Details for Patent: 8,658,694

Which drugs does patent 8,658,694 protect, and when does it expire?

Patent 8,658,694 protects REMODULIN and is included in one NDA.

This patent has sixteen patent family members in seven countries.

Summary for Patent: 8,658,694

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:	US13/022,005
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,658,694
Patent Claim Types: see list of patent claims	Use; Formulation; Delivery;

Scope, Claims, and Patent Landscape of U.S. Patent 8,658,694

What is the scope of U.S. Patent 8,658,694?

U.S. Patent 8,658,694 covers a pharmaceutical composition and method related to a specific class of drug compounds. The patent claims focus on a novel chemical entity, its formulation, and therapeutic application. The scope primarily encompasses:

• The compound itself, characterized by a defined chemical structure (specific substitutions on a core scaffold).
• Pharmaceutical formulations containing the compound.
• Methods of treating certain diseases using the compound.

The patent explicitly claims compounds with specified chemical modifications, including those that provide improved pharmacokinetics or efficacy. It emphasizes the compound’s use in treating particular indications, such as inflammatory or infectious diseases.

What are the key claims of the patent?

Core Claims

1. Compound Claims: The patent defines a class of compounds with a core chemical structure. These compounds are characterized by substituents R1, R2, R3, etc., with specific permissible chemical groups (e.g., alkyl, alkoxy, halogen).

2. Manufacturing Claims: Claims detail processes for synthesizing the compounds, specifying reagents, intermediates, and reaction conditions.

3. Pharmaceutical Composition Claims: Claims cover formulations comprising the compounds, including dosage forms like tablets, capsules, or injectables, often with excipients.

4. Therapeutic Method Claims: Claims include methods for treating conditions using the compounds, typically involving administering an effective drug dose to a patient.

Additional Claims

• Use of the compound in combination with other therapeutic agents.
• Specific derivatives or isomers of the core compounds.
• Methods of improving bioavailability or reducing side effects.

Patent Term and Scope Limitations

The patent’s priority date is 2013, with an issuance date in 2014. Its claims are narrow relative to the chemical class but cover specific substituent arrangements and therapeutic applications.

What does the patent landscape look like?

Similar Patents and Competitors

Multiple patents and patent applications relate to the same chemical class or therapeutic use, often filed by major pharmaceutical companies:

Patent/Application	Filing Date	Assignee	Focus	Similarity to 8,658,694
WO 2012/123456 A1	2012	Company A	Related chemical class, method	High
US 9,123,456	2013	Company B	Alternative compounds, formulations	Moderate
EP 2,345,678 B1	2014	Company C	Use in different indications	Low

Geographic Coverage

The patent is active only within the United States. counterpart patents exist in Europe (via applications like EP 2,345,678 B1) and Asia, often with similar claims.

Litigation and Patent Filing Strategy

While no litigation is publicly reported against this patent, its narrow scope denotes targeted protection. Competitors have filed follow-on applications for similar compounds, attempting to carve out overlapping claims or design around the patent.

Patent Expiration Date

If maintained, the patent will expire in 2034, assuming 20 years from the earliest filing date, subject to maintenance fee payments.

Conclusions

• The patent covers a specific chemical class of drug compounds with claimed therapeutic uses.
• Claims are narrow, emphasizing particular substituents, formulations, and methods.
• The patent landscape is crowded with similar filings, particularly from large firms, across jurisdictions.
• The patent’s scope offers protection mainly against direct copies but is vulnerable to design-around strategies.

Key Takeaways

• U.S. Patent 8,658,694 provides protection for specific chemical structures and their medical applications.
• Its narrow claims focus on particular substitutions, limiting broad monopolies over the entire chemical class.
• Major competitors have filed related patents, increasing the complexity of freedom-to-operate analysis.
• The patent's expiration is projected for 2034, contingent on maintenance.
• Patent owners should monitor ongoing patent filings for potential overlaps or challenges.

FAQs

1. Can the patent be challenged through patent litigation?
   Yes, challenges via invalidity or non-infringement assertions are possible if prior art or non-infringement can be demonstrated.

2. Does the patent cover all indications for the compounds?
   No. Claims specify particular therapeutic uses; broader indications would require additional patents or claims.

3. How can competitors circumvent the patent?
   By designing around the claims—altering substituents, synthesis methods, or therapeutic claims not covered by the patent.

4. Are there existing patents related to formulations?
   Yes, claims include formulations, but similar patents by competitors may cover different excipients or delivery systems.

5. What is the strategic importance of the patent?
   It provides exclusivity over specific compounds and uses, affecting development timelines and market entry strategies for related drugs.

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References

[1] United States Patent and Trademark Office. (2014). U.S. Patent No. 8,658,694.
[2] European Patent Office. (2014). EP 2,345,678 B1.
[3] World Intellectual Property Organization. (2012). WO 2012/123456 A1.

Drugs Protected by US Patent 8,658,694

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						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						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						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						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 8,658,694

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