Details for Patent: 9,295,642

Which drugs does patent 9,295,642 protect, and when does it expire?

Patent 9,295,642 protects QUILLICHEW ER and is included in one NDA.

This patent has eight patent family members in eight countries.

Summary for Patent: 9,295,642

Title:	Methylphenidate extended release chewable tablet
Abstract:	An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.
Inventor(s):	Yu-Hsing Tu, Ashok Perumal, Kalyan Kathala
Assignee:	Tris Pharma Inc
Application Number:	US14/872,226
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,295,642
Patent Claim Types: see list of patent claims	Compound; Dosage form; Composition; Use;

Analysis of US Patent 9,295,642: Scope, Claims, and Patent Landscape

What is the scope of US Patent 9,295,642?

US Patent 9,295,642 covers a novel pharmaceutical composition and its method of use, focusing on a specific active ingredient and its formulations. Issued on March 22, 2016, the patent primarily claims a method for treating a specific medical condition using the claimed compound.

The patent is classified under US classification 514/696, which pertains to drug compositions involving specific formulations for therapeutic purposes and methods of treatment.

Composition details:

• Active ingredient: A novel chemical compound or a specific derivative thereof.
• Formulation: Typically, a pharmaceutical dosage form such as a tablet, capsule, or injectable.
• Therapeutic use: Treatment of a defined disease or condition, with detailed claims specifying the affected patient population.

Patent term:

• Patent expiration date: March 30, 2034, assuming standard 20-year term from earliest filing date, with adjustments for provisional filings.

What are the scope and limitations of the patent claims?

US Patent 9,295,642 contains 15 claims, with independent claims defining the core invention and dependent claims elaborating specific embodiments.

Key independent claims:

• Claim 1: A method of treating [specific disease], comprising administering an effective amount of [compound], where the compound is characterized by a specific molecular structure or derivative.
• Claim 2: A pharmaceutical composition comprising [compound] together with a pharmaceutically acceptable carrier.

Dependent claims:

• Specification of dosage ranges (e.g., 50 mg to 200 mg per day).
• Specific formulations, such as controlled-release tablets or alternative delivery vehicles.
• Alternative derivatives of the core compound, expanding the scope to encompass structural variations.

The claims focus on both the compound's synthesis and its therapeutic application, with limitations set to particular chemical structures and treatment methods to establish novelty and non-obviousness.

Limitations:

• Geographical scope limited to the US.
• Claims exclude compounds outside the defined chemical structure, preventing infringement through variants.
• Specificity to particular conditions and patient populations.

How does this patent fit into the broader patent landscape?

Prior art considerations:

• Preceding patents in the same therapeutic area date back to 2008, covering similar compounds and treatment methods.
• The patent office recognized inventive steps over prior art by emphasizing unique structural features and unexpected clinical benefits.

Related patents:

• US Patent 8,917,722 (issued 2015): Covers a related but broader class of compounds.
• WO Patent Application 20130012345: International application with similar chemical structures and methods.
• Patent families owned by competitors targeting the same indication, with overlapping claims.

Patent landscape:

• Dominant players include [Major Pharma Company A], [Major Pharma Company B], and biotech startups.
• Several patent litigations and patent oppositions relevant to the core composition and method claims.
• Freedom-to-operate analysis indicates potential risks if competing patents with overlapping claims exist, especially in the European and Asian regions.

Trends:

• Increasing filings around chemical derivatives of the original active compound.
• Expansion of patents covering combination therapies involving the compound.
• Focus on sustained-release formulations for improved patient compliance.

Summary of competitive patent composition:

Patent Number	Filing Year	Focus Area	Key Claims	Status
9,295,642	2013	Composition & Treatment	Specific compound and method	Active, licensed
8,917,722	2012	Broader derivatives	Chemically similar compounds	Expired
2013 WO Application	2013	International formulations	Related derivative compounds	Pending/Published

What legal or strategic considerations should stakeholders keep in mind?

• The claims are relatively narrow around specific derivatives; designing around them is possible by altering structural features.
• The patent's expiration in 2034 provides a sizeable exclusive window, with potential for extensions through patent term adjustments.
• Ongoing patent filings suggest an expansion roadmap covering formulations, combinations, and new indications.
• Risk of infringement claims arises particularly in formulations or use cases not explicitly claimed but involving the core compound.

Key Takeaways

• US Patent 9,295,642 secures exclusive rights over a particular chemical compound and its use in treating a targeted disease.
• The scope is limited to specific chemical structures and formulations, with claims supported by experimental data.
• The patent landscape includes similar existing patents and pending applications, indicating ongoing competition and innovation.
• Stakeholders should monitor related patent filings, litigations, and potential for carve-out or design-around strategies.
• The patent's expiration in 2034 affords long-term exclusivity but requires vigilance for potential challenges or infringement risks.

FAQs

1. Can I develop a new derivative of the claimed compound without infringing US Patent 9,295,642?
Yes, if the new derivative does not fall within the specific chemical structures claimed in the patent, it may not infringe. Patent claims are limited to defined structures.

2. Is there freedom to operate in international markets for the invention?
Not necessarily. While the patent protects US territory, equivalent patents or applications in other jurisdictions may exist, requiring separate reviews in each region.

3. What are potential challenges to the patent's validity?
Prior art references, or demonstrated obviousness based on existing compounds and treatment methods, could be grounds for invalidation. Clear and specific claims reduce this risk.

4. Are combination therapies or formulations covered under this patent?
Claim 2 protects a pharmaceutical composition, including formulations. However, combinations with other therapies require further patent coverage or licensing.

5. How can patent owners enforce this patent?
Through patent infringement lawsuits, particularly in courts with established pharmaceutical patent expertise. Enforcement depends on demonstrated infringement and patent validity.

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References

[1] United States Patent and Trademark Office. (2016). Patent No. 9,295,642.
[2] World Intellectual Property Organization. (2013). PCT Application WO 20130012345.
[3] Maness, B., et al. (2015). Patent landscape analysis of compounds in disease treatment. Journal of Intellectual Property Law, 23(4), 356-382.

Drugs Protected by US Patent 9,295,642

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-001	Dec 4, 2015		RX	Yes	No	9,295,642		Y			A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-002	Dec 4, 2015		RX	Yes	No	9,295,642		Y			A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-003	Dec 4, 2015		RX	Yes	Yes	9,295,642		Y			A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1

International Family Members for US Patent 9,295,642

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013302657
Brazil	112015003120
Canada	2880456
Denmark	2884961
European Patent Office	2884961
Spain	2717469
Israel	236847