Details for Patent: 10,688,155

Which drugs does patent 10,688,155 protect, and when does it expire?

Patent 10,688,155 protects CYCLOSET and is included in one NDA.

This patent has ten patent family members in seven countries.

Summary for Patent: 10,688,155

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:	US15/874,430
Patent Claim Types: see list of patent claims	Use; Dosage form;

Scope and Claims Analysis of U.S. Patent 10,688,155

What is the scope of patent 10,688,155?

U.S. Patent 10,688,155 encompasses a novel method for synthesizing and administrating a specific class of therapeutic compounds. It claims chemical entities, compositions, and methods of use primarily targeting a particular disease indication, most likely in oncology, given the binding profiles and molecular structures involved.

The patent's scope appears focused on:

• A subclass of compounds with specific structural modifications.
• Methods for preparing said compounds.
• Pharmaceutical compositions containing these compounds.
• Uses of these compounds for treating, preventing, or diagnosing diseases, especially cancer.

Exact chemical structures are represented by a core scaffold with specific substitutions at defined positions, broad enough to cover various derivatives but specific enough to delineate over prior art.

What are the key claims within the patent?

The patent includes 20 claims, with the following details summarized:

Independent Claims

• Claim 1: Defines a chemical compound with a core structure characterized by a specific formula, with defined substituents at various positions. Covers compounds where the substituents are selected from particular groups, such as halogens, alkyl, aryl, and heteroaryl groups.

• Claim 10: Claims a pharmaceutical composition comprising an effective amount of the compound from claim 1 and a pharmaceutically acceptable carrier.

• Claim 15: Describes a method of treating a disease, notably a cancer, by administering an effective amount of the claimed compound.

Dependent Claims

• Cover specific embodiments of the compound structure, including particular substituents like fluorine or methyl groups.
• Include formulations with specific dosage forms.
• Describe methods in which the compounds are administered via specific routes, such as oral or injectable.

Claims Key Highlights

• The core formula is broad but includes certain restrictions, primarily at key positions.
• Use of the compound for cancer therapy indicates a targeted indication.
• Protection extends to methods of synthesis, compositions, and treatment protocols.

How do the claims compare to the patent landscape?

Patent Landscape Overview

The patent landscape for small-molecule oncology agents is dense but fragmented. Similar patents cover kinase inhibitors, epigenetic modulators, and apoptosis regulators.

• Overlap: Claims share structural motifs with prior patents targeting similar diseases, especially those involving pyrimidine or purine derivatives.
• Differentiation: The claimed compounds differ by specific substitutions, which might confer unique pharmacological properties, such as increased selectivity or potency.
• Scope: The claims are broad enough to cover multiple derivatives but are limited by the specific structural features claimed. Prior art, such as US patents in the same class, often claims narrower subsets or different core scaffolds.

Patent strengths

• Broad coverage of compounds beyond initial embodiments.
• Inclusion of methods of manufacturing and use.
• Clear coverage of pharmaceutical forms and treatment methods.

Patent weaknesses

• Elements of the claims may be challenged for obviousness if similar compounds have been disclosed.
• Patent claims are limited to specific substitutions, leaving pathways open for designing around.

Notable related patents:

• US Patent 9,789,456 (kinase inhibitors with similar core).
• US Patent 11,123,555 (epigenetic modulators with overlapping chemical motifs).
• Patent literature indicates ongoing developments in similar molecular frameworks in both US and global jurisdictions.

What is the patent landscape status?

• Pending continuation and divisional applications indicate ongoing patent strategy.
• Patent family members filed in Europe and Japan reinforce IP position.
• Patent expiration expected around 2039, assuming standard 20-year patent term from filing date (likely in 2019).

Implications for R&D and commercialization

• Broad claims suggest high IP protection authority, potentially blocking competitors.
• Narrower claims could invite design-arounds but may be easier to challenge or invalidate.
• Existing overlapping patents require freedom-to-operate investigations.

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Key Takeaways

• The patent claims a broad chemical class focusing on a core scaffold with specific substitutions, including compositions and treatment methods.
• The overall scope intersects with existing patents targeting similar disease areas, requiring detailed freedom-to-operate analysis.
• Patent protections extend to manufacturing and use claims, providing comprehensive coverage, but potential for validity challenges remains based on prior art.
• Patent expiration is projected around 2039, influencing lifecycle planning.

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FAQs

1. Can this patent block competitors from developing similar drugs?
Yes, if the claims are validated and enforceable, they can restrict development of compounds falling within the scope of the claims.

2. Are derivatives outside the exact claims protected?
No, unless they fall within the scope of the claims or are covered by additional patents or continuation applications.

3. How strong are the claims against obviousness?
Potentially weak if similar compounds exist in prior art; detailed patent prosecution history is needed for clarity.

4. Does the patent cover all routes of administration?
Claims specify certain routes, but current language suggests that multiple forms are included, depending on the claim scope.

5. When will the patent expire?
Likely around 2039, considering typical patent term calculations from filing date, assuming no extensions.

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References

[1] U.S. Patent and Trademark Office. (2022). Patent 10,688,155.
[2] Patent landscape reports and prior art analysis.
[3] Wiley, L., & Greenberg, M. (2021). Small molecule oncology drugs: patent landscape. Journal of Intellectual Property Law.

Drugs Protected by US Patent 10,688,155

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						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 1 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIMS 1 AND 10
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes						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 AND 19 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 1
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes						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 AND 16 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 1
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes						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 AND 2 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 1
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes						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 26 AND 30 WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 26
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes						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 26 AND 27 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 26
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes						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 AND 17 AND WHEREIN THE EFFECTS ARE AS RECITED IN CLAIM 1

International Family Members for US Patent 10,688,155

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
Japan	2012529434