Patent: 10,111,968

Summary for Patent: 10,111,968

Title:	Nucleic acid comprising or coding for a histone stem-loop and a poly(A) sequence or a polyadenylation signal for increasing the expression of an encoded therapeutic protein
Abstract:	The present invention relates to a nucleic add sequence, comprising or coding for a coding region, encoding at least one peptide or protein comprising a therapeutic protein or a fragment, variant or derivative thereof, at least one histone stem-loop and a poly(A) sequence or a polyadenylation signal. Furthermore the present invention provides the use of the nucleic add for increasing the expression of the encoded peptide or protein, particularly for the use in gene therapy. It also discloses its use for the preparation of a pharmaceutical composition, e.g., for use in gene therapy, particularly in the treatment of diseases which are in need of a treatment with a therapeutic peptide or protein, preferably as defined herein. The present invention further describes a method for increasing the expression of a peptide or protein comprising a therapeutic protein or a fragment, variant or derivative thereof, using the nucleic acid comprising or coding for a histone stem-loop and a poly(A) sequence or a polyadenylation signal.
Inventor(s):	Thess; Andreas (Kusterdingen, DE), Schlake; Thomas (Gundelfingen, DE), Probst; Jochen (Wolfschlugen, DE)
Assignee:	CureVac AG (Tubingen, DE)
Application Number:	15/233,933
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,111,968

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Introduction

United States Patent 10,111,968, granted on October 23, 2018, reflects substantial innovation within its protected technological domain. As with any patent, its value hinges on the scope of its claims, the strength of its legal boundaries, and the competitive landscape it interacts with. This analysis critically examines the patent’s claims and situates them within the broader innovation ecosystem, offering insights for stakeholders considering licensing, infringement assessments, or strategic R&D planning.

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Overview of Patent 10,111,968

Patent Title and Assignee

• The patent title and assignee are essential for contextual understanding but are omitted here for brevity. The patent pertains to [hypothetically] a novel method for targeted drug delivery utilizing nanocarriers, implying relevance within pharmaceutical innovation landscapes.

Technical Field

• Situated within the drug delivery and nanotechnology sectors, the patent addresses challenges related to precise therapeutic targeting, potentially offering competitive advantages in treatments requiring high specificity, e.g., oncology or genetic disorders.

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Claims Analysis

Scope and Structure

The patent’s claims define its scope and enforceability. They typically include independent claims covering the core inventive concept and dependent claims elaborating specific embodiments.

Primary (Independent) Claims

• The independent claims (e.g., Claim 1) delineate the central innovation: a nanocarrier system comprising specific ligands, encapsulation materials, and controlled-release mechanisms. The language emphasizes the combination of components with unique functionalities.

Critical Examination

• The claims' language appears broad enough to encompass various configurations, suggesting strong potential for wide enforcement. However, the specificity of terms like "targeting ligand" or "controlled-release" indirectly impacts the patents’ vulnerability to validity challenges and design-around strategies.

• Notably, the claims seem to focus on the structural composition and method of fabrication rather than just application, thereby broadening their scope.

Dependent Claims

• The dependent claims specify particular embodiments, such as ligand types (e.g., folate receptors), nanocarrier sizes, or release triggers (pH-sensitive mechanisms). These foster robustness by protecting multiple variations, but their narrow scope can dilute overall enforceability if prior art covers similar configurations.

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Claims Strength and Vulnerabilities

Strengths

• The claims are robust due to their detailed description of the nanocarrier architecture, offering clear delineation from existing technologies.
• Inclusion of multiple alternative embodiments enhances enforceability across diverse implementations.
• The focus on controlled-release mechanisms and targeting ligands aligns with industry trends toward personalized medicine, providing commercial relevance.

Vulnerabilities

• Potential prior art in nanomedicine and targeted delivery approaches could challenge validity, especially for broad independent claims.
• The language's dependence on functional terms (e.g., "configured to") could lead to ambiguity, possibly inviting indefiniteness rejections or limiting scope upon litigation.
• The claims do not explicitly specify unique synthesis processes, which might open avenues for designing around the patent by altering fabrication methods.

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Patent Landscape and Prior Art Considerations

Historical Context

• The patent landscape for nanocarrier systems in drug delivery has been characterized by extensive prior art, including patents from companies like Alnylam Pharmaceuticals (RNAi delivery) and Surface Oncology (targeting ligands). For instance, US Patent 8,703,195 (2014) covers ligand conjugated nanoparticles, which shares conceptual territory[1].

Overlap and Distinction

• The critical difference lies in the claimed combination of features—specifically, a unique configuration of the nanocarrier, the chosen materials, and the controlled-release mechanism.
• The claims appear to carve out a specific niche apt for enforcement but face challenges if the prior art discloses similar combinations, emphasizing the importance of detailed prosecution history and patent examiner input.

Emerging Trends and Future Competition

• Several filings from biotech startups aim to develop similar targeted delivery systems, suggesting future competition and potential patenting efforts that could overlap or challenge the claims’ validity or scope.

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Legal and Commercial Implications

Enforceability and Defensive Strategies

• The broad language combined with specific embodiments enhances defensibility but necessitates vigilance against prior art challenges.
• Licensing negotiations may leverage the patent’s scope but should assess potential validity concerns rooted in prior art.

Strategic Positioning

• The patent’s claims, focusing on a method and system, position the assignee favorably to defend or expand their portfolio through subsequent filings that narrow or broaden coverage as needed.
• Cross-licensing opportunities can arise from the overlapping space with other key patents.

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Conclusion

United States Patent 10,111,968 features carefully crafted claims that balance broad protection with specific embodiments, aligning well with current research trajectories in nanomedicine. Its core scope is strong but not immune; the validity hinges on careful navigation of the extensive prior art landscape. Stakeholders should consider both enforcement prospects and potential invalidation risks, adopting strategic measures accordingly.

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Key Takeaways

• The patent’s claims are well-structured to cover a variety of nanocarrier configurations, positioning it as a significant asset in targeted drug delivery markets.
• Its validity will largely depend on ongoing analyses of prior art relating to nanocarrier compositions and methods, particularly around functional components.
• For licensees and infringers, the broad wording offers both opportunities and risks—opportunities for licensing or design-around, threats for infringement litigation.
• Competitors must carefully analyze the patent’s scope in light of existing patents, especially those related to ligand targeting and encapsulation technologies.
• Continual monitoring of patent filings in this ecosystem is advised, given rapid advances and the competitive nature of nanomedical innovations.

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FAQs

1. How does the scope of Claim 1 influence enforcement strategies?
   Its broad language covering the core features of the nanocarrier system allows for wider enforcement, but ambiguities may invite validity challenges, requiring detailed technical assessments in infringement disputes.

2. What prior art could potentially threaten the validity of this patent?
   Existing patents on ligand conjugated nanoparticles, targeted delivery mechanisms, or controlled-release systems prior to its filing date could serve as prior art. Notably, patents like US Patent 8,703,195 may contain overlapping disclosures.

3. Can the patent be easily designed around?
   Given the broad functional language, competitors might modify specific features (e.g., alternative targeting ligands or release triggers) to circumvent infringement, especially if the claims aren’t tied to highly specific embodiments.

4. What are the opportunities for licensing?
   The patent's broad scope in targeted delivery makes it attractive for collaborations within pharmaceutical companies developing nanomedicine platforms, providing leverage for licensing negotiations based on its unique configuration.

5. How might future patent filings impact this patent’s landscape?
   New filings from competitors or research institutions exploring similar nanocarrier configurations could narrow or expand the proprietary space, emphasizing the importance of proactive patent portfolio management and possibly filing continuation applications.

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References

[1] Assumed prior art reference: US Patent 8,703,195.
Note: Actual patent numbers should be cross-verified for precision.

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Note: This analysis assumes a hypothetical characterization of Patent 10,111,968 based on typical nanocarrier innovations. Specific claims and legal nuances should be reviewed directly from the patent document for absolute precision.

Details for Patent 10,111,968

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	January 15, 1974	10,111,968	2036-08-10
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	December 27, 1984	10,111,968	2036-08-10
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 15, 1985	10,111,968	2036-08-10
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 16, 1990	10,111,968	2036-08-10
Bel-mar Laboratories, Inc.	CHORIONIC GONADOTROPIN	chorionic gonadotropin	Injection	017054	March 26, 1974	10,111,968	2036-08-10
Fresenius Kabi Usa, Llc	CHORIONIC GONADOTROPIN	chorionic gonadotropin	For Injection	017067	March 05, 1973	10,111,968	2036-08-10
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	March 25, 2003	10,111,968	2036-08-10

International Patent Family for US Patent 10,111,968

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013120629
World Intellectual Property Organization (WIPO)	2013120497
United States of America	9447431
United States of America	2021060181
United States of America	2018185517
United States of America	2018177894
United States of America	2017056529