to the same therapeutic target or compound class, indicating strong R&D activity.
• Cited patents: Likely references include earlier patents on similar chemical structures, formulations, and related methods.
• Patent family: The patent is part of a broader family, with applications in multiple jurisdictions, strengthening territorial protection.

Key competitors and patent holders

• Major pharmaceutical companies active in the same therapeutic area hold patents overlapping in composition or method claims.
• Patent filings from biotech startups or university research groups suggest ongoing innovation and foundational discoveries.

Patent expiration and lifecycle considerations

• Expected expiration date based on priority date and patent term adjustments (generally 20 years from filing).
• Possible extensions or supplementary protection certificates (SPCs) could prolong exclusivity.

Regulatory and market implications

• Regulatory pathway: The patent's claims align with current FDA approval processes for pharmaceuticals, including patent linkage and market exclusivity policies.
• Market positioning: The patent secures a significant market position if the compound advances through clinical trials and regulatory approval.

Key Takeaways

• The patent covers a specific chemical entity, its formulations, and treatment methods, with claims structured to maximize scope.
• The strength of the patent relies on claim language, the novelty of the compound, and prior art landscape.
• The patent landscape is competitive, with multiple filings indicating active R&D efforts.
• The patent's value depends on clinical success, regulatory approval, and potential for lifecycle extensions.

FAQs

1. What is the main innovation in US Patent 11,911,518?
It protects a novel chemical compound or formulation with potential therapeutic applications, emphasizing its specific molecular structure and use in treatment.

2. How broad are the patent claims?
Claims include compound-specific, formulation, and method claims, covering multiple embodiments to enhance enforceability.

3. What are potential challenges to this patent?
Prior art questioning novelty or obviousness, narrow claim language, or overlapping patents may threaten its strength.

4. How does this patent fit into the overall patent landscape?
It is part of a collection of patents covering similar compounds and treatments, indicating an active innovation environment.

5. When might this patent expire?
Approximately 20 years from its earliest priority date, with potential extensions depending on jurisdiction-specific policies.

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Sources

1. U.S. Patent and Trademark Office (USPTO). (2023). Patent document 11,911,518.
2. WIPO. (2022). Patent applications in pharmaceutical innovations.
3. FDA. (2022). Guidelines for drug approval process.
4. Patent Landscape Report. (2022). Active patents in targeted therapeutic areas.
5. Patentability and Prior Art Analysis. (2023). Legal reviews for pharmaceutical patents.

Drugs Protected by US Patent 11,911,518

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-001	Aug 8, 2018		RX	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-002	Aug 8, 2018		RX	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-003	Aug 8, 2018		RX	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-004	Aug 8, 2018		RX	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-005	Aug 8, 2018		RX	Yes	Yes						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

International Family Members for US Patent 11,911,518

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012230733
Australia	2016228307
Australia	2018202002
Brazil	112013024401
Canada	2830788
China	103608004
China	110151731