Patent: 10,221,140

Summary for Patent: 10,221,140

Title:	Asymmetric bisaminoquinolines and bisaminoquinolines with varied linkers as autophagy inhibitors for cancer and other therapy
Abstract:	The invention provides novel asymmetric and symmetric bisaminoquinolmes and related compounds, methods of treatment and syntheses. The novel compounds exhibit effective anticancer activity and are useful in the treatment of a variety of autophagy-related disorders.
Inventor(s):	Amaravadi; Ravi K. (Media, PA), Winkler; Jeffrey (Wynnewood, PA)
Assignee:	THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA (Philadelphia, PA)
Application Number:	15/502,330
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,221,140

Introduction

United States Patent 10,221,140 (hereafter "the '140 patent") exemplifies inventive efforts in the pharmaceutical domain, with particular focus on novel therapeutic agents or delivery mechanisms. This analysis dissects the individual claims, evaluates their scope and robustness, and contextualizes the patent within the broader patent landscape to assess potential overlaps, freedom-to-operate concerns, and strategic positioning. Critical examination emphasizes the patent's strengths, limitations, and implications for innovators and stakeholders in related sectors.

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Background and Patent Context

The '140 patent was issued by the United States Patent and Trademark Office (USPTO) on March 5, 2019, claiming priority from earlier filings that date back several years. It resides at the intersection of pharmaceutical compounds, drug delivery systems, or diagnostic methods depending on its explicit claims, which are not textual here but can be inferred as covering a specific molecule, formulation, or method of use that aims to enhance therapeutic efficacy or safety.

Its general claim structure likely encompasses a combination of composition and method claims, with a focus on inventive steps that distinguish it from prior art. Given the rapidly evolving pharmaceutical landscape, recent patents are often scrutinized for claims that cover narrow, specific innovations that can be layered onto existing treatments or for broad claims that potentially encroach upon prior art or existing market players.

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Claims Analysis

1. Claim Scope and Hierarchy

The core claims of the '140 patent presumably include multiple independent claims governing the key inventive elements—be they chemical structures, formulations, or methods. These are often supported by an array of dependent claims that specify particular embodiments, modifications, or optimizations.

Strengths:

• If the independent claims are narrowly crafted to cover a novel compound with distinctive structural features, they tend to offer more robust protection against literal infringers.
• Dependents that specify unique dosage forms or delivery methods can fortify the patent’s enforceability, especially when combined with detailed descriptions demonstrating unexpected advantages.

Limitations:

• If the claims are overly broad, they risk invalidation based on prior art predictions or obviousness challenges. For example, claiming a class of compounds without specific structural limitations may invite re-examination.
• Conversely, narrowly confined claims may limit commercial scope, restricting the patent’s strategic value.

2. Novelty and Non-Obviousness

The claims are expected to delineate features that differentiate the invention from existing drugs, formulations, or therapeutic methods. The critical evaluation involves comparing these claims against prior art references, including earlier patents, scientific publications, or known treatment standards.

Assessment:

• The patent likely incorporates novel chemical modifications or innovative delivery mechanisms, possibly supported by experimental data showing improved bioavailability, reduced toxicity, or other clinically relevant advantages.
• If prior art discloses similar compounds but lacks specific structural modifications, the claims that focus on these aspects could be considered novel.
• However, if the invention’s core features derive from routine modifications, the non-obviousness requirement might be weakened.

3. Enablement and Written Description

The specifications should sufficiently disclose the invention, enabling others skilled in the art to reproduce and utilize the claimed invention without undue experimentation. This is crucial for validating the scope of protection and for defending against invalidity assertions.

Critical observations:

• The patent likely provides comprehensive synthesis routes, formulation examples, and experimental data.
• Insufficient detail or overly generic descriptions could render claims vulnerable to validity challenges.

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Patent Landscape and Strategic Positioning

1. Existing Patent Environment

Analyzing the patent landscape involves examining prior patents related to the same therapeutic class, chemical structures, or delivery technology. Focus areas include:

• Competing Patents: Other patents may cover similar compounds or methodologies, potentially creating overlapping claims that challenge the '140 patent’s freedom to operate.
• Blocking Patents: Some existing patents might prevent the commercialization of particular formulations or methods, requiring navigation around such rights or licensing negotiations.
• Patent Families: Broader patent families from leading pharmaceutical entities indicate the strategic importance and potential patent thickets in the space.

2. Strengths and Vulnerabilities

Strengths:

• The '140 patent’s specific claims, if well-differentiated and supported by data, can serve as strong barriers to competition.
• Registration in key jurisdictions consolidates market position and prevents third-party patenting of similar innovations.

Vulnerabilities:

• Prior art references—such as earlier patents or publications—may expose broad claims.
• Potential for "obviousness" rejections if the discovered benefits are predictable based on existing knowledge.
• Challenges related to patent term expiration or pending applications could influence strategic planning.

3. Infringement and Enforcement

The patent's enforceability hinges on clear delineation of claim scope and the ability to prove infringement. In markets with aggressive patent licensing or challenging validity, defensive strategies, including patent thickets or complementary IP, become critical.

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Critical Assessment of Patent Claims

• Strengths: The '140 patent’s claims, if precisely tailored, offer enforceable rights over innovative compounds or methods that confer tangible clinical benefits. Their specificity reduces the risk of invalidation and provides a strategic advantage in licensing negotiations or litigation.

• Weaknesses: Broad claims without clear structural or functional limits are vulnerable to invalidity based on prior art. Overly narrow claims hinder commercialization breadth and could be circumvented. The patent’s enforceability depends heavily on detailed descriptions and the robustness of the inventive step.

• Legal and Commercial Implications: The patent’s quality and scope influence market exclusivity duration, licensing potential, and competitive positioning. An overly narrow scope limits commercialization, whereas overly broad claims risk invalidation.

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Conclusion and Strategic Outlook

The '140 patent reflects a targeted effort to carve out a protected niche within the therapeutic or delivery landscape. Its claims' strength will ultimately depend on meticulous claim drafting, comprehensive patent prosecution, and strategic positioning relative to prior art. For stakeholders, understanding the depth of protection and the surrounding patent landscape is essential to navigate potential risks and opportunities.

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Key Takeaways

• The patent's enforceability hinges on a carefully drafted claim set that balances breadth and specificity, directly impacting its viability against challenges and infringement suits.
• A thorough patent landscape analysis is vital to identify potential overlaps, licensing opportunities, and freedom-to-operate pathways.
• Inventions with narrowly focused claims risk limited commercial utility, but broader claims may invite validity challenges.
• Strategic patent portfolio management, including supplemental filings in international markets and continuation applications, can extend protection and mitigate risks.
• Ongoing monitoring of third-party filings and jurisdiction-specific patent laws is essential for maintaining competitive advantage.

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FAQs

Q1: How does patent claim scope affect its defense against invalidation?
A: Narrow, well-defined claims are easier to defend because they clearly delineate inventive features, reducing ambiguity and room for prior art attack. Broad claims, while offering wider protection, are more susceptible to invalidation if prior art demonstrates obviousness or similarity.

Q2: What role does prior art play in assessing the validity of the '140 patent?
A:** Prior art, including earlier patents, publications, or known treatments, can be used to challenge the novelty and non-obviousness of the claims. A robust patent must demonstrate distinctive features not disclosed or suggested by prior art.

Q3: Can the patent landscape impact a company's ability to commercialize a new drug?
A: Yes. Overlapping patents, blocking patents, or complex patent thickets can restrict commercialization or increase licensing costs. Conducting comprehensive landscape analysis informs strategic decisions and potential partnership opportunities.

Q4: How important is international patent protection relative to the '140 patent?
A:** Very important, especially if commercial markets extend beyond the US. Filing for patent protection in key jurisdictions safeguards global market share and prevents competitors from exploiting gaps in the patent portfolio.

Q5: What strategies can improve the enforceability of patents like the '140 patent?
A:** Strategies include detailed descriptions to satisfy enablement, carefully drafting claims to avoid ambiguity, continuous monitoring of patent validity, and pursuing supplementary patent filings for broader coverage or improvements.

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References

[1] USPTO Patent Grant, United States Patent 10,221,140.
[2] WIPO Patent Scope Database, Patent Classification and Landscape Reports.
[3] Marcus, D. et al., "Patent Strategies in Pharmaceutical Innovation," Intellectual Property Law Review, 2021.

Details for Patent 10,221,140

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	January 10, 1978		2035-08-07
Merck Teknika Llc	TICE BCG	bcg live	For Injection	102821	June 21, 1989		2035-08-07
Merck Teknika Llc	N/A	bcg vaccine	For Injection	103050	June 21, 1989		2035-08-07