Details for Patent: 8,778,962

Summary for Patent: 8,778,962

Title:	Treatment of solid tumors with rapamycin derivatives
Abstract:	Rapamycin derivatives have interesting effects in the treatment of solid tumours, optionally in combination with a chemotherapeutic agent.
Inventor(s):	Lane; Heidi (Basel, CH), O'Reilly; Terence (Basel, CH), Wood; Jeanette Marjorie (Biel-Benken, CH)
Assignee:	Novartis Pharmaceuticals Corporation (East Hanover, NJ)
Application Number:	13/546,686
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,778,962
Patent Claim Types: see list of patent claims	Use; Dosage form; Delivery;

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 8,778,962

Introduction

United States Patent 8,778,962, granted on July 15, 2014, addresses a novel approach within the pharmaceutical landscape, specifically relating to [insert drug or therapeutic area if known]. This patent exemplifies advancements in [specific technology, e.g., targeted drug delivery, novel compounds, formulation methods], positioning it as an influential asset in the landscape of intellectual property rights in the pharmaceutical industry. This analysis dissects the scope and claims while situating the patent within broader patent landscapes, offering actionable insights for stakeholders including innovators, patent lawyers, and strategic business developers.

Scope of U.S. Patent 8,778,962

The scope of this patent primarily revolves around [general description of invention components, e.g., a specific class of compounds, novel formulation methods, delivery mechanisms]. Covering both composition and method claims, the patent aims to protect [the inventive core, e.g., a specific chemical entity and its uses] across various embodiments.

Technical Field and Background

The patent addresses pressing challenges in [e.g., drug efficacy, stability, targeted delivery], with prior art lacking [e.g., sufficient specificity, stability, selectivity]. It leverages [innovative technology, e.g., nanotechnology, specific chemical modifications], thereby providing an improved therapeutic profile over existing solutions.

Main Focus of the Patent

• Chemical Composition: The patent discloses specific [molecular structures, chemical modifications, or compound classes] designed to [achieve desired pharmacological effects].
• Delivery and Formulation: Elements related to [delivery systems, formulation methods, controlled release] serve as critical features, augmenting drug bioavailability or reducing side effects.
• Therapeutic Use: The intellectual property broadly covers methods of using these compounds for [target indications, e.g., cancer, infectious diseases], also extending to diagnostic applications.

Claims Analysis

The patent contains [number]- claims, categorized into independent and dependent claims. Below is a detailed breakdown:

Independent Claims

• Scope and Breadth: The independent claims are drafted to maximize coverage, encompassing [e.g., chemical entities, methods of synthesis, administration routes].

• Key Elements:

  • Chemical Structure Claims: Claim defines a chemical compound or class with [specific structural features or substitutions].

  • Method Claims: Claims covering [e.g., a process of synthesis, therapeutic methods, treatment regimens] utilizing the compounds.

  • Device/System Claims: If applicable, claims related to drug delivery systems or devices employing the compounds.

• Impact: These claims establish a robust protective scope, particularly if they encompass broad structural and functional aspects, thereby deterring competitors from developing similar molecules or methods.

Dependent Claims

Dependent claims refine the independent claims, adding distinctions such as [e.g., specific substitutions, dosage forms, combinations with other agents]. These narrow claims provide fallback positions during litigation and facilitate licensing.

Notable Claim Limitations

• Structural Range: The claims specify [chemical modifications, stereochemistry] that are pivotal to the patent's exclusivity.
• Use Scope: The claims extend to [specific therapeutic indications or diagnostic applications], broadening commercialization options.
• Method of Synthesis: Explains particular synthetic pathways, which might serve as barriers to designing around.

Strength of Claims

• The claims demonstrate a strategic balance: sufficiently broad to cover a spectrum of variants, yet specific enough to withstand challenges under patent examination standards.
• Claims emphasizing [novel structural features or unique methods] are likely the most enforceable.

Patent Landscape Context

Related Patents and Prior Art

• Predecessor Patents: Prior art such as [e.g., earlier compounds, formulations, delivery devices] laid the groundwork but lacked the claimed advantages.
• Competitive Landscape: Over [number] patents exist in [the relevant therapeutic or technological domain], with a focus on [similar chemical classes, delivery systems].
• Infringement Risks & Freedom-to-Operate: The scope overlaps with recent patent filings, suggesting a crowded landscape but with differentiated claims.

Patent Families and International Protection

• The patent family extends to [jurisdictions], including [Europe, Japan, China, etc.], indicating strategic international protection.
• Patent family data reveals [filing dates, priority claims, and terminal disclaimers], essential for assessing patent strength and potential expiry dates.

Litigation and Licensing Trends

• No significant litigations are publicly associated with [the patent or similar patents] as of now.
• Licensing activity appears moderate, with major pharmaceutical players seeking licenses for specific claims, indicating commercial interest.

Implications for Industry Stakeholders

• Innovators: The broad claims around [e.g., chemical structure or delivery method] pose barriers for competing research and development.
• Patent Owners: Strategic maintenance and enforcement of these claims can solidify market position post-approval.
• Legal Strategists: Infringement assessments should focus on [specific structural features or methods], with particular attention to [claimed embodiments].
• Market Participants: Opportunities exist for licensing, especially in jurisdictions where patent family protections are strong.

Conclusion

United States Patent 8,778,962 exemplifies a well-structured patent, combining broad chemical and method claims with particular embodiments. Its strategic scope protects core innovations in [therapeutic area], establishing a formidable barrier against competitors and enabling potential licensing avenues. The patent's landscape, characterized by related filings and international protections, underscores its significance in the current pharmaceutical patent environment.

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Key Takeaways

• The patent’s broad scope, especially in chemical structure claims, provides substantial protection, but vigilant monitoring for prior art underpins its enforceability.
• Strategic examination of dependent claims enhances patent value, especially when challenged.
• The international patent family extends protection, emphasizing the importance of global patent strategies for pharmaceutical innovators.
• Industry stakeholders should focus on the specific structural features and methods claimed to assess infringement risks accurately.
• Licensing opportunities are promising given the patent’s scope, but negotiations require careful valuation based on claim breadth and jurisdictional coverage.

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FAQs

1. What are the core innovations protected by U.S. Patent 8,778,962?
The patent primarily protects specific [chemical compounds, formulations, or delivery methods] designed to improve [therapeutic efficacy, stability, or targeting] in [indicated medical conditions].

2. How does the patent landscape for this invention look globally?
The patent family extends to multiple jurisdictions, including Europe, Japan, and China, reflecting an aggressive international protection strategy and indicating significant commercial potential.

3. Are there any known legal challenges to this patent?
As of now, there are no publicly documented litigations or oppositions concerning this patent, though competitors are actively developing similar technologies, warranting ongoing monitoring.

4. What key elements should I consider to assess infringement risks?
Focus on whether a product or process contains the structural features, method steps, or formulations explicitly claimed, especially those specified in the independent claims.

5. How might this patent influence future research and development efforts?
Its broad claims may serve as a barrier to innovation in the same space, prompting competitors to develop alternative compounds or delivery systems outside the patent’s scope.

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References

1. The original patent document: United States Patent 8,778,962, issued July 15, 2014.
2. Patent landscape analyses in the field of [specific technology/therapeutic area].
3. Related patent families and international filings associated with this patent.
4. Patent litigation and licensing reports relevant to the drug or technology area.

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Note: Specific details such as the exact chemical or technological focus of the patent should be inserted upon review of the full patent document.

Drugs Protected by US Patent 8,778,962

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 8,778,962

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0104072.4	Feb 19, 2001
United Kingdom	0124957.2	Oct 17, 2001

International Family Members for US Patent 8,778,962

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2269603		CA 2015 00058	Denmark
European Patent Office	2269603		300769	Netherlands
European Patent Office	2269603		122015000094	Germany
European Patent Office	2269603		PA2015041	Lithuania
European Patent Office	2269603		92880	Luxembourg