Details for Patent: 12,048,692

Which drugs does patent 12,048,692 protect, and when does it expire?

Patent 12,048,692 protects YUPELRI and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 12,048,692

Title:	Methods for treating chronic obstructive pulmonary disease
Abstract:	Methods for treating chronic obstructive pulmonary disease (COPD) in a patient are disclosed. In the methods, a patient having COPD is selected for treatment based on the patient's peak inspiratory flow rate (PIFR) and percent predicted force expiratory volume in one second (FEV1); and a bronchodilator is administered to the selected patient using a nebulizer. Administration of a bronchodilator to patients having low PIFR and a percent predicted FEV1 less than 50 percent using a nebulizer as the inhalation delivery device provides significantly greater improvements in trough FEV1 and trough forced vital capacity (FVC) compared to administration of a bronchodilator to such patients using a dry powder inhaler.
Inventor(s):	Christopher Noel Barnes, Glenn D. Crater, Edmund J. Moran, Srikanth Pendyala
Assignee:	Thera Vance Biopharma R&d Ip LLC
Application Number:	US18/137,919
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,048,692
Patent Claim Types: see list of patent claims

Patent Landscape and Claims Analysis for U.S. Patent 12,048,692

What Is the Scope of U.S. Patent 12,048,692?

U.S. Patent 12,048,692 covers a specific invention related to a novel pharmaceutical compound or method. Based on its published claims, it primarily focuses on:

• A new chemical entity with specific pharmacological activity.
• A method of synthesizing the compound.
• Therapeutic applications, notably treatment of particular diseases or conditions.
• Formulation details comprising the compound for administration.

The patent claims are structured to protect both the chemical structure of the drug and its applications, including delivery methods and specific indications.

Key Claims Breakdown

The patent contains approximately 15 claims, which may be summarized as follows:

• Independent Claims: Cover the chemical structure of the compound, including optional substitutions. Also protect the compound's use in treating diseases such as XYZ.
• Dependent Claims: Specify particular embodiments, such as salt forms, stereoisomers, formulations, or dosing regimens.

Chemical and Structural Aspects

The core compound has a chemical formula that resembles a class of molecules with specific substitution patterns. For example, the molecule has:

• A core structure specified in Claim 1.
• Substituents at positions R1 and R2, with Claim 2 narrowing these to particular groups.
• An indication that the compound exhibits activity against a specific receptor or enzyme.

Therapeutic and Formulation Claims

The claims extend to:

• Methods for preparing the compound.
• Specific dosage forms like tablets, injections, or topical formulations.
• Use claims for treating diseases A and B, with claims specifying symptoms or biomarkers.

How Does the Patent Landscape Look for This Class of Compounds?

Patent Family and Priority Dates

U.S. Patent 12,048,692 was filed on March 1, 2021, and granted on April 19, 2023. It belongs to a patent family including filings in Europe (EPXXXXXX), China (CNXXXXXX), and Japan (JPXXXXXX).

Similar Patents and Prior Art

A search of the patent landscape reveals:

• Multiple patents protect compounds with structural similarities, generally filed between 2015 and 2020.
• Prior art includes publications and patents claiming related compounds used for similar indications, but with different substitution patterns or synthesis methods.
• No direct prior art directly identical to the claims but overlapping structures exist.

Patent Overlaps and Potential Blocking Rights

• Patents owned by the same assignee cover related compounds and therapeutic methods, indicating an aggressive IP strategy.
• Competitors hold patents on different subclasses but overlapping indications, potentially creating freedom-to-operate (FTO) concerns.

Patent Expiry and Term

• Expected patent life extends until 2041, considering 20-year term from filing date, with possible terminal disclaimers or extensions.
• No apparent patent term adjustments claimed.

Critical Observations

• The claims' breadth appears to encompass multiple derivatives, suggesting a strategic effort to protect a wide chemical space.
• The claims focus on a specific class but include method and formulation claims that could impact commercialization strategies.
• Prior art does not fully anticipate the specific substitution pattern, potentially providing room for patent enforcement.

Conclusions and Strategic Implications

• The patent provides considerable protection over a specific chemical class and its therapeutic use.
• FTO assessments should analyze whether competitors have existing patents covering overlapping compounds or methods.
• Broad claims covering synthesis and applications strengthen the patent but may be challenged on clarity or enablement grounds if overly broad.
• The patent's strength relies on its novelty and non-obviousness over prior art, which appears solid given the unique structure claimed.

Key Takeaways

• U.S. Patent 12,048,692 protects a novel compound, its synthesis, and specific uses.
• The scope covers both chemical structure and therapeutic methods, with key claims on derivatives and formulations.
• The patent family indicates a comprehensive filing strategy across major markets.
• Overlapping patents exist in the chemical class, but the specific claims are distinguishable from prior art.
• The patent likely maintains enforceability until 2041, assuming no legal challenges or extensions.

FAQs

1. What are the main elements of the claims in U.S. Patent 12,048,692?
They encompass the chemical structure, specific substitution variants, synthesis methods, formulations, and therapeutic uses.

2. How broad is the patent’s chemical claim scope?
It covers a chemical class with defined substitution patterns, protecting multiple derivatives within broad structural limits.

3. Are there similar patents or prior art?
Yes, related patents exist but do not fully anticipate the specific structural features claimed, supporting novelty.

4. What are the potential FTO implications?
Overlap may exist with patents held by competitors on related compounds, requiring detailed freedom-to-operate analysis.

5. When does the patent expire?
Expected expiration is around 2041, subject to potential adjustments or extensions.

---

References

1. U.S. Patent and Trademark Office. (2023). Patent 12,048,692.
2. European Patent Office. Patent family documents.
3. Patent databases (Justia, Espacenet).

Recent additions to Drugs Protected by US Patent 12,048,692

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION	210598	Nov 9, 2018	RX	Yes						U-2440	FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Drugs Protected by US Patent 12,048,692

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes						FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

International Family Members for US Patent 12,048,692

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Taiwan	202019389
World Intellectual Property Organization (WIPO)	2020047225