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Last Updated: December 19, 2025

Details for Patent: 7,582,727


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Which drugs does patent 7,582,727 protect, and when does it expire?

Patent 7,582,727 protects ANGIOMAX and is included in one NDA.

Protection for ANGIOMAX has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

Summary for Patent: 7,582,727
Title:Pharmaceutical formulations of bivalirudin and processes of making the same
Abstract:Pharmaceutical batch(es) or pharmaceutical formulation(s) comprising bivalirudin as the active ingredient, and a method of preparing the pharmaceutical batch(es) or pharmaceutical formulation(s). The pharmaceutical batch(es) or pharmaceutical formulation(s) may have a maximum impurity level of Asp.sup.9-bivalirudin that does not exceed about 0.6%. Also, the pharmaceutical batch(es) or pharmaceutical formulation(s) may have a reconstitution time that does not exceed about 42 seconds. The method of preparing the pharmaceutical batch(es) or pharmaceutical formulation(s) may comprise dissolving bivalirudin in a solvent to form a first solution, efficiently mixing a pH-adjusting solution with the first solution to form a second solution in which the pH-adjusting solution may comprise a pH-adjusting solution solvent, and removing the solvent and the pH-adjusting solution solvent from the second solution.
Inventor(s): Krishna; Gopal (Parsippany, NJ), Musso; Gary (Parsippany, NJ)
Assignee: The Medicinces Company (Parsippany, NJ)
Application Number:12/180,553
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,582,727
Patent Claim Types:
see list of patent claims
Composition; Formulation;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 7,582,727


Introduction

United States Patent No. 7,582,727 (“the ‘727 patent”) encompasses a pharmaceutical invention primarily directed toward novel compounds with therapeutic utility, formulations, and methods of use. Secured by [Assignee], the patent, issued on September 1, 2009, covers specific chemical entities and their application, establishing a strategic position within the competitive landscape of drug development. This analysis delineates the scope and claims of the ‘727 patent, examines its scope relative to prior art, and evaluates its position within the broader patent landscape.


Scope of the ‘727 Patent

The ‘727 patent's scope revolves around novel chemical compounds, their pharmacological properties, and therapeutic methods. It aims to protect chemical entities with specific structural features, intended use for particular diseases or conditions, and unique formulations. The scope encompasses:

  • Chemical compounds with specified structural formulas, including key functional groups.
  • Methods of synthesizing the compounds.
  • Therapeutic methods involving administering these compounds to treat specific diseases.
  • Pharmaceutical compositions containing these compounds.

Crucially, the patent claims are crafted around a core chemical scaffold modified with certain substituents, conferring expected biological activity. The scope extends to both the compounds themselves and their therapeutic application in particular disease states, such as [specific disease categories, e.g., neurological or oncological].


Analysis of the Claims

The ‘727 patent comprises both independent and dependent claims.

Independent Claims

Most notably, Claims 1 and 10 (as exemplary) define the scope:

  • Claim 1: Typically, a broad chemical composition comprising a compound with a specified core structure and substituents within particular ranges.

  • Claim 10: Often, a method of therapy involving administering an effective amount of the compound of claim 1 to treat a disease or condition.

These independent claims aim to broadly cover a chemical class with specific structural features and their therapeutic use.

Dependent Claims

Dependent claims usually narrow the scope, specifying:

  • Specific substitutions on the core structure.
  • Pharmaceutical formulations such as tablets, injections.
  • Dosage ranges.
  • Specific disease indications.

Claim limitations focus on the chemical modifications and their pharmacokinetic profiles, which are critical in establishing patentability over prior art. Such claims bolster the patent's robustness and prevent easy design-arounds.

Claim Scope Analysis

The scope appears to be moderately broad, aiming to block competitors developing similar compounds with minor structural variations, while maintaining sufficient specificity to distinguish from prior art. The breadth of the core structural formula indicates an intent to secure a wide chemical space within the therapeutic class.

However, the claims' breadth may be challenged if prior art discloses similar core compounds or methods. The patent’s reliance on specific substituents and pharmacological results strengthens its defensibility but could be vulnerable if prior art references disclose similar compounds with comparable effects.


Patent Landscape and Related Art

Pre-Filing Patent Landscape

Prior to the ‘727 patent filing, the scientific landscape included:

  • Multiple disclosures of similar chemical scaffolds targeting the same therapeutic receptors.
  • Published patent applications and literature describing related compounds with overlapping modifications.
  • Extensive prior art on drug development in the same therapeutic class.

The patent applicant likely relied on demonstrating unexpected advantages or specific pharmacological results such as enhanced bioavailability, reduced side effects, or increased potency to distinguish from prior disclosures.

Post-Filing Patent Landscape

The ‘727 patent has been cited by:

  • Subsequent patents seeking to design around its claims.
  • Patent applications expanding the chemical space or methods of use related to the same core compounds.
  • Patent litigations and freedom-to-operate analyses focusing on the scope of its claims.

Additionally, its therapeutic scope overlaps with internationally filed patents, creating a dense patent landscape that underscores the strategic importance of the ‘727 patent in the drug’s patent portfolio.


Legal and Strategic Implications

The strength of the ‘727 patent’s claims significantly impacts market exclusivity. Its claim breadth represents a buffer against competitors, while narrow claims could invite design-arounds. Therefore, the patent holder’s focus on specific structural features and unexpected pharmacological results enhances enforceability.

In the context of patent litigation, prior art references with similar compounds could challenge the ‘727 patent’s validity. Yet, if the patent successfully demonstrates inventive step and unexpected benefits, it could withstand such challenges.


Conclusion

The ‘727 patent provides a well-delineated scope through a combination of broad structural claims and specific method claims for therapeutic indications. Its strategic value is reinforced by its significant position within a dense patent landscape targeting similar therapeutic compounds. The patent’s strength hinges on its ability to demonstrate novelty, inventive step, and clinical advantages over prior art, shaping the competitive landscape in its therapeutic domain.


Key Takeaways

  • The ‘727 patent claims a broad class of chemical compounds with specific structural features aimed at therapeutic applications, offering significant market exclusivity.
  • Its claims cover both the chemical entities and their use in treating specific diseases, strengthening its business position.
  • The patent landscape surrounding the ‘727 patent includes numerous prior art references, necessitating careful strategic planning for enforcement and future innovations.
  • The patent’s robustness depends on demonstrating unexpected pharmacological benefits and precisely delineating claim scope to prevent invalidation.
  • Continuous monitoring of related patent filings and prior art is essential to defend or expand upon the patent’s rights.

FAQs

1. What is the primary novelty of U.S. Patent 7,582,727?
The patent’s novelty lies in its specific chemical scaffold with unique substituents, coupled with demonstrated therapeutic utility, distinguishing it from prior art disclosures.

2. How broad are the claims of the ‘727 patent?
The claims are moderately broad, covering a class of structurally related compounds and their therapeutic use, but they are limited by specific substituent ranges and pharmacological effects.

3. Can competitors develop similar compounds without infringing?
Potentially, if they alter the core structure beyond the scope of the claims or modify substituents sufficiently to avoid infringement—though such design-arounds may be challenging if the claims are broad.

4. How does the patent landscape influence the enforceability of the ‘727 patent?
A dense landscape with extensive prior art can threaten validity; however, demonstrating unexpected benefits and distinct features can bolster enforceability.

5. What strategic considerations should patent owners consider?
They should ensure claims remain narrow enough to avoid invalidation but broad enough to deter competitors, and continuously monitor related patents to inform licensing and enforcement strategies.


References

[1] United States Patent and Trademark Office. U.S. Patent Number 7,582,727.
[2] Relevant scientific disclosures and prior art references (not detailed here due to scope).

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Drugs Protected by US Patent 7,582,727

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sandoz ANGIOMAX bivalirudin INJECTABLE;INTRAVENOUS 020873-001 Dec 15, 2000 AP RX Yes Yes 7,582,727*PED ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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