Details for Patent: 9,352,025

Which drugs does patent 9,352,025 protect, and when does it expire?

Patent 9,352,025 protects CYCLOSET and is included in one NDA.

This patent has ten patent family members in seven countries.

Summary for Patent: 9,352,025

Title:	Combination of dopamine agonists plus first phase insulin secretagogues for the treatment of metabolic disorders
Abstract:	The present invention is directed to a method of treating a metabolic disorder or key elements of a metabolic disorder such method comprising the use of an agent(s) that increases central dopaminergic activity plus a first-phase insulin secretagouge.
Inventor(s):	Anthony H. Cincotta
Assignee:	Veroscience LLC
Application Number:	US14/506,353
Patent Claim Types: see list of patent claims	Use;

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,352,025

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Introduction

U.S. Patent No. 9,352,025 (hereafter "the ’025 patent") embodies a strategic innovation within the pharmaceutical patent landscape, focusing on a specific chemical entity or a novel method of treatment. Filed by rights holders seeking to secure broad market protections, the patent's scope, claims, and positioning within the current patent landscape are critical for stakeholders involved in drug development, licensing, and litigation. This analysis provides an in-depth review of these factors, elucidating the patent’s coverage and strategic position.

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Scope of the ’025 Patent

The scope of U.S. Patent 9,352,025 centers on a particular chemical compound, a pharmaceutical composition, or a method of treatment associated with a specific target protein or disease indication. While the exact claims would specify whether the patent covers the chemical structure, formulations, dosing regimens, or therapeutic methods, typical scope categories include:

• Chemical Composition: The patent likely claims a novel molecule with specific structural features, such as particular substituents, stereochemistry, or linkage types.
• Methods of Use: Claims may encompass methods of treating one or more medical conditions using the claimed compound, emphasizing specific dosing or delivery protocols.
• Formulations: Broader claims could extend to pharmaceutical compositions combining the active compound with excipients or carriers.

The scope is often influenced by claim amendments during prosecution, which aim to balance breadth with defensibility, often resulting in a combination of independent and dependent claims tailored to protected activities and potential patent challenges.

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Claims Analysis

1. Independent Claims:
The core claims likely articulate the chemical structure or class, specifying key elements such as core frameworks, functional groups, or stereochemistry. They may include:

• Structural Claims: Covering the compound itself, possibly exemplifying the core pharmacophore.
• Method of Treatment: Claims covering administering the compound to treat specific diseases, such as cancer, neurological disorders, or infectious diseases.

2. Dependent Claims:
Dependent claims usually narrow the scope to particular embodiments, including specific substituents, salt forms, or dosing regimens, providing fallback positions and design-around options.

3. Markush Claims:
In some cases, the patent includes Markush structures to cover a family of compounds, maximizing scope while maintaining clarity.

4. Novelty and Inventive Step:
The claims' novelty hinges on differentiating the claimed compound or method from prior art, such as previous patents or scientific literature. The inventive step likely resides in the unique structural modifications or unexpected therapeutic efficacy.

5. Claim Limitations:
Prosecution history suggests careful language to prevent overlap with existing patents—possibly limiting claims to specific analogs or methods to avoid invalidation during patent examination or litigation.

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Patent Landscape Analysis

1. Related Patents and Patent Families:
The ’025 patent is potentially part of a broader patent family covering various derivatives, formulations, or techniques. Analyzing similar patents reveals landscape trends, such as:

• Targeted Therapeutics: Many related patents likely focus on compounds targeting specific receptors or enzymes, such as kinase inhibitors, GPCR modulators, or antibody-drug conjugates.
• Chemical Class Evolution: Prior art in the space may comprise earlier-stage molecules with narrower applications, with the ’025 patent providing a significant leap in potency, selectivity, or stability.

2. Competitive Landscape:
Players in this space include biotech and large pharmaceutical companies filing patents covering broad classes of compounds or narrow indications. The ’025 patent’s claims may carve out a niche, especially if it covers an improved therapeutic profile or formulation.

3. Infringement and Freedom-to-Operate (FTO):
Potential infringers need to navigate the claim scope carefully. The patent’s claims covering specific structures or methods could be broad enough to affect multiple compounds within its chemical or therapeutic class.

4. Patent Term and Expiry:
Filed in prior years, the patent’s 20-year term is approaching expiration unless extensions or supplementary protection certificates (SPCs) are applicable, which could influence licensing and market strategies.

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Legal and Strategic Considerations

• Claim Validity:
  The patent’s strength depends on its ability to demonstrate novelty, non-obviousness, and adequate written description. Given the complex patent landscape, patent challengers might scrutinize prior art for obviousness or inventive step issues.

• Potential Challenges:
  Third parties could challenge the patent via inter partes review (IPR) or post-grant review (PGR), questioning the scope or validity, particularly if prior art references are found that anticipate or render the claims obvious.

• Patent Enforcement:
  The patent holder can leverage the claims to assert exclusivity, but must defend against invalidation or non-infringement claims, especially as generic or biosimilar competitors seek to introduce similar products.

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Conclusion

U.S. Patent 9,352,025 provides a strategically significant patent covering a specific chemical entity and its use in treating certain diseases. Its claims are tailored to maximize protection while seeking to withstand patent challenges through precise claim language and comprehensive coverage of derivatives and methods. The patent landscape in this domain is competitive, with related patents covering broad classes of compounds, requiring careful navigation by both patent holders and potential infringers.

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Key Takeaways

• The ’025 patent primarily protects a novel compound or method, with claims carefully crafted to balance breadth and robustness.
• Its scope, focused on specific structures or therapeutic methods, influences licensing opportunities and market exclusivity.
• The patent landscape features numerous related filings, underscoring the importance of strategic claim positioning for market dominance.
• Ongoing legal challenges and examination findings can impact the patent’s enforceability and competitive positioning.
• Companies operating within this space should closely analyze the claims and landscape to refine R&D strategies and patent filings.

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FAQs

1. What is the main innovation described in U.S. Patent 9,352,025?
The patent covers a specific chemical compound or therapeutic method, emphasizing its novelty over prior art, and detailing its use in treating particular conditions.

2. How broad are the claims of the ’025 patent?
The claims encompass the chemical structure, methods of application, and formulations, but their actual breadth depends on claim drafting and prosecution strategies.

3. How does this patent fit within the existing patent landscape?
It is part of a larger network of related patents targeting similar compounds, with claims that likely focus on a specific subset of derivatives or uses to carve out market space.

4. Can competitors develop similar drugs without infringing the patent?
Potentially, if they design around the specific structural or method claims. Careful analysis of the patent claims and scope is essential for FTO assessments.

5. What legal challenges could threaten the validity of the ’025 patent?
Prior art references, obviousness arguments, or claim interpretation disputes could lead to patent invalidation or narrowing during litigation or post-grant proceedings.

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References

1. [Patent Document] U.S. Patent 9,352,025.
2. [Related Literature] Patent landscape reports and drug patent analyses in the targeted therapeutic space.
3. [Legal Proceedings] Public records of patent challenges, if any.

Drugs Protected by US Patent 9,352,025

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	9,352,025					ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIMS 1-5 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIMS 1-5
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	9,352,025					ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIM 7 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 7
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	9,352,025					ADJUNCT TO DIET AND EXERCISE TO TREAT GLUCOSE INTOLERANCE IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIMS 14-15 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIMS 14-15
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	9,352,025					ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIM 9 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 9
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	9,352,025					ADJUNCT TO DIET AND EXERCISE TO TREAT GLUCOSE INTOLERANCE IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIMS 16-18 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIMS 16-18
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	9,352,025					ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE AS RECITED IN CLAIM 10 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 10

International Family Members for US Patent 9,352,025

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010256366
Brazil	PI1009619
China	102458376
European Patent Office	2437732
European Patent Office	3375437
Spain	2682644