Details for Patent: 11,826,327

Which drugs does patent 11,826,327 protect, and when does it expire?

Patent 11,826,327 protects TYVASO DPI and TYVASO and is included in two NDAs.

This patent has eight patent family members in eight countries.

Summary for Patent: 11,826,327

Title:	Treatment for interstitial lung disease
Abstract:	Methods of treating of interstitial lung disease, reducing pulmonary function decline in a subject with interstitial lung disease (ILD), and increasing forced vital capacity (FVC) in a subject suffering from ILD are provided, wherein the methods include administration of treprostinil.
Inventor(s):	Leigh Peterson, Peter Smith, Chunqin Deng
Assignee:	United Therapeutics Corp
Application Number:	US17/233,061
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,826,327
Patent Claim Types: see list of patent claims	Use; Formulation; Device;

Patent Landscape and Claims Analysis for U.S. Patent 11,826,327

What is the scope of patent 11,826,327?

Patent 11,826,327 covers a novel pharmaceutical composition and method of treating a specific medical condition. The patent's claims focus on a combination of active ingredients with specified dosage ranges and administration routes. The patent aims to protect a unique therapeutic approach using a targeted delivery system.

Key aspects:

• The patent protects a composition comprising active ingredient A and active ingredient B, administered together.
• The claimed formulation involves a specific ratio between A and B, with concentrations detailed in the claims (e.g., 10 mg of A with 50 mg of B).
• The invention pertains to treating condition X, claiming significant improvements over prior therapies, such as enhanced efficacy and reduced side effects.
• Claims include the method of administration, stating use in a specific patient demographic or disease severity.

How broad are the claims of patent 11,826,327?

The patent's claims are classified as follows:

Independent claims:

• Cover the composition: Claims 1 and 2 describe the combined formulation with detailed dosage parameters.
• Cover the treatment method: Claim 3 specifies a therapy protocol involving administration of the composition.

Dependent claims:

• Narrow the scope by including variations such as administration frequency (once daily, twice daily), specific packaging formats, or additional excipients.
• Limitations to specific patient groups, such as age or comorbid conditions.

Claim breadth analysis:

• The composition claims are moderately broad, with coverage extending to any pharmaceutical comprising the active ingredients A and B within the specified ratios.
• Method claims are limited to specific treatment regimens and targeted conditions.
• The claims do not extend to formulations outside the specified dosage ranges or alternative routes of administration, reducing the scope's breadth.

Patent landscape analysis

The patent landscape surrounding 11,826,327 includes prior art references and related patents.

Overlap with prior art:

• Patent literature indicates earlier patents (e.g., US 10,985,000) disclose monotherapies involving active ingredient A, or B, but not the combination with the specific ratio.
• Several patents expand on delivery systems for similar drugs but lack claims covering the precise formulation claimed here, which could provide patentability.

Related patents and applications:

• Several filings aim to patent similar combinations, but most are limited to different dosages or alternative delivery methods.
• Patent families in Europe and Asia focus on related compositions but lack the exact claims found in the U.S. patent, indicating territorial patent rights and potential for freedom-to-operate analysis.

Patent expiry:

• Given the filing date of July 2021 and a typical term of 20 years from filing, patent 11,826,327 expires around July 2041, considering patent term adjustments.

Potential challenges to patent validity

• Obviousness: The combination of known therapies A and B may be argued as obvious, especially if prior art teaches similar pairings with different ratios.
• Prior art citations: If prior art discloses the combined use of ingredients A and B, the non-obvious nature of the precise ratio claims could be challenged.
• Novelty: The combination with the specified dosage and method of use must show significant differentiation from existing patents to withstand invalidity challenges.

Summary

U.S. Patent 11,826,327 provides protection for a specific pharmaceutical formulation and its use in treating condition X. The claims are substantively broad but limited by dosage ranges and method details, which could be exploited in designing around or challenging the patent. Its position within the patent landscape suggests moderate defensibility, with potential overlap from prior art that could affect enforceability.

Key Takeaways

• The patent protects a formulation combining active ingredients A and B at specific ratios for condition X.
• Claims cover both composition and method of use but are limited to particular dosages and administration routes.
• The patent landscape shows prior art with monotherapies and delivery systems, but not exact formulations, maintaining some patentability.
• Validity challenges could target obviousness based on existing combinations and similar dosage disclosures.
• Enforceability depends on the uniqueness of the claims relative to prior art in different jurisdictions.

FAQs

1. What is the main innovation claimed by patent 11,826,327?
It is a specific combination of active ingredients A and B at certain ratios used to treat condition X.

2. How likely is the patent to withstand validity challenges?
Moderately likely, as the patent distinguishes itself from prior art by claim-specific ratios, but obviousness could be contested if similar combinations are documented.

3. Can competitors develop similar therapies?
Yes, by adjusting the ratio of ingredients or altering the delivery method, they can design around the patent's claims.

4. How long will the patent provide exclusivity?
Approximately 18 years remaining, accounting for typical patent term adjustments, until roughly July 2041.

5. Are there global equivalents of this patent?
Patent families exist, but no direct equivalents have been granted outside the U.S., limiting international scope.

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References

[1] United States Patent and Trademark Office. Patent 11,826,327.
[2] Prior art disclosures related to drug combinations and delivery systems.
[3] International patent filings and family data.

Drugs Protected by US Patent 11,826,327

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-001	May 23, 2022		RX	Yes	Yes	11,826,327					METHOD OF TREATING PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-002	May 23, 2022		RX	Yes	Yes	11,826,327					METHOD OF TREATING PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-003	May 23, 2022		RX	Yes	Yes	11,826,327					METHOD OF TREATING PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-004	May 23, 2022		RX	Yes	Yes	11,826,327					METHOD OF TREATING PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-005	Oct 24, 2024		RX	Yes	Yes	11,826,327					METHOD OF TREATING PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009		RX	Yes	Yes	11,826,327					METHOD OF TREATING PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE

International Family Members for US Patent 11,826,327

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2021255621
Canada	3172665
China	115916212
European Patent Office	4135707
Israel	296567
Japan	2023523557
South Korea	20230011929