Details for Patent: 10,406,172

Which drugs does patent 10,406,172 protect, and when does it expire?

Patent 10,406,172 protects TRIJARDY XR and is included in one NDA.

This patent has forty-two patent family members in thirty-five countries.

Summary for Patent: 10,406,172

Title:	Pharmaceutical composition, methods for treating and uses thereof
Abstract:	The invention relates to a pharmaceutical composition according to the claim 1 comprising an SGLT2 inhibitor, a DPPIV inhibitor and a third antidiabetic agent which is suitable in the treatment or prevention of one or more conditions selected from type 1 diabetes mellitus, type 2 diabetes mellitus, impaired glucose tolerance and hyperglycemia. In addition the present invention relates to methods for preventing or treating of metabolic disorders and related conditions.
Inventor(s):	Eickelmann; Peter (Mittelbiberach, DE), Mark; Michael (Biberach an der Riss, DE), Seman; Leo John (Cheshire, CT), Thomas; Leo (Biberach an der Riss, DE), Broedl; Uli (Ingelheim am Rhein, DE), Grempler; Rolf (Birkenhard Warthausen, DE)
Assignee:	Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE)
Application Number:	13/912,599
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,406,172
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

United States Patent 10,406,172: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 10,406,172, titled "Pharmaceutical composition, methods for treating and uses thereof," is a significant patent in the pharmaceutical industry, particularly in the treatment of diabetes. This patent is held by Boehringer Ingelheim International GmbH and is part of a broader portfolio of patents related to antidiabetic treatments.

Background

The patent was granted on September 10, 2019, and is associated with the development of pharmaceutical compositions that include a combination of active ingredients for treating diabetes and related conditions[4].

Scope of the Patent

Pharmaceutical Composition

The patent describes a pharmaceutical composition that includes an SGLT2 (sodium-glucose cotransporter 2) inhibitor, a DPPIV (dipeptidyl peptidase-4) inhibitor, and a third antidiabetic agent. This combination is designed to provide a comprehensive approach to managing type 2 diabetes by addressing multiple pathways involved in glucose regulation[4].

Active Ingredients

• SGLT2 Inhibitor: Empagliflozin is a common SGLT2 inhibitor used in these compositions. It works by inhibiting the reabsorption of glucose in the kidneys, thereby increasing glucose excretion through urine[2].
• DPPIV Inhibitor: Linagliptin is an example of a DPPIV inhibitor, which works by increasing the levels of incretin hormones, enhancing the release of insulin when glucose levels are elevated, and decreasing the release of glucagon[4].
• Third Antidiabetic Agent: This could be metformin, which decreases glucose production in the liver and increases insulin sensitivity[4].

Claims of the Patent

The patent includes several claims that define the scope of the invention:

• Claim 1: The primary claim describes the pharmaceutical composition comprising an SGLT2 inhibitor, a DPPIV inhibitor, and a third antidiabetic agent.
• Subsequent Claims: These claims specify various aspects of the composition, including the specific types of inhibitors, the dosage forms, and the methods of administration[4].

Patent Landscape

Related Patents

The patent 10,406,172 is part of a series of patents held by Boehringer Ingelheim related to antidiabetic treatments. Other relevant patents include:

• US 9,949,998: Covers similar pharmaceutical compositions and methods for treating diabetes.
• US 10,258,637: Another patent related to the combination of SGLT2 and DPPIV inhibitors with other antidiabetic agents.
• US 8,551,957: An earlier patent covering the use of SGLT2 inhibitors in combination with other antidiabetic agents[5].

Litigation and Infringement

Boehringer Ingelheim has been involved in several litigation cases to protect its patents against generic manufacturers. For instance, the company has sued Lupin Ltd. for alleged infringement of its patents, including the 10,406,172 patent, related to the generic version of Trijardy XR, a drug that combines empagliflozin, linagliptin, and metformin[5].

Expiration Dates

The patent 10,406,172 is set to expire on June 15, 2030. This expiration date is crucial for generic manufacturers, as it marks the period after which they can legally produce and market generic versions of the drug without infringing on the patent[2].

Impact on the Pharmaceutical Industry

Innovation and Competition

The patent landscape around antidiabetic treatments is highly competitive, with several major pharmaceutical companies holding patents in this area. The 10,406,172 patent and related patents held by Boehringer Ingelheim contribute to the company's market position and influence the development of new treatments by other companies[5].

Generic Challenges

Generic manufacturers often challenge the validity of these patents or argue that their products do not infringe on the claims. For example, Alembic Pharmaceuticals Limited has submitted paragraph IV certifications stating that the patents are invalid, unenforceable, or will not be infringed by their manufacture, use, or sale of generic empagliflozin tablets[2].

Measuring Patent Scope

The scope of a patent like 10,406,172 can be measured using metrics such as independent claim length and independent claim count. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].

Conclusion

The United States Patent 10,406,172 is a critical component of Boehringer Ingelheim's intellectual property portfolio in the antidiabetic treatment space. It defines a specific pharmaceutical composition and method of treatment that combines multiple active ingredients to manage type 2 diabetes effectively. The patent's scope and claims are well-defined, and its protection is vigorously defended through litigation against generic manufacturers.

Key Takeaways

• The patent covers a pharmaceutical composition including an SGLT2 inhibitor, a DPPIV inhibitor, and a third antidiabetic agent.
• It is part of a broader portfolio of patents related to antidiabetic treatments held by Boehringer Ingelheim.
• The patent is set to expire on June 15, 2030.
• Boehringer Ingelheim has been involved in litigation to protect this and related patents against generic manufacturers.
• The patent's scope can be measured using metrics such as independent claim length and count.

FAQs

1. What is the primary claim of the United States Patent 10,406,172?

The primary claim describes a pharmaceutical composition comprising an SGLT2 inhibitor, a DPPIV inhibitor, and a third antidiabetic agent.

2. Which company holds the United States Patent 10,406,172?

Boehringer Ingelheim International GmbH holds the patent.

3. What is the expiration date of the United States Patent 10,406,172?

The patent is set to expire on June 15, 2030.

4. Why is the patent 10,406,172 significant in the pharmaceutical industry?

It is significant because it defines a specific and effective combination of antidiabetic agents, influencing the development and marketing of similar treatments by other companies.

5. How does Boehringer Ingelheim protect its patents against generic manufacturers?

Boehringer Ingelheim protects its patents through litigation, as seen in cases against companies like Lupin Ltd. and Alembic Pharmaceuticals Limited.

Cited Sources:

1. United States Patent and Trademark Office. US 11,090,323 B2, August 17, 2021.
2. U.S. Food & Drug Administration. Empagliflozin Tablets, September 30, 2019.
3. SSRN. Patent Claims and Patent Scope, September 29, 2016.
4. Google Patents. US10406172B2 - Pharmaceutical composition, methods for treating and uses thereof, September 10, 2019.
5. Law Street Media. Boehringer Ingelheim Pharmaceuticals Alleges Lupin Infringing on Patents for Trijardy XR, April 14, 2021.

Drugs Protected by US Patent 10,406,172

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 A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020		RX	Yes	No			Y			METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020		RX	Yes	No			Y			METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN

International Family Members for US Patent 10,406,172

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	075421
Australia	2010212867
Brazil	PI1008560