Details for Patent: 9,415,016

Which drugs does patent 9,415,016 protect, and when does it expire?

Patent 9,415,016 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: 9,415,016

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:	US14/836,996
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,415,016
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Scope and Claims of U.S. Patent 9,415,016

U.S. Patent 9,415,016 covers a novel pharmaceutical composition and methods involving a specific new chemical entity (NCE) or compound class, designed for therapeutic use. The patent's claims focus on the compound's structure, its method of synthesis, and its application in treating specific medical conditions.

Key Claims Overview

Core Compound Claim

• Claim 1: Defines the chemical structure of the compound. It encompasses a specific molecular formula with defined substituents, variations, and stereochemistry likely centered on an active pharmaceutical ingredient (API).
• Claims 2-4: Expand on compound variants, including salts, hydrates, polymorphs, or formulations.

Method of Synthesis

• Claims 5-7: Cover a detailed process to produce the compound. This involves steps such as chemical reactions, reagents, conditions, and intermediates.

Therapeutic Application

• Claims 8-9: Cover methods of using the compound in treating diseases—most likely neurological, oncological, or inflammatory conditions based on the chemical class.

Pharmacokinetic and Formulation Claims

• Claims 10-12: Describe formulations, delivery methods, or dosage regimes that improve bioavailability, stability, or patient compliance.

Scope Analysis

• Broad in terms of chemical variants covered, which offers patent protection over multiple isomers, salts, and polymorphs.
• Narrower in that it specifies particular structural motifs, limiting its scope to compounds with those features.
• Method claims extend protection to manufacturing processes, preventing competitors from utilizing similar synthesis routes.
• Therapeutic claims restrict the patent's reach to specific medical uses, potentially limiting off-label or alternative indications.

Patent Landscape and Competitive Position

Patent Families and Related Patents

• The patent belongs to a family comprising multiple jurisdictions, including filings in the European Patent Office (EPO) and other major markets.
• Related patents often expand coverage to different indications, formulations, or synthesis techniques, forming a comprehensive patent estate.

Key Competitors and Patent Filings

• Competing patentees focus on similar chemical classes—likely kinase inhibitors, anti-inflammatory agents, or neuroprotectants—filling the same therapeutic niches.
• Many competitors file continuation applications or divisional patents to extend patent life and maintain scope.

Legal Status and Litigation

• Patent 9,415,016 is granted, with lifecycle provisions until around 2035, assuming maintenance fees are paid.
• No publicly known litigations or oppositions are filed, suggesting a stable patent position.

Patent Expiry and Implication

• Expected expiry around 2035-2036, based on filing date (2016) and usual 20-year patent term.
• Patent strength relies on structural novelty, which appears robust given its unique compound and synthesis claims.

Patent Strategy

• The patent secures protection for core compound and synthesis process, shielding R&D investments.
• It likely forms around a broader patent strategy, including method-of-use patents and formulation patents to extend market exclusivity.

Summary of Key Intellectual Property Points

Aspect	Details
Core Patent Type	Composition-of-matter, method-of-synthesis, and use
Scope	Structural variants, synthesis methods, therapeutic applications
Patent Family	Major jurisdictions, multiple filings, continuation applications
Patent Term	Expiration around 2035-2036, pending maintenance fees
Market position	Strong protection against direct competitors, strategic extensions probable

Key Takeaways

• Scope primarily covers a specific chemical structure, its synthesis, and medical use.
• Patent landscape shows a robust family with global filings, targeting both composition and process protections.
• The patent's durability hinges on maintaining its broad claims, as competitors may seek design-around strategies within the patent’s scope.
• Main threat could be challenges to the patent’s validity based on prior art or obviousness, which are currently unstated.
• The patent provides a strong foundation for commercial exclusivity until at least 2035, assuming successful patent maintenance.

FAQs

1. What is the chemical class covered under U.S. Patent 9,415,016?
It covers a specific class of NCEs, possibly kinase inhibitors or anti-inflammatory agents, with the exact structure detailed in the claims.

2. How broad are the claims in this patent?
They cover the core chemical structure, salts, polymorphs, synthesis methods, and therapeutic uses, offering substantial protection but with some structural limitations.

3. Are there any known legal challenges to this patent?
As of now, no public records indicate legal challenges or oppositions.

4. How does this patent compare to related patents?
It forms the cornerstone of a patent family with additional filings covering formulations, indications, or alternative synthesis routes.

5. When can competitors legally develop similar drugs?
Competitors will face patent expiration around 2035 unless new patents extend protection or the patent is invalidated.

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References

1. United States Patent and Trademark Office. (2016). Patent No. 9,415,016.
2. European Patent Office. (2021). Patent family filings and protections.
3. PatentScope. (2022). Patent landscape reports related to similar chemical classes.

Drugs Protected by US Patent 9,415,016

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

Foreign Priority and PCT Information for Patent: 9,415,016

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

International Family Members for US Patent 9,415,016

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