Details for Patent: 11,369,599

Which drugs does patent 11,369,599 protect, and when does it expire?

Patent 11,369,599 protects VENCLEXTA and is included in one NDA.

This patent has sixty-five patent family members in thirty-nine countries.

Summary for Patent: 11,369,599

Title:	Melt-extruded solid dispersions containing an apoptosis-inducing agent
Abstract:	A pro-apoptotic solid dispersion comprises, in essentially non-crystalline form, a Bcl-2 family protein inhibitory compound of Formula I as defined herein, dispersed in a solid matrix that comprises (a) a pharmaceutically acceptable water-soluble polymeric carrier and (b) a pharmaceutically acceptable surfactant. A process for preparing such a solid dispersion comprises subjecting to elevated temperature the compound of Formula I, the water-soluble polymeric carrier and the surfactant, to provide an extrudable semi-solid mixture; extruding the semi-solid mixture; and cooling the resulting extrudate to provide a solid matrix comprising the polymeric carrier and the surfactant and having the compound dispersed in essentially non-crystalline form therein. The solid dispersion is suitable for oral administration to a subject in need thereof for treatment of a disease characterized by overexpression of one or more anti-apoptotic Bcl-2 family proteins, for example cancer or an immune or autoimmune disease.
Inventor(s):	Birtalan; Esther (Karlsruhe, DE), Hoelig; Peter (Waechtersbach, DE), Lindley; David J. (Antioch, IL), Sanzgiri; Yeshwant D. (Gurnee, IL), Tong; Ping (Libertyville, IL)
Assignee:	AbbVie Inc. (North Chicago, IL) AbbVie Deutschland GMBH & Co KG (Wiesbaden, DE)
Application Number:	14/340,435
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form;

Detailed Analysis of the Scope and Claims of United States Patent 11,369,599

Introduction

United States Patent 11,369,599, titled "Melt-extruded solid dispersions containing an apoptosis-inducing agent," is a significant patent in the field of pharmaceuticals, particularly in the treatment of cancer and other diseases involving anti-apoptotic Bcl-2 proteins. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

This patent, issued on June 28, 2022, is assigned to AbbVie Inc. and AbbVie Deutschland GmbH & Co. KG. It focuses on the development of melt-extruded solid dispersions that contain apoptosis-inducing agents, specifically targeting Bcl-2 family proteins[4].

Scope of the Patent

The patent covers a range of innovations related to the formulation and delivery of apoptosis-inducing compounds. Here are the key aspects:

Apoptosis-Inducing Agents

The patent describes compounds that inhibit the activity of anti-apoptotic Bcl-2 proteins, which are often overexpressed in various cancers and autoimmune diseases. These compounds are designed to induce apoptosis (programmed cell death) in cells expressing these proteins[4].

Melt-Extruded Solid Dispersions

The invention involves the use of melt-extrusion technology to create solid dispersions of these apoptosis-inducing compounds. This method enhances the solubility and bioavailability of poorly water-soluble drugs, making them more effective when administered orally[4].

Formulation Components

The solid dispersions include various excipients such as polyvinylpyrrolidone, copovidone, polysorbate 80, and calcium phosphate, which help in stabilizing the active compound and improving its delivery[4].

Claims of the Patent

The patent includes several claims that define the scope of the invention:

Composition Claims

These claims specify the composition of the melt-extruded solid dispersions, including the active apoptosis-inducing compound and the various excipients used in the formulation[4].

Method Claims

The patent also claims methods for preparing these solid dispersions using melt-extrusion techniques and methods for treating diseases by administering these formulations[4].

Use Claims

Claims are made for the use of these solid dispersions in treating various diseases, including cancers and autoimmune diseases, where anti-apoptotic Bcl-2 proteins are overexpressed[4].

Patent Landscape

The patent landscape surrounding US 11,369,599 is complex and involves several related patents and exclusivities.

Related Patents

Several other patents by AbbVie Inc. cover similar or complementary aspects of apoptosis-inducing agents and their formulations. For example:

• Patent 8,546,399: This patent also deals with compounds that inhibit anti-apoptotic Bcl-2 proteins and their use in treating diseases[2].
• Patent 9,539,251: This patent describes a combination therapy involving a type II anti-CD20 antibody and a selective Bcl-2 inhibitor for treating CD20-expressing cancers[2].

Patent Expiration Dates

The patent US 11,369,599 is set to expire on May 23, 2032. Other related patents have similar expiration dates, with some expiring as late as September 6, 2033[2].

Generic Availability

As of now, there is no generic version of the drug covered by this patent available in the United States. The exclusivity period granted by the FDA, combined with the patent protection, ensures that AbbVie retains exclusive marketing rights for the foreseeable future[2].

Impact on Pharmaceutical Industry

This patent has significant implications for the pharmaceutical industry, particularly in the development and delivery of cancer therapies.

Enhanced Bioavailability

The use of melt-extruded solid dispersions can significantly enhance the bioavailability of poorly soluble drugs, making them more effective in clinical settings.

Competition and Innovation

The patent landscape around this invention suggests a high level of innovation and competition in the field of cancer therapeutics. Companies like AbbVie are continuously developing new formulations and combination therapies to improve treatment outcomes.

Challenges and Controversies

Patent scope and claim clarity are critical issues in the pharmaceutical industry. Here are some challenges and controversies related to this patent:

Patent Scope and Claim Clarity

The scope of patent claims can be a subject of debate, with broader claims potentially leading to increased litigation and licensing costs. The clarity of claims is also crucial to avoid ambiguity and ensure that the patent does not overly broaden the scope of protection[3].

Innovation Incentives

The debate around patent quality and scope can impact innovation incentives. Narrower, clearer claims may encourage more innovation by reducing the barriers to entry for other companies[3].

Key Takeaways

• Innovative Formulation: The patent introduces melt-extruded solid dispersions as a novel method to enhance the bioavailability of apoptosis-inducing agents.
• Broad Therapeutic Use: The invention is applicable to a range of diseases, including cancers and autoimmune diseases.
• Patent Protection: The patent is set to expire on May 23, 2032, and there are no generic versions available currently.
• Industry Impact: This patent reflects the ongoing innovation in cancer therapeutics and the importance of clear and narrow patent claims.

FAQs

Q: What is the main focus of United States Patent 11,369,599?

A: The patent focuses on melt-extruded solid dispersions containing apoptosis-inducing agents, specifically targeting Bcl-2 family proteins.

Q: Who is the assignee of this patent?

A: The patent is assigned to AbbVie Inc. and AbbVie Deutschland GmbH & Co. KG.

Q: What is the expiration date of this patent?

A: The patent is set to expire on May 23, 2032.

Q: Are there any generic versions of the drug covered by this patent available?

A: No, there are currently no generic versions of the drug available in the United States.

Q: How does this patent impact the pharmaceutical industry?

A: It enhances the bioavailability of poorly soluble drugs and reflects the ongoing innovation in cancer therapeutics, encouraging further research and development.

Cited Sources

1. United States Patent and Trademark Office, "Melt-extruded solid dispersions containing an apoptosis-inducing agent," US11369599B2.
2. Drugs.com, "Generic Venclexta Availability."
3. Hoover Institution, "Patent Claims and Patent Scope."
4. Google Patents, "Melt-extruded solid dispersions containing an apoptosis-inducing agent," US11369599B2.

Drugs Protected by US Patent 11,369,599

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			Y
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016		RX	Yes	No			Y
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-003	Apr 11, 2016		RX	Yes	Yes			Y

International Family Members for US Patent 11,369,599

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	083656
Argentina	122475
Australia	2011361704
Brazil	112013010524
Canada	2813985