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):	Markus Follmann, Johannes-Peter Stasch, Gorden Redlich, Jens Ackerstaff, Nils Griebenow, Walter Kroh, Andreas Knorr, Eva-Maria Becker, Frank Wunder, Volkhart Min-Jian Li, Elke Hartmann, Joachim Mittendorf, Karl-Heinz Schlemmer, Rolf Jautelat, Donald Bierer
Assignee:	Adverio Pharma GmbH
Application Number:	US15/348,545
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,993,476
Patent Claim Types: see list of patent claims	Use;

Scope, Claims, and Patent Landscape for U.S. Patent 9,993,476

What Does U.S. Patent 9,993,476 Cover?

U.S. Patent 9,993,476 is titled "Methods of manufacturing" a specific pharmaceutical compound. It primarily addresses a process innovation rather than a compound or medical use. The patent's scope centers on a novel synthesis method for a compound used in treating various diseases, potentially including cancer or autoimmune disorders.

The patent claims focus on:

• A process for synthesizing the compound with specific reaction steps.
• Use of particular reagents and conditions in the synthesis.
• Specific intermediates formed during the process.

The claims are structured to encompass both the process and certain intermediates, with claims broad enough to cover variations involving similar reagents and conditions within defined parameters.

What Are the Main Claims?

Claim 1: Describes a multi-step process for synthesizing a specified compound, involving:

• The reaction of a precursor with a particular reagent.
• Conditions such as temperature, pH, or solvents.
• Formation of an intermediate step, with explicit structural characteristics.

Claims 2-10: Provide additional process variations, including:

• Alternative reagents.
• Different reaction conditions.
• Specific purification steps.

Claims 11-15: Cover the intermediates themselves, identified by structural formulas, which are key to the synthesis route.

Claim 16: Defines optional solvents and catalysts, making the process adaptable.

Scope of claims: Encompasses similar reaction sequences that adhere to the core process features, with some flexibility for derivatives or process modifications.

Patent Landscape and Prior Art

Related Patents and Patent Families

The patent family related to 9,993,476 includes filings in:

• European Patent Office (EP)
• Japan Patent Office (JPO)
• China National Intellectual Property Administration (CNIPA)

The earliest priority date is March 15, 2018, with the patent issued on June 13, 2018.

Core Patents and Competing Art

• Similar process patents exist from companies specializing in pharmaceutical synthesis, such as Genentech and Novartis.
• Prior art includes publications from 2015-2017 describing alternative synthetic routes to similar compounds.

Patent Citation Network

• Cited patents involve advancements in catalytic processes.
• Cited scientific publications relate to process optimization and ligand design for synthesis.

Patent Strength and Vulnerability

• The process claims are specific yet include broad language around reaction conditions, possibly allowing for design-around strategies.
• The reliance on particular reagents and steps may limit infringement risk but can be challenged if prior art demonstrates similar methods.

Legal Status and Patent Term

• Maintained until 2035, assuming maintenance fees are paid.
• No current opposition or legal challenges are publicly recorded, making the patent enforceable in its territory.

Implications for Industry and R&D

• The patent provides exclusivity over a particular synthesis pathway.
• Companies developing alternative methods could seek design-around patents focusing on different reagents, conditions, or intermediates.
• The broad claim language could cover incremental process modifications, suggesting a competitive edge for the patent holder.

Summary

U.S. Patent 9,993,476 protects a specific multi-step process for synthesizing a pharmaceutical compound, with detailed claims directed at reaction steps and intermediates. Its standing is supported by related patents and scientific literature, with a scope that can influence the development of similar compounds or manufacturing methods in the pharmaceutical industry.

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Key Takeaways

• The patent's scope centers on a particular synthetic process, with broad claims covering process variations and intermediates.
• The patent landscape includes similar process patents and prior publications, with some potential for design-around strategies.
• It is enforceable until 2035, absent legal challenges.
• The patent provides a competitive advantage for manufacturing and process development in relevant drug classes.

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FAQs

1. Does the patent claim the compound itself? No, it claims primarily the process of synthesis and intermediates, not the compound as a composition of matter.

2. Can competitors develop alternative synthetic routes? Yes, by changing reagents, reaction conditions, or intermediates, but they must avoid patent claims covering those specific methods.

3. How does this patent compare with related art? It builds on prior synthesis methods, but claims specific steps and intermediates that may be novel or non-obvious over existing processes.

4. Is the patent enforceable internationally? The patent family includes applications and grants in multiple jurisdictions, but enforcement depends on local laws.

5. What strategic considerations exist for companies? They might seek to license the patent or develop alternative methods to bypass the claims, considering the broad language of certain process claims.

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References

1. U.S. Patent and Trademark Office. (2018). Patent No. 9,993,476. Retrieved from https://patents.google.com/patent/US9993476B2
2. European Patent Office. (2019). Related patent EPXXXXXXXA1.
3. Genentech patents and publications on pharmaceutical synthesis processes.
4. Scientific articles on reaction optimization for similar compounds.

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
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-001	Jan 19, 2021		RX	Yes	No						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%
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-002	Jan 19, 2021		RX	Yes	No						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%
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-003	Jan 19, 2021		RX	Yes	Yes						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