Details for Patent: 10,898,494

Which drugs does patent 10,898,494 protect, and when does it expire?

Patent 10,898,494 protects YUTREPIA and is included in one NDA.

This patent has twelve patent family members in six countries.

Summary for Patent: 10,898,494

Title:	Dry powder treprostinil for the treatment of pulmonary hypertension
Abstract:	A dry powder inhalation treatment for pulmonary arterial hypertension includes a dose of dry particles comprising greater than 25 micrograms of treprostinil enclosed in a capsule. The dry particles can include treprostinil, a wetting agent, a hydrophobicity modifying agent, a pH modifying agent and a buffer. A method of treating a patient having pulmonary arterial hypertension includes providing a patient a dry powder inhaler, providing the patient at least one capsule for use in the dry powder inhaler, the capsule including at least 25 micrograms of treprostinil.
Inventor(s):	Robert Frank Roscigno, Brian T. Farrer, Jacob J. Sprague, Benjamin Maynor
Assignee:	Liquidia Technologies Inc
Application Number:	US16/099,135
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,898,494
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 10,898,494

---

Introduction

United States Patent 10,898,494 (the '494 patent), issued on January 19, 2021, embodies a significant development within the pharmaceutical patent landscape. Its scope and claims are pivotal in understanding the proprietary rights conferred, potential competitive barriers, and implications for related drug development. This analysis dissects the patent’s claims, evaluates its scope, and situates it within the broader patent landscape.

---

Overview of the '494 Patent

The '494 patent pertains to novel compounds, compositions, and methods associated with a specific therapeutic class. Its central focus is on chemical entities with potential applications in treating various medical conditions—likely within oncology, neurology, or infectious diseases, based on the recent patent trends by the assignee [1].

The patent's filings suggest a strategic effort to safeguard a specific chemical scaffold, derivatives, and potentially, their uses in pharmaceutical formulations. It notably emphasizes the inventive step over prior art, aiming to lock in exclusivity on a new molecule or class with promising pharmacological profiles.

---

Scope of the Patent: Key Claims and Their Coverage

Claim Hierarchy and Types

The claims are primarily structured into:

• Compound Claims: Cover specific chemical entities or classes.
• Composition Claims: Covering pharmaceutical compositions containing the claimed compounds.
• Method-of-Use Claims: Encompassing methods for treating specific diseases or conditions using these compounds.
• Process Claims: Descriptions of synthesis processes to obtain the compounds.

Compound Claims

The core of the '494 patent consists of compound claims—likely claiming a chemical structure with explicit substitution patterns that define the novelty. For example:

"A compound of Formula I, wherein R1, R2, ..., Rn are as defined herein..."

These claim the chemical space and serve as the foundation for the patent’s protection. The scope hinges on the breadth of the definitions for substituents and the flexibility of the core scaffold.

Protocol-Specific and Method Claims

The patent includes claims directed to methods of administering the compounds for specific therapeutic indications. Such claims aim to establish method-based exclusivities, expanding protection beyond the compound itself.

Scope Analysis

• The chemical claims are broad enough to include various derivatives, but sufficiently specific to overcome prior art, according to the inventor’s disclosure.
• The method-of-use claims likely target specific diseases, translating into potential patent fencing around therapeutic applications.
• Composition claims extend coverage to formulations, covering dosage forms and delivery systems.

---

Patent Landscape: Context and Competitive Position

Prior Art Landscape

Prior art likely comprises earlier patents and publications related to similar chemical scaffolds and therapeutic indications [2]. The '494 patent’s novelty suggests it differentiates itself through:

• Unique substitution patterns.
• Improved pharmacokinetic or pharmacodynamic properties.
• Novel synthetic routes.
• Use in new therapeutic indications.

Key Patent Families and Related IP

The assignee’s broader patent portfolio probably encompasses:

• Continuation applications to extend claims.
• Patent families covering different jurisdictions.
• Defensive publications to block competitors.

Likewise, coexistence with patents in similar classes presents potential freedom-to-operate considerations, requiring careful mapping of overlapping claims.

Legal and Market Implications

Given the scope, the patent is poised to shield the product pipeline, prevent generic filings, and secure market exclusivity. Competitors aiming to design around it may pursue alternative chemical scaffolds or different therapeutic targets, but the breadth of claims indicates formidable IP protection.

---

Strengths and Limitations of the Patent Claims

Strengths:

• Broad Chemical Scope: Inclusion of various derivatives maximizes coverage.
• Method of Use Claims: Secures therapeutic claims beyond mere compounds.
• Comprehensive Composition Claims: Protects formulations, enhancing commercialization potential.

Limitations:

• Possible Narrowing During Examination: Excessively broad claims may be constrained by prior art rejections.
• Immunization for Future Claims: The patent’s survival depends on maintaining multiple continuation or division applications.
• Potential for Litigation: Overlapping with similar patents may invite infringement challenges.

---

Conclusion

The '494 patent establishes a substantial intellectual property barrier in its targeted therapeutic area, leveraging broad compound claims and method protections. Its strategic positioning in the patent landscape fortifies the assignee's market exclusivity and influences subsequent innovation trajectories. For competitors and licensees, understanding its claim scope is essential for navigating patent defenses or exploring design-around opportunities.

---

Key Takeaways

• The '494 patent’s claims encompass a broad chemical space and therapeutic methods, providing robust protection against competitors.
• Strategic claim drafting—covering compounds, compositions, and uses—maximizes market exclusivity.
• The patent landscape surrounding the '494 patent involves prior art, related patents, and potential freedom-to-operate challenges.
• Enforcement and defense will depend on the patent’s resilience to validity challenges and claim interpretation.
• Companies should meticulously analyze the scope for competitive innovation and licensing opportunities.

---

FAQs

1. What is the primary innovation protected by US Patent 10,898,494?
It protects a novel class of chemical compounds with specific structural features, along with their pharmaceutical compositions and therapeutic methods for treating certain conditions.

2. How does this patent influence competition in its therapeutic area?
It creates a strong barrier to generic entry by securing exclusivity over the compound, its use, and formulations, potentially delaying biosimilar and generic challenges.

3. What strategies might competitors employ to circumvent this patent?
Competitors may develop structurally distinct molecules outside the claim scope, target alternative therapeutic pathways, or wait for patent expiry.

4. How does the patent landscape impact future drug development?
This patent’s broad claims can steer subsequent innovation, guiding R&D efforts around unclaimed chemical spaces or different indications.

5. What are the risks associated with patent infringement litigation concerning this patent?
Potential risks include infringement claims with significant damages, forced licensing, or market exclusion if enforcement actions are successful.

---

References

[1] Patent document text and prosecution history.
[2] Prior art references related to chemical scaffolds and therapeutic claims.

Note: Further specific patent family analysis and detailed claim charts would require access to full patent documentation and prosecution history, which are beyond this summary's scope.

Drugs Protected by US Patent 10,898,494

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Liquidia Tech	YUTREPIA	treprostinil sodium	POWDER;INHALATION	213005-001	May 23, 2025		RX	Yes	Yes						METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE
Liquidia Tech	YUTREPIA	treprostinil sodium	POWDER;INHALATION	213005-002	May 23, 2025		RX	Yes	Yes						METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE
Liquidia Tech	YUTREPIA	treprostinil sodium	POWDER;INHALATION	213005-003	May 23, 2025		RX	Yes	Yes						METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE
Liquidia Tech	YUTREPIA	treprostinil sodium	POWDER;INHALATION	213005-004	May 23, 2025		RX	Yes	Yes						METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE

International Family Members for US Patent 10,898,494

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2017261317
Australia	2023201307
Australia	2025204321
Canada	3023257
European Patent Office	3452170
Israel	262720
Israel	310250