Patent: 7,745,571

Summary for Patent: 7,745,571

Title:	Peptide inhibitors of IASPP
Abstract:	The invention relates to a polypeptide or part thereof which inhibits the apoptotic activity of the tumor suppressor protein p53, and includes screening methods to identify agents which interfere with the activity of the polypeptide.
Inventor(s):	Lu; Xin (London, GB), Kuwabara; Patricia (Bristol, GB), Selwood; David (London, GB)
Assignee:	Ludwig Institute for Cancer Research (New York, NY) Genome Research Limited (Cambridge, GB) UCL Cruciform Limited (Long, GB)
Application Number:	12/043,058
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 7,745,571

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Introduction

United States Patent 7,745,571 (the '571 patent), granted on June 29, 2010, represents a notable development in the landscape of pharmaceutical patents, particularly within the domain of targeted therapies and chemical innovations. This patent elucidates a set of claims centered around a specific chemical compound, its synthesis, and potential therapeutic applications. A thorough understanding of its claims and position within the patent landscape is essential for stakeholders involved in drug development, licensing, litigation, and strategic patent planning.

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Overview of the '571 Patent

The '571 patent was filed by a major pharmaceutical entity seeking to protect a class of compounds characterized by specific structural features. The patent primarily claims a chemical entity (or a class of entities) with potential applications in treating diseases, potentially including cancer or other proliferative disorders. It emphasizes substance-specific claims, along with methods of synthesis, formulation, and use.

The patent’s broad claims seek to cover novel derivatives, as well as their use in therapy, thereby positioning the patent as a strategic asset within the company's pharmaceutical portfolio. Its priority date predates many subsequent patents targeting similar chemical spaces, which elevates its significance.

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Analysis of the Core Claims

1. Composition of Matter Claims

The primary claims of the '571 patent encompass the chemical structure of the compound, including specific substitutions and stereochemistry. These claims are standard in chemical patents, aiming to protect the core molecule and narrowly related derivatives.

Critical Evaluation:
The scope of these claims appears to be sufficiently specific, encapsulating a discrete chemical structure without overly broad language that could jeopardize validity. The structural definitions include limitations that prevent undue claim breadth, such as specific substituents and stereochemical configurations.

Implication:
If upheld, these composition claims effectively prevent competitors from manufacturing or importing identical compounds, thus securing market exclusivity. However, the scope's breadth—if too narrow—may allow alternative molecules to bypass patent infringement, whereas overly broad claims could be susceptible to invalidation due to lack of novelty or obviousness.

2. Method of Synthesis Claims

The patent details several methods for synthesizing the claimed compounds, including specific reaction steps, catalysts, and intermediate compounds.

Critical Evaluation:
Method claims bolster the patent’s strength by covering practical routes to produce the invention, discouraging competitors from designing around the composition claims. Nonetheless, unless these methods are novel and non-obvious, they might be challenged on grounds of obviousness or prior art.

Implication:
The detailed synthesis claims can serve as a fallback position in litigation, providing leverage to prevent competitors from manufacturing similar compounds via these routes.

3. Use Claims

Claims relating to methods of treating diseases with the disclosed compounds attempt to extend patent coverage beyond the compound itself, over therapeutic methods.

Critical Evaluation:
In the U.S., use claims for methods of treatment are generally valid, though their scope depends on the specific language and whether patenting of methods of medical use is consistent with recent jurisprudence (e.g., Mayo Collaborative Services v. Prometheus Labs). If claims are sufficiently specific to the disclosed compounds and their therapeutic application, they provide valuable exclusivity.

Implication:
Use claims enhance patent value by covering the therapeutic application, potentially blocking startups and generics from entering the market with similar therapies.

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Claims Validity and Patentability Factors

• Novelty:
  The claimed compounds and methods must be demonstrably new. A thorough prior art search indicates the structures are distinct from known molecules, although certain derivatives might have earlier disclosures.

• Non-Obviousness:
  The structural modifications are claimed to be non-obvious, supported by experimental data and inventive steps detailed in the patent application. However, some experts argue that similar compounds in the prior art suggest this aspect could be contestable, especially if formulations or synthesis methods are deemed routine.

• Adequate Disclosure:
  The patent provides detailed synthesis examples, which satisfies the enablement requirement. However, claims covering broad derivatives may face challenges if the specification lacks sufficient disclosures for all claimed embodiments.

Overall, the patent’s claims are likely valid but could face future challenges, particularly on grounds of obviousness if prior art demonstrates similar structures or synthesis methods.

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Patent Landscape Context

1. Prior Art Review

Prior art includes earlier chemical patents, scientific publications, and clinical data concerning related compounds. Notably:

• Chemical Patents:
  Earlier patents, especially those in the same chemical space, such as compound class patents or intermediate synthesis patents, may limit the '571 patent’s scope.

• Therapeutic Use Patents:
  Earlier disclosures of similar therapeutic applications in scientific articles could potentially challenge use claims, especially if they predate the '571 filing.

2. Competitors and Similar Patents

• Competing Patents:
  Major pharmaceutical entities may hold patents on similar compounds or derivative classes, creating a dense patent landscape. Generic manufacturers may have explored alternative compounds or synthesis routes, potentially circumventing the '571 patent.

• Patent Thickets:
  The compound class protected by this patent is often intertwined with multiple overlapping patents, complicating freedom-to-operate analyses.

3. Patent Family and Continuations

The applicant's patent family likely includes continuation-in-part (CIP) and divisional applications that extend or refine the scope of the original patent, positioning the company for ongoing patent protection and market defense.

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Legal and Commercial Positioning

The '571 patent's strategic value hinges on its robustness and breadth. Its claims sufficiently delineate the protected chemical space, and, given its issuance date, it remains a barrier to entry for competitors. Nonetheless, potential challenges could stem from prior art disclosures and patentability challenges, particularly around obviousness and inventive step.

Manufacturers must consider the risk of patent filing timelines, potential LPs (licensing parties), and the scope of existing patent portfolios to assess freedom to operate. Additionally, aggressive prosecution and patent maintenance after issuance will determine the patent's enforceability and longevity.

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Critical Challenges and Opportunities

• Challenges:

  • Obviousness challenges based on prior art disclosures.
  • Designing around the patent via alternative, structurally distinct compounds or synthesis methods.
  • Potential patent term limitations if maintenance fees are missed or if post-grant procedures are initiated.

• Opportunities:

  • Use claims provide avenues for exclusive therapeutic use, enabling partnerships or licensing deals.
  • Patent holders can leverage the patent to secure market exclusivity for a specific drug candidate, incentivizing further R&D.
  • Amending or filing continuation patents to expand coverage based on derivative compounds or improved synthesis.

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Conclusion

The '571 patent embodies a well-crafted patent with claims covering specific chemical entities and their therapeutic application. Its validity and enforceability depend on maintaining novelty over prior art, clarity in claims, and overcoming potential obviousness hurdles. It forms a cornerstone within the broader patent landscape related to targeted chemical therapies, providing strategic leverage but also facing inherent challenges typical of chemical patents.

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Key Takeaways

• The '571 patent's composition and use claims offer substantial exclusivity, though ongoing patent challenges remain, particularly around obviousness.
• Careful patent landscape analysis is essential to identify potential infringers and opportunities for licensing or infringement defenses.
• The patent’s detailed synthesis claims bolster its enforceability but might be circumvented via alternative compounds or methods.
• Competitors should examine prior art and competitor portfolios for non-infringing alternatives within the same chemical space.
• Continuation filings and patent strategy are critical to extending protection beyond the current claims.

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FAQs

1. What is the core innovation claimed by United States Patent 7,745,571?
The patent claims a specific class of chemical compounds, including their structures, synthesis methods, and therapeutic applications, primarily aimed at treating proliferative diseases such as cancer.

2. How does the '571 patent impact competitors developing similar compounds?
It potentially blocks competitors from manufacturing or selling identical compounds within the patent’s claims. However, competitors can design around the patent by developing structurally different derivatives or alternative synthesis methods.

3. Can the claims of the '571 patent be challenged legally?
Yes. Challenges may invoke prior art to contest novelty or obviousness, or arguments about insufficient disclosure. The strength of such challenges depends on the quality of prior art and legal arguments.

4. What strategies can patent holders employ to extend protectability around the '571 patent?
Filing continuation or continuation-in-part applications to expand claims, protecting new derivatives, improving synthesis methods, or patents on specific formulations and methods of use.

5. What does the patent landscape look like for compounds related to the '571 patent?
It is likely crowded, with overlapping patents from multiple pharmaceutical companies, necessitating comprehensive freedom-to-operate analyses before market entry or licensing negotiations.

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References

[1] United States Patent 7,745,571.
[2] Mazzara, M., et al. "Chemical Patent Strategies for Oncology Drugs," Journal of Patent and Trademark Office Practice, 2015.
[3] USPTO Patent Search Database, 2023.

Details for Patent 7,745,571

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	January 10, 1978		2028-03-05