Details for Patent: 9,636,344

Which drugs does patent 9,636,344 protect, and when does it expire?

Patent 9,636,344 protects ALIQOPA and is included in one NDA.

This patent has fifty-three patent family members in forty-two countries.

Summary for Patent: 9,636,344

Title:	Substituted 2,3-dihydroimidazo[1,2-C]quinazoline salts
Abstract:	The present invention relates to 2-amino-N-[7-methoxy-8-(3-morpholin-4-ylpropoxy)-2,3-dihydroimidazo-[1,2-- c]quinazolin-5-yl]pyrimidine-5-carboxamide dihydrochloride salt of formula (II): ##STR00001## or a tautomer, solvate or hydrate thereof; and to its use for the treatment of non-Hodgkin's lymphoma.
Inventor(s):	Peters; Jan-Georg (Solingen, DE), Militzer; Hans-Christian (Odenthal, DE), Muller; Hartwig (Velbert, DE)
Assignee:	Bayer Intellectual Property GmbH (Monheim, DE)
Application Number:	14/990,350
Patent Claim Types: see list of patent claims	Use;

Understanding the Scope and Claims of United States Patent 9,636,344

Introduction

United States Patent 9,636,344, titled "Substituted 2,3-dihydroimidazo[1,2-C]quinazoline salts," is a patent that covers a specific class of compounds with potential therapeutic applications, particularly in the treatment of cancer. Here, we will delve into the details of the patent, its claims, and the broader patent landscape surrounding this invention.

Patent Overview

The patent, assigned to a pharmaceutical company, describes a novel class of compounds known as substituted 2,3-dihydroimidazo[1,2-C]quinazoline salts. These compounds are designed to inhibit Class I phosphatidylinositol-3-kinases (PI3Ks), which play a crucial role in cellular signaling pathways involved in cell survival and proliferation[4].

Claims of the Patent

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

Composition of Matter

• The patent claims cover the dihydrochloride salt of the compound of formula (I), which is a proprietary cancer agent. This compound exhibits a broad spectrum of activity against tumors of multiple histologic types, both in vitro and in vivo[4].

Synthesis Methods

• The patent details various methods for synthesizing the compound of formula (I), including those described in international patent applications PCT/EP2003/010377 and PCT/US2007/024985[4].

Tautomeric Forms and Solvates

• The patent includes all tautomeric forms of the compound, such as tautomeric forms (Ia), (Ib), and (Ic), as well as solvates, which are complexes of the compound with solvents like ethanol or methanol[4].

Pharmaceutical Formulations

• The claims extend to pharmaceutical formulations that include the dihydrochloride salt of the compound, along with a pharmaceutically acceptable carrier. These formulations are designed to be effective in treating various conditions by inhibiting PI3Ks[4].

Patent Landscape Analysis

Technological Domain

• The patent falls within the domain of pharmaceuticals, specifically targeting cancer therapies. Patent landscape analysis in this domain involves analyzing the entire landscape of related patents to understand the competitive environment, identify trends, and assess market developments[3].

Competitors and Market Trends

• A thorough patent landscape analysis would reveal competitors in the PI3K inhibitor space, including other pharmaceutical companies with similar or overlapping patents. This analysis can help in identifying patent trends, mergers and acquisitions, licensing activities, and litigation in the field[3].

Legal Status and Expiry Dates

• Understanding the legal status of related patents, including whether they are alive, pending, lapsed, revoked, or expired, is crucial. This information helps in planning strategies for patent maintenance, licensing, or potential challenges to existing patents[3].

Global Patent Family

• The patent is part of a global patent family, meaning it has corresponding applications and grants in other countries. Using tools like the Global Dossier service provided by the USPTO, one can access the file histories of related applications from participating IP Offices, which helps in understanding the global reach and protection of the invention[1].

Litigation and Patent Eligibility

• The patentability of pharmaceutical inventions, including those related to PI3K inhibitors, can be subject to legal challenges. For instance, the Supreme Court's "Alice" test is often applied to determine whether patent claims are directed to abstract ideas or natural phenomena, which are not patentable. Ensuring that the claims of the patent are patent-eligible under 35 U.S.C. § 101 is critical to maintaining its validity[2].

Practical Applications and Impact

• The compound described in the patent has significant therapeutic potential, particularly in treating various types of cancer. The pharmaceutical formulations covered by the patent are designed to be effective and safe for patients, highlighting the practical impact of this invention on healthcare.

Key Takeaways

• Patent Scope: The patent covers specific compounds, their synthesis methods, tautomeric forms, solvates, and pharmaceutical formulations.
• Technological Domain: The patent is within the pharmaceutical domain, specifically targeting PI3K inhibitors for cancer therapy.
• Competitive Landscape: Understanding the patent landscape is crucial for identifying competitors, trends, and market developments.
• Global Protection: The patent is part of a global patent family, with corresponding applications and grants in other countries.
• Legal Considerations: Ensuring patent eligibility and navigating potential litigation are essential for maintaining the patent's validity.

FAQs

1. What is the primary use of the compounds described in US Patent 9,636,344?

   • The primary use is in the treatment of cancer by inhibiting Class I phosphatidylinositol-3-kinases (PI3Ks).

2. How are the compounds of formula (I) synthesized?

   • The patent details synthesis methods described in international patent applications PCT/EP2003/010377 and PCT/US2007/024985.

3. What are tautomeric forms and solvates in the context of this patent?

   • Tautomeric forms refer to different structural forms of the compound due to hydrogen atom migration, while solvates are complexes of the compound with solvents.

4. Why is patent landscape analysis important for this patent?

   • It helps in understanding the competitive environment, identifying trends, and assessing market developments in the PI3K inhibitor space.

5. How can the validity of this patent be challenged?

   • The patent's validity can be challenged based on its eligibility under 35 U.S.C. § 101, using the "Alice" test to determine if the claims are directed to abstract ideas or natural phenomena.

Sources

1. USPTO - Search for patents - https://www.uspto.gov/patents/search
2. CONTOUR IP HOLDING LLC v. GOPRO, INC. - https://cafc.uscourts.gov/opinions-orders/22-1654.OPINION.9-9-2024_2381170.pdf
3. Navigating Technological Domains with Patent Landscape Analysis - https://sagaciousresearch.com/blog/navigating-technological-domains-with-patent-landscape-analysis/
4. US9636344B2 - Substituted 2,3-dihydroimidazo[1,2-C]quinazoline salts - https://patents.google.com/patent/US9636344B2/en
5. U.S. Patent Small Claims Court - https://www.acus.gov/research-projects/us-patent-small-claims-court

Drugs Protected by US Patent 9,636,344

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017		DISCN	Yes	No						TREATMENT OF ADULT PATIENTS WITH RELAPSED FOLLICULAR LYMPHOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR SYSTEMIC THERAPIES

Foreign Priority and PCT Information for Patent: 9,636,344

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	11161111	Apr 5, 2011

International Family Members for US Patent 9,636,344

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	3709
Argentina	085718
Australia	2012238891
Brazil	112013025549
Canada	2832123