Details for Patent: 7,579,449

Which drugs does patent 7,579,449 protect, and when does it expire?

Patent 7,579,449 protects SYNJARDY XR, TRIJARDY XR, GLYXAMBI, JARDIANCE, and SYNJARDY, and is included in five NDAs.

Protection for SYNJARDY XR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has seventy-four patent family members in thirty-six countries.

Summary for Patent: 7,579,449

Title:	Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
Abstract:	Glucopyranosyl-substituted benzene derivatives of general formula I ##STR00001## where the groups R.sup.1 to R.sup.6 as well as R.sup.7a, R.sup.7b, R.sup.7c are defined herein and the tautomers, the stereoisomers thereof, the mixtures thereof and the salts thereof. The compounds according to the invention are suitable for the treatment of metabolic disorders.
Inventor(s):	Eckhardt; Matthias (Biberach, DE), Eickelmann; Peter (Mittelbiberach, DE), Himmelsbach; Frank (Mittelbiberach, DE), Barsoumian; Edward Leon (Toyonaka, JP), Thomas; Leo (Biberach, DE)
Assignee:	Boehringer Ingelheim International GmbH (Ingelheim, DE)
Application Number:	11/080,150
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,579,449
Patent Claim Types: see list of patent claims	Compound;

Understanding the Scope and Claims of United States Patent 7,579,449

Introduction

United States Patent 7,579,449, issued on August 25, 2009, is a significant patent in the pharmaceutical industry, particularly for the drug empagliflozin, which is used in the treatment of type 2 diabetes. Here, we will delve into the details of the patent's scope, claims, and the surrounding patent landscape.

Inventors and Assignee

The patent was invented by Matthias Eckhardt, Peter Eickelmann, Frank Himmelsbach, Edward Leon Barsoumian, and Leo Thomas, and is assigned to Boehringer Ingelheim International GmbH, a German pharmaceutical company[4].

Patent Description

The patent describes glucopyranosyl-substituted benzene derivatives, medicaments containing these compounds, their use, and the process for their manufacture. These derivatives are designed to have an enhanced inhibitory effect on certain biological targets, making them valuable in the development of new drugs[4].

Claims of the Patent

The patent includes several claims that define the scope of the invention. Here are some key points:

• Claim 1: This claim describes the general formula for the glucopyranosyl-substituted benzene derivatives, which includes various substituents and structural elements. This is a genus claim, meaning it encompasses a broad class of compounds rather than a single specific compound[2].
• Claims 2, 8, 10-13, and 16: These claims are more specific and read on the approved product empagliflozin. They detail the specific structural elements and substituents that define empagliflozin and its use in medicaments[1].

Patent Term and Extensions

The original term of the patent was set to expire on March 15, 2025, based on the 20-year basic patent term. However, due to a Patent Term Adjustment (PTA) of 235 days under 35 U.S.C. § 154(b), the patent term was extended to November 5, 2025. Boehringer Ingelheim has also applied for a further extension of the patent term by 1,001 days, which would extend the expiration date to August 1, 2028[1].

Patent Landscape

The patent landscape surrounding U.S. Patent 7,579,449 is complex and involves multiple related patents:

• U.S. Patent 7,713,938: This patent, also owned by Boehringer Ingelheim, claims a specific crystalline form of empagliflozin and is set to expire on April 15, 2027. This patent is another key component in the protection of empagliflozin[2].
• Other Related Patents: The protection of empagliflozin involves a portfolio of patents, each covering different aspects of the drug, such as its chemical structure, crystalline forms, and manufacturing processes. This multi-layered approach helps to extend the exclusivity period and protect the drug from generic competition[2].

Generic Competition and Litigation

As the patent terms approach their expiration dates, the likelihood of generic competition increases. Pharmaceutical companies often engage in litigation to protect their patents against potential generic entrants. For example, litigation has been initiated against companies like Alembic for infringement of related patents[5].

Strategic Importance

The strategic importance of U.S. Patent 7,579,449 lies in its role in protecting empagliflozin, a significant drug for Boehringer Ingelheim. The patent's claims and the broader patent landscape are crucial in maintaining market exclusivity and preventing generic competition.

Industry Impact

The expiration of key patents like U.S. Patent 7,579,449 can significantly impact the pharmaceutical industry. Generic versions of empagliflozin could enter the market, potentially reducing the market share and revenue of the original drug. This scenario highlights the importance of patent strategy and management in the pharmaceutical sector.

Expert Insights

Industry experts emphasize the importance of robust patent portfolios in protecting pharmaceutical products. As noted by experts in patent portfolio creation and management, the filings with the Patent Trial and Appeal Board (PTAB) and the number of patent cases in U.S. district courts have increased, reflecting the intense competition and legal battles in the pharmaceutical industry[3].

Key Takeaways

• Broad Claims: U.S. Patent 7,579,449 includes broad genus claims that cover a wide range of glucopyranosyl-substituted benzene derivatives.
• Specific Claims: The patent also includes specific claims that read on the approved product empagliflozin.
• Patent Term Extensions: The patent term has been extended due to PTA and an application for further extension is pending.
• Related Patents: The protection of empagliflozin involves multiple related patents covering different aspects of the drug.
• Litigation and Generic Competition: The patent's expiration dates and related litigation are critical in determining the timing of generic competition.

FAQs

1. What is the main subject of U.S. Patent 7,579,449?

   • The main subject is glucopyranosyl-substituted benzene derivatives, including their use and manufacture, particularly in relation to the drug empagliflozin.

2. Who are the inventors of U.S. Patent 7,579,449?

   • The inventors are Matthias Eckhardt, Peter Eickelmann, Frank Himmelsbach, Edward Leon Barsoumian, and Leo Thomas.

3. What is the current expiration date of U.S. Patent 7,579,449?

   • The current expiration date is November 5, 2025, with an application pending for a further extension.

4. How does the patent landscape impact the protection of empagliflozin?

   • The patent landscape involves multiple related patents that collectively protect different aspects of empagliflozin, extending its market exclusivity.

5. What are the implications of the patent's expiration for the pharmaceutical industry?

   • The expiration could lead to generic competition, potentially reducing the market share and revenue of the original drug.

Cited Sources

1. Application for Patent Term Extension - U.S. Patent and Trademark Office[1].
2. Using Solid Form Patents to Protect Pharmaceutical Products — Part I - ebarashlaw.com[2].
3. The BioLoquitur Bulletin - Seyfarth Shaw LLP[3].
4. United States Patent - googleapis.com[4].
5. Empagliflozin Tablets - FDA[5].

Drugs Protected by US Patent 7,579,449

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	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016		RX	Yes	No	7,579,449*PED				Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016		RX	Yes	No	7,579,449*PED				Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016		RX	Yes	No	7,579,449*PED				Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes	7,579,449*PED				Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-001	Jan 27, 2020		RX	Yes	No	7,579,449*PED				Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020		RX	Yes	No	7,579,449*PED				Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020		RX	Yes	No	7,579,449*PED				Y

Foreign Priority and PCT Information for Patent: 7,579,449

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	10 2004 012 676	Mar 16, 2004
Germany	10 2004 040 168	Aug 18, 2004
Germany	10 2004 061 145	Dec 16, 2004
	05002628	Feb 9, 2005

International Family Members for US Patent 7,579,449

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1730131		62/2014	Austria
European Patent Office	1730131		C300696	Netherlands
European Patent Office	1730131		PA2014035	Lithuania
European Patent Office	1730131		92555	Luxembourg
European Patent Office	1730131		CA 2014 00054	Denmark
European Patent Office	1730131		1490061-7	Sweden
European Patent Office	1730131		14C0074	France