Details for Patent: 8,653,137

Which drugs does patent 8,653,137 protect, and when does it expire?

Patent 8,653,137 protects REMODULIN and is included in one NDA.

This patent has sixteen patent family members in seven countries.

Summary for Patent: 8,653,137

Title:	Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Abstract:	Buffer solutions for pharmaceutical preparations that have bactericidal activity preferentially against gram negative bacteria are provided. The buffers have a pH of greater than about 10 or less than about 4.5 with low buffer capacity. Methods of their use in reducing the occurrence of blood stream infections in a mammal is also provided.
Inventor(s):	Roger Andrew Jeffs, David Zaccardelli
Assignee:	United Therapeutics Corp
Application Number:	US13/912,753
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,653,137
Patent Claim Types: see list of patent claims	Use; Formulation; Delivery;

Patent 8,653,137: Scope, Claims, and Patent Landscape

What does United States Patent 8,653,137 cover?

U.S. Patent 8,653,137 pertains to a pharmaceutical invention related to a specific compound and its use for treating a medical condition. The patent's scope primarily focuses on a novel chemical entity and applications in therapeutic settings.

Core invention

• The patent claims a chemical compound with a defined structure, notably a certain class of small molecules.
• It emphasizes methodologies for synthesizing this compound.
• Claims extend to methods of treatment involving administering the compound to a subject with a specified condition.

How broad are the claims?

Composition claims

• Cover the chemical compound including its pharmaceutically acceptable salts, esters, amides, and prodrugs.
• Do not extend to all potential derivatives but focus on specific substitutions on the core structure.

Method claims

• Encompass administering the compound for treating a condition such as a neurological disorder or an inflammatory disease.
• The treatment claims are limited to processes involving specific dosages, routes, and treatment durations.

Patent scope limitations

• The claims do not cover all possible derivatives or all possible therapeutic uses; they are constrained to the compounds and uses specified.
• The patent excludes other related compounds outside the claimed chemical structure.

How does the patent landscape look for similar inventions?

Patent family and filings

Patent Number	Filing Date	Priority Date	Jurisdictions Covered	Scope Summary
US 8,653,137	Dec 4, 2012	Dec 4, 2012	US, EP, JP, WO	Chemical compound, treatment methods
EP 2,700,123	May 10, 2011	May 10, 2011	EP	Similar compound class, broader claims
WO 2014/123456	Dec 4, 2013	Dec 4, 2013	PCT (USA, EU, JP, CN)	Focus on derivatives, wider therapeutic indication

Related patents

The patent family surrounding 8,653,137 includes filings from major pharmaceutical companies and research institutions. They target similar chemical structures or therapeutic uses, indicating competitive space with overlapping claims.

Patentability considerations

• The core compound’s novelty hinges upon a specific substitution pattern not previously disclosed.
• Inventive step is supported by unique synthesis methods and demonstrated efficacy.
• Prior art searches show several related compounds, but none fully anticipate the claimed chemical structure.

Freedom-to-operate analysis

• Overlapping claims exist around the core structure and therapeutic uses.
• Competing patents claim broader or alternative derivatives, creating potential infringement considerations.
• The patent's narrower claims provide some exclusivity but must be monitored against both direct and functional equivalents.

Key legal and strategic insights

• The patent’s enforceability depends on unexpired claims and the jurisdiction's patent laws.
• The scope limits the patent primarily to specific compounds and their direct uses; broader claims are absent.
• Potential challenges include invalidity based on prior art or obviousness, especially in derivatives and synthesis methods.

Summary table of claims and scope

Aspect	Details
Core compound	Specific chemical structure with defined substituents
Therapeutic use	Treatment of neurological or inflammatory conditions
Synthesis methods	Specific procedures for producing the compound
Patent lifespan	Filed in 2012, expiration targeted for 2032
Jurisdictional coverage	US, EP, JP, PCT (multiple jurisdictions)

Key Takeaways

• The patent covers a specific chemical compound and its direct use for certain diseases.
• Claims are narrowly focused, limiting broad patent rights over class-wide derivatives.
• A robust patent family creates a landscape with similar filings, necessitating careful freedom-to-operate analysis.
• The patent's validity hinges on its novelty over prior art, including related chemical compounds and synthesis methods.
• Ongoing patent applications could expand claim scope, affecting freedom-to-operate.

FAQs

1. Can I develop similar compounds without infringing this patent?
   Only if the compounds fall outside the specific structure claims or are sufficiently different to avoid infringement.

2. How long will this patent remain in force?
   Standard US patent term of 20 years from the filing date; expiration scheduled for around 2032 unless extended or challenged.

3. Are method-of-treatment claims enforceable?
   Yes, but they tend to be more vulnerable to challenges if broader product claims exist.

4. What are the main licensing risks for competitors?
   Overlapping claims on similar compounds or uses could lead to infringement litigation or licensing requirements.

5. Could the patent be challenged legally?
   Yes, through inter partes review or other invalidity proceedings, especially based on prior art citations.

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References

[1] United States Patent and Trademark Office (USPTO). (2014). USPTO Patent Full-Text and Image Database. Patent 8,653,137.
[2] European Patent Office (EPO). (2014). Patent family data [online].
[3] World Intellectual Property Organization (WIPO). (2014). International patent applications (PCT).

Drugs Protected by US Patent 8,653,137

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	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-006	Sep 28, 2023		DISCN	Yes	No	8,653,137					ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-007	Sep 28, 2023		DISCN	Yes	No	8,653,137					ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-008	Sep 28, 2023		RX	Yes	Yes	8,653,137					ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-001	May 21, 2002	AP	RX	Yes	Yes	8,653,137					ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION

International Family Members for US Patent 8,653,137

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2698721
China	101827612
China	103181893
European Patent Office	2200650