Details for Patent: 7,407,955

Which drugs does patent 7,407,955 protect, and when does it expire?

Patent 7,407,955 protects JENTADUETO XR, TRIJARDY XR, GLYXAMBI, JENTADUETO, and TRADJENTA, and is included in five 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 one hundred and six patent family members in thirty-eight countries.

Summary for Patent: 7,407,955

Title:	8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Abstract:	The present invention relates to substituted xanthines of general formula ##STR00001## wherein R.sup.1 to R.sup.3 are defined as in claims 1 to 16, the tautomers, the stereoisomers, the mixtures, the prodrugs thereof and the salts thereof which have valuable pharmacological properties, particularly an inhibiting effect on the activity of the enzyme dipeptidylpeptidase-IV (DPP-IV).
Inventor(s):	Himmelsbach; Frank (Mittelbiberach, DE), Langkopf; Elke (Warthausen, DE), Eckhardt; Matthias (Biberach, DE), Mark; Michael (Biberach, DE), Maier; Roland (Biberach, DE), Lotz; Ralf R. H. (Schemmerhofen, DE), Tadayyon; Mohammad (Ulm, DE)
Assignee:	Boehringer Ingelheim Pharma GmbH & Co., KG (Ingelheim, DE)
Application Number:	10/639,036
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,407,955
Patent Claim Types: see list of patent claims	Compound; Composition;

Understanding the Scope and Claims of United States Patent 7,407,955

Introduction

The United States Patent 7,407,955, hereafter referred to as the '955 patent, is a critical component of the patent landscape surrounding the pharmaceutical compound linagliptin, used in the treatment of type 2 diabetes. This analysis will delve into the scope, claims, and the broader patent landscape associated with this patent.

Patent Overview

The '955 patent, titled "8-[3-amino-piperidin-1-yl]-xanthines," was issued to Boehringer Ingelheim Pharmaceuticals, Inc. and pertains to a class of substituted xanthines. These compounds are significant in the context of diabetes treatment due to their role as dipeptidyl peptidase-4 (DPP-4) inhibitors[5].

Claim Construction

Claim construction is a crucial aspect of patent law, as it defines the scope of what is protected by the patent. Here are some key points regarding the claim construction of the '955 patent:

Claim Language

The patent includes multiple claims that define the chemical structure and properties of the substituted xanthines. Claims 1 to 16 specify various aspects of the compounds, including the general formula and the definitions of the substituents R1 to R3[5].

Context and Specification

The meaning of claim terms is often derived from the context in which they are used within the patent specification. The specification serves as the single best guide to the meaning of disputed terms, as it may include definitions or clarifications provided by the patentee[1].

Scope of Protection

The scope of the '955 patent is defined by its claims and the specification.

Chemical Structure

The patent protects specific chemical structures of substituted xanthines, which are essential for their function as DPP-4 inhibitors. This specificity ensures that the patent does not overly broaden the scope of protection, which could lead to disputes over patent quality and validity[3].

Method of Use

While the '955 patent itself does not claim methods of use, it is part of a broader portfolio that includes method-of-use patents. For example, other related patents like the '927 and '695 patents claim methods of treating type 2 diabetes using linagliptin, often in combination with other drugs like metformin or insulin[2][4].

Patent Expiration and Litigation

Expiration Date

The '955 patent is set to expire on May 2, 2025, marking the end of its exclusive protection period[2].

Litigation

The '955 patent has been involved in litigation related to generic drug approvals. For instance, Boehringer Ingelheim initiated litigation against generic drug manufacturers like Zydus and Dr. Reddy's Laboratories Limited for infringement of this and other related patents[2][4].

Broader Patent Landscape

The '955 patent is part of a complex patent landscape surrounding linagliptin and its use in treating type 2 diabetes.

Related Patents

Other patents such as the '648, '927, '695, '156, and '859 patents are also crucial in this landscape. These patents cover various aspects, including different methods of use and combinations with other drugs. The '648 patent, for example, pertains to the use of linagliptin in combination with insulin, while the '695 patent covers a broader range of treatment methods[2][4].

Patent Quality and Scope

The debate over patent quality often centers on the breadth and clarity of patent claims. Metrics such as independent claim length and count can be used to measure patent scope. In the case of the '955 patent, the specificity of the chemical structures and the clear definitions within the specification help to maintain a balanced scope that does not overly broaden the protection[3].

Regulatory Environment

The FDA plays a significant role in the approval process of generic drugs, which often involves navigating the patent landscape.

ANDA Filings

Generic drug manufacturers must file Abbreviated New Drug Applications (ANDAs) and address any relevant patents listed in the FDA's Orange Book. For the '955 patent, generic manufacturers have submitted paragraph IV certifications, arguing that the patent is invalid, unenforceable, or will not be infringed by their products[2][4].

Key Takeaways

• Specificity in Claims: The '955 patent's claims are specific to the chemical structures of substituted xanthines, ensuring a clear scope of protection.
• Broader Patent Portfolio: The patent is part of a larger portfolio that includes method-of-use patents, such as the '927 and '695 patents.
• Litigation and Expiration: The patent has been involved in litigation and is set to expire on May 2, 2025.
• Regulatory Compliance: Generic drug manufacturers must navigate the patent landscape, including addressing the '955 patent in their ANDA filings.

FAQs

Q: What is the main subject of the '955 patent? A: The '955 patent pertains to substituted xanthines, specifically those used as DPP-4 inhibitors in the treatment of type 2 diabetes.

Q: When is the '955 patent set to expire? A: The '955 patent is set to expire on May 2, 2025.

Q: What other patents are related to the '955 patent in the context of linagliptin? A: Other related patents include the '648, '927, '695, '156, and '859 patents, which cover various methods of use and combinations with other drugs.

Q: How do generic drug manufacturers address the '955 patent in their ANDA filings? A: Generic manufacturers submit paragraph IV certifications, arguing that the patent is invalid, unenforceable, or will not be infringed by their products.

Q: What role does the FDA play in the approval process of generic drugs related to the '955 patent? A: The FDA requires generic manufacturers to address any relevant patents listed in the Orange Book, including the '955 patent, as part of their ANDA filings.

Sources

1. Boehringer Ingelheim Pharms., Inc. v. Hec Pharm Co. - Casetext
2. Linagliptin Tablets - FDA
3. Patent Claims and Patent Scope - Hoover Institution
4. Linagliptin Tablets - FDA
5. US-7407955-B2 - Unified Patents Portal

Drugs Protected by US Patent 7,407,955

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	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No	7,407,955*PED				Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes	7,407,955*PED				Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-001	Jan 27, 2020		RX	Yes	No	7,407,955*PED				Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020		RX	Yes	No	7,407,955*PED				Y

Foreign Priority and PCT Information for Patent: 7,407,955

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	102 38 243	Aug 21, 2002
Germany	103 12 353	Mar 20, 2003

International Family Members for US Patent 7,407,955

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1532149		C300504	Netherlands
European Patent Office	1532149		1190035-4	Sweden
European Patent Office	1532149		PA2011013	Lithuania
European Patent Office	1532149		C20110018 00046	Estonia