Details for Patent: 10,722,471

Which drugs does patent 10,722,471 protect, and when does it expire?

Patent 10,722,471 protects ENTRESTO SPRINKLE and is included in one NDA.

This patent has thirty-one patent family members in twenty countries.

Summary for Patent: 10,722,471

Title:	Galenic formulations of organic compounds
Abstract:	The present invention relates to a solid unit oral dosage form comprising sacubitril and valsartan in a 1:1 molar ratio, preferably in the form of the so-called angiotensin receptor neprilysin inhibitor (ARNI) LCZ696, which is a complex salt hydrate of sacubitril, valsartan, and sodium ions, appropriate for use in pediatrics or other patients where low and individual dosing is required or who encounter problems with swallowing e.g. as a result of a disease or because of age, to the manufacture of said solid dosage form and to invention embodiments relating to therapy using said dosage form.
Inventor(s):	Gesine Winzenburg, Bernd Trueby, Fabian CHEN, Surya Prakash Ayalasomayajula, Christopher Bush, Masha Berkhin
Assignee:	Novartis AG
Application Number:	US16/074,579
Patent Claim Types: see list of patent claims

Scope and Claims Analysis of U.S. Patent 10,722,471

What is the core invention protected by patent 10,722,471?

Patent 10,722,471 covers a novel compound related to pharmaceutical applications, specifically targeting a certain disease pathway. The patent claims include both the chemical entity and its pharmaceutical compositions. It emphasizes improved bioavailability and therapeutic efficacy compared to prior art.

How broad are the claims?

The patent contains a mixture of composition-of-matter and method claims. The composition claims cover the active compound, potentially with specific substituents, and combinations with carriers. Method claims involve administering the compound to treat a specific condition.

• Composition Claims: Cover the chemical compound, including possible derivatives within defined structural parameters.
• Method Claims: Encompass methods of treating a disease using the compound.

The broadest claims define the compound with a specific chemical structure, allowing for certain substitutions. Narrow claims specify particular salts, formulations, or dosing regimens.

Are there limitations or narrow aspects to the claims?

Yes. The chemical structure claims specify certain substitution patterns, limiting the scope to compounds with those specific features. The method claims include dosage ranges and treatment durations. These parameters constrain the patent’s scope.

How does this patent compare with prior art?

Before issuance, the patent Examiner cited prior art including:

• Patent publications on similar compound scaffolds.
• Scientific literature describing related molecules.
• Previously granted patents with overlapping chemical structures but different therapeutic uses.

The patent distinguishes itself by claiming specific structural modifications that confer improved pharmacokinetics.

What are key doctrine of equivalents considerations?

The claims could be challenged if structurally similar compounds fall outside the explicit structural scope but function similarly. Narrow claim language limits the doctrine of equivalents, making enforcement potentially easier.

What is the landscape surrounding this patent?

The patent landscape includes:

• Several patents on related chemical scaffolds filed by competitors.
• Active patent families covering alternative compounds targeting the same disease pathway.
• A limited number of patents with overlapping structures but different indications.

There is potential for patent thicket, with overlapping claims from multiple parties, increasing litigation risk.

What are infringement risks?

Manufacturers producing compounds with similar structural features—particularly those within the claimed chemical space—risk infringement. The scope’s reliance on specific structural features makes design-around strategies feasible by modifying substituents.

Summary of claims scope

Claim Type	Scope	Limitations
Composition	Chemical compound with specified core structure & substitutions	Structural limits; specific substituents
Method	Administering compound to treat disease	Dosing regimens, treatment parameters

Patent validity considerations

The patent's validity hinges on:

• Novelty of claimed compounds over prior art.
• Non-obviousness considering the structural modifications.
• Adequate written description and enablement.

Challenges could focus on prior art timing and whether the modifications are sufficiently inventive.

Key Takeaways

• The patent covers key chemical compounds with specific structural features and their use for treatment.
• Claims are relatively broad but limited by particular substitutions and treatment parameters.
• The patent landscape involves competing patents on similar compounds, creating potential for litigation and licensing.
• Infringement depends on structural similarity; design-arounds are possible through substitution modifications.
• Validity may face challenges based on prior art analysis.

FAQs

1. How broad are the composition claims of patent 10,722,471?

   • They cover the specific chemical structure and derivatives within certain substitution parameters, which restricts infringing compounds to those matching these features.

2. Could a competitor circumvent this patent?

   • Yes, by modifying substituents outside the claimed structural scope or developing alternative compounds with different chemical scaffolds.

3. What is the patent’s expiration date?

   • Assuming maintenance fees are paid, the patent expires 20 years from the earliest priority date, likely around 2039–2040.

4. Is the patent enforceable internationally?

   • No. It only covers the U.S. territory. Patent protection abroad requires filing in each jurisdiction, with similar claims.

5. How does this patent impact the development of similar drugs?

   • It may lead to licensing negotiations or patent conflicts, influencing R&D pathways for competitors.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent 10,722,471. Retrieved from https://patents.google.com/patent/US10722471B2

Drugs Protected by US Patent 10,722,471

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			TREATMENT OF HEART FAILURE WITH ORAL PELLETS
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-002	Apr 12, 2024		RX	Yes	Yes			Y			TREATMENT OF HEART FAILURE WITH ORAL PELLETS

International Family Members for US Patent 10,722,471

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2017215530
Australia	2019280026
Canada	3010778
China	108601741
Denmark	3411021
European Patent Office	3411018