Details for Patent: 9,993,476

Which drugs does patent 9,993,476 protect, and when does it expire?

Patent 9,993,476 protects VERQUVO and is included in one NDA.

This patent has eighty-seven patent family members in forty-six countries.

Summary for Patent: 9,993,476

Title:	Substituted 5-flouro-1H-pyrazolopyridines and their use
Abstract:	The present application relates to novel substituted 5-fluoro-1H-pyrazolopyridines, to processes for their preparation, to their use alone or in combinations for the treatment and/or prophylaxis of diseases, and to their use for producing medicaments for the treatment and/or prophylaxis of diseases, in particular for the treatment and/or prophylaxis of cardiovascular disorders.
Inventor(s):	Follmann; Markus (Cologne, DE), Stasch; Johannes-Peter (Solingen, DE), Redlich; Gorden (Bochum, DE), Ackerstaff; Jens (Dusseldorf, DE), Griebenow; Nils (Dormagen, DE), Kroh; Walter (Wuppertal, DE), Knorr; Andreas (Erkrath, DE), Becker; Eva-Maria (Wuppertal, DE), Wunder; Frank (Wuppertal, DE), Li; Volkhart Min-Jian (Velbert, DE), Hartmann; Elke (Wuppertal, DE), Mittendorf; Joachim (Wuppertal, DE), Schlemmer; Karl-Heinz (Wuppertal, DE), Jautelat; Rolf (Haan, DE), Bierer; Donald (Berlin, DE)
Assignee:	ADVERIO PHARMA GMBH (Schonefeld, DE)
Application Number:	15/348,545
Patent Claim Types: see list of patent claims	Use;

United States Patent 9,993,476: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 9,993,476, titled "Substituted 5-fluoro-1H-pyrazolopyridines and their use," is a significant patent in the pharmaceutical sector, particularly in the development of novel compounds for various medical treatments. This patent, assigned to Merck Sharp and Dohme Corp., is part of a broader landscape of intellectual property related to substituted pyrazolopyridines.

Background and Context

The patent 9,993,476 is part of a series of patents filed by Merck Sharp and Dohme Corp. that focus on the development and use of substituted 5-fluoro-1H-pyrazolopyridines. These compounds are of interest due to their potential therapeutic applications, including the treatment of cardiovascular disorders and other diseases[4].

Scope of the Patent

Claims

The patent includes multiple claims that define the scope of the invention. These claims are categorized into independent and dependent claims.

• Independent Claims: These claims define the broadest scope of the invention. For example, Claim 1 typically describes the general structure of the substituted 5-fluoro-1H-pyrazolopyridines, including the specific substitutions and their positions on the pyrazolopyridine ring[4].
• Dependent Claims: These claims narrow down the scope by specifying particular aspects of the compounds, such as specific substituents, their combinations, and the methods for preparing these compounds.

Compound Structure

The patent describes novel substituted 5-fluoro-1H-pyrazolopyridines, which are characterized by their unique chemical structure. The compounds include a pyrazolopyridine core with various substituents, such as fluoro, methyl, and fluorobenzyl groups, attached at specific positions[4].

Methods of Preparation

The patent also details methods for preparing these substituted pyrazolopyridines. These methods involve various chemical reactions and synthesis steps that are crucial for producing the desired compounds with high purity and yield[4].

Therapeutic Uses

The compounds described in the patent are intended for therapeutic use, particularly in the treatment of cardiovascular disorders. The patent mentions the potential of these compounds in treating conditions such as pulmonary hypertension and other cardiovascular diseases[2][4].

Patent Landscape

Related Patents

The patent 9,993,476 is part of a larger family of patents related to substituted pyrazolopyridines. Other patents in this family include US9604948, US10736896, and US8420656, which also cover various aspects of these compounds, such as their preparation, dosage forms, and therapeutic applications[5].

Patent Expiration and Maintenance

The patent is currently active, with maintenance fees paid to keep it in force. The expiration dates for related patents vary, with some expiring as early as 2031 and others in 2032[5].

Regulatory and Administrative Actions

Recent administrative actions include payments of maintenance fees, letters to regulatory agencies, and notifications related to the patent term adjustment (PTA) and patent term extension (PTE) applications[5].

Impact on Innovation and Industry

Innovation Incentives

The granting of this patent and others in the same family can influence innovation in the pharmaceutical industry. Narrower claims, as discussed in patent scope analyses, can lead to a higher probability of grant and shorter examination processes, which can encourage further research and development[3].

Licensing and Litigation

The scope and claims of this patent can also impact licensing and litigation costs. Broad or overly broad claims might lead to increased costs and disputes, while well-defined claims can provide clarity and reduce the risk of litigation[3].

Expert Insights

Industry experts often emphasize the importance of clear and well-defined patent claims. For instance, "Patent scope is one of the important aspects in the debates over ‘patent quality.’ The purported decrease in patent quality over the past decade or two has supposedly led to granting patents of increased breadth (or ‘overly broad’ patents), decreased clarity, and questionable validity"[3].

Statistics and Data

• Forward Citations: Patents with narrower claims tend to receive more forward citations, indicating their influence on subsequent innovations[3].
• Patent Maintenance Payments: The payment of maintenance fees for this patent and related ones underscores their commercial and therapeutic significance[5].

Key Takeaways

• The United States Patent 9,993,476 covers novel substituted 5-fluoro-1H-pyrazolopyridines and their therapeutic applications.
• The patent includes detailed claims and methods for preparing these compounds.
• It is part of a broader patent landscape related to pyrazolopyridines, with various patents covering different aspects of these compounds.
• The patent's scope and claims can significantly impact innovation, licensing, and litigation in the pharmaceutical industry.

FAQs

What is the main subject of United States Patent 9,993,476?

The main subject of this patent is the development and use of novel substituted 5-fluoro-1H-pyrazolopyridines for therapeutic applications.

What are the potential therapeutic uses of the compounds described in this patent?

The compounds are intended for the treatment of cardiovascular disorders, including pulmonary hypertension and other related conditions.

How does the scope of this patent impact innovation in the pharmaceutical industry?

The scope and claims of this patent can influence innovation by providing clear boundaries for what is protected, thereby encouraging further research and development.

What is the current status of this patent?

The patent is currently active, with maintenance fees paid to keep it in force.

When are the related patents expected to expire?

Related patents are expected to expire between 2031 and 2032, depending on the specific patent.

Cited Sources

1. United States Patent and Trademark Office. DIAZABICYCLIC SUBSTITUTED IMIDAZOPYRIMIDINES AND THEIR USE FOR THE TREATMENT OF BREATHING DISORDERS, US 11,098,063 B2.
2. United States Patent and Trademark Office. Method of treating pulmonary hypertension, US 11,439,642 B2.
3. SSRN. Patent Claims and Patent Scope, September 29, 2016.
4. Google Patents. Substituted 5-flouro-1H-pyrazolopyridines and their use, US9993476B2.
5. Pharsight - GreyB. Verquvo patent expiration.

Drugs Protected by US Patent 9,993,476

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Merck Sharp Dohme	VERQUVO	vericiguat	TABLET;ORAL	214377-001	Jan 19, 2021		RX	Yes	No	9,993,476					REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) HOSPITALIZATION FOLLOWING A HOSPITALIZATION FOR HF OR NEED FOR OUTPATIENT IV DIURETICS, IN ADULTS WITH SYMPTOMATIC CHRONIC HF AND EJECTION FRACTION LESS THAN 45%
Merck Sharp Dohme	VERQUVO	vericiguat	TABLET;ORAL	214377-002	Jan 19, 2021		RX	Yes	No	9,993,476					REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) HOSPITALIZATION FOLLOWING A HOSPITALIZATION FOR HF OR NEED FOR OUTPATIENT IV DIURETICS, IN ADULTS WITH SYMPTOMATIC CHRONIC HF AND EJECTION FRACTION LESS THAN 45%
Merck Sharp Dohme	VERQUVO	vericiguat	TABLET;ORAL	214377-003	Jan 19, 2021		RX	Yes	Yes	9,993,476					REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) HOSPITALIZATION FOLLOWING A HOSPITALIZATION FOR HF OR NEED FOR OUTPATIENT IV DIURETICS, IN ADULTS WITH SYMPTOMATIC CHRONIC HF AND EJECTION FRACTION LESS THAN 45%

Foreign Priority and PCT Information for Patent: 9,993,476

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	10 2010 021 637	May 26, 2010

International Family Members for US Patent 9,993,476

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2576547		PA2021518	Lithuania
European Patent Office	2576547		CA 2021 00032	Denmark
European Patent Office	2576547		LUC00221	Luxembourg
European Patent Office	2576547		122021000048	Germany
European Patent Office	2576547		301146	Netherlands