Details for Patent: 11,203,593

Which drugs does patent 11,203,593 protect, and when does it expire?

Patent 11,203,593 protects ADEMPAS and is included in one NDA.

This patent has twenty-four patent family members in twenty-one countries.

Summary for Patent: 11,203,593

Title:	Forms of methyl {4,6-diamino-2-[1(2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimid- ino-5-yl}methyl carbamate
Abstract:	This present invention relates to forms of methyl {4.6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3.4-b]pyridino-3-yl]pyrimi- dino-5-yl}methylcarbamate comprising its Modification I. Modification II. mono-DMSO solvate. sesqui-DMSO solvate and 1/4-ethyl acetate solvate.
Inventor(s):	Keil; Birgit (Duesseldorf, DE), Mais; Franz-Josef (Duesseldorf, DE), Joentgen; Winfried (Cologne, DE), Grunenberg; Alfons (Wuppertal, DE)
Assignee:	Adverio Pharma GmbH (Leverkusen, DE)
Application Number:	16/848,249
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Analyzing the Scope and Claims of United States Patent 11,203,593

Introduction

United States Patent 11,203,593, titled "1-Halobenzyl-1H-indazole-3-carboxylic acids. A New Class of Antispermatogenic Agents," is a patent that covers a specific class of compounds with potential therapeutic applications. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

The patent, granted on April 14, 2020, describes a new class of antispermatogenic agents, which are compounds designed to inhibit sperm production. These compounds belong to the 1-halobenzyl-1H-indazole-3-carboxylic acid family and are intended for use in various medical applications, including male contraception and treatment of conditions related to excessive sperm production[4].

Claims Analysis

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims typically describe the chemical structure of the compounds, their synthesis, and their use in therapeutic applications. Here are some key aspects of the independent claims:

• Chemical Structure: The claims specify the general structure of the 1-halobenzyl-1H-indazole-3-carboxylic acids, including variations in the halogen substituents and other functional groups[4].
• Synthesis: The patent describes methods for synthesizing these compounds, which is crucial for determining the scope of protection.
• Therapeutic Use: Claims also cover the use of these compounds as antispermatogenic agents, outlining their potential in medical treatments.

Dependent Claims

Dependent claims further narrow down the scope by specifying particular embodiments of the invention. These claims often include specific examples of compounds, their formulations, and detailed methods of synthesis. For instance, dependent claims might describe specific halogen substituents or additional functional groups that enhance the therapeutic efficacy of the compounds.

Scope of Protection

Geographical Scope

The patent is granted in the United States, providing protection within the U.S. territory. However, the scope of protection can be extended through international patent applications and agreements such as the Patent Cooperation Treaty (PCT).

Temporal Scope

The patent is valid for a period of 20 years from the date of filing, subject to maintenance fees and other regulatory requirements. This period can be extended under certain circumstances, such as delays in the patent office or regulatory approvals.

Patent Landscape

Related Patents

The patent landscape for antispermatogenic agents is complex, with multiple patents covering various aspects of sperm inhibition and male contraception. Other patents may cover different classes of compounds, methods of delivery, or specific therapeutic applications. For example, patents like those in the Hatch-Waxman context often involve complex litigation and settlement agreements, which can impact the landscape for similar therapeutic areas[2].

Litigation and Settlements

While the specific patent 11,203,593 may not be involved in current litigation, the broader pharmaceutical patent landscape is often marked by intense litigation and settlement agreements. For instance, cases like Novo Nordisk Inc. v. Alvogen, Inc. and Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd. illustrate the complexities and legal battles that can arise in the pharmaceutical patent space[2].

Patent Quality and Scope Metrics

Claim Length and Count

Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth and clarity. Narrower claims, as measured by claim length and count, are often associated with a higher probability of grant and a shorter examination process. This metric can be applied to analyze the quality and scope of patent 11,203,593, though specific data on this patent would be needed for a detailed analysis[3].

Examination Process

The examination process at the U.S. Patent and Trademark Office (USPTO) tends to narrow the scope of patent claims. This process ensures that the claims are clear, specific, and do not overly broaden the scope of the invention. For patent 11,203,593, the examination process would have involved a thorough review to ensure that the claims are valid and enforceable.

Extraterritorial Infringement

Given the global nature of pharmaceutical research and development, the issue of extraterritorial infringement is crucial. The Bayer decision and subsequent cases have established that for a product to be considered infringing under § 271(g), it must be physical and tangible. This means that if the compounds covered by patent 11,203,593 are manufactured abroad using a patented process and then imported into the U.S., they would need to meet the physical and tangible product requirement to be considered infringing[1].

Key Takeaways

• Chemical Structure and Synthesis: The patent covers a specific class of 1-halobenzyl-1H-indazole-3-carboxylic acids, including their synthesis and therapeutic use.
• Scope of Protection: The patent provides protection within the U.S. for a period of 20 years, subject to maintenance fees and regulatory requirements.
• Patent Landscape: The patent operates within a complex landscape of pharmaceutical patents, with potential for litigation and settlement agreements.
• Claim Metrics: The clarity and breadth of the claims can impact the patent's validity and enforceability.
• Extraterritorial Infringement: The patent must meet specific requirements for physical and tangible products to be considered infringing under § 271(g).

FAQs

Q: What is the primary focus of United States Patent 11,203,593? A: The primary focus is on a new class of antispermatogenic agents, specifically 1-halobenzyl-1H-indazole-3-carboxylic acids.

Q: How long is the patent valid for? A: The patent is valid for 20 years from the date of filing, subject to maintenance fees and other regulatory requirements.

Q: What are the key aspects of the independent claims in this patent? A: The independent claims describe the chemical structure of the compounds, their synthesis, and their therapeutic use.

Q: How does the Bayer decision impact extraterritorial infringement claims for this patent? A: The Bayer decision requires that the product must be physical and tangible to be considered infringing under § 271(g).

Q: What metrics can be used to analyze the quality and scope of this patent? A: Metrics such as claim length and count can be used to analyze the quality and scope of the patent, indicating its breadth and clarity.

Sources

1. Closing the Bayer Loophole: An Analysis of Extraterritorial Patent Infringement Claims Under § 271(g)
2. ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan LLP
3. Patent Claims and Patent Scope - Hoover Institution
4. United States Patent 11,203,593

Drugs Protected by US Patent 11,203,593

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 Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-001	Oct 8, 2013	AB	RX	Yes	No	11,203,593		Y	Y		TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-001	Oct 8, 2013	AB	RX	Yes	No	11,203,593		Y	Y		TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-002	Oct 8, 2013	AB	RX	Yes	No	11,203,593		Y	Y		TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-002	Oct 8, 2013	AB	RX	Yes	No	11,203,593		Y	Y		TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-003	Oct 8, 2013	AB	RX	Yes	No	11,203,593		Y	Y		TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS

Foreign Priority and PCT Information for Patent: 11,203,593

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Canada	CA 2806895	Feb 21, 2013
Canada	CA 2807859	Feb 21, 2013

International Family Members for US Patent 11,203,593

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014220801
Brazil	112015019571
Canada	2807859
Canada	2901636
Chile	2015002304