Details for Patent: 9,173,859

Which drugs does patent 9,173,859 protect, and when does it expire?

Patent 9,173,859 protects GLYXAMBI and JENTADUETO XR and is included in two 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 ninety-four patent family members in thirty-three countries.

Summary for Patent: 9,173,859

Title:	Uses of DPP IV inhibitors
Abstract:	The specification describes the use of selected DPP IV inhibitors for the treatment of physiological functional disorders and for reducing the risk of the occurrence of such functional disorders in at-risk patient groups. In addition, the use of the above-mentioned DPP IV inhibitors in conjunction with other active substances is described, by means of which improved treatment outcomes can be achieved. These applications may be used to prepare corresponding medicaments.
Inventor(s):	Dugi; Klaus (Dresden, DE), Himmelsbach; Frank (Mittelbiberach, DE), Mark; Michael (Biberach an der Riss, DE)
Assignee:	Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE)
Application Number:	14/161,007
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,173,859
Patent Claim Types: see list of patent claims	Use; Delivery; Dosage form; Composition; Formulation;

Understanding the Scope and Claims of United States Patent 9,173,859

Introduction

United States Patent 9,173,859, issued on November 3, 2015, is a significant patent in the field of pharmaceuticals, particularly for the treatment of type 2 diabetes. This patent, along with others in the same family, has been the subject of several legal battles and interpretations. Here, we will delve into the details of its scope, claims, and the broader patent landscape surrounding it.

Background of the Patent

The '859 patent is a continuation of patent application 12/946,193, which is also related to the '927 patent issued on March 18, 2014. This continuity means that the disclosure of the '859 patent is essentially the same as that of the '927 patent[1].

Claims and Scope

The '859 patent pertains to methods of treating type 2 diabetes using DPP-IV inhibitors, such as linagliptin. Here is a breakdown of the key claims:

Claim 1

Claim 1 of the '859 patent is representative and states: "A method of treating type 2 diabetes comprising administering a pharmaceutically effective amount of linagliptin and metformin to a patient in need thereof, wherein the linagliptin is administered in an oral dosage form of 2.5 mg or 5 mg once daily, and the metformin is administered in an oral dosage form of 500 mg, 850 mg, or 1000 mg twice or three times daily[1][4].

Other Claims

Other claims in the '859 patent include variations of this method, specifying different dosages and modes of administration. These claims are crucial as they define the scope of protection for the patented method.

Patent Landscape and Related Patents

The '859 patent is part of a larger family of patents related to the treatment of type 2 diabetes using DPP-IV inhibitors.

Related Patents

• U.S. Patent 8,673,927 ('927 patent): This patent, issued on March 18, 2014, is closely related to the '859 patent and shares the same disclosure. It also pertains to methods of treating type 2 diabetes with linagliptin and metformin[1][4].
• U.S. Patent 8,178,541 ('541 patent): This patent was used as a reference in determining the validity of the '859 and '927 patents. It is broader in scope, covering a "pharmaceutically effective amount of linagliptin and metformin" without specifying dosages[4].

Legal Challenges and Validity

The '859 patent has faced significant legal challenges, particularly regarding its validity.

Obviousness-Type Double Patenting

The district court and the Federal Circuit have ruled that certain claims of the '859 and '927 patents are invalid due to obviousness-type double patenting. This decision was based on the fact that the claims were not patentably distinct from the earlier '541 patent. The court found that a person of ordinary skill in the art (POSA) could have arrived at the claimed dosages through routine experimentation[4][5].

Obviousness

In addition to double patenting issues, the claims were also found invalid for obviousness under 35 U.S.C. § 103. The court determined that the claimed dosages were obvious in view of prior art, specifically the '510 publication, which is part of the same patent family as the '541 patent[4][5].

Impact on Pharmaceutical Industry

The invalidation of these patents has significant implications for the pharmaceutical industry.

Generic Competition

The ruling opens the door for generic versions of linagliptin and linagliptin/metformin combinations, potentially reducing costs for patients and increasing competition in the market[5].

Patent Strategy

This case highlights the importance of careful consideration in drafting patent claims, especially when dealing with ranges and specific properties. It underscores the need for distinct and non-obvious claims to avoid invalidation due to double patenting or obviousness[4].

Measuring Patent Scope

The scope of a patent is crucial in determining its protective breadth. Traditional measures such as the number of patent classes, citations, and claims have been found to be less reliable compared to newer methods.

Claim Length and Scope

Research indicates that the length of the first claim can be a more accurate measure of patent scope. Longer claims typically imply more conditions that must be met for infringement, making the patent narrower[3].

Conclusion

The '859 patent, while significant in its field, has faced substantial legal challenges that have impacted its validity. Understanding the scope and claims of this patent, as well as the broader patent landscape, is essential for pharmaceutical companies and patent practitioners.

Key Takeaways

• The '859 patent pertains to methods of treating type 2 diabetes using linagliptin and metformin.
• The patent is a continuation of the '927 patent and shares the same disclosure.
• Claims were invalidated due to obviousness-type double patenting and obviousness.
• The ruling has implications for generic competition and patent strategy.
• Measuring patent scope accurately is crucial for determining protective breadth.

FAQs

Q1: What is the main subject of United States Patent 9,173,859? A1: The main subject is a method of treating type 2 diabetes using DPP-IV inhibitors such as linagliptin and metformin.

Q2: Why were the claims of the '859 patent invalidated? A2: The claims were invalidated due to obviousness-type double patenting and obviousness in view of prior art.

Q3: What is the significance of the '541 patent in this context? A3: The '541 patent was used as a reference to determine the validity of the '859 and '927 patents, showing that the claimed dosages were not patentably distinct.

Q4: How does the invalidation of the '859 patent affect the pharmaceutical industry? A4: The invalidation opens the door for generic competition, potentially reducing costs for patients and increasing market competition.

Q5: What is a more accurate measure of patent scope according to recent research? A5: Research suggests that the length of the first claim is a more accurate measure of patent scope, with longer claims indicating narrower patents.

Sources

1. Boehringer Ingelheim Pharms., Inc. v. Hec Pharm Co. - Casetext
2. US FOOD & DRUG - accessdata.fda.gov
3. The Ways We've been Measuring Patent Scope are Wrong: - Boston University Law
4. A Non-Precedential Case Study: Federal Circuit Says District Court... - Finnegan
5. Linagliptin / Linagliptin & Metformin – USA - Pharma IP Circle

Drugs Protected by US Patent 9,173,859

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	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No			Y		Y	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes			Y		Y	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
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

Foreign Priority and PCT Information for Patent: 9,173,859

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	06009203	May 4, 2006

International Family Members for US Patent 9,173,859

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	060757
Australia	2007247141
Brazil	PI0711308
Canada	2651019
Canada	2833705
Canada	2875706