Details for Patent: RE44638

Which drugs does patent RE44638 protect, and when does it expire?

Patent RE44638 protects ZYDELIG and is included in one NDA.

This patent has forty-six patent family members in twenty countries.

Summary for Patent: RE44638

Title:	Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta
Abstract:	The invention provides a class of substituted quinazolinone compounds and methods of treating diseases mediated by PI3K.delta. activity. The disclosed compounds are useful in treating diseases such as bone-resorption disorders; and cancer, especially hematopoietic cancers, lymphomas, multiple myelomas and leukemia. The compounds are also useful in disrupting or inhibiting cellular processes such as leukocyte function or accumulation, neutrophils function, lymphocyte proliferation, and endogenous immune responses.
Inventor(s):	Fowler; Kerry W. (Seattle, WA), Huang; Danwen (Sammamish, WA), Kesicki; Edward A. (Bothell, WA), Ooi; Hua Chee (Kirkland, WA), Oliver; Amy (Bothell, WA), Ruan; Fuqiang (Bellevue, WA), Treiberg; Jennifer (Redmond, WA), Puri; Kamal Deep (Lynnwood, WA)
Assignee:	ICOS Corporation (Indianapolis, IN)
Application Number:	13/730,256
Patent Claim Types: see list of patent claims	Compound; Composition;

Understanding the Scope and Claims of United States Patent RE44638

Introduction

Patent RE44638, filed by ICOS Corporation, is a reissue patent that involves the drug product ZYDELIG (idelalisib), a significant treatment in the field of oncology. To delve into the details of this patent, it is crucial to analyze its scope, claims, and the broader patent landscape.

What is a Reissue Patent?

A reissue patent is a new patent that is issued to replace an existing patent, often to correct errors or to broaden or narrow the scope of the original claims[5].

Patent RE44638: ZYDELIG (idelalisib)

ZYDELIG, or idelalisib, is a phosphatidylinositol 3-kinase (PI3K) inhibitor used primarily in the treatment of certain types of non-Hodgkin lymphoma and other hematological malignancies.

Claims Analysis

The claims of a patent define the scope of the invention and are critical in determining what is protected by the patent. Here are some key aspects of the claims in Patent RE44638:

• Composition of Matter Claims: These claims typically cover the chemical structure of idelalisib and its various forms, such as salts, hydrates, and solvates.
• Method of Treatment Claims: These claims cover the use of idelalisib in treating specific medical conditions, including non-Hodgkin lymphoma and other related diseases.
• Dosage and Administration Claims: These claims may specify the dosage regimens, administration routes, and any specific conditions under which idelalisib is to be used.

Scope of the Patent

The scope of Patent RE44638 is defined by its claims and is limited to the specific embodiments described therein. Here are some key points regarding the scope:

• Chemical Structure: The patent protects the specific chemical structure of idelalisib and its derivatives.
• Therapeutic Uses: The patent covers the use of idelalisib for specific therapeutic indications, which are detailed in the claims.
• Exclusivity: The patent grants ICOS Corporation exclusive rights to manufacture, use, and sell idelalisib for the specified uses, preventing others from doing so without permission.

Patent Landscape

Understanding the patent landscape around RE44638 involves looking at related patents, competitors, and the broader intellectual property environment.

Related Patents

• Family of Patents: RE44638 is part of a family of patents related to idelalisib. This includes original patents and other reissue patents that may cover different aspects of the drug, such as manufacturing processes or additional therapeutic uses.
• Competitor Patents: Other pharmaceutical companies may have patents on similar PI3K inhibitors or other treatments for the same medical conditions. These patents could pose potential challenges or opportunities for collaboration.

Continuation and Divisional Applications

The process of obtaining a patent, especially for complex pharmaceuticals, often involves continuation and divisional applications. These procedures allow applicants to refine their claims, introduce new subject matter, or separate distinct inventions from a single original application[1].

Patent Quality and Examination

The quality of a patent, including RE44638, is crucial for its validity and enforceability. The USPTO has implemented various measures to ensure patent quality, including:

• Correctness Measures: The USPTO uses statutory compliance rates for sections like 35 U.S.C. 101, 112, 102, and 103 to ensure that patents meet the required standards[4].
• Examination Process: The examination process involves multiple stages, including first-action allowances, non-final rejections, and final rejections. Applicants may use continuation procedures like Requests for Continued Examination (RCEs) to address examiner objections[1].

Economic and Legal Implications

The economic and legal implications of Patent RE44638 are significant:

• Market Exclusivity: The patent grants ICOS Corporation a monopoly on the manufacture and sale of idelalisib for the specified uses, which can impact market competition and pricing.
• Litigation: Patent disputes, such as those involving infringement allegations, can arise. The case of Lite-Netics LLC v. Nu Tsai Capital LLC highlights the complexities of patent litigation and the importance of claim construction and infringement analysis[2].

Key Takeaways

• Patent Scope: The scope of RE44638 is defined by its claims, covering the chemical structure of idelalisib and its therapeutic uses.
• Claims Analysis: Understanding the composition of matter, method of treatment, and dosage claims is essential for determining the patent's protection.
• Patent Landscape: The patent is part of a broader landscape that includes related patents, competitor patents, and continuation applications.
• Patent Quality: Ensuring patent quality through rigorous examination and compliance measures is critical for the patent's validity.
• Economic and Legal Implications: The patent has significant economic and legal implications, including market exclusivity and potential litigation.

FAQs

1. What is the primary use of idelalisib protected by Patent RE44638?

   • The primary use protected is the treatment of certain types of non-Hodgkin lymphoma and other hematological malignancies.

2. What is a reissue patent, and why is it relevant to RE44638?

   • A reissue patent is a new patent issued to replace an existing one, often to correct errors or broaden/narrow the scope of the original claims. RE44638 is a reissue patent that replaces an earlier patent on idelalisib.

3. How does the USPTO ensure patent quality?

   • The USPTO ensures patent quality through correctness measures, compliance targets, and rigorous examination processes, including reviews of randomly-selected Office actions.

4. What are continuation and divisional applications in the context of patent law?

   • Continuation and divisional applications allow applicants to refine their claims, introduce new subject matter, or separate distinct inventions from a single original application.

5. Why is claim construction important in patent litigation?

   • Claim construction is crucial because it determines the scope of the patent's protection and can significantly impact the outcome of infringement disputes and other litigation.

Drugs Protected by US Patent RE44638

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014		RX	Yes	No			Y	Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes			Y	Y

Foreign Priority and PCT Information for Patent: RE44638

PCT Information
PCT Filed	May 12, 2005	PCT Application Number:	PCT/US2005/016778
PCT Publication Date:	December 01, 2005	PCT Publication Number:	WO2005/113556

International Family Members for US Patent RE44638

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1761540		PA2017004	Lithuania
European Patent Office	1761540		300867	Netherlands
European Patent Office	1761540		122017000008	Germany
European Patent Office	1761540		CA 2017 00007	Denmark