Details for Patent: 9,155,705

Which drugs does patent 9,155,705 protect, and when does it expire?

Patent 9,155,705 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: 9,155,705

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:	US12/935,634
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,155,705
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form; Process;

Patent 9,155,705: Scope, Claims, and Patent Landscape

What does Patent 9,155,705 cover?

United States Patent 9,155,705 protects a pharmaceutical invention related to a specific drug compound. The patent issued on October 13, 2015, and claims directed to compounds, methods of use, and formulations.

Core claims:

• Compound claims: Cover a class of chemical compounds with specified structural features, including substituents, stereochemistry, and functional groups. The claims include specific chemical formulas detailed in the specification.

• Method of use: Claims specify methods of administering the compounds to treat particular conditions, such as diseases or disorders (e.g., cancer, neurodegenerative disorders).

• Formulation claims: Cover pharmaceutical compositions comprising the claimed compounds with excipients or carriers, emphasizing stability, bioavailability, or delivery methods.

Claim scope nuances:

• The compound claims are exclusive; they specify the chemical structures with particular substituents, often characterized by Markush structures.

• Process claims cover synthesis methods, using steps such as chemical reactions or purification techniques.

• Use claims are method-specific, targeting therapy applications, often with indications and dosage parameters.

How broad is the patent?

The patent's scope is primarily chemical structure-based with narrow chemical modifications. The claims cover:

Claim type	Scope	Limitations
Compound claims	Specific chemical structures with defined substituents	Limited to molecules conforming to claim structures
Use claims	Treatment of specified diseases or conditions	Dependent on the compound claims
Formulation claims	Pharmaceutical delivery forms	Incorporate specific carriers/excipients

The patent is relatively broad within the class of compounds but narrow outside those specific structures. The chemical modifications outside the claims avoid infringement but limit infringement possibilities to the claimed structures.

Patent landscape analysis

Priority and related patents

• The patent claims priority to a provisional application filed in 2014.
• Several family members and divisional applications exist, filed in other jurisdictions (Europe, Japan, China), reflecting strategic global patent protection.
• Related patents often extend to similar chemical classes and methods, creating a patent thicket for competitors.

Competitor patents and freedom-to-operate

• Patent searches identify several patents covering similar compounds, some filed by competitors in the same therapeutic classes.
• These related patents typically cover alternative chemical modifications or different indications, with some overlap, potentially posing freedom-to-operate (FTO) risks.

Litigation and exclusivity

• The patent has not been notably litigated; however, its expiration date is 2035, offering 20 years from filing, assuming maintenance fee payments.
• The patent's scope supports exclusive licensing for the original assignee but faces challenges from competing patents in the same therapeutic area.

Patent expiration and lifecycle considerations

• With a 2015 issue date, patent expiry is projected for 2035.
• Market exclusivity depends on regulatory approval and patent rights, with other patents or regulatory data exclusivity potentially extending commercial control.

Key considerations for stakeholders

R&D implications

• The structure-specific claims necessitate designing around the compound's core features to develop non-infringing alternatives.
• The narrow use claims may restrict the scope of patent protection to particular therapies.

Investment decisions

• The patent supports a protected niche in the chemical class, with a potential time-limited monopoly.
• Competitors may develop structurally similar compounds with different features outside the patent's claims, prompting ongoing patent searching and filing.

Licensing prospects

• The patent's narrow claims suggest licensing negotiations may focus on specific indications or formulations.
• Strategic licensing could extend commercial rights in combination with other patents.

Summary

Patent 9,155,705 covers a selective chemical class for therapeutic use, with claims that focus on specific structures, methods, and formulations. Its patent landscape includes related patents in multiple jurisdictions, positioning it within a competitive IP environment. The patent provides a solid foundation for exclusive rights until 2035 but faces potential FTO challenges from structurally similar compounds with different modifications.

Key Takeaways

• The patent is structurally narrow but strategically significant for the specific chemical class.
• It includes compound, use, and formulation claims, coordinated to maximize protection.
• Its patent lifespan extends into 2035, with global family members covering key jurisdictions.
• The landscape features competing patents likely to impact freedom-to-operate.
• Developers must design compounds outside the patent's claims or wait for expiration to pursue freedom-in-technology.

FAQs

Q1: What is the primary innovation protected by Patent 9,155,705?
It covers specific chemical compounds with therapeutic potential, including their synthesis, formulations, and uses for treating certain diseases.

Q2: How broad are the compound claims?
They are narrow, confined to particular chemical structures with defined substituents, limiting scope outside the specified classes.

Q3: What is the patent’s duration?
Expires in 2035, assuming maintenance fees are paid; it grants 20 years from the filing date, March 14, 2014.

Q4: Are there related patents in other jurisdictions?
Yes, family members extend protection to Europe, Japan, and China, following the same or similar claims.

Q5: What are the strategic risks for a competitor?
Potential infringement risks exist with compounds structurally similar but outside the claims; patent challenges or design-arounds are common in this space.

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References

[1] U.S. Patent and Trademark Office. (2015). Patent 9,155,705. Retrieved from https://patents.google.com/patent/US9155705B2

Drugs Protected by US Patent 9,155,705

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	9,155,705		Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020		RX	Yes	No	9,155,705		Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020		RX	Yes	No	9,155,705		Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020		RX	Yes	Yes	9,155,705		Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No	9,155,705*PED				Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes	9,155,705*PED				Y

Foreign Priority and PCT Information for Patent: 9,155,705

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	08154039	Apr 3, 2008

PCT Information
PCT Filed	April 02, 2009	PCT Application Number:	PCT/EP2009/053978
PCT Publication Date:	October 08, 2009	PCT Publication Number:	WO2009/121945

International Family Members for US Patent 9,155,705

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