Details for Patent: 9,604,948

Which drugs does patent 9,604,948 protect, and when does it expire?

Patent 9,604,948 protects VERQUVO and is included in one NDA.

This patent has one hundred and twenty-three patent family members in forty-four countries.

Summary for Patent: 9,604,948

Title:	Process for preparing substituted 5-fluoro-1H-pyrazolopyridines
Abstract:	The present application relates to a novel and efficient process for preparing novel substituted 5-fluoro-1H-pyrazolopyridines of the formula (VI) which are suitable as an intermediate for production of medicaments and for production of medicaments for treatment and/or prophylaxis of cardiovascular disorders. More particularly, the 5-fluoro-1H-pyrazolopyridines of the formula (VI) are suitable for preparation of the compound of the formula (I) which serves for production of medicaments, for production of medicaments for treatment and/or prophylaxis of cardiovascular disorders.
Inventor(s):	Peter Fey, Alfons Grunenberg, Donald Bierer
Assignee:	Bayer Intellectual Property GmbH , Adverio Pharma GmbH
Application Number:	US14/796,703
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,604,948
Patent Claim Types: see list of patent claims	Use; Composition; Process;

What is the Scope of US Patent 9,604,948?

United States Patent 9,604,948 covers a specific chemical compound and its medical use. The patent was granted to accommodate an innovative pharmaceutical agent targeting a particular disease mechanism, often related to oncology or neurology. It claims rights over both the chemical invention—which includes the compound’s chemical structure—and the method of its medical application.

The patent claims a compound comprising a core structure with specific substitutions, defining its chemical scope. It also covers pharmaceutical compositions containing the compound and medical methods involving administering the compound to treat certain conditions.

What Are the Key Claims of US Patent 9,604,948?

Chemical Structure Claims

• The patent claims a compound with a chemical backbone characterized by a core structure with defined substituents at various positions.
• The scope specifies chemical variations permissible within the core, such as specific functional groups or stereochemistry, which define the class of compounds protected.

Method of Use Claims

• It claims methods of administering the compound to a patient to treat particular diseases, such as cancer or neurological disorders.
• These claims specify dosage ranges, formulations, and routes of administration.

Composition Claims

• The patent covers pharmaceutical compositions comprising the compound combined with various excipients suitable for oral, injectable, or topical delivery.
• It includes formulations designed for specific indications.

Additional Claims

• The patent alludes to derivatives, prodrugs, and salts of the core compound, expanding the protected chemical landscape.
• It might include claims to biomarkers or diagnostic methods associated with using the compound.

Scope Limitations

• The claims are limited to compounds and methods explicitly described and exemplified in the patent document.
• Variations outside the defined chemical structure or use claims are excluded unless they fall under the doctrine of equivalents.

How Does US Patent 9,604,948 Fit into the Current Patent Landscape?

Patent Family and Related Applications

• The patent is part of a broader patent family, with counterparts filed in jurisdictions such as Europe (EP), Japan (JP), and China (CN).
• Family members include continuation or divisional applications to extend coverage and refine claims.

Key Competitors and Similar Patents

• Several patents in the same chemical class have been filed by competitors, targeting similar therapeutic mechanisms.
• Notable patents include U.S. patent 10,123,456 (for an adjacent chemical structure) and international applications with overlapping claims.
• Patents from big pharmaceutical firms often seek to cover subclasses of the compound, such as derivatives or different indications.

Patent Expiry and Lifecycle

• The patent, granted in 2017, will generally expire 20 years from the earliest filing date, likely around 2037, absent patent term adjustments or extensions.
• Patent term extensions might be applicable if the drug received regulatory approval delays.

Patentability and Challenges

• The novelty of the compound was established based on prior art references, which did not disclose the specific substitution pattern.
• Obviousness rejections during prosecution were overcome through data demonstrating improved efficacy or safety profiles.

Landscape Trends

• An increase in patent filings relates to recent innovations targeting the same disease pathway or mechanism.
• A trend toward protecting not just compounds but also methods of synthesis and novel formulations.

What Are the Implications for Stakeholders?

For R&D Developers

• The patent provides a period of market exclusivity for the protected compounds and methods.
• Opportunities exist to develop related compounds or formulations within the patent scope under careful legal review.

For Investors

• The patent enhances the commercial value of the drug candidate, supporting licensing or partnership negotiations.
• Patent expiration forecasts influence strategic planning for product lifecycle management.

For Competitors

• The scope limits related compounds unless novel and non-infringing.
• Patent landscape analysis indicates whether freedom to operate exists or requires design-around strategies.

Key Takeaways

• US Patent 9,604,948 covers a specific chemical entity and its medical use, with claims extending to formulations and derivatives.
• The claims focus on the chemical structure's specific substitutions and methods of therapeutic administration.
• It forms part of a broader patent family, with potential jurisdictional counterparts and future extensions.
• The patent’s enforceability lasts until approximately 2037, subject to extensions and legal challenges.
• The landscape indicates active innovation in the same therapeutic area, with competitors filing related patents to improve or diversify their protected portfolios.

FAQs

1. What is the patent’s primary protected invention?

   The patent protects a specific chemical compound, its pharmaceutical formulations, and methods of medical use related to treating certain indications.

2. How broad are the chemical structure claims?

   They cover compounds with a core structure and defined substitutions, with variations explicitly disclosed and some scope for derivatives classified as salts or prodrugs.

3. Can competitors develop similar compounds?

   Yes, but they must avoid infringing on the specific chemical substitutions or methods claimed unless they design-around the patent.

4. Is the patent still enforceable?

   Yes, with an expiration date around 2037, barring legal challenges or extensions.

5. How does this patent relate to similar patents?

   It forms part of a patent family with counterparts worldwide, with additional patents covering related compounds, synthesis methods, and uses.

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Sources:

[1] United States Patent and Trademark Office. Patent 9,604,948.
[2] European Patent Office. Patent family filings.
[3] Patent landscape analysis reports (industry-standard).

Drugs Protected by US Patent 9,604,948

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	9,604,948		Y	Y		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	9,604,948		Y	Y		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	9,604,948		Y	Y		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: 9,604,948

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	11190789	Nov 25, 2011
	11192301	Dec 7, 2011

International Family Members for US Patent 9,604,948

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	3898
Argentina	088983
Argentina	125027
Australia	2012342547