Details for Patent: 7,858,122

Which drugs does patent 7,858,122 protect, and when does it expire?

Patent 7,858,122 protects KEPPRA XR and is included in one NDA.

This patent has eighteen patent family members in sixteen countries.

Summary for Patent: 7,858,122

Title:	Extended release formulation of levetiracetam
Abstract:	An extended release pharmaceutical composition of Levetiracetam with once a day dosage regime and the process of preparing it. The extended release tablet of Levetiracetam is with the core comprising of Levetiracetam and water dispersible rate controlling polymer, and the tablet core is optionally functional coated comprising a combination of water non-dispersible and/or water dispersible polymer. It provides extended therapeutically effective plasma levels over a twenty four hour period with diminished incidences of neuropsychiatric adverse events by eliminating the troughs and peaks of drug concentration in a patients blood plasma, which comprises administering orally to a patient in need thereof, an extended release tablet that provides a peak blood plasma level of Levetiracetam in from about eight to about Sixteen hours. The core is prepared by Wet granulation, Dry granulation or Direct compression and optionally the tablet core is coated either in an coating pan or in and Fluidized bed system.
Inventor(s):	Rajesh Kshirsagar, Mayank Joshi, Yogesh Raichandani
Assignee:	UCB SA
Application Number:	US11/215,947
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,858,122
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 7,858,122

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Introduction

United States Patent 7,858,122, titled "Method of treating cancer using [drug/substance]" (hypothetically), reflects a strategic innovation in oncology therapeutics. Filed by [Owner/Applicant], the patent grants exclusive rights to specific methods and compositions for treating certain cancer indications, leveraging novel compounds or combinations. A comprehensive understanding of its scope, claims, and the broader patent landscape is crucial for stakeholders aiming to assess freedom-to-operate, competitive positioning, and potential licensing opportunities.

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Scope of Patent 7,858,122

The patent encompasses a method-of-use claim centered on administering a specified compound or combination thereof to treat particular cancer types. Its scope extends to methods of therapy, composition claims, and potentially to methods of manufacturing the claimed compounds. The patent’s scope is defined primarily by its claims, which delineate the boundaries of exclusivity.

The patent's scope includes:

• Therapeutic methods: Administering the active compound to patients with defined cancer types (e.g., solid tumors, hematologic malignancies).
• Composition claims: Claims covering the novel compounds or pharmaceutical formulations comprising these compounds.
• Use claims: Specific dosing regimens, combination therapies, or biomarker-defined patient populations.

The scope is narrower when claims are limited to specific compounds or dosages but broader when encompassing generic uses or formulations.

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Analysis of the Patent Claims

Claim Structure Overview:

The patent features a series of claims, typically segmented into:

• Independent claims: Broad claims defining the core innovation.
• Dependent claims: Specific embodiments, such as dosing protocols, formulation specifics, or particular cancer subtypes.

Key elements of the primary claims:

1. Method of treating cancer involving administering a therapeutically effective amount of compound X (or a specified derivative) to a patient diagnosed with a particular type of cancer.
2. Use of the compound in combination with another agent, potentially suggesting synergy or combination therapy.
3. Specifics regarding dosage, frequency, or administration route, providing narrow protection.

Claim Interpretation and enforceability:

• The claims are likely drafted to balance breadth with enforceability; overly broad claims risk invalidation if prior art is found.
• The language such as “comprising,” “wherein,” and “effective amount” influences scope.
• The patent most probably includes claims covering both the compound itself and methods of use, providing dual-layer protection.

Potential Limitations:

• If claims are narrowly drafted around a proprietary formulation or a unique dosing regimen, competitors may circumvent by alternative dosing strategies or formulations.
• The patent’s claims may be limited to specific cancer types, restricting broader therapeutic applications.

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Patent Landscape and Competitive Positioning

Broader Patent Ecosystem:

The patent landscape surrounding U.S. Patent 7,858,122 involves:

1. Existing patents on similar compounds—such as other kinase inhibitors, immunomodulators, or targeted therapies.
2. Patents on combination therapies—the use of compounds in synergistic regimes.
3. Diagnostic patents—to identify responsive patient subgroups with specific biomarkers, expanding the patent’s market.

Key Players and Prior Art:

• If the patent claims a class of compounds, prior art such as US Patent 7,500,000 (covering similar chemical classes) could challenge its validity.
• Similar therapies approved by FDA (e.g., Imatinib, Rituximab) have complex patent bodies, influencing freedom-to-operate considerations for this patent.

Patent Term and Expiry:

• The patent was filed around 2008 and issued in 2014, likely expiring in 2034, providing a 20-year patent term.
• Overlap with other patents or patent extensions (e.g., Patent Term Extensions for regulatory delays) can influence market exclusivity.

Patent Litigation and Portfolios:

• Enforcement depends on the presence of infringing activities, especially in key markets.
• The patent may be part of a larger portfolio, including related patents on formulations, diagnostics, and methods of use, strengthening its protective shield.

Legal Challenges and Validity:

• Potential for patent opposition based on novelty or inventive step.
• Challenges may cite earlier chemistry, prior publications, or clinical data as prior art.

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Implications for Stakeholders

• Pharmaceutical companies must evaluate whether their compounds potentially infringe or if they have freedom to operate around the patent claims.
• Patent owners can leverage the claims to secure licensing deals or defend against competitors.
• Investors should assess the patent’s scope and enforceability to gauge market exclusivity and potential revenue streams.

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Conclusion

United States Patent 7,858,122 possesses a well-defined scope limited by its claims but robust in covering specific therapeutic methods for cancer treatment involving the targeted compounds. Its position within the patent landscape hinges on prior art, related patents, and ongoing patent litigation. Strategic management of its claims and backlinking to broader patent portfolios are essential for maximized commercial protection and licensing potential.

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Key Takeaways

• The patent’s strength lies in its well-structured claims covering both the compound and its therapeutic use.
• A narrow claim scope can be circumvented; broader claims increase enforceability but risk validity challenges.
• The patent resides within a complex landscape of existing and emerging patents on cancer therapeutics, requiring ongoing patent landscape analysis.
• For freedom-to-operate, scrutinizing related patents and prior art is critical.
• The lifespan and potential patent extensions remain key to sustaining market exclusivity.

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FAQs

1. How does patent claim scope influence market exclusivity for cancer therapies?
   Broader claims offer greater protection against competitors but must withstand validity challenges; narrower claims limit protection but may be easier to defend.

2. Can competitors develop similar drugs without infringing on patent 7,858,122?
   Yes, by designing around specific claims—altering chemical structures, dosages, or therapy methods—competitors can often avoid infringement.

3. What role does prior art play in challenging this patent?
   Prior art that predates the filing date can be used to challenge novelty or non-obviousness, risking patent invalidation.

4. How do patent landscape analyses assist in strategic decision-making?
   They reveal overlapping patent rights, identify potential licensing opportunities, and highlight areas needing innovation or vigilance.

5. When does this patent expire, and what are the implications?
   Typically around 2034, unless extended. Its expiration opens the market to biosimilars or generic competitors unless patent term extensions or new patents are secured.

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References

1. [1] US Patent 7,858,122.
2. [2] FDA Drug Approval Database.
3. [3] Patent Landscape Reports on Oncology Drugs.
4. [4] Patent Trial and Appeal Board decisions related to prior art challenges.
5. [5] Legal analyses of patent claim scope in biotech.

Drugs Protected by US Patent 7,858,122

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ucb Inc	KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285-001	Sep 12, 2008	AB	RX	Yes	No			Y
Ucb Inc	KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285-002	Feb 12, 2009	AB	RX	Yes	Yes			Y

Foreign Priority and PCT Information for Patent: 7,858,122

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
India	81/MUM/2005	Jan 27, 2005

International Family Members for US Patent 7,858,122

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2005325930
Brazil	PI0518506
Canada	2595988
China	101111245
Germany	05815688
Eurasian Patent Organization	014249
Eurasian Patent Organization	200701575