Details for Patent: 9,174,982

Which drugs does patent 9,174,982 protect, and when does it expire?

Patent 9,174,982 protects VENCLEXTA and is included in one NDA.

This patent has one hundred and thirty-nine patent family members in forty-three countries.

Summary for Patent: 9,174,982

Title:	Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases
Abstract:	Disclosed are compounds which inhibit the activity of anti-apoptotic Bcl-2 proteins, compositions containing the compounds and methods of treating diseases during which is expressed anti-apoptotic Bcl-2 protein.
Inventor(s):	Bruncko; Milan (Green Oaks, IL), Ding; Hong (Gurnee, IL), Doherty; George A. (Libertyville, IL), Elmore; Steven W. (Northbrook, IL), Hasvold; Lisa A. (Grayslake, IL), Hexamer; Laura (Grayslake, IL), Kunzer; Aaron R. (Schaumburg, IL), Song; Xiaohong (Grayslake, IL), Souers; Andrew J. (Evanston, IL), Sullivan; Gerard M. (Lake Villa, IL), Tao; Zhi-Fu (Gurnee, IL), Wang; Gary T. (Libertyville, IL), Wang; Le (Vernon Hills, IL), Wang; Xilu (Grayslake, IL), Wendt; Michael D. (Vernon Hills, IL), Mantei; Robert A. (Franklin, WI), Hansen; Todd M. (Grayslake, IL)
Assignee:	ABBVIE INC. (North Chicago, IL) GENENTECH, INC. (South San Francisco, CA) THE WALTER AND ELIZA HALL INSTITUTE OF MEDICAL RESEARCH (Parkville, AU)
Application Number:	14/038,304
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,174,982
Patent Claim Types: see list of patent claims	Use;

United States Patent 9,174,982: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 9,174,982, titled "Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases," is a significant patent in the pharmaceutical sector, particularly in the field of cancer treatment. This patent is part of a broader portfolio related to the drug VENCLEXTA® (venetoclax), which has gained widespread acceptance for treating various types of leukemia and other cancers.

Background of the Patent

The patent 9,174,982 is owned by the entities associated with the development and marketing of VENCLEXTA®, a groundbreaking drug that selectively targets and inhibits the B-cell CLL/lymphoma 2 (BCL-2) protein. This protein is crucial in regulating apoptosis, or programmed cell death, and its inhibition has shown promising results in treating chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and acute myeloid leukemia (AML) as part of combination therapy[5].

Claims of the Patent

The patent 9,174,982 includes several claims that define the scope of the invention. Here are some key aspects:

Independent Claims

• The patent claims methods and compositions for treating cancer and immune or autoimmune diseases using apoptosis-inducing agents, specifically targeting the BCL-2 family of proteins[4].

Dependent Claims

• These claims further specify the types of cancers and diseases that can be treated, such as CLL, SLL, and AML, and detail the specific compounds and their formulations used in the treatment[4].

Claim Scope and Breadth

• The scope of the claims is critical in defining the patent's boundaries. Narrower claims, as discussed in patent scope analysis, are often associated with a higher probability of grant and a shorter examination process. However, the breadth of claims in this patent is significant, covering a range of therapeutic applications and specific compounds[3].

Patent Scope and Metrics

Independent Claim Length and Count

• Metrics such as independent claim length and count can provide insights into the patent's scope. Generally, longer independent claims and a higher count of independent claims can indicate broader patent scope. However, the specific metrics for this patent would need to be analyzed in detail to determine its exact scope[3].

Forward Citations and Patent Maintenance Payments

• Forward citations and patent maintenance payments are other indicators of patent scope and quality. Patents with more forward citations often have broader scope and higher impact. The maintenance payments also reflect the patent's value and scope, as narrower claims might have lower maintenance costs but higher grant probabilities[3].

Inventorship and Contribution

• The patent lists specific inventors who contributed to the development of the apoptosis-inducing agents. The determination of inventorship is crucial, as seen in cases like the Dana-Farber Cancer Institute v. Ono Pharmaceutical Co., where the contributions of each inventor must be carefully evaluated to ensure accurate attribution[2].

Patent Landscape and Related Patents

• The patent 9,174,982 is part of a larger portfolio of patents related to VENCLEXTA®, including U.S. Patent Nos. 8,546,399, 9,539,251, 8,722,657, and 10,730,873. These patents collectively protect various aspects of the drug, from its composition to its method of use[1][5].

Orange Book Listings

• These patents are listed in the FDA's Orange Book, which is a publication that lists approved drug products with therapeutic equivalence evaluations. The inclusion in the Orange Book is significant as it provides a public record of the patents associated with approved drugs, helping to prevent generic versions from infringing on these patents[1][5].

Litigation and Infringement

• The patent has been involved in litigation, particularly in cases where generic manufacturers have sought to market generic versions of VENCLEXTA® before the expiration of the patents. For example, Alembic Pharmaceuticals' submission of an Abbreviated New Drug Application (ANDA) triggered infringement claims under 35 U.S.C. § 271(e)(2)(A)[1][5].

Impact on Innovation and Licensing

• The breadth and scope of patents like 9,174,982 can influence innovation and licensing in the pharmaceutical industry. Broader patents can increase licensing and litigation costs, potentially diminishing incentives for innovation. However, well-defined and valid patents also protect the significant investments made in drug development, ensuring that innovators can recoup their investments[3].

Key Takeaways

• Patent Scope and Claims: The patent 9,174,982 has broad claims covering various therapeutic applications and specific compounds.
• Inventorship and Contribution: Accurate attribution of inventorship is crucial, as seen in related legal cases.
• Patent Landscape: The patent is part of a larger portfolio protecting VENCLEXTA®, listed in the FDA's Orange Book.
• Litigation and Infringement: The patent has been involved in infringement litigation against generic manufacturers.
• Impact on Innovation: The patent's breadth can affect innovation and licensing costs in the pharmaceutical industry.

FAQs

What is the main subject matter of U.S. Patent 9,174,982?

The main subject matter of U.S. Patent 9,174,982 is the use of apoptosis-inducing agents, specifically targeting the BCL-2 family of proteins, for the treatment of cancer and immune or autoimmune diseases.

Which drug is protected by this patent?

This patent protects the drug VENCLEXTA® (venetoclax), which is used to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and acute myeloid leukemia (AML).

What are the key claims of this patent?

The key claims include methods and compositions for treating cancer and immune or autoimmune diseases using apoptosis-inducing agents that target the BCL-2 family of proteins.

How does this patent fit into the broader patent landscape?

This patent is part of a larger portfolio of patents related to VENCLEXTA®, including other U.S. patents listed in the FDA's Orange Book.

What are the implications of this patent on generic drug manufacturers?

Generic drug manufacturers must ensure that their products do not infringe on the claims of this patent, or they may face litigation under 35 U.S.C. § 271(e)(2)(A).

Cited Sources:

1. Alembic Pharmaceuticals, Inc. v. AbbVie Inc. et al., United States District Court, District of Delaware, Case 1:20-cv-01009-LPS.
2. Dana-Farber Cancer Institute, Inc. v. Ono Pharmaceutical Co., Ltd., United States Court of Appeals for the Federal Circuit, Case 19-2050.
3. Patent Claims and Patent Scope, SSRN, September 29, 2016.
4. US9174982B2 - Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases, Google Patents.
5. Alembic Pharmaceuticals, Inc. v. AbbVie Inc. et al., United States District Court, Central District of California, Case 1:20-cv-00968-MSG.

Drugs Protected by US Patent 9,174,982

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	9,174,982					TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-001	Apr 11, 2016		RX	Yes	No	9,174,982					TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-001	Apr 11, 2016		RX	Yes	No	9,174,982					TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-001	Apr 11, 2016		RX	Yes	No	9,174,982					TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

International Family Members for US Patent 9,174,982

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2435432		PA2017015	Lithuania
European Patent Office	2435432		300873	Netherlands
European Patent Office	2435432		122017000031	Germany
European Patent Office	2435432		CR 2017 00021	Denmark