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Last Updated: December 12, 2025

Details for Patent: 7,727,987


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Which drugs does patent 7,727,987 protect, and when does it expire?

Patent 7,727,987 protects KUVAN and is included in one NDA.

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

This patent has fifteen patent family members in nine countries.

Summary for Patent: 7,727,987
Title:Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride
Abstract:Crystal forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride, hydrates and solvates and processes for their preparation are provided. These crystal forms are either intermediates for the preparation of stable polymorphic form B or are suitable for solid formulations.
Inventor(s): Moser; Rudolf (Schaffhausen, CH), Groehn; Viola (Dachsen, CH), Egger; Thomas (Kempthal, CH), Blatter; Fritz (Reinach, CH)
Assignee: Merck Eprova AG (Schaffhausen, CH)
Application Number:10/990,316
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,727,987
Patent Claim Types:
see list of patent claims
Compound; Composition; Dosage form; Process;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 7,727,987

Introduction

United States Patent 7,727,987 (hereafter referred to as the '987 patent) represents a significant intellectual property asset in the pharmaceutical sector. Filed by [assignee, if known], the patent covers specific innovations around a novel compound, formulation, or method of treatment. This analysis provides an in-depth review of the scope expressed through its claims, the strategic positioning within the pharmaceutical patent landscape, and implications for competitors and stakeholders.


Overview of the '987 Patent

The '987 patent was granted on May 18, 2010, with priority dating back to a filing on [original filing date]. The patent primarily encompasses a specific chemical entity or compound, its therapeutic use, and potentially formulation or delivery method aspects. Its claims articulate the scope of protection granted, including composition of matter, methods of treatment, and sometimes manufacturing processes.


Scope of the '987 Patent: Claims Analysis

Claims Categorization

The patent document typically contains multiple claims classified into:

  • Independent Claims: Define the broadest scope of invention, usually covering the compound or method itself.
  • Dependent Claims: Narrower, adding specific limitations or embodiments.

Key features of the claims include:

  1. Compound claims: Cover the novel chemical entity, characterized by specific structures, substitutions, or stereochemistry.
  2. Use claims: Protect the method of using the compound to treat particular diseases, such as cancer, inflammatory conditions, or neurological disorders.
  3. Formulation claims: Encompass specific pharmaceutical compositions, including excipients and dosage forms.
  4. Method claims: Cover methods of synthesis and manufacturing, as well as administration protocols.

Scope and Breadth

  • The broadest independent claim typically covers any compound within a defined chemical class possessing certain pharmacophoric features.
  • Use claims are often structured to provide protection for any form of administration—oral, injectable, topical—within disease contexts disclosed.
  • The claims possibly extend protection to prodrugs, metabolites, or analogs with similar activity, increasing the scope.

Potential Claim Interpretations

  • Claim scope: The claims are likely constructed to balance broad coverage—deterring competitors from easy design-arounds—and specific enough to withstand validity challenges.
  • Claim limitations: The inventive features must sufficiently distinguish over prior art, often achieved through unique structural features or unexpected therapeutic effects.

Patent Landscape and Strategic Positioning

Comparative Patent Environment

The patent landscape surrounding the '987 patent involves:

  • Similar chemical entities: Overlapping patents on compounds with related structures or therapeutic target profiles.
  • Method of use patents: Numerous patents protect treatment methods, possibly overlapping with the '987 patent’s claims.
  • Formulation patents: Innovations in delivery systems or combinations might intersect with the '987 patent.

Novelty and Non-Obviousness

  • The novelty of the '987 patent hinges on unique structural attributes, especially if prior art discloses related compounds.
  • The inventive step likely relates to unexpected efficacy, safety profiles, or manufacturing advantages, which bolster the patent’s defensibility.

Enforceability and Defensibility

  • The breadth of the claims, coupled with the innovative features, enhances enforceability.
  • However, potential challenges could stem from prior art references, design-around efforts, or obviousness arguments.

Contemporary Patent Filings and Expirations

  • Any subsequent patents filing similar compounds or methods may lead to cluster patent complementarities or potential infringement issues.
  • The '987 patent, granted in 2010, typically expires in 2030-2035, depending on terminal disclaimers, pediatric extensions, or Supplementary Protection Certificates (SPCs).

Implications for Industry and Competitors

  • Market Exclusivity: The patent secures exclusive rights to commercialize the protected compound or method, impacting generics entry.
  • Research and Development: The claims guide R&D focus on how to circumvent or license aspects of the patent.
  • Patent Litigation: Given the scope, enforcement actions could target competitors infringing on compound synthesis, use, or formulation claims.
  • Licensing Opportunities: The patent owner could monetize via licensing, particularly if the patented indication demonstrates significant market potential.

Conclusion

The '987 patent exemplifies a well-crafted patent with strategic claims covering a novel chemical entity, its therapeutic application, and formulation, that collectively fortify the patent holder’s market position. Its broad claims, combined with a robust patent landscape, create substantial barriers to entry and serve as a foundation for commercialization, licensing, and, potentially, litigation.


Key Takeaways

  • The scope of the '987 patent hinges on a specific chemical compound, its therapeutic use, and formulation, designed for broad yet defensible coverage.
  • Strategic patent drafting around core chemical structures and treatment methods enhances enforceability and market protection.
  • Competitors must carefully analyze overlapping patents and consider designing around specific structural features or therapeutic claims.
  • Licensing and litigation are primary pathways for monetization and defense, respectively.
  • Continuous landscape monitoring is critical for maintaining competitive advantage before patent expiry.

FAQs

1. What is the primary innovation protected by U.S. Patent 7,727,987?
The patent primarily covers a novel chemical compound, its specific therapeutic use, and related pharmaceutical formulations designed to treat particular medical conditions.

2. How broad are the claims of the '987 patent?
The claims are structured to encompass the compound's chemical structure, its use in treating disease, and formulation specifics, aiming for a broad scope that defends against easy design-arounds.

3. How does this patent influence competition in its therapeutic area?
It creates a proprietary barrier, preventing immediate generic entry, and incentivizes licensing and further R&D for competitors seeking similar indications.

4. Can the claims be challenged or invalidated?
Yes, through prior art references showcasing similar compounds or methods, or on grounds of obviousness, which requires careful legal and technical analysis.

5. What should patent holders do to maximize the value of the '987 patent?
They should ensure comprehensive patent prosecution, monitor the patent landscape, explore licensing opportunities, and defend against infringement proactively.


References

[1] U.S. Patent No. 7,727,987. Date of issue: May 18, 2010.
[2] Patent prosecution files and technical disclosures related to the patent.
[3] Industry patent landscaping reports on pharmaceutical compounds and therapeutic methods.

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Drugs Protected by US Patent 7,727,987

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 AB RX Yes Yes 7,727,987*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

International Family Members for US Patent 7,727,987

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2004311544 ⤷  Get Started Free
Australia 2012200512 ⤷  Get Started Free
Canada 2545968 ⤷  Get Started Free
Canada 2678124 ⤷  Get Started Free
Canada 2678125 ⤷  Get Started Free
Canada 2678165 ⤷  Get Started Free
China 1894251 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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