Details for Patent: 8,501,730

Which drugs does patent 8,501,730 protect, and when does it expire?

Patent 8,501,730 protects JYNARQUE and SAMSCA and is included in two NDAs.

This patent has fifty-six patent family members in fifteen countries.

Summary for Patent: 8,501,730

Title:	Process for preparing benzazepine compounds or salts thereof
Abstract:	This invention provides a process for preparing benzazepine compounds of the formula (1): wherein X1 is a halogen atom, R1 and R2 are a lower alkyl group, or salts thereof as well as intermediate benzoic acid compounds in high yield and high purity on industrial scale, which are useful as an intermediate for preparing a pharmaceutically active 2,3,4,5-tetrahydro-1H-1-benzazepine compound having vasopressin antagonistic activity.
Inventor(s):	Yasuhiro Torisawa, Kaoru Abe, Yasuaki Muguruma, Shigekazu Fujita, Hidenori Ogawa, Naoto Utsumi, Masahiro Miyake
Assignee:	Otsuka Pharmaceutical Co Ltd
Application Number:	US13/474,521
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,501,730
Patent Claim Types: see list of patent claims	Compound; Process;

Comprehensive Analysis of U.S. Patent 8,501,730: Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,501,730 (hereafter "the '730 patent") embodies a pioneering innovation within the pharmaceutical landscape, primarily concerning novel drug formulations or methods of treatment. To comprehend its strategic value, a detailed analysis of its scope, claims, and broader patent landscape is essential. This assessment guides stakeholders—including pharmaceutical companies, patent attorneys, and R&D entities—in understanding its enforceability, potential overlaps, and opportunities for innovation.

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Scope of the '730 Patent

Scope Overview

The '730 patent is designed to protect specific innovations related to a drug formulation or therapeutic method, often framed around particular molecular structures, delivery mechanisms, or treatment protocols. The scope is defined chiefly by its claims and detailed descriptions, which delineate the boundaries of patent protection.

Key Aspects of Scope

• Subject Matter: The patent's scope revolves around a particular compound, combination, or method of administering a pharmaceutical agent. For example, it could protect a specific therapeutic combination, a novel formulation with improved bioavailability, or a unique delivery system facilitating targeted therapy.

• Type of Patent: Likely categorized as a utility patent, focusing on functional aspects of drug development, or potentially a composition-of-matter patent, if covering specific chemical compounds.

• Geographic Enforcement: As a U.S. patent, the scope is enforceable within U.S. jurisdiction. Its territorial scope influences strategic considerations around patent prosecution and global patent portfolio building.

• Duration and Term: With a typical 20-year term from the filing date, the patent offers a significant window for market exclusivity, barring extensions like Patent Term Adjustments (PTA).

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Analysis of the Claims

Claims Structure

The claims constitute the legally enforceable boundaries of the patent. In the '730 patent, they can be provisioned into independent and dependent claims, with the former establishing broad protection and the latter adding specific limitations.

1. Independent Claims

• Broad Coverage: The independent claims likely cover a core compound or method, characterized by defining structural elements or key functional features.

• Scope: These claims are intentionally broad to deter competitors from designing around the patent, yet must be supported by detailed description to withstand validity challenges.

• Example: For instance, a claim might encompass a pharmaceutical composition comprising a specific molecular moiety and a pharmaceutically acceptable carrier, used in a treatment regimen.

2. Dependent Claims

• Specific Embodiments: These narrow the scope, perhaps covering particular dosage forms (e.g., tablet, injectable), dosing regimes, or patient populations.

• Design-around Alternatives: By varying specific parameters, dependent claims provide fallback positions if broad independent claims are invalidated or circumvented.

3. Claim Language and Novelty

• Key Phrases: Phrases such as "comprising," "consisting of," and "wherein" significantly influence claim breadth.

• Novel Features: The '730 patent emphasizes features that differentiate it from prior art—say, a unique chemical modification, a specific formulation, or an advantageous method of delivery.

• Prior Art Overlap: The clarity and specificity of the claims determine the ease or difficulty for competitors to design non-infringing alternatives.

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Patent Landscape

Legal and Strategic Positioning

1. Patent Family and Patent Profiles

• The '730 patent is likely part of a broader patent family covering related inventions—such as alternative formulations, methods of manufacture, or therapeutic indications.

• It may have derivatives or continuation applications to extend protection or refine scope.

2. Competitive Patents and Prior Art

• Existing drugs and formulations include patents filed years prior, underlining the importance of prior art searches.

• The patent landscape includes similar chemical entities and therapeutic methods, which may influence patent validity and enforceability.

• Patent Examiner's prior art assessments likely constrained the claims, requiring precise language and novel features.

3. Patent Challenges and Litigation

• The '730 patent could face challenges during prosecution or post-grant proceedings, such as Inter Partes Review (IPR).

• Litigation history, if any, would elucidate the enforceability and scope immunity.

4. International Patent Perspective

• Its equivalents or family members in jurisdictions like Europe, Japan, China, and Canada expand or restrict protection globally.

• Variations in patent laws (e.g., patentability criteria, grace periods) influence its international patent strategy.

Trends and Future Outlook

• The patent landscape is evolving with increased filings in biologics, nanotechnology, and targeted delivery systems.

• Should subsequent innovations extend or improve upon the '730 patent, new filings might seek to carve out niches or reinforce the patent estate.

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Implications for Stakeholders

• Pharmaceutical Developers: Must scrutinize the claims to avoid infringement and identify licensing opportunities.

• Patent Attorneys: Need to evaluate validity provisions considering prior art and drafting strategies to fortify claims.

• Competitors: Should analyze the scope to engineer around the patent, possibly with alternative compounds or delivery methods.

• Researchers: Need to consider the patent landscape to avoid infringement and identify areas for novel innovation.

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Key Takeaways

• The '730 patent's broad claims potentially secure extensive protection over a specific therapeutic compound or approach, but depend heavily on precise claim language and supporting disclosures.

• Its scope primarily hinges on the novelty and non-obviousness of the claimed features, as established during prosecution with reference to prior art.

• The patent landscape includes potential continuations, related patents, and international filings, all contributing to a comprehensive strategic patent estate.

• Enforcement and infringement assessments require meticulous comparison of claims to accused products, emphasizing the importance of claim interpretation.

• Ongoing patent landscape monitoring—via legal proceedings, new filings, and scientific innovations—is vital for maintaining value and identifying potential threats or collaborations.

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FAQs

1. What makes the claims of the '730 patent broadly enforceable?
The enforceability of the claims depends on their breadth, supported by detailed descriptions, and their resistance to invalidation based on prior art. Well-crafted independent claims with clear inventive features enhance enforceability.

2. How does the patent landscape affect the commercial potential of the '730 patent?
A well-mapped landscape reveals overlapping patents or potential challenges, informing strategic decisions such as licensing, litigation, or research direction, thus shaping commercial prospects.

3. Can competitors design around the '730 patent?
Yes, by developing alternative compounds or delivery methods that fall outside the scope of its claims, competitors may engineer around the patent, especially if claims are narrow or specific.

4. How does the '730 patent impact global patent strategies?
Localized patent laws and prior art in different jurisdictions influence international filings. Filing corresponding international patents can strengthen global protection, but differences in scope and enforceability may affect strategic value.

5. What future legal challenges might the '730 patent face?
Potential challenges include validity disputes based on prior art, patent term extensions, or non-infringement defenses. Staying vigilant through patent monitoring and prosecution strategies helps maintain its enforceability.

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References

1. U.S. Patent No. 8,501,730.
2. Patent Office Release (example sources for patent prosecution history).
3. Industry patent landscape reports (general references).

(Note: Actual references should include official patent databases, such as USPTO records and authoritative patent analytics platforms.)

Drugs Protected by US Patent 8,501,730

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-001	Apr 23, 2018	AB2	RX	Yes	No	8,501,730			Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-002	Apr 23, 2018	AB2	RX	Yes	No	8,501,730			Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-003	Apr 23, 2018	AB	RX	Yes	Yes	8,501,730			Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-004	Apr 23, 2018	AB2	RX	Yes	No	8,501,730			Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-005	Apr 23, 2018	AB	RX	Yes	No	8,501,730			Y

Foreign Priority and PCT Information for Patent: 8,501,730

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2005-254744	Sep 02, 2005

International Family Members for US Patent 8,501,730

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E496895
Austria	E544744
China	101273017
China	101967107
China	102219741