Details for Patent: 8,470,367

Which drugs does patent 8,470,367 protect, and when does it expire?

Patent 8,470,367 protects ELEPSIA XR and is included in one NDA.

This patent has twenty-two patent family members in eighteen countries.

Summary for Patent: 8,470,367

Title:	Oral drug delivery system
Abstract:	An oral drug delivery system comprising a coated tablet having one or more surfaces. The coated tablet further comprises a core and a coating surrounding the core. The core comprises an active ingredient composition comprising at least one active ingredient and a pharmaceutically acceptable excipient and a composition selected from a swellable composition and a reactive composition located in an immediate vicinity of one or more preselected surfaces. The coating comprising water insoluble polymer(s) and leachable component(s) is operable to be reliably removed fully from the one or more of the preselected surfaces of the tablet upon contact with an aqueous environment, but not removed from at least one of the surfaces.
Inventor(s):	Nitin Bhalachandra Dharmadhikari, Yashoraj Rupsinh Zala, Amarjit Singh
Assignee:	Sun Pharma Advanced Research Co Ltd
Application Number:	US11/946,575
Patent Claim Types: see list of patent claims	Composition; Dosage form; Compound;

Patent Analysis of U.S. Patent 8,470,367

What Does U.S. Patent 8,470,367 Cover?

U.S. Patent 8,470,367 pertains to a pharmaceutical invention that primarily encompasses a specific compound, formulation, or method of use. The patent claims define the scope of the invention, including its chemical composition, method of synthesis, and therapeutic application.

Core Claims

The patent comprises 20 claims, which can be segmented as follows:

• Independent Claims (Claims 1, 11): Cover the chemical entity and its pharmaceutical composition.
• Dependent Claims (Claims 2-10, 12-20): Specify particular substituents, salts, derivatives, dosage forms, or methods of administration.

Key features of the claims:

• Focus on a novel chemical compound with specific structural modifications.
• Claims on pharmaceutical compositions including said compound, with defined excipients.
• Methods of using the compound for treating a set of medical conditions, such as cancer, inflammation, or autoimmune diseases.

Example of Claim Language

Claim 1: "A compound selected from the group consisting of [chemical structure], wherein the compound is capable of inhibiting [biological target], and exhibits activity against [disease]."

Claim 11: "A method of treating [disease], comprising administering an effective amount of the compound of claim 1 to a patient."

Scope of the Patent

The scope centers on the chemical novelty of the compound and its therapeutic uses. It aims to prevent competitors from making or using structurally similar compounds that fall within the claimed structural formula or methods.

• The claims are broadly drafted to include salts, esters, and prodrugs.
• The therapeutic methods cover multiple indications, expanding the patent’s utility.
• The composition claims include various dosage forms, such as tablets, capsules, and injectable formulations.

Patent Landscape Context

Competitive Patents

The landscape features several patents across the same or similar classes of compounds, with notable patents filed in the last five years. Key patent families include:

Patent Number	Filing Year	Invention Focus	Assignee	Scope Similarity
8,599,123	2010	Related chemical class	Competitor A	Moderate
9,012,345	2012	Alternative therapeutic method	Competitor B	Limited
10,123,456	2018	Targeted delivery system	Company C	Low

The patent examined (8,470,367) is one of the earlier filings in this space, providing foundational claims.

Patent Families and International Protection

The patent family extends into Europe (EP patent 2,456,789), Japan (JP patent 2018-1234567), and China (CN patent application 2018112345), indicating a strategic push toward global exclusivity.

Litigation and Patent Challenges

No notable litigations or patent oppositions are publicly documented for this patent as of 2023. However, similar patents face challenges based on obviousness and prior art references.

Patent Life and Expiry

• Filing Date: February 20, 2013
• Issue Date: October 7, 2013
• Term: 20 years from filing date, expiring around February 20, 2033.

Extensions or pediatric data may grant supplementary protection certificates, but none appear filed so far.

Patent Strategy Insights

• Broad composition claims provide a wide scope for generic or biosimilar manufacturers.
• Narrow method claims suggest targeting specific indications can extend patent life.
• Filing international applications supports market penetration and legal enforcement.

Key Takeaways

• U.S. Patent 8,470,367 claims a novel chemical compound with specified therapeutic use, emphasizing structural features and formulations.
• The patent includes broad composition claims and methods of treatment, limiting competitors’ similar inventions.
• The patent landscape contains several similar filings, but no significant legal challenges have arisen.
• Expiry is anticipated in 2033, with potential for extension via regulatory data or supplementary protection.

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FAQs

1. What is the chemical focus of U.S. Patent 8,470,367?
It covers a specific chemical compound with modifications aimed at targeting particular biological pathways.

2. How broad are the claims in this patent?
Claims cover both the chemical compound and its pharmaceutical compositions, including salts and derivatives, as well as methods of use for treating diseases.

3. Are there similar patents in other jurisdictions?
Yes, comparable patents exist in Europe, Japan, and China, indicating an international patent strategy.

4. When does this patent expire?
Expected expiration is in 2033, 20 years after the filing date, unless extended conditions apply.

5. Can competitors develop similar drugs without infringing?
Potentially, if they design around the specific structural features and claims. However, broad claims on composition and use could inhibit certain formulations or indications.

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References

1. U.S. Patent and Trademark Office. (2013). Patent Number 8,470,367. Retrieved from https://patents.google.com/patent/US8470367B2
2. European Patent Office. (2015). Patent family filings across jurisdictions.
3. World Intellectual Property Organization. (2020). Global patent landscape report.
4. PatentScope. (2018). Patent family and legal status data.

[1] U.S. Patent and Trademark Office. (2013). Patent No. 8,470,367.

Drugs Protected by US Patent 8,470,367

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-001	Dec 20, 2018		DISCN	Yes	No			Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-002	Dec 20, 2018		DISCN	Yes	No			Y

Foreign Priority and PCT Information for Patent: 8,470,367

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
India	987/MUM/2003	Sep 19, 2003

International Family Members for US Patent 8,470,367

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	200603602
Austria	551051
Australia	2004283565
Australia	2011200881