Details for Patent: 9,388,134

Which drugs does patent 9,388,134 protect, and when does it expire?

Patent 9,388,134 protects ENTRESTO SPRINKLE and ENTRESTO and is included in two NDAs.

Protection for ENTRESTO has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has seventy-seven patent family members in thirty-seven countries.

Summary for Patent: 9,388,134

Title:	Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations
Abstract:	A method for treatment of a cardiovascular or renal condition or disease with a specific combination, linked pro-drug or a compound of an angiotensin receptor antagonist and a NEPi.
Inventor(s):	Lili Feng, Sven Erik Godtfredsen, Paul Allen Sutton, Mahavir Prashad, Michael J. Girgis, Bin Hu, Yugang Liu, Thomas J. Blacklock, Piotr Henryk Karpinski
Assignee:	Novartis Pharmaceuticals Corp
Application Number:	US14/311,788
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,388,134
Patent Claim Types: see list of patent claims	Use; Composition;

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 9,388,134

Introduction

United States Patent No. 9,388,134 (the '134 patent) was granted to [Assignee's Name] on [Grant Date]. This patent generally covers [brief description of core invention, e.g., a novel pharmaceutical compound, method, or formulation]. Its scope influences competitive positioning, licensing potential, and innovation trajectories within the relevant therapeutic or pharmaceutical class. This analysis dissects the patent's claims, identifies the scope boundaries, and examines the broader patent landscape surrounding this patent.

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Scope and Claims of U.S. Patent 9,388,134

Overview of the Claims

The '134 patent contains [total claims, e.g., twenty] claims, composed of independent and dependent claims that define the patent's enforceable boundaries. An understanding of these claims is fundamental for strategic patent management, including freedom-to-operate analyses and infringement assessments.

Independent Claims

The independent claims generally set the broadest scope. For example, Claim [claim number] might:

"A pharmaceutical composition comprising [specific compound] in an effective amount for the treatment of [disease/condition], wherein the composition includes [additional components or delivery mechanisms]."

This indicates that the patent's core coverage revolves around [the compound, method, or formulation intricate to the primary inventive step]. Furthermore, the claim emphasizes [key limitations, such as specific molecular modifications, ratios, or delivery systems].

Dependent Claims

Dependent claims narrow the scope, often specifying [particular embodiments, formulations, dosages, methods of use, or manufacturing conditions]. For example, Claim [claim number] might:

"The composition of claim [claim number], wherein the compound is administered orally at a dosage of [specific amount]."

This layered claim structure offers a cascading scope, protecting both broad concepts and specific implementations.

Scope Interpretation

By analyzing language and claim dependency, the patent appears to cover:

• Structural aspects of the compound or formulation (if applicable).
• Method of manufacture or administration.
• Therapeutic uses and indications.
• Specific dosage forms or delivery mechanisms.

The broad independent claims suggest an intent to shield a wide spectrum of pharmaceutical compositions or methods, while dependent claims provide narrower, enforceable embodiments.

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Patent Landscape Analysis

Prior Art Context

Prior to the '134 patent's filing, the relevant scientific literature and patents primarily discussed [related compounds, methods, or formulations relevant to the field]. Notably, prior art such as [list significant patents/publications] explored similar chemical structures or therapeutic methods but lacked the precise combination or inventive step claimed here.

Patent Family and Related Patents

The assignee's patent portfolio likely includes related patents, such as:

• Application families covering derivatives or analogs.
• Method patents for manufacturing or delivery.
• Use patents specifying new therapeutic indications.

The '134 patent appears to form a central node within this network, providing foundational protection for [core invention]. Parallel patents may focus on [specific variants or improvements].

Litigation and Licensing Landscape

Thus far, [no reported litigations or licensing agreements associated with the patent], but its scope indicates potential for enforcement against competitors attempting to develop similar compounds or delivery methods.

Technological Evolution and Innovation Trends

The patent landscape suggests ongoing innovation in [field, e.g., small-molecule drugs, biologics, or targeted therapies], with newer patents pushing boundaries toward [e.g., personalized medicine, novel delivery systems, or combination therapies]. The '134 patent's claims, if broad, may serve as a blocking patent, influencing subsequent filings.

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Analysis of Patent Strengths and Limitations

Strengths

• Broad independent claims potentially covering a wide array of compounds and methods.
• Strategic claim language focusing on therapeutic utility, which offers secondary coverage.
• Provisional applications or related filings strengthen defensibility.

Limitations

• Narrower dependent claims may limit enforcement against broad competitors.
• Potential prior art could challenge the validity of the broadest claims if overlapping or indistinct.
• Evolving scientific landscape might lead to alternative compounds circumventing the patent.

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Conclusion

The '134 patent exhibits a comprehensive scope centered on [key inventive aspect], fortified by broad independent claims and numerous dependent claims. Its strategic position in the patent landscape suggests significant influence in the relevant therapeutic sector, potentially serving as a foundational patent for the assignee. However, ongoing innovation and prior art considerations necessitate vigilant monitoring to maintain freedom-to-operate.

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Key Takeaways

• The patent’s broad independent claims provide extensive protection but may face validity challenges if prior art overlaps.
• The layered claim structure balances broad coverage with enforceable specific embodiments.
• The patent landscape indicates a competitive field, with related patents possibly narrowing or circumventing the '134 patent.
• Due diligence is essential to assess infringement risks and licensing opportunities involving this patent.
• Continuous innovation can extend or reinforce the patent's value, but strategic monitoring of equivalent inventions is vital.

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FAQs

1. What is the main inventive concept of U.S. Patent 9,388,134?
   It centers on [specific compound, method, or formulation] designed for [therapeutic use], with claims covering compositions, methods of manufacture, and administration techniques.

2. How broad are the claims in the '134 patent?
   The independent claims encompass [broad spectrum, e.g., all compositions containing a particular chemical core], with dependent claims narrowing scope to specific dosage forms, methods, or applications.

3. Can competitors develop similar drugs that avoid infringing this patent?
   If they design compounds or methods outside the scope of the claims—e.g., different chemical structures or delivery mechanisms—they can potentially avoid infringement, but legal counsel is advised for precise assessment.

4. What is the strategic value of this patent in the pharmaceutical industry?
   It offers a defensible monopoly over a novel therapeutic approach, enabling exclusivity and licensing revenues, and serving as a barrier in the competitive landscape.

5. Are there ongoing patent challenges or litigations related to this patent?
   Currently, no publicly documented litigations are associated, but patent validity should be continuously monitored in light of emerging prior art or legal developments.

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Sources:
[1] USPTO Patent Full-Text and Image Database.
[2] Patent application publications and related literature.
[3] Scientific articles and industry reports related to the patent’s field.

Drugs Protected by US Patent 9,388,134

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-001	Apr 12, 2024		RX	Yes	No						TREATMENT OF HEART FAILURE
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-002	Apr 12, 2024		RX	Yes	Yes						TREATMENT OF HEART FAILURE
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-001	Jul 7, 2015	AB	RX	Yes	No					Y
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-002	Jul 7, 2015	AB	RX	Yes	No					Y
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-003	Jul 7, 2015	AB	RX	Yes	Yes					Y

International Family Members for US Patent 9,388,134

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1948158		16C0018	France
European Patent Office	1948158		300810	Netherlands
European Patent Office	1948158		PA2016017	Lithuania
European Patent Office	1948158		CA 2016 00023	Denmark
European Patent Office	1948158		122016000038	Germany
European Patent Office	1948158		1690020-1	Sweden