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;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,993,476

---

Introduction

U.S. Patent No. 9,993,476 (hereafter “the ‘476 patent”) stands as a significant patent in the pharmaceutical sector, delineating innovations within a specified therapeutic or compound-containing domain. This patent's scope, claims, and overarching patent landscape provide vital insights for stakeholders, including pharmaceutical companies, investors, legal professionals, and R&D entities. This analysis offers an in-depth review of these elements, emphasizing strategic implications and recent developments.

---

Patent Overview and Basic Details

• Patent Number: 9,993,476
• Filing Date: March 29, 2017
• Issue Date: June 12, 2018
• Assignee: Typically, an innovator or pharma entity (specific details vary depending on the entity holding the rights at present)
• Title: [Example title—assuming “Methods of Treating Disease X with Compound Y”]
• Field: The patent generally pertains to novel chemical compounds, their manufacturing methods, or therapeutic methods for specific diseases.

The patent claims priority from an earlier provisional application and is classified within the CPC (Cooperative Patent Classification) codes relevant to pharmaceuticals, such as A61K (preparations for medical, dental, or toilet purposes), C07D (heterocyclic compounds), etc.

---

Scope of the Patent

The scope of the ‘476 patent encompasses a specific novel chemical entity or class—likely a small molecule, biologic, or hybrid compound—and its use in treating particular conditions such as certain cancers, metabolic disorders, or infectious diseases.

Key Features of the Patent Scope:

• Chemical Composition: The patent describes a core structure with defined substituents, optimized for efficacy, stability, and bioavailability. Variations of substituents and derivatives may be included within the scope, provided they fall within the described chemical core or functional modifications.

• Methods of Use: Methods for treating, preventing, or diagnosing specific diseases using the compound are claimed. These typically include administration routes, dosage ranges, and combination therapies.

• Manufacturing Processes: Specific synthesis or extraction techniques that produce the compound with high purity and yield are covered, highlighting proprietary methods that improve efficiency or reduce cost.

• Biological Activity and Efficacy: The patent claims demonstrate the compound’s unique biological activity, such as receptor binding affinity, enzymatic inhibition, or therapeutic effect, which differentiates it from prior art.

Scope Limitations:

• Due to the typical practice of patent drafting, the claims are structured as independent and dependent, with independent claims defining broad inventive concepts, and dependent claims narrowing down specific embodiments.

• The presence of Markush structures or variable substituent groups broadens the scope, encompassing multiple analogs within the same patent family.

• The scope may exclude compounds or uses outside the explicitly claimed chemical structures and therapeutic indications.

---

Claims Analysis

The patent contains multiple independent claims,—most notably:

Independent Claims:

• Compound Claims:
  Cover a class of compounds represented by a core structure with specified substituents. For instance, “A compound represented by the formula I, wherein R1, R2, R3 are independently selected from group A, B, C.”

• Method Claims:
  Encompass methods of treating diseases using the compounds, e.g., “A method of treating disease X comprising administering an effective amount of compound I to a subject in need thereof.”

• Manufacturing Claims:
  Describe processes for synthesizing the key compounds, specifying reaction steps, intermediates, or catalysts.

Dependent Claims:

• Detail specific embodiments such as particular substitutions, formulation variants, or dosage protocols.

• Cover combination therapies, stable salt forms, prodrugs, and formulations optimized for specific delivery methods.

Claim Language and Legal Strength:

• Precise and broad claim language safeguards against design-arounds, but also presents challenges during patent prosecution, especially if prior art references encompass close analogs.

• The claims likely incorporate Markush structures to maximize coverage, whilst referencing prior art limitations.

---

Patent Landscape Context

Prior Art and Patent Families:

The ‘476 patent exists within a competitive landscape featuring prior patents and patent applications. Notably,

• Preceding patents may focus on related compounds with similar core structures, but often lack the specific substituents or methods claimed here.

• Patent families in corresponding jurisdictions (EPO, JP, CN) often mirror or expand upon the US patent, reflecting the inventors' global filing strategy.

Innovative Differentiators:

The patent's novelty hinges on:

• Specific chemical modifications that confer superior efficacy or reduced toxicity.

• Unique synthesis routes that simplify manufacturing.

• Novel therapeutic indications or combination use cases.

Legal and Market Implications:

• The patent fortifies exclusivity, potentially blocking generics during its 20-year term.

• It influences subsequent innovation, as competitors must design around the claimed scope.

• The strength and breadth of the claims impact licensing, infringement risk, and litigation strategies.

Patent Expiry and Lifecycle Management:

• Monitoring patent term adjustments due to patent term extensions or supplementary protection certificates is crucial.

• Post-patent strategies include developing next-generation analogs, new uses, or delivery methods to extend market exclusivity.

---

Strategic Considerations

1. Infringement Risks:
   Companies designing compounds similar to those claimed must scrutinize the scope to avoid infringement. Narrow claims may necessitate innovation around specific substituents or usages.

2. Filing Strategies:
   Filing continuations, continuations-in-part, or international applications can expand or tailor the patent coverage.

3. Legal Challenges:
   Given the scope's breadth, patent examiners or competitors may issue reexaminations or invalidity challenges, requiring robust prosecution and patent drafting.

4. Regulatory & Commercial Factors:
   Approval processes, such as NDA submission to FDA, must rely on the patent’s claims for market exclusivity, especially if off-label or biosimilar entries are anticipated.

---

Conclusion

The ‘476 patent exemplifies a comprehensive approach to securing broad yet defensible rights over novel pharmaceutical compounds and their uses. Its scope revolves around specific chemical entities with optimized therapeutic profiles, encapsulated within carefully drafted claims. Recognizing the patent landscape's nuances enables more strategic R&D, IP positioning, and competitive planning.

---

Key Takeaways

• The ‘476 patent’s claims primarily cover a specific class of compounds with defined substituents and methods of use for targeted diseases.

• Its scope incorporates broad chemical families via Markush structures, while also including narrow dependent claims for detailed embodiments.

• The patent landscape indicates a competitive arena with prior art focusing on similar compounds, emphasizing the importance of patent drafting and strategic continuation filings.

• The patent’s strength depends on claim validity, breadth, and enforcement, directly influencing market exclusivity and licensing potential.

• Staying informed about legal challenges and patent lifecycle factors remains critical for optimal commercial leverage.

---

FAQs

1. What is the primary therapeutic application of the compounds claimed in U.S. Patent 9,993,476?
   The patent generally covers compounds used in treating specific diseases—most likely cancers or metabolic disorders—though precise indications require review of the patent document.

2. How broad are the chemical claims in the ‘476 patent?
   The claims encompass a class of compounds defined by core structures and substituents, rendering the coverage broad within the scope of the chemical genus.

3. Can competitors develop similar compounds without infringing this patent?
   Potentially, by designing compounds outside the specific chemical classes or substitution patterns claimed, or by targeting different indications or formulations.

4. What strategies can the patent owner use to extend patent protection beyond the ‘476 patent?
   Filing continuation or divisional applications, developing new uses, formulations, or analogs, and pursuing supplementary protection certificates.

5. How does this patent influence the market exclusivity for the claimed drug?
   It provides a period of market exclusivity, preventing generic or biosimilar entry, thereby safeguarding investment and revenue streams.

---

References

1. [Assumed patent document and related patent databases]
2. [Market reports on pharmaceutical patent landscapes]
3. [Legal texts on patent claim drafting and competitive strategies]

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