Details for Patent: 10,730,873

Which drugs does patent 10,730,873 protect, and when does it expire?

Patent 10,730,873 protects VENCLEXTA and is included in one NDA.

This patent has thirty-two patent family members in twenty-six countries.

Summary for Patent: 10,730,873

Title:	Salts and crystalline forms of an apoptosis-inducing agent
Abstract:	Salts and crystalline forms of 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin- -1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}-sulfon- yl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide are suitable active pharmaceutical ingredients for pharmaceutical compositions useful in treatment of a disease characterized by overexpression of one or more anti-apoptotic Bcl-2 family proteins, for example cancer.
Inventor(s):	Catron; Nathaniel (Vernon Hills, IL), Chen; Shuang (Gurnee, IL), Gong; Yuchuan (Waukegan, IL), Zhang; Geoff G. (Vernon Hills, IL)
Assignee:	AbbVie Inc. (Chicago, IL)
Application Number:	15/806,964
Patent Claim Types: see list of patent claims	Composition; Compound; Process;

Understanding the Scope and Claims of United States Patent 10,730,873

Introduction

United States Patent 10,730,873, hereafter referred to as the '873 Patent, is a significant intellectual property asset in the pharmaceutical industry, particularly related to the drug VENCLEXTA® (venetoclax). This patent is part of a broader portfolio of patents protecting VENCLEXTA®, a groundbreaking drug used to treat various types of leukemia and lymphoma.

Background of VENCLEXTA®

VENCLEXTA® is a selective inhibitor of the BCL-2 protein, which plays a crucial role in apoptosis, or programmed cell death. The drug has gained widespread acceptance in the medical community for its efficacy in treating chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and acute myeloid leukemia (AML) as part of a combination therapy[4].

Patent Overview

The '873 Patent is one of several patents listed in the FDA's Orange Book for VENCLEXTA®, along with other patents such as U.S. Patent Nos. 8,546,399, 9,174,982, 9,539,251, and 8,722,657[1][4].

Claims Analysis

Independent and Dependent Claims

Patent claims are the heart of any patent, defining the scope of protection. The '873 Patent includes both independent and dependent claims. Independent claims stand alone and define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional limitations to the independent claims.

For instance, independent claims might describe the composition of matter or the method of use of venetoclax, while dependent claims could specify particular dosages, formulations, or treatment regimens[3].

Claim Language and Scope

The scope of a patent is often debated in terms of its breadth and clarity. Metrics such as independent claim length and independent claim count can provide insights into the patent's scope. Longer independent claims and a higher number of independent claims can indicate a broader scope, but may also raise issues of clarity and validity[3].

Patent Scope Measurements

Research by the USPTO and other institutions has highlighted the importance of measuring patent scope using simple metrics. These metrics include:

Independent Claim Length

This metric measures the complexity and breadth of the independent claims. Longer claims often indicate more detailed and specific descriptions, which can affect the patent's enforceability and validity[3].

Independent Claim Count

The number of independent claims can also reflect the patent's scope. A higher number of independent claims may suggest a broader protection but could also lead to increased complexity and potential litigation issues[3].

Litigation and Enforcement

The '873 Patent, like other patents protecting VENCLEXTA®, has been involved in litigation. For example, generic manufacturers like Alembic have submitted Notice Letters challenging the validity and enforceability of these patents. These challenges require detailed analyses of each claim, explaining why the claim is not infringed, invalid, or unenforceable[1][4].

Regulatory Compliance

Notice Letters, such as those submitted by Alembic, must comply with FDA regulations. These letters must include a detailed statement of the factual and legal bases for the applicant's opinion on the patent's validity and enforceability, including a claim-by-claim analysis[1].

Impact on Innovation

The breadth and clarity of patent claims can significantly impact innovation. Overly broad patents with decreased clarity can lead to increased licensing and litigation costs, potentially diminishing incentives for further innovation. Therefore, the '873 Patent's scope and claims are crucial in balancing protection with the need for continued innovation in the pharmaceutical sector[3].

Statistical Insights

The USPTO's Patent Claims Research Dataset provides valuable statistical insights into patent claims. For instance, the dataset includes claim-level statistics and document-level statistics, which can help in understanding the trends and measurements of patent scope over time[2].

Expert Perspectives

Industry experts emphasize the importance of well-defined measurements of patent scope. For example, Alan C. Marco and Joshua D. Sarnoff have discussed the need for clear metrics to evaluate patent quality and scope, highlighting the impact on innovation and litigation costs[3].

Key Diseases Treated

The '873 Patent, through its protection of VENCLEXTA®, is critical for the treatment of several serious diseases, including:

• Chronic Lymphocytic Leukemia (CLL)
• Small Lymphocytic Lymphoma (SLL)
• Acute Myeloid Leukemia (AML)[4]

Conclusion

The '873 Patent is a vital component of the intellectual property landscape surrounding VENCLEXTA®, a drug that has significantly improved treatment options for patients with certain types of leukemia and lymphoma. Understanding the scope and claims of this patent is essential for navigating the complex world of pharmaceutical patents, ensuring both protection for innovators and continued innovation in the field.

Key Takeaways

• Patent Scope: The '873 Patent's scope is defined by its independent and dependent claims.
• Claim Analysis: Metrics like independent claim length and count are crucial for understanding the patent's breadth and clarity.
• Litigation: The patent has been involved in litigation, highlighting the importance of detailed claim analyses.
• Regulatory Compliance: Notice Letters must comply with FDA regulations, including detailed claim-by-claim analyses.
• Impact on Innovation: The patent's scope affects innovation by balancing protection with the need for continued research and development.

FAQs

Q1: What is the '873 Patent, and what does it protect? The '873 Patent protects the drug VENCLEXTA® (venetoclax), a selective inhibitor of the BCL-2 protein used to treat various types of leukemia and lymphoma.

Q2: How are patent claims structured in the '873 Patent? The patent includes both independent and dependent claims, with independent claims defining the broadest scope of the invention and dependent claims narrowing it down.

Q3: What metrics are used to measure patent scope? Metrics such as independent claim length and independent claim count are used to measure the scope of a patent.

Q4: Why is the '873 Patent involved in litigation? The '873 Patent is involved in litigation due to challenges from generic manufacturers regarding its validity and enforceability.

Q5: How does the '873 Patent impact innovation in the pharmaceutical sector? The patent's scope can impact innovation by affecting licensing and litigation costs, which can either encourage or diminish further research and development.

Sources

1. United States District Court Document: "In the United States District Court" - RPX Insight.
2. USPTO Patent Claims Research Dataset: "Patent Claims Research Dataset" - USPTO.
3. Hoover Institution Paper: "Patent Claims and Patent Scope" - Hoover Institution.
4. United States District Court Document: "In the United States District Court" - RPX Insight.
5. Google Patents: "EP2643322B1 - Salts and crystalline forms of an apoptosis-inducing agent" - Google Patents.

Drugs Protected by US Patent 10,730,873

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-001	Apr 11, 2016		RX	Yes	No	10,730,873			Y
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016		RX	Yes	No	10,730,873			Y
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-003	Apr 11, 2016		RX	Yes	Yes	10,730,873			Y

International Family Members for US Patent 10,730,873

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011332043
Brazil	112013012740
Canada	2817629