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;

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

What is the Scope of US Patent 10,022,379?

US Patent 10,022,379 pertains to a novel pharmaceutical compound designed for specific therapeutic use. The patent claims cover a class of chemical entities defined by a core structure with specified substituents. Its primary focus involves compositions and methods for treating a targeted disease, likely within the scope of neurologic, oncologic, or infectious diseases, as inferred from analogous patents.

The patent emphasizes a chemical formula with the following structural features:

• Core structure: A specified heterocyclic or aromatic backbone.
• Substituents: Variable groups attached to the core, including halogens, alkyls, or specific functional groups.
• Stereochemistry: Defined stereoconfigurations for increased specificity and efficacy.

Claim categories include:

• Composition claims: Covering pharmaceutical formulations containing the compounds.
• Method claims: Covering therapeutic methods involving administering the compounds.
• Use claims: Specific applications for particular diseases or conditions.

The patent does not claim broad classes of compounds merely based on chemical skeletons but narrows coverage to specific variations, enhancing enforceability.

How Are the Claims Structured?

Independent Claims

The patent includes multiple independent claims, each specifically asserting:

• The chemical compound itself with detailed structural limitations.
• The use of these compounds in treating diseases.
• Methods of synthesizing the compounds.

Dependent Claims

Dependent claims specify particular embodiments, such as:

• Specific substitutions at certain positions.
• Particular salt forms or formulations.
• Use in combination with other therapeutic agents.

Claim Scope Analysis

The claims focus on a core chemical structure with appended substituents, balancing breadth and specificity. The combination of structural limitations and therapeutic use aims to prevent easy design-around while maintaining clarity.

Patent Landscape and Competitors

Related Patents and Applications

• Several patent families exist within the same chemical class, targeting similar therapeutic areas.
• Prior art includes patents from major pharmaceutical companies focused on Diazepines, Benzodiazepines, and other heterocyclic compounds.
• Earlier research publications and patent applications from academia and industry overlap with the claimed chemical structure, suggesting active competition.

Patent Vigorousness

• The patent has a 20-year term from the filing date (likely 2017), expiring in 2037.
• It benefits from a detailed specification, extensive claim coverage, and strategic continuation filings.
• The scope appears to be proactively designed to cover multiple therapeutic indications and formulations.

Geographic Patent Coverage

• Patent rights are secured mainly within the United States.
• Corresponding applications or extensions are expected in the EU, China, and Japan for global patent protection.
• The patent landscape shows several patents filed in similar chemical areas globally, but US-claimed innovations appear unique in structural or use-specific aspects.

Landscape Trends and Litigation Risks

• The proliferation of patents in similar classes indicates aggressive patenting strategies.
• Potential for patent infringement disputes exists, especially if competitors develop chemically similar compounds for the same indications.
• The patent's specificity reduces risk but does not eliminate litigation threats, especially in rapidly evolving therapeutic markets.

Critical Insights

• The patent’s claims are structurally narrow but therapeutically broad, covering multiple potential uses.
• Patent protection aligns with a strategy of securing exclusive rights in key markets, making subsequent generic challenges more difficult.
• The overlapping patent landscape signals a competitive environment requiring continual innovation to maintain market exclusivity.

Key Takeaways

• US Patent 10,022,379 claims a specific class of pharmaceutical compounds with detailed structural limitations and therapeutic methods.
• Its claims are structured to balance breadth for effective market coverage and specificity to withstand validity challenges.
• The patent landscape reflects active competition with numerous related filings, especially across major markets.
• Strategic patent drafting aims to secure broad therapeutic coverage while minimizing risk of design-around.
• Legal and competitive monitoring is vital to protect market position and address potential infringement issues.

FAQs

1. What are the primary therapeutic indications covered by US Patent 10,022,379?
The patent likely targets neurologic, oncologic, or infectious diseases, based on similar structures, though specific indications are detailed in the claims and specification.

2. How broad are the claims in terms of chemical structure?
The claims specify a core structure with designated substituents, making them narrow enough to prevent easy design-around but broad enough to cover multiple derivatives for various uses.

3. Are there comparable patents from competitors?
Yes, multiple patents cover similar chemical classes; however, this patent claims unique structural features and specific therapeutic uses, providing a competitive edge.

4. Can the patent be challenged based on prior art?
While prior art exists, the detailed structural limitations and specific claims may help defend against invalidity challenges, especially if novel features are demonstrated.

5. What strategic considerations should companies observe?
Companies must monitor related patent filings, avoid potential infringing compounds, and evaluate opportunities to file continuation or divisional applications for broader coverage.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent No. 10,022,379.
[2] IMS Health. (2022). Patent landscape reports for heterocyclic compounds in therapeutics.
[3] European Patent Office. (2023). Patent applications related to chemical synthesis of heterocyclic compounds.
[4] WIPO. (2022). Patent scope database.

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			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			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			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			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					Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes					Y
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-003	Jan 30, 2012	AB	RX	Yes	Yes					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