Details for Patent: 10,040,872

Which drugs does patent 10,040,872 protect, and when does it expire?

Patent 10,040,872 protects EVOMELA and is included in one NDA.

This patent has twenty-eight patent family members in nineteen countries.

Summary for Patent: 10,040,872

Title:	Alkylated cyclodextrin compositions and processes for preparing and using the same
Abstract:	The present invention related to low-chloride alkylated cyclodextrin compositions, along with processes for preparing and using the same. The processes of the present invention provide alkylated cyclodextrins with low levels of drug-degrading agents and chloride.
Inventor(s):	Antle; Vincent D. (Olathe, KS), Lopes; lvaro (Loures, PT), Monteiro; Daniel (Loures, PT)
Assignee:	CyDex Pharmaceuticals, Inc. (San Diego, CA)
Application Number:	14/437,439
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,040,872
Patent Claim Types: see list of patent claims	Use; Composition; Process;

United States Patent 10,040,872: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,040,872, titled "Alkylated Cyclodextrin Compositions and Processes for Preparing and Using the Same," is a significant patent in the pharmaceutical industry, particularly in the realm of cyclodextrin compositions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background

Cyclodextrins are cyclic oligosaccharides with a hydrophobic interior and a hydrophilic exterior, making them useful for encapsulating and stabilizing drugs. The patent in question, owned by CyDex Pharmaceuticals, pertains to specific alkylated cyclodextrin compositions and their preparation and use methods[2].

Scope of the Patent

The scope of U.S. Patent 10,040,872 encompasses several key aspects:

Alkylated Cyclodextrin Compositions

The patent describes specific compositions of alkylated cyclodextrins, which are modified cyclodextrins with alkyl groups attached. These compositions are designed to enhance the solubility and stability of pharmaceutical active ingredients[2].

Preparation Methods

The patent details various methods for preparing these alkylated cyclodextrin compositions. These methods involve chemical reactions that introduce alkyl groups into the cyclodextrin molecule, resulting in the desired properties for pharmaceutical applications[2].

Uses of the Compositions

The patent specifies the use of these compositions in pharmaceutical formulations, particularly for improving the bioavailability and stability of drugs. This includes formulations for injection, such as the EVOMELA® product, which is a Captisol®-enabled melphalan hydrochloride for injection[2].

Claims of the Patent

The claims of U.S. Patent 10,040,872 are crucial as they define the legal boundaries of the invention. Here are some key claims:

Composition Claims

• The patent claims specific alkylated cyclodextrin compositions, including their chemical structures and the process of their synthesis.
• These claims are detailed and specific, ensuring that any similar compositions would infringe on the patent unless they significantly differ from the described structures[2].

Method Claims

• The patent includes claims related to the methods of preparing these alkylated cyclodextrin compositions.
• These method claims cover various steps and conditions under which the compositions are synthesized, ensuring that any similar preparation methods would also be considered infringing[2].

Use Claims

• The patent claims the use of these compositions in pharmaceutical formulations.
• These use claims are broad enough to cover a range of applications but specific enough to protect the unique benefits provided by the alkylated cyclodextrin compositions[2].

Patent Landscape

Understanding the patent landscape is essential for navigating the intellectual property rights surrounding U.S. Patent 10,040,872.

Related Patents

• The patent is part of a family of patents related to cyclodextrin compositions and their applications.
• Other patents, such as U.S. Patent 9,200,088, also owned by CyDex Pharmaceuticals, cover related aspects of cyclodextrin technology[2].

Industry Trends

• The pharmaceutical industry has seen a significant increase in the use of cyclodextrins for drug formulation due to their ability to enhance solubility and stability.
• This trend is reflected in the high number of patents filed in this area, with companies like CyDex Pharmaceuticals at the forefront of innovation[1].

Global Patent System

• The patent is part of the global patent system, with corresponding patents filed in other jurisdictions.
• Tools like the Global Dossier and Common Citation Document (CCD) facilitate the management and analysis of these global patent families[4].

Patent Analytics and Claim Coverage

To fully understand the protection and gaps in the patent landscape, patent analytics tools are invaluable.

Claim Coverage Matrix

• A Claim Coverage Matrix can help identify which patents and claims are actively protecting the intellectual property related to U.S. Patent 10,040,872.
• This matrix categorizes patents by claims and scope concepts, providing a clear view of the coverage and any potential gaps[3].

Claim Charts

• Interactive claim charts generated by tools like ClaimScape® can be used to review patent coverage with engineers, scientists, and management.
• These charts help in determining whether a particular scope concept is applicable to a target product or method, highlighting areas where claim coverage may be lacking[3].

Litigation and Enforcement

Given the importance of this patent, litigation and enforcement are critical aspects to consider.

Patent Infringement

• CyDex Pharmaceuticals has taken legal action against companies like Lupin Limited for alleged infringement of this patent.
• The lawsuit highlights the importance of protecting intellectual property rights in the pharmaceutical industry[2].

Damages and Relief

• In cases of infringement, the patent holder can seek damages, injunctive relief, and other forms of compensation.
• The court may also award attorneys’ fees and costs if the case is deemed exceptional[2].

Key Takeaways

• Scope and Claims: U.S. Patent 10,040,872 covers specific alkylated cyclodextrin compositions, their preparation methods, and their use in pharmaceutical formulations.
• Patent Landscape: The patent is part of a broader landscape of cyclodextrin-related patents, with significant industry trends and global implications.
• Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for managing and analyzing the patent landscape.
• Litigation and Enforcement: Protecting intellectual property rights through litigation is crucial in the pharmaceutical industry.

FAQs

1. What is the main subject of U.S. Patent 10,040,872?

   • The main subject is alkylated cyclodextrin compositions and their preparation and use methods in pharmaceutical formulations.

2. Who owns U.S. Patent 10,040,872?

   • CyDex Pharmaceuticals owns this patent.

3. What are the key claims of the patent?

   • The patent includes claims related to the compositions, preparation methods, and uses of the alkylated cyclodextrins.

4. How does the patent fit into the broader patent landscape?

   • It is part of a family of patents related to cyclodextrin technology and is significant in the global patent system.

5. What tools can be used to analyze the patent landscape?

   • Tools such as Claim Coverage Matrix, Claim Charts, Global Dossier, and Common Citation Document (CCD) are useful for analyzing the patent landscape.

Sources

1. National Science Foundation. Invention: U.S. and Comparative Global Trends. January 15, 2020.
2. United States District Court for the District of Delaware. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE. October 29, 2019.
3. Schwegman, Lundberg & Woessner, P.A. Patent Analytics. Retrieved December 19, 2024.
4. United States Patent and Trademark Office. Search for patents. October 18, 2018.

Drugs Protected by US Patent 10,040,872

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes			Y

International Family Members for US Patent 10,040,872

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013334921
Brazil	112015008954
Canada	2888822
Chile	2015001016
Chile	2016003320
China	105073785
Eurasian Patent Organization	032006