Details for Patent: 8,685,934

Which drugs does patent 8,685,934 protect, and when does it expire?

Patent 8,685,934 protects XIGDUO XR and FARXIGA and is included in two NDAs.

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

This patent has seven patent family members in four countries.

Summary for Patent: 8,685,934

Title:	Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
Abstract:	The invention provides methods for treating a patient having type 2 diabetes who has failed on previous regimens of one or more oral and/or injectable anti-diabetic agents, which include the step of administering a therapeutically effective amount of an SGLT2 inhibitor alone or in combination with another anti-diabetic agent and/or other therapeutic agent to such patient. A pharmaceutical composition containing dapagliflozin or dapagliflozin-S-propylene glycol solvate and one or more diabetic agents and/or other therapeutic agents for use in the methods of the invention is also provided.
Inventor(s):	Strumph; Paul (Pennington, NJ), Moran; Stephanie (Princeton, NJ), List; James (Princeton, NJ)
Assignee:	Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:	13/321,103
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,685,934
Patent Claim Types: see list of patent claims	Use;

Understanding the Scope and Claims of United States Patent 8,685,934: A Detailed Analysis

Introduction

The United States Patent 8,685,934, related to the drug dapagliflozin, is a critical component of the patent landscape surrounding this medication. Dapagliflozin, marketed under the brand name Farxiga, is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used in the treatment of type 2 diabetes and other conditions. This article delves into the scope, claims, and the broader patent landscape associated with this patent.

Background on Dapagliflozin

Dapagliflozin is a key drug in the management of type 2 diabetes, working by inhibiting the SGLT2 protein in the kidneys, which helps to reduce blood glucose levels. The drug has been developed and marketed by AstraZeneca, with significant contributions from other pharmaceutical companies in terms of patent filings and research[1].

Patent Details: 8,685,934

Patent Number and Expiration Date

The United States Patent 8,685,934 is scheduled to expire on May 26, 2030. This patent is one of the several patents listed in the FDA's Orange Book for dapagliflozin, which details the approved drug products with their respective patent expiration dates[2][5].

Claims and Scope

The patent 8,685,934 covers specific aspects of dapagliflozin, including its formulation, method of use, and possibly its manufacturing process. While the exact claims of this patent are not detailed here, it is part of a broader patent thicket that protects various facets of the drug.

Method-of-Use Patents

It is important to note that some patents related to dapagliflozin, including method-of-use patents, do not claim any indication or other conditions of use for which generic approval is sought. For instance, the FDA has acknowledged that certain method-of-use patents do not affect the approval of generic versions for specific indications[2].

Patent Landscape for Dapagliflozin

Multiple Patents and Expiration Dates

The patent landscape for dapagliflozin is complex, with multiple patents expiring at different dates. Key patents include those expiring in 2025 (e.g., 7,456,254 and 8,431,685), 2026 (e.g., 8,329,648 and 8,906,851), 2027 (e.g., 8,501,698), and beyond, up to 2030 (e.g., 8,685,934 and 9,616,028)[2][5].

Top Assignees

AstraZeneca is the primary assignee for many dapagliflozin patents, holding over 40 patents related to the drug. Other significant assignees include Sichuan Haisco Pharma, Boehringer, Sun Pharma, Coherus Bioscience, Merck, and Sanofi, each with more than five patents. This diverse involvement underscores the strategic importance of dapagliflozin in the pharmaceutical industry[1].

Impact of Patent Expirations

Generic Competition

The expiration of key patents, such as those in 2025 and 2026, will open the door for generic competition. Generic manufacturers can file Abbreviated New Drug Applications (ANDAs) with paragraph IV certifications, challenging the validity or enforceability of the existing patents. This competition can lead to lower drug prices and increased accessibility for patients[2][3].

Patent Litigation and Challenges

The patent landscape for dapagliflozin is also marked by litigation and challenges. Generic applicants often file paragraph IV certifications, which can lead to patent infringement lawsuits. The number of patent cases, including those at the US District Courts and the Patent Trial and Appeal Board (PTAB), reflects the ongoing legal battles surrounding these patents[3].

Strategic Implications

Patent Thickets and Terminal Disclaimers

The use of patent thickets, where multiple patents are filed to protect different aspects of a drug, is a common strategy. Terminal disclaimers, where later-filed patents are disclaimed to avoid double patenting, are also employed. This strategy helps in maintaining a robust patent protection while navigating the complexities of patent law[4].

Innovation and Protection

The extensive patent filings for dapagliflozin highlight the innovative and inventive steps taken by pharmaceutical companies. These patents reflect the significant investment in research and development, ensuring that the drug remains protected while also allowing for future innovations through reissuance and other legal mechanisms[4].

Conclusion

The United States Patent 8,685,934 is a pivotal part of the complex patent landscape surrounding dapagliflozin. Understanding its scope, claims, and the broader patent environment is crucial for pharmaceutical companies, generic manufacturers, and regulatory bodies. As patents expire, the landscape will evolve, potentially leading to increased generic competition and continued innovation in the field.

Key Takeaways

• Patent Expiration Dates: The patent 8,685,934 expires on May 26, 2030, as part of a series of expirations for dapagliflozin-related patents.
• Multiple Assignees: AstraZeneca and several other pharmaceutical companies hold significant patents related to dapagliflozin.
• Generic Competition: Expiring patents will facilitate generic competition, potentially reducing drug prices.
• Patent Litigation: Ongoing legal challenges and paragraph IV certifications are common in the patent landscape for dapagliflozin.
• Strategic Patent Filings: The use of patent thickets and terminal disclaimers is a strategic approach to maintain robust patent protection.

FAQs

What is the expiration date of the United States Patent 8,685,934?

The United States Patent 8,685,934 is scheduled to expire on May 26, 2030.

Who are the primary assignees for dapagliflozin patents?

AstraZeneca is the primary assignee, with other significant assignees including Sichuan Haisco Pharma, Boehringer, Sun Pharma, Coherus Bioscience, Merck, and Sanofi.

What is the impact of patent expirations on generic competition?

The expiration of key patents will allow generic manufacturers to file ANDAs, leading to increased competition and potentially lower drug prices.

What is a patent thicket, and how is it relevant to dapagliflozin?

A patent thicket refers to the practice of filing multiple patents to protect different aspects of a drug. This strategy is employed for dapagliflozin to maintain robust patent protection.

How do terminal disclaimers affect patent validity?

Terminal disclaimers are used to avoid double patenting by disclaiming later-filed patents. This does not render the remaining claims invalid but ensures that the patents remain enforceable under specific conditions.

Sources

1. GreyB: Farxiga Patent Thicket Patents expiring in 2025.
2. FDA: Dapagliflozin Tablets - accessdata.fda.gov.
3. Seyfarth Shaw LLP: The BioLoquitur Bulletin.
4. Regulations.gov: Letterhead DC Office - Regulations.gov.
5. FDA: Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets.

Drugs Protected by US Patent 8,685,934

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017		RX	Yes	No	8,685,934*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-002	Oct 29, 2014		RX	Yes	No	8,685,934*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014		RX	Yes	No	8,685,934*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014		RX	Yes	Yes	8,685,934*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014		RX	Yes	No	8,685,934*PED				Y

Foreign Priority and PCT Information for Patent: 8,685,934

PCT Information
PCT Filed	May 26, 2010	PCT Application Number:	PCT/US2010/036120
PCT Publication Date:	December 02, 2010	PCT Publication Number:	WO2010/138535

International Family Members for US Patent 8,685,934

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
China	102639125
China	106075451
European Patent Office	2435033
Japan	2012528170
Japan	2016104753