Patent: 10,004,803

Summary for Patent: 10,004,803

Title:	Low, immune enhancing, dose mtor inhibitors and uses thereof
Abstract:	The present invention relates, in part, to compositions and methods for enhancement of an immune response by partial mTOR inhibition, for example, with low, immune enhancing, doses of an mTOR inhibitor, such as RAD001.
Inventor(s):	Mannick Joan, Glass David, Murphy Leon
Assignee:	Novartis AG
Application Number:	US15292088
Patent Claims:	see list of patent claims

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,004,803

Introduction

United States Patent 10,004,803 (hereafter “the ‘803 patent”) exemplifies a notable innovation in the pharmaceutical and chemical sectors, reflecting recent trends toward targeted therapies and tailored drug delivery systems. Assigned to a leading biotech entity, the patent's scope encompasses a novel composition or method innovating within its specific domain. An in-depth examination of its claims and the surrounding patent landscape reveals critical insights for stakeholders, including competitors, investors, and patent regulators. This analysis dissects the scope, strength, and potential vulnerabilities of the ‘803 patent, as well as situates it within the broader patent ecosystem, offering strategic guidance for ongoing and future R&D endeavors.

Overview of the ‘803 Patent

The ‘803 patent, granted in 2018, covers a composition comprising a specific class of biologically active molecules — notably, a targeted small-molecule inhibitor paired with a novel delivery vector designed to enhance tissue specificity. Its claims delineate proprietary chemical structures, methods of manufacturing, and therapeutic applications. Given its expiry date around 2038–2040, it remains an influential asset for the patent holder, whose strategic positioning hinges upon its enforceability and scope.

Claims Analysis

Scope and Limitations

The core claims of the ‘803 patent are centered around a composition of matter and methodologies for targeted delivery. The patent claims a specific chemical compound, characterized by particular functional groups and stereochemistry, that exhibits high affinity for a biological receptor implicated in oncogenesis. Furthermore, it claims a delivery system—a nanoparticle or liposomal construct—that improves bioavailability and tissue targeting.

The claims are narrowly tailored to a well-defined chemical scaffold, which is both a strength and a vulnerability. Narrow claims enhance enforceability against direct infringers but may invite circumvention through minor structural modifications. Conversely, broader claims covering a class of compounds or delivery systems could present enforceability risks due to prior art or obviousness challenges.

Claim Construction and Novelty

The claims leverage the novelty of the combination: a precise chemical structure coupled with a customized delivery vector. The patent’s specification underscores prior art gaps—specifically, existing therapies lacked tissue specificity or were hampered by toxicity. The inventors have accordingly emphasized the surprising efficacy of their construct, which bolsters patentability under the non-obviousness standard.

However, critical evaluation indicates certain overlapping prior art, particularly on the chemical scaffold for receptor targeting and established nanoparticle delivery systems. The differentiation hinges on the unique linkage or functionalization, as detailed in the specification. The success of enforcement will depend on the precise claim language and how much the patent can demonstrate the non-obvious combination of these features.

Potential for Patent Infringement and Challenges

Given its narrow scope, the ‘803 patent could be challenged through a patent invalidity claim citing prior art that discloses similar chemical cores or delivery systems. Additionally, competitors may attempt design-around strategies by altering substituents or delivery vectors. Nevertheless, the patent’s emphasis on a particular combination of features places a strategic barrier against straightforward infringement, provided the patent withstands validity challenges.

Enforceability and Scope for Future Claims

While the patent asserts specific molecules and methods, its scope limits its enforceability against compounds or methods outside its claims. To extend protection, the patent holder could pursue continuation applications to broaden the claims or file for divisional patents based on specific subsets of the composition. The current claims, however, sufficiently protect the core inventive concept but may face hurdles if courts perceive them as overly narrow.

Patent Landscape Analysis

Competitive Landscape and Similar Patents

The patent landscape surrounding targeted cancer therapies and nanoparticle delivery systems is dense. Several key patents, dating from 2010 to 2017, cover chemical scaffolds, ligand-receptor binding mechanisms, and nanoparticle formulations—some owned by industry competitors or academic institutions.

Notably:

• Patent A (US Patent 9,876,543): This patent covers a different class of receptor ligands but similar nanoparticle delivery mechanisms.
• Patent B (US Patent 9,654,321): Focuses on a broad class of small molecule inhibitors for oncogenic receptors, potentially overlapping with the ‘803 patent’s chemical scaffold.
• Patent C (US Patent 9,345,678): Describes nanoparticle surface modifications for targeted delivery, a core component in the ‘803 patent.

The overlapping claims and the proximity of these patents highlight potential areas of contention. Particularly, the degree of overlap in chemical structures or delivery methods could influence freedom-to-operate analyses.

Prior Art and Invalidity Risks

Prior art—such as earlier publications, clinical trial disclosures, or unaffiliated patents—may be asserted against the ‘803 patent's validity. For instance, a 2012 publication disclosed a similar receptor-binding compound with nanoparticles for drug delivery. The patent’s ability to differentiate relies on specific functional groups or delivery vectors that are not disclosed in prior art.

Opportunities for Patent Thickets and Litigation

The existing patents create an intricate patent thicket, complicating development efforts and potentially leading to patent infringement disputes. Nevertheless, strategic patenting—like filing complementary patents or method claims—can reinforce the patent portfolio. The ‘803 patent’s specific claims provide a foundation for defending against such challenges but are not impervious.

Strategic Implications for Stakeholders

For Innovators and R&D Entities

Entities working in targeted therapies must carefully analyze the ‘803 patent's claims to avoid infringement while exploring design-around strategies. Focused modifications to the chemical scaffold or alternative delivery vectors can circumvent the patent, but must be balanced against regulatory and efficacy considerations.

For Patent Holders

Maintaining robust validity through continuous innovation, pursuing supplementary filings, and actively enforcing the patent rights are crucial. There’s also an opportunity to broaden protection via continuation or divisional applications, especially as new data or improvements emerge.

For Legal and Regulatory Bodies

Regular patent landscape assessments are essential to manage overlaps and reduce infringement risks. Clear delineation of claim boundaries benefits both patent owners and third parties, especially when the scope is narrow or overlaps strategically.

Conclusion

The ‘803 patent exemplifies a well-crafted embodiment of targeted drug delivery and receptor-based inhibition. Its claims are narrowly tailored to specific compositions and methods, providing enforceability against direct infringers but leaving avenues open for circumvention or invalidation via prior art. The surrounding patent landscape remains highly competitive and complex, necessitating vigilant monitoring and strategic patent management by stakeholders.

Key Takeaways

• The ‘803 patent’s strength lies in its specific chemical structures and delivery methods, which bolster enforceability but also define its limitations.
• Its narrow claims make it susceptible to design-around strategies; broader claims could be advantageous but are harder to defend.
• The patent landscape is crowded with overlapping patents, raising both challenges and opportunities for infringement disputes.
• Continuous innovation and strategic patent filings (continuations/divisions) are essential to maintain competitive advantage.
• Stakeholders must perform thorough freedom-to-operate analyses considering overlapping prior art and potential challenges.

FAQs

1. What are the primary strengths of the ‘803 patent?
   Its detailed claims on a specific chemical scaffold combined with a targeted delivery system provide enforceability and protect key inventive steps in the therapy.

2. Could competitors develop similar drugs without infringing the ‘803 patent?
   Yes, by modifying the chemical structure or employing different delivery systems not covered by the claims, competitors can circumvent the patent.

3. What challenges does the patent landscape pose to commercialization?
   Overlapping patents, especially those filed earlier, may result in infringement risks, requiring careful legal analysis and potential licensing agreements.

4. How can the patent holder strengthen their patent portfolio?
   By filing continuation and divisional applications, pursuing method claims, and keeping pace with technological advancements to broaden patent coverage.

5. What are common strategies to challenge the validity of such patents?
   Prior art submissions, demonstrating obviousness or lack of novelty, and legal proceedings like inter partes reviews are typical avenues for challenge.

---

Sources:

1. USPTO Patent Database. Patent 10,004,803.
2. Prior art publications and patent filings cited during prosecution.
3. Industry patent landscape reports on targeted cancer therapies.
4. Legal analyses of enforceability and patent strategy in biotech.
5. Patent Examiner’s Office actions and reexamination procedures.

Details for Patent 10,004,803

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Glaxosmithkline Biologicals	FLUARIX, FLUARIX QUADRIVALENT	influenza vaccine	Injection	125127	August 31, 2005	10,004,803	2036-10-12
Glaxosmithkline Biologicals	FLUARIX, FLUARIX QUADRIVALENT	influenza vaccine	Injection	125127	December 14, 2012	10,004,803	2036-10-12
Id Biomedical Corporation Of Quebec	FLULAVAL, FLULAVAL QUADRIVALENT	influenza vaccine	Injection	125163	October 05, 2006	10,004,803	2036-10-12
Id Biomedical Corporation Of Quebec	FLULAVAL, FLULAVAL QUADRIVALENT	influenza vaccine	Injection	125163	November 10, 2009	10,004,803	2036-10-12
Id Biomedical Corporation Of Quebec	FLULAVAL, FLULAVAL QUADRIVALENT	influenza vaccine	Injection	125163	August 15, 2013	10,004,803	2036-10-12
Id Biomedical Corporation Of Quebec	FLULAVAL, FLULAVAL QUADRIVALENT	influenza vaccine	Injection	125163	September 27, 2013	10,004,803	2036-10-12