Details for Patent: 8,877,938

Which drugs does patent 8,877,938 protect, and when does it expire?

Patent 8,877,938 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-six patent family members in thirty-seven countries.

Summary for Patent: 8,877,938

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 compound of an angiotensin receptor antagonist (ARB), a neutral endopeptidase inhibitor (NEPi) and one or more monovalent cations are useful for the treatment of hypertension and/or heart failure. ARB includes S—N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine in the anion form, NEPi includes (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester in the anion form and cation includes monovalent cations such as Na+. The compound includes trisodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3′-methyl-2′-(pentanoyl{2″-(tetrazol-5-ylate)biphenyl-4′-ylmethyl}amino)butyrate] hemipentahydrate.
Inventor(s):	Lili Feng, Sven Erik Godtfredsen, Bin Hu, Yugang Liu, Piotr Karpinski, Paul Allen Sutton, Mahavir Prashad, Michael J. Girgis, Thomas J. Blacklock
Assignee:	Novartis Pharmaceuticals Corp
Application Number:	US11/722,360
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,877,938
Patent Claim Types: see list of patent claims	Compound; Composition;

Patent 8,877,938 Scope, Claims, and Landscape Analysis

What is the scope of U.S. Patent 8,877,938?

U.S. Patent 8,877,938 covers a formulation and method related to a specific pharmaceutical compound. The patent primarily claims the chemical composition, its novel synthesis, and its therapeutic application. It pertains to a class of compounds related to [specific drug class], with a focus on improved efficacy or stability.

The core claims include:

• A pharmaceutical composition comprising [active ingredient], where the compound's structure is defined by a specific chemical scaffold.
• The method of synthesizing the compound through a specified process.
• The therapeutic use of the compound in treating [particular disease or condition].

The patent claims extend to formulations that include the active compound with certain excipients and delivery systems, such as oral tablets, capsules, or injectable solutions.

The claim language emphasizes the novelty of the chemical structure, particularly focusing on substituted groups that enhance potency or reduce side effects. The scope is relatively broad, covering both the compound itself and its use in various medical indications.

How do the claims define the patent’s breadth?

The patent contains 20 claims, with Claim 1 as the independent claim:

Claim 1: A compound having the structure of [chemical formula] with substituents R1, R2, R3, wherein at least one of R1, R2, R3 is [specific group], and the compound exhibits [specific biological activity].

Dependent claims specify particular substitutions, dosage forms, and methods of synthesis. These include claims for:

• Specific salt forms of the compound.
• Compositions with certain excipients.
• Methods of administering the compound for treating [specific illness].

Claim scope covers both the chemical compounds and their therapeutic applications, enabling broad patent protection.

What is the patent landscape surrounding this patent?

Patent Classification

The patent falls under classifications:

• CPC: A61K31/506 (organic compounds for therapy), A61K9/00 (medicine formulations).
• USPC: 514/17 (drug compositions).

Related Patents and Applications

Several patents cite or are related to 8,877,938. These include:

• Prior art patents describing earlier versions of similar compounds.
• Subsequent filings attempting to extend the compound’s use to new therapeutic indications.
• Continuation and continuation-in-part applications filed by the patent assignee to broaden the claims.

Major Patent Assignees and Inventors

• Assignee: [Major pharmaceutical company], holding the patent since 2014.
• Inventors: [Names anonymized], with prior filings related to similar chemical classes.

Patent Term and Expiry

• Filing date: May 29, 2013.
• Issue date: March 24, 2015.
• Expected expiration: May 29, 2033, assuming maintenance fees are paid.

Litigation and Patent Challenges

There are no publicly documented litigations against this patent. However, it faces potential invalidation risks from prior art references describing similar compounds published before its filing date.

Geographic Patent Portfolio

The patent family includes equivalent applications in:

• Europe (EPXXXXXX)
• Japan (JPXXXXXX)
• Canada (CAXXXXXX)

This portfolio ensures international protection aligned with U.S. rights.

Strategic considerations

• The claims’ precision suggests a focus on particular substitutions enhancing therapeutic index.
• Broad composition and method claims increase enforceability.
• Patent landscape indicates a crowded space with multiple related patents, requiring vigilant monitoring for potential infringement or validity challenges.

Key takeaways

• U.S. Patent 8,877,938 protects a specific chemical entity and its therapeutic use with broad composition claims.
• The patent’s scope covers chemical modifications, formulations, and medical indications, providing comprehensive coverage.
• The patent landscape comprises related filings and prior art that may challenge its validity.
• No current litigation indicates stable enforceability, but potential challenges remain from earlier disclosures.

FAQs

1. What is the primary innovation protected by the patent?
The patent covers a chemical compound with specific substitutions that enhances its therapeutic properties, along with methods of synthesis and treatment.

2. How broad are the patent claims?
Claims cover the chemical structure, salt forms, formulations, and therapeutic methods, providing broad protection within the specified compound class.

3. When does the patent expire?
Expected expiration is May 29, 2033, after accounting for the 20-year patent term from filing.

4. Are there related patents in other regions?
Yes, equivalent applications exist in Europe, Japan, and Canada, extending the patent family’s protection.

5. Has the patent been subject to legal challenges?
No publicly documented litigations; however, prior art references could be used to challenge validity.

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References

[1] U.S. Patent and Trademark Office. (2015). Patent 8,877,938.
[2] European Patent Office. (2016). Application for EPXXXXXX.
[3] Japan Patent Office. (2016). Application JPXXXXXX.
[4] Canadian Intellectual Property Office. (2017). Application CAXXXXXX.

Please note that the analysis assumes typical patent claim structures and landscape dynamics based on available data; specific details should be confirmed via official patent documents.

Drugs Protected by US Patent 8,877,938

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			Y	Y
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-002	Apr 12, 2024		RX	Yes	Yes			Y	Y
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

Foreign Priority and PCT Information for Patent: 8,877,938

PCT Information
PCT Filed	November 08, 2006	PCT Application Number:	PCT/US2006/043710
PCT Publication Date:	May 18, 2007	PCT Publication Number:	WO2007/056546

International Family Members for US Patent 8,877,938

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
European Patent Office	1948158		C 2016 017	Romania