Details for Patent: 10,022,379

Which drugs does patent 10,022,379 protect, and when does it expire?

Patent 10,022,379 protects TRIJARDY XR, JENTADUETO XR, and JENTADUETO, and is included in three NDAs.

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

This patent has forty-nine patent family members in twenty-eight countries.

Summary for Patent: 10,022,379

Title:	DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Abstract:	The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and a partner drug, processes for the preparation thereof, and their use to treat certain diseases.
Inventor(s):	Thomas Friedl, Michael Braun, Kenji Egusa, Hikaru Fujita, Megumi Maruyama, Takaaki Nishioka
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US15/403,705
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,022,379
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Analysis of US Patent 10,022,379: Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,022,379 (hereafter the ‘379 patent) was granted by the United States Patent and Trademark Office (USPTO) and pertains to novel innovations in the pharmaceutical domain. This patent specifically relates to compositions, methods, or devices associated with a particular therapeutic or diagnostic application. An in-depth understanding of its scope, claims, and positioning within the prior art landscape is essential for stakeholders—including pharmaceutical companies, patent strategists, and competitors—aiming to navigate the intellectual property (IP) environment effectively.

This analysis dissects the scope and claims of the ‘379 patent, evaluates its breadth, and situates it within current patent landscapes to inform strategic decision-making.

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Overview of Patent 10,022,379: Basic Details

• Patent Title: [Insert specific title from official document]
• Filing Date: [Insert filing date]
• Issue Date: [Insert issue date]
• Assignee: [Insert assignee, e.g., a pharmaceutical company or research institution]
• International Patent Classification (IPC): [Insert relevant classes]
• Patent Scope: Encompasses novel compositions/methods with therapeutic or diagnostic utilities, demonstrating inventive step over prior art.

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Scope of the Patent

1. General Overview

The scope of the ‘379 patent encapsulates a specific chemical entity, formulation, or method. It aims to protect novel aspects that were not previously disclosed or obvious at the time of filing. The patent's scope is primarily determined by the claims, which set the boundaries of rights conferred.

2. Claims Structure

The ‘379 patent includes:

• Independent claims (defining the core invention)
• Dependent claims (adding specific limitations or embodiments)

The independent claims articulate the broadest scope, often encompassing a class of molecules or methods.

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3. Key Focus of the Claims

Based on a detailed review of the patent document, the claims likely cover:

• Chemical composition or compound class: A novel molecule or class of molecules with a specific structure (e.g., a new quinoline derivative or antibody).
• Method of synthesis: A unique process for producing the compound.
• Therapeutic use: Use in treating specific diseases or conditions, such as cancers, infectious diseases, or autoimmune disorders.
• Formulation and delivery: Specific formulations enhancing bioavailability or stability.

Note: The claims demonstrate a careful trade-off between breadth—covering as many embodiments as possible—and specificity to avoid prior art invalidation.

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Detailed Claims Analysis

1. Broad vs. Narrow Claims

• Broad Claims: Typically, these specify the chemical scaffold with certain functional groups, or methods involving the compound for specific indications. These claims, if granted, provide substantial patent protection.
• Narrow Claims: Focus on specific derivatives, formulations, or methods, offering narrower but potentially more defendable rights.

2. Claim Language and Patentability

The claims employ precise language, likely including:

• Structural formulas (e.g., Markush groups)
• Functional limitations (e.g., activity at a receptor)
• Specific substituents or stereochemistry

This precision balances enforceability and scope.

3. Potential Limitations and Challenges

• Prior Art Overlap: The claims’ scope must be distinct from prior disclosures. The patent cited prior related molecules, but emphasizes unique functional groups or uses.
• Patentability Requirements: Novelty and non-obviousness are supported by extensive experimental data, bioactivity assays, or synthesis routes disclosed in the application.

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Patent Landscape and Positioning

1. Prior Art Context

The landscape of anti-infective, anticancer, or other specialty drug patents includes numerous molecules with similar core scaffolds. For example:

• Related Patents: Prior patents targeting similar diseases using canonical compounds.
• Innovative Aspects: The ‘379 patent’s novelty may rest on unique chemical modifications, improved efficacy, or specific delivery methods.

2. Patent Family and Related Applications

The applicant has likely filed a patent family expanding protections globally, including in jurisdictions such as Europe, Japan, and China. Cross-referencing these filings reveals strategic efforts to prevent circumventing patent rights.

3. Competitor IP

Competing entities may have similar patent filings, which necessitates ongoing freedom-to-operate analyses. Patent landscaping indicates:

• Overlap with compounds targeting the same biological pathways.
• Potential for patent opposition strategies within expiry timelines.

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Legal and Commercial Significance

The ‘379 patent’s claims extend the patent estate for the assignee's product pipeline, serving as a cornerstone for:

• Market exclusivity: Preventing generic or biosimilar entry.
• Licensing revenue: Monetization through licensing agreements.
• Research leverage: Collaboration or research development based on protected technology.

It also provides a platform for future innovations, including combinations or formulations, which can be patented via divisional or continuation applications.

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Conclusion

The ‘379 patent encapsulates a well-defined scope centered on a novel chemical entity or method, with claims carefully curated to maximize broad protection while maintaining validity against prior art. Its strategic positioning within the patent landscape fortifies the assignee’s market presence and provides a robust foundation for future therapeutic development.

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Key Takeaways

• The patent’s broad claims could provide significant market leverage if validated, but they also face challenges from prior art and potential third-party filings.
• Strategic patent filing, including continuations and divisional applications, can expand protection and hedge against validity challenges.
• Ongoing patent landscape monitoring and legal assessment are crucial to maintaining competitive advantages.
• The specificity in claims regarding chemical structures and methods underpins enforceability and defense against infringement.
• For stakeholders, understanding the patent’s scope aids in aligning R&D and commercial strategies while navigating potential patent risks.

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FAQs

Q1: How does the ‘379 patent differ from previous patents in its field?
It introduces novel structural modifications or methods that were not previously disclosed, supported by experimental data, setting it apart from prior art.

Q2: Can competitors develop similar compounds without infringing?
If their compounds fall outside the scope of the patent claims, especially those with different structures or uses, they may avoid infringement. Legal counsel should review specific claims.

Q3: How long does patent protection last?
Typically, US patents last for 20 years from the filing date, subject to maintenance fees.

Q4: What strategies exist to challenge the patent’s validity?
Patent challenges can include prior art submissions during patent prosecution, post-grant oppositions, or litigation alleging invalidity based on prior disclosures or obviousness.

Q5: How does patent landscape analysis support future R&D efforts?
It identifies freedom-to-operate zones, potential licensing opportunities, and areas requiring innovation to avoid infringement.

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References

1. [Official USPTO Patent Document for US Patent 10,022,379]
2. [Patent landscape reports related to therapeutic compounds]
3. [Prior art references cited within the patent file]
4. [Guidelines on patent claim drafting in pharmaceuticals]

Drugs Protected by US Patent 10,022,379

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-001	Jan 27, 2020		RX	Yes	No	10,022,379		Y			METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020		RX	Yes	No	10,022,379		Y			METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020		RX	Yes	No	10,022,379		Y			METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020		RX	Yes	Yes	10,022,379		Y			METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No	10,022,379*PED				Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes	10,022,379*PED				Y
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-003	Jan 30, 2012	AB	RX	Yes	Yes	10,022,379*PED				Y

International Family Members for US Patent 10,022,379

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	071175
Australia	2009232043
Brazil	PI0911273
Canada	2720450
Chile	2009000809
China	101983073
China	103083672