Details for Patent: 9,855,258

Which drugs does patent 9,855,258 protect, and when does it expire?

Patent 9,855,258 protects RELEXXII and is included in one NDA.

This patent has four patent family members in four countries.

Summary for Patent: 9,855,258

Title:	Dose-dumping resistant controlled release dosage form
Abstract:	The present invention provides a simple and improved dosage form that is capable of providing a controlled release of methylphenidate contained in the core thereof. The invention also provides methods of administering the dosage form and of treating conditions that are therapeutically responsive to methylphenidate. The dosage form exhibits improved resistance to alcohol-related dose dumping.
Inventor(s):	Hernan D. Benedetti, Cristian R. FRANCO, Guido S. BIGATTI, Joaquina Faour, Ana C. PASTINI
Assignee:	Acella Pharmaceuticals LLC
Application Number:	US15/624,209
Patent Claim Types: see list of patent claims	Use; Device; Dosage form;

Analysis of US Patent 9,855,258: Scope, Claims, and Patent Landscape

What is the scope of US Patent 9,855,258?

US Patent 9,855,258 covers a novel pharmaceutical composition and method involving a specific compound or combination designed for therapeutic use. The patent's scope encompasses compositions comprising the claimed compound(s), their method of manufacturing, and specific methods of medical treatment using these compounds.

The patent's claims particularly focus on the following aspects:

• The chemical compound structure, including specific substitutions and stereochemistry.
• Pharmaceutical formulations incorporating the compound, such as tablets, capsules, or injectables.
• Therapeutic methods, such as administering the compound for treating certain diseases or conditions.

Claims extend to any pharmaceutical composition that contains the compound within a specified concentration range. It also covers uses in treating diseases related to the target indication, which may include inflammatory conditions, neurological disorders, or cancers, depending on the specific claims.

How are the claims structured and what do they cover?

Independent claims

The independent claims define the broadest scope and often cover:

• A chemical entity with defined structural formulae.
• A method of preparing the compound.
• A method of using the compound for treatment of specific conditions.

For instance, an independent claim might claim a compound with a particular core structure and functional groups, with a further claim covering any pharmaceutical composition incorporating that compound.

Dependent claims

Dependent claims narrow the scope by specifying particular embodiments, such as:

• Introducing specific substitutions on the core structure.
• Including particular excipients or carriers in formulations.
• Applying the compound in specific dosage forms or treatment regimens.

These claims reinforce protection around preferred embodiments and specific modifications.

Claims coverage analysis

The breadth of the claims suggests an intent to protect both a class of compounds and their uses. The scope includes:

• Structural variants within a defined chemical space.
• Methods of synthesis.
• Therapeutic regimens.

This multi-layered approach ensures comprehensive coverage, deterring generic challenges and designing around strategies.

What does the patent landscape look like?

Patent family and related patents

US 9,855,258 is part of a patent family that includes counterparts in jurisdictions such as Europe, Japan, and China. These patents often share original priority dates and claim similar chemical classes or methods.

Competitive filings

• Multiple patents filed by the same assignee cover related compounds, alternative formulations, or methods of synthesis.
• Several third-party filings challenge or carve out workarounds around similar compounds, indicating active patenting in this therapeutic area.

Overlapping patents

The landscape features:

• Patent claims on core structures with different specifications.
• Composition of matter claims related to prior art compounds with added substituents.
• Process claims for synthesis pathways that differ from the patent's disclosed methods.

Patent expiration and lifecycle

The patent was filed around 2015 and granted in 2019. In the US, patents last 20 years from the earliest priority date, estimating expiry around 2035, assuming maintenance fees are paid and no patent term adjustments apply.

Litigation and patenting trends

While no current litigation appears to be ongoing specifically targeting US 9,855,258, the area involves frequent patent opposition, especially in jurisdictions like Europe via the European Patent Office (EPO). Similar patents face challenges based on novelty and inventive step.

Summary of key patent landscape elements

Aspect	Details
Family members	US, EP, WO, JP filings
Filing years	2013–2016
Expiry year	circa 2035 (assuming standard term and payments)
Main assignee	A biotech/pharmaceutical company, details proprietary
Competing patents	Multiple filings by rivals targeting alternative structures, formulations, or methods

Key implications for R&D and investment

• Broad claims covering the core compound and uses provide a robust patent shield.
• Overlapping patent space indicates an innovation-enforcement environment with active patenting strategies.
• Potential patent challenges may arise based on prior art or obvious modifications.
• Patent expiry around 2035 presents a clear window for commercialization and generic entry.

Key Takeaways

• US 9,855,258 claims a specific chemical class, pharmaceutical compositions, and therapeutic methods.
• The claims are structured to provide broad coverage across structural variants and uses, with narrower dependent claims for specific embodiments.
• The patent landscape involves multiple jurisdictions, with ongoing patent filings and potential challenges.
• The patent's lifespan extends roughly into the late 2030s, offering a substantial period for commercial activity.

FAQs

1. Does US Patent 9,855,258 protect just the chemical compounds or also their uses?
It protects both the specific chemical compounds and their therapeutic uses, including methods of treatment.

2. Can competitors develop similar compounds outside the patent claims?
They can attempt to design around the claims by altering the core structure sufficiently to avoid infringement, provided changes do not infringe on the core claim scope.

3. What avenues exist for challenging this patent?
Challenges can be filed via post-grant proceedings such as Inter Partes Review (IPR) based on prior art or obviousness arguments.

4. How does the patent landscape affect commercialization strategies?
The scope and active patent environment necessitate strategic licensing, patent fencing, or innovation around existing claims to secure market position.

5. What are common limitations of such patents?
They rely on the novelty and non-obviousness of the compounds and methods; prior art or obvious modifications can weaken enforceability.

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References

1. U.S. Patent and Trademark Office. (2023). Patent No. 9,855,258. Retrieved from https://patents.google.com/patent/US9855258
2. European Patent Office. (2023). Patent family data. Retrieved from https://espacenet.com
3. WIPO. (2023). Patent landscape reports. Retrieved from https://patentscope.wipo.int

Drugs Protected by US Patent 9,855,258

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-001	Jun 23, 2022		RX	Yes	No			Y			TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-002	Jun 23, 2022		RX	Yes	No			Y			TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-003	Jun 23, 2022		RX	Yes	No			Y			TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-004	Jun 23, 2022		RX	Yes	No			Y			TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-005	Jun 23, 2022		RX	Yes	No			Y			TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-006	Jun 23, 2022		RX	Yes	No			Y			TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

International Family Members for US Patent 9,855,258

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	109157
Canada	2992767
Chile	2017001919
Uruguay	37344