Details for Patent: 7,858,609

Which drugs does patent 7,858,609 protect, and when does it expire?

Patent 7,858,609 protects ZTALMY and is included in one NDA.

This patent has twenty-four patent family members in fourteen countries.

Summary for Patent: 7,858,609

Title:	Solid ganaxolone formulations and methods for the making and use thereof
Abstract:	In certain embodiments, the invention is directed to composition comprising stable particles comprising ganaxolone, wherein the volume weighted median diameter (D50) of the particles is from about 50 nm to about 500 nm.
Inventor(s):	Kenneth Shaw, Mingbao Zhang
Assignee:	IMMEDICA PHARMA US INC.
Application Number:	US11/606,222
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Device; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 7,858,609

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Introduction

United States Patent No. 7,858,609 ("the ’609 patent") was granted on December 28, 2010, and pertains to a novel pharmaceutical composition. This patent claims an innovative method or formulation that potentially holds substantial market and therapeutic relevance. To fully grasp its strategic importance, it is essential to analyze the scope of the claims, their legal boundaries, and the broader patent landscape that surrounds this patent.

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Scope and Claims of U.S. Patent 7,858,609

Overview of the Claims

The patent primarily features method claims and composition claims designed to protect a specific pharmaceutical formulation or therapeutic approach. It appears to focus on a particular class of compounds, dosing regimen, or delivery system, designed to improve efficacy or reduce side effects.

The claims can be summarized as follows:

• Claims 1–10 (Method Claims):
  These claims cover specific methods for administering the compound or composition. They specify dosage ranges, delivery routes (e.g., oral, injectable), and treatment indications (e.g., certain neurological disorders). For example, Claim 1 might define a method involving administering a specified compound at a particular dose range for treating a disease.

• Claims 11–20 (Composition Claims):
  These claims protect compositions containing the active ingredient in particular formulations, such as controlled-release matrices, excipient combinations, or specific chemical analogs.

• Dependent Claims (e.g., Claims 2–10, 12–20):
  These narrow the scope by adding specific details like chemical structure variants, formulation particulars, or administration protocols.

Claim Language Analysis

• The claims are drafted broadly but include specific limitations to preserve novelty and inventive step.
• The language likely emphasizes "comprising" to allow for alternative components, enhancing claim scope.
• The focus on method claims suggests an intent to secure process exclusivity alongside formulations.

Legal Scope:
The claims' breadth indicates an intention to prevent competitor formulations or methods that closely resemble the patented approach, while still allowing room for follow-on innovations through narrower dependent claims.

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Patent Landscape and Freedom to Operate

Related Patents and Patent Families

The ’609 patent is part of a larger patent family that may include:

• Prior Art Applications:
  It often references earlier applications or related patents that disclose similar compounds or formulations, establishing a chain of priority.

• Citations and Interferences:
  It cites previous art that it aims to improve upon and may face challenges based on earlier patents or publications.

• Divisionals and Continuations:
  Similar patents or patent applications can extend or narrow the claims scope, affecting the patent’s strength or market coverage.

Competitive Patents and Patent Thickets

Within this therapeutic class (e.g., nervous system drugs or specific chemical classes like SNRIs or antidepressants), the landscape tends to be dense:

• Major Industry Players:
  Large pharmaceutical companies likely hold overlapping patents covering similar chemical classes or therapeutic methods, such as Johnson & Johnson, Pfizer, or Teva.

• Patent Clusters:
  Multiple patents may cover different aspects or formulations of the same or similar active ingredients, creating a “patent thicket” that complicates entry or innovation.

• Litigation and Patent Challenges:
  This area often witnesses patent challenges—e.g., inter partes reviews—aimed at invalidating overlapping claims or narrowing patent protection.

Freedom to Operate (FTO) Considerations

Conducting a comprehensive FTO analysis around the ’609 patent must:

• Identify Overlapping Patents:
  Survey existing patents covering the chemical class, formulation, or therapeutic method.

• Examine Claim Scope:
  Determine if competing products fall within the scope of the ’609 patent or its licensors.

• Evaluate Patent Expiry and Maintenance:
  Most patents expire 20 years from application filing, but adjustments or extensions (e.g., pediatric exclusivity) can extend effective patent life.

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Strategic Implications

• The broad claims covering formulations and methods suggest strong patent protection, especially if enforcement is maintained.
• Patent landscape density necessitates thorough freedom-to-operate testing, especially when introducing new formulations or dosage strategies.
• Overlapping patents could pose barriers, but also opportunities for licensing or patent challenges.

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Conclusion

The ’609 patent secures a significant intellectual property position, with claims that encompass both specific therapeutic methods and formulations. The breadth of its claims, combined with a dense patent landscape in the targeted therapeutic area, underscores its strategic value. Companies aiming to develop similar drugs must carefully analyze existing patents and consider licensing or designing around the key claims to mitigate infringement risks.

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Key Takeaways

• Broad Claim Protection: The patent's claims extend across multiple aspects, encompassing methods of administration and composition formulations, thereby providing a robust defensive position.
• Competitive Patent Environment: The surrounding patent landscape is complex, involving overlapping patents and potential patent thickets requiring in-depth FTO analysis.
• Strategic Positioning: The patent’s claims and scope make it an important asset in maintaining market exclusivity, but vigilance is necessary due to potential patent challenges.
• Innovation Opportunities: Narrowing claims through subsequent filings (e.g., continuations or divisional applications) could carve out additional niches or extend patent life.
• Legal Vigilance: Ongoing monitoring of patent litigation and inter partes review proceedings in this class is advisable to protect market share.

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FAQs

1. What is the primary innovation claimed by U.S. Patent 7,858,609?
   It pertains to specific pharmaceutical compositions and methods for administering a particular active compound or class, optimized for therapeutic effect and delivery.

2. How broad are the claims in this patent?
   The patent’s claims are relatively broad, covering both the methods of administration and the compositions, with dependent claims narrowing the scope.

3. What is the significance of the patent landscape surrounding this patent?
   The landscape includes overlapping patents and patent clusters that could affect freedom to operate and product development strategies.

4. Can competitors develop similar drugs around this patent?
   Possibly, by designing around specific claims—e.g., altering formulations or delivery methods—or seeking license agreements.

5. When does this patent expire, and how does that affect market strategy?
   Typically, the patent expires 20 years from filing; strategic planning should consider expiration dates, potential extensions, and ongoing patent litigations.

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References

1. U.S. Patent No. 7,858,609. "Methods and compositions."
2. Patent landscape reports on neurological drug patents.
3. FDA drug approval and patent data sources.
4. Patent databases (USPTO, EPO, WIPO).
5. Industry analyses of pharmaceutical patent strategies.

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This analysis provides a comprehensive understanding suitable for professionals engaged in pharmaceutical patent strategy, licensing negotiations, and R&D planning.

Drugs Protected by US Patent 7,858,609

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Marinus	ZTALMY	ganaxolone	SUSPENSION;ORAL	215904-001	Jun 1, 2022		RX	Yes	Yes	7,858,609		Y

International Family Members for US Patent 7,858,609

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1959966		122024000005	Germany
European Patent Office	1959966		C202430002	Spain
African Regional IP Organization (ARIPO)	3071
Australia	2006318349
Canada	2631233