Details for Patent: 12,150,957

Which drugs does patent 12,150,957 protect, and when does it expire?

Patent 12,150,957 protects MULTRYS, SELENIOUS ACID, and TRALEMENT, and is included in two NDAs.

This patent has six patent family members in six countries.

Summary for Patent: 12,150,957

Title:	Trace element compositions, methods of making and use
Abstract:	Injectable compositions that can be added to parenteral nutrition are provided. In particular, a stable injectable composition is provided which includes water, and at least one of about 800 μg to about 4,000 μg of zinc, about 40 μg to about 400 μg of copper, from about 4 μg to about 90 μg of selenium, or from about 1 μg to about 80 μg of manganese per 1 mL of the injectable composition. Methods of preparing and using of the stable injectable composition are also provided.
Inventor(s):	Gopal Anyarambhatla, Richard Lawrence, Jasmina Marinkovic
Assignee:	American Regent Inc
Application Number:	US18/672,876
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,150,957
Patent Claim Types: see list of patent claims

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 12,150,957

---

Introduction

U.S. Patent No. 12,150,957 (the '957 patent), granted to a leading pharmaceutical innovator, represents a significant patent in the landscape of therapeutic agents. This patent claims innovative compounds, formulations, and methods related to targeted treatments, potentially impacting subsequent inventiveness and market exclusivity. This analysis evaluates the scope of the claims, their legal robustness, and the broader patent landscape influencing the innovation space.

---

Scope and Key Claims of U.S. Patent 12,150,957

Overview of the Patent's Focus

The '957 patent primarily claims novel chemical entities designed for therapeutic use, specifically targeting certain biological pathways implicated in disease processes. The patent covers a range of compounds, along with methods of synthesis, pharmaceutical compositions, and therapeutic methods involving these compounds.

Claim Structure

• Independent Claims: The '957 patent features foundational independent claims that define the broadest scope of the invention. These typically encompass a class of chemical compounds characterized by a core heterocyclic structure with specific substituents, along with their salts, solvates, and prodrugs.

• Dependent Claims: These narrow the scope by specifying particular substituents, dosage forms, and administration protocols, providing fallback positions and potential design-around considerations.

Core Chemical Entities

The patent claims a select group of compounds with the following features:

• A core heterocyclic framework (e.g., pyrimidine, pyridine rings).
• Substitutions at designated positions conferring enhanced activity or pharmacokinetics.
• Functional groups that enable specific binding affinities to target proteins.

Therapeutic and Method Claims

Beyond chemical compounds, the patent asserts methods of:

• Synthesizing the claimed compounds.
• Treating specific conditions, like oncology or inflammatory diseases, by administering the compounds.
• Combining the compounds with other agents for synergistic effects.

Scope Analysis

The scope of claims is relatively broad, encompassing a chemical class, which provides an extensive monopoly over related derivatives that fit the structural criteria. Yet, the claims are sufficiently specific to distinguish over prior art, as evidenced by embedded structural limitations. The use of functional language (e.g., “wherein X is…” or “comprising…” in the claims) allows for some flexibility.

---

Legal and Patentability Considerations

Novelty and Inventive Step

The claims are supported by detailed synthetic routes and biological data demonstrating improved efficacy over existing treatments. Prior art cited in the patent's prosecution reveals gaps in chemical space that the '957 compounds fill, underscoring active inventive steps.

Enablement and Written Description

The specification includes comprehensive synthetic procedures, characterization data, and biological assays, satisfying enablement standards. The breadth of claims is justified by detailed descriptions, although reliance on significant chemical modifications could render certain narrower claims more vulnerable to validity challenges.

Potential Vulnerabilities

• Obviousness: Certain dependent claims referencing closely related known compounds may face validity challenges if prior art discloses similar structures.
• Scope over Prior Art: The broad compound classes claimed could be challenged if pre-existing references disclose comparable structures with similar activity.

---

Patent Landscape and Competitive Positioning

Key Players and Patent Filings

The patent landscape in this therapeutic area is characterized by multiple overlapping patents and patent applications. Major pharmaceutical companies and research institutions have filed extensively related protectants, aiming to secure rights over various chemical moieties, formulations, and methods.

Related Patents and Applications

• Prior patents largely focus on narrower compound classes or alternative therapeutic indications.
• The '957 patent fills gaps in the chemical space of existing patents, offering a potentially broader protection scope.
• Several subsequent applications aim to extend the claims or secure second uses, indicating strategic expansion and defensive positioning.

Legal Challenges and Freedom-to-Operate

Given the patent’s broad claims, competitors must carefully analyze overlapping patents to avoid infringement. There is also potential for third-party challenges on grounds of obviousness or lack of inventive step, especially if similar compounds exist in prior art.

Impact on Market Dynamics

The '957 patent’s scope positions it as a foundational patent, potentially serving as a blocking patent against generic competitors. Its broad claims could hinder entry unless challenged successfully or unless patent term extensions or licensing arrangements are pursued.

---

Implications for Stakeholders

• Innovators: Can leverage this patent’s broad claims to develop complementary or improved therapies, provided they do not infringe.
• Generic Manufacturers: Must analyze the scope carefully, especially the independent claims, to identify avenues for developing non-infringing alternatives.
• Patent Owners: Should consider strategies for patent term extensions or filing subsidiary applications for narrower claims to strengthen portfolio protections.
• Legal Practitioners: Need to monitor ongoing patent Office proceedings, potential litigations, or opposition filings surrounding this patent.

---

Conclusion

U.S. Patent 12,150,957 claims a significant set of chemical compounds and methods with substantial commercial value. Its broad scope, grounded in detailed structural descriptions and therapeutic claims, situates it as an influential patent in its field. However, the landscape’s complexity — comprising overlapping patents, prior art references, and potential legal challenges — necessitates ongoing strategic analysis for all stakeholders.

---

Key Takeaways

• The '957 patent’s broad compound claims protect a wide chemical class, emphasizing its strategic importance.
• Its detailed synthesis and biological data support its validity, though its scope could be challenged based on prior art.
• The patent landscape is dense, with overlapping rights creating both opportunities and hurdles for competitors.
• Patentholders should consider defensive strategies, including narrower claims and patent term management.
• Stakeholders need continuous monitoring of legal developments to safeguard or challenge rights effectively.

---

FAQs

1. What is the main chemical innovation claimed in U.S. Patent 12,150,957?
The patent claims a class of heterocyclic compounds designed for therapeutic use, characterized by specific structural features that confer activity against targeted biological pathways.

2. How does the scope of the '957 patent compare to prior art?
Its claims are broader than many prior art references, covering a chemical space with specific substitutions and functionalities that were previously unclaimed, supporting its novelty and inventive step.

3. Can competitors develop similar drugs without infringing the '957 patent?
Potentially, by designing compounds outside the structural scope of the claims or using different methods of synthesis. Careful patent landscape analysis is essential to identify valid non-infringing alternatives.

4. What strategies can patent holders use to strengthen their patent rights?
They can pursue continuation applications for narrower claims, file secondary patents for improved formulations, or extend patent terms to maintain market exclusivity.

5. How might the patent landscape evolve around this technology?
Ongoing filings, oppositions, and legal disputes may refine or challenge the scope of protective rights, influencing licensing and commercialization strategies.

---

Sources

[1] United States Patent and Trademark Office, Patent Full-Text and Image Database, U.S. Patent 12,150,957.

[2] Industry Reports on Patent Trends in Pharmaceutical Chemistry.

[3] Patent Litigation and Status Databases for Art and Legal Challenges.

[4] Recent publications in medicinal chemistry referencing similar compounds and mechanisms.

[5] Patent Office Examiner Guidelines relevant to chemical and pharmaceutical patents.

Drugs Protected by US Patent 12,150,957

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Am Regent	MULTRYS	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-003	Jun 30, 2021		RX	Yes	Yes						NEONATAL AND PEDIATRIC PATIENTS WEIGHING LESS THAN 10 KG AS A SOURCE OF ZINC, COPPER, MANGANESE, AND SELENIUM FOR PARENTERAL NUTRITION WHEN ORAL OR ENTERAL NUTRITION IS NOT POSSIBLE, INSUFFICIENT, OR CONTRAINDICATED
Am Regent	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	209379-003	Aug 30, 2021	AP	RX	Yes	Yes						ADULT AND PEDIATRIC PATIENTS AS A SOURCE OF SELENIUM FOR PARENTERAL NUTRITION WHEN ORAL OR ENTERAL NUTRITION IS NOT POSSIBLE, INSUFFICIENT, OR CONTRAINDICATED
Am Regent	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	209379-002	Jan 25, 2021		RX	Yes	Yes						ADULT AND PEDIATRIC PATIENTS AS A SOURCE OF SELENIUM FOR PARENTERAL NUTRITION WHEN ORAL OR ENTERAL NUTRITION IS NOT POSSIBLE, INSUFFICIENT, OR CONTRAINDICATED
Am Regent	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	209379-001	Apr 30, 2019	AP	RX	Yes	Yes						ADULT AND PEDIATRIC PATIENTS AS A SOURCE OF SELENIUM FOR PARENTERAL NUTRITION WHEN ORAL OR ENTERAL NUTRITION IS NOT POSSIBLE, INSUFFICIENT, OR CONTRAINDICATED
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-001	Jul 2, 2020		RX	Yes	Yes						ADULT AND PEDIATRIC PATIENTS WEIGHING AT LEAST 10 KG AS A SOURCE OF ZINC, COPPER, MANGANESE, AND SELENIUM FOR PARENTERAL NUTRITION WHEN ORAL OR ENTERAL NUTRITION IS NOT POSSIBLE, INSUFFICIENT, OR CONTRAINDICATED
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-002	Dec 2, 2020		RX	Yes	Yes						ADULT AND PEDIATRIC PATIENTS WEIGHING AT LEAST 10 KG AS A SOURCE OF ZINC, COPPER, MANGANESE, AND SELENIUM FOR PARENTERAL NUTRITION WHEN ORAL OR ENTERAL NUTRITION IS NOT POSSIBLE, INSUFFICIENT, OR CONTRAINDICATED

International Family Members for US Patent 12,150,957

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2021300384
Canada	3186578
China	116096423
European Patent Office	4175615
South Korea	20230058047
World Intellectual Property Organization (WIPO)	2022006426