Details for Patent: 7,919,598

Which drugs does patent 7,919,598 protect, and when does it expire?

Patent 7,919,598 protects QTERNMET XR, QTERN, XIGDUO XR, and FARXIGA, and is included in four 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 seventy-eight patent family members in thirty-two countries.

Summary for Patent: 7,919,598

Title:	Crystal structures of SGLT2 inhibitors and processes for preparing same
Abstract:	The present invention relates to physical crystal structures of a compound of the formula I: ##STR00001## wherein R.sup.1, R.sup.2, R.sup.2a, R.sup.3 and R.sup.4 are as defined herein, especially ##STR00002## pharmaceutical compositions containing structures of compound I or II, processes for preparing same, intermediates used in preparing same, and methods of treating diseases such as diabetes using such structures.
Inventor(s):	Gougoutas; Jack Z. (Princeton, NJ), Lobinger; Hildegard (Regensburg, DE), Ramakrishnan; Srividya (Milltown, NJ), Deshpande; Prashant P. (Princeton, NJ), Bien; Jeffrey T. (Princeton, NJ), Lai; Chiajen (Kendall Park, NJ), Wang; Chenchi (Somerset, NJ), Riebel; Peter (Ruhstorf a.d. Rott, DE), Grosso; John Anthony (Princeton Junction, NJ), Nirschl; Alexandra A. (Yardley, PA), Singh; Janak (Lawrenceville, NJ), DiMarco; John D. (East Brunswick, NJ)
Assignee:	Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:	11/765,481
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,919,598
Patent Claim Types: see list of patent claims	Compound; Use; Process;

Understanding the Scope and Claims of United States Patent 7,919,598

Introduction

United States Patent 7,919,598 is one of the many patents listed in the Orange Book for various pharmaceutical products. To delve into the specifics of this patent, it is crucial to analyze its scope, claims, and the broader patent landscape in which it operates.

Patent Overview

Patent Number and Title

• The patent in question is U.S. Patent No. 7,919,598. While the specific title of this patent is not provided in the sources, it is associated with pharmaceutical formulations, a common theme among patents listed in the Orange Book.

Expiration Date

• The patent is set to expire on December 16, 2029, which includes any patent term extensions under relevant U.S. patent laws[2].

Scope and Claims

Pharmaceutical Formulations

• The patent is directed to pharmaceutical formulations, which typically involve specific compositions, methods of preparation, or uses of drugs. For example, patents in this domain often cover formulations for treating specific diseases or conditions, such as diabetes or related diseases, as seen in other related patents[5].

Claims

• The claims of a patent define the scope of the invention and what is protected. For U.S. Patent 7,919,598, the specific claims are not detailed in the provided sources, but they would generally include:
  • Composition Claims: These would describe the specific ingredients and their proportions in the formulation.
  • Method Claims: These might cover the process of preparing the formulation or the method of using it.
  • Use Claims: These would specify the therapeutic uses of the formulation.

Patent Landscape

Orange Book Listing

• The patent is listed in the Orange Book, which is a publication of the U.S. Food and Drug Administration (FDA) that lists approved drugs and their corresponding patents. This listing indicates that the patent is associated with an approved drug product and serves as a barrier to generic competition until its expiration[2].

Terminal Disclaimers and Patent Thickets

• Many patents, including those related to pharmaceuticals, are part of larger patent families where multiple patents are filed to protect various aspects of a single invention. This can create "patent thickets" where multiple patents overlap and extend the monopoly period. For instance, 75% of the remaining patents for the drug IMBRUVICA are terminally disclaimed, indicating a complex patent landscape designed to extend protection[1].

Litigation and Enforcement

• Patents like U.S. Patent 7,919,598 are often the subject of litigation, particularly when generic manufacturers seek to enter the market. The filing of Abbreviated New Drug Applications (ANDAs) by generic companies can trigger patent infringement lawsuits, as seen in cases involving other related patents[5].

Impact on Generic Competition

Barriers to Entry

• Patents such as U.S. Patent 7,919,598 act as significant barriers to generic competition. Generic manufacturers must wait until the patent expires or successfully challenge the patent's validity or enforceability to enter the market. This can result in delayed access to more affordable generic versions of the drug[1][4].

Economic Implications

• The extension of monopoly periods through patenting practices can lead to substantial economic losses for Medicare and patients. For example, the Inflation Reduction Act analysis highlights that patenting practices can result in lost savings to Medicare ranging from $4.9 to $5.4 billion for certain drugs[4].

Regulatory and Legal Framework

USPTO Rules and Authority

• The United States Patent and Trademark Office (USPTO) has the authority to implement rules that affect the filing and enforcement of patents. This includes rules related to terminal disclaimers and the restriction of claims to prevent obviousness-type double patenting rejections[1].

Court Jurisprudence

• The enforcement and validity of patents are often decided in court. The Federal Circuit and district courts play crucial roles in determining the scope and enforceability of patents, including those related to pharmaceutical formulations[3].

Key Takeaways

• Patent Scope and Claims: U.S. Patent 7,919,598 covers specific pharmaceutical formulations, with claims that define the protected invention.
• Orange Book Listing: The patent is listed in the Orange Book, indicating its association with an approved drug product.
• Patent Thickets and Terminal Disclaimers: The patent is part of a larger patent landscape that can extend monopoly periods.
• Litigation and Enforcement: The patent is subject to litigation, particularly from generic manufacturers.
• Economic Impact: The patent can delay generic competition, leading to significant economic implications.

FAQs

1. What is the expiration date of U.S. Patent 7,919,598?

   • The patent is set to expire on December 16, 2029[2].

2. What is the Orange Book, and why is U.S. Patent 7,919,598 listed in it?

   • The Orange Book is a publication by the FDA that lists approved drugs and their corresponding patents. U.S. Patent 7,919,598 is listed because it is associated with an approved drug product[2].

3. How do terminal disclaimers affect the patent landscape?

   • Terminal disclaimers can create patent thickets by extending the protection period of related patents, delaying generic competition[1].

4. What are the economic implications of patenting practices like those associated with U.S. Patent 7,919,598?

   • These practices can result in significant lost savings to Medicare and patients due to delayed access to generic drugs[4].

5. What role does the USPTO play in regulating patents like U.S. Patent 7,919,598?

   • The USPTO has the authority to implement rules that affect the filing and enforcement of patents, including rules related to terminal disclaimers and obviousness-type double patenting rejections[1].

Sources

1. Letterhead DC Office - Regulations.gov
2. ANDA 211414 - accessdata.fda.gov
3. The BioLoquitur Bulletin - Seyfarth Shaw LLP
4. Using the Inflation Reduction Act to Rein in Patenting ... - Citizen.org
5. in the united states district court - RPX Insight

Drugs Protected by US Patent 7,919,598

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	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019		DISCN	Yes	No				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019		DISCN	Yes	No				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019		DISCN	Yes	No				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No				Y

International Family Members for US Patent 7,919,598

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	061730
Australia	2007265246
Brazil	122017015106
Brazil	122017021516