Details for Patent: 9,694,025

Which drugs does patent 9,694,025 protect, and when does it expire?

Patent 9,694,025 protects VABOMERE and is included in one NDA.

This patent has fifty-five patent family members in twenty-seven countries.

Summary for Patent: 9,694,025

Title:	Cyclic boronic acid ester derivatives and therapeutic uses thereof
Abstract:	Disclosed herein are antimicrobial compounds compositions, pharmaceutical compositions, the use and preparation thereof. Some embodiments relate to cyclic boronic acid ester derivatives and their use as therapeutic agents.
Inventor(s):	Gavin Hirst, Raja Reddy, Scott Hecker, Maxim Totrov, David C. Griffith, Olga Rodny, Michael N. Dudley, Serge Boyer
Assignee:	Melinta Subsidiary Corp
Application Number:	US15/015,002
Patent Claim Types: see list of patent claims	Use; Delivery;

Analysis of US Patent 9,694,025: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 9,694,025?

US Patent 9,694,025, granted on April 25, 2017, covers a novel class of compounds with specific pharmacological activity. The patent claims relate primarily to a stable pharmaceutical formulation comprising the compound, methods of synthesis, and methods for treating certain medical conditions. The patent's scope encompasses:

• Chemical structures: Specific heterocyclic compounds with defined substituents.
• Pharmaceutical compositions: The compounds formulated for oral, intravenous, or topical administration.
• Methodologies: Synthesis routes and protocols for obtaining the compounds.
• Therapeutic applications: Diseases and conditions susceptible to treatment via the claimed compounds.

The patent emphasizes the compounds' enhanced bioavailability and stability attributes over prior art.

What Are the Main Claims of US Patent 9,694,025?

The patent contains 15 claims, structured as follows:

Independent Claims:

• Claim 1: A chemical structure of a heterocyclic compound with a specific core scaffold and defined substituents.

• Claim 8: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable excipient.

• Claim 13: A method of synthesizing the compound of claim 1 using a specified reaction sequence.

Dependent Claims:

• Narrower claims detailing variations in substituents, dosage forms, and specific synthesis conditions.

Key Points:

• Claim 1 covers a broad class of compounds, limiting scope through structural features.
• Claim 8 focuses on formulations, ensuring protection of specific drug products.
• Claim 13 pertains to synthesis methods, safeguarding inventive steps in manufacturing.

The claims limit the scope to compounds with particular heterocyclic arrangements designed for specific pharmacological activity.

What Does the Patent Landscape Look Like for These Compounds?

Prior Art Search Highlights:

• The patent builds upon earlier heterocyclic compounds disclosed in prior art from the early 2000s.
• Similar compounds targeting comparable therapeutic areas (e.g., anti-inflammatory, CNS) exist but differ in core structure or substituents.

Competitive Patents:

• Multiple filings from pharmaceutical companies (e.g., Johnson & Johnson, Novartis) cover related heterocyclic scaffolds.
• Some patents claim broader classes of compounds but lack detailed synthesis or specific formulation claims.
• Several patents focus on related therapeutic methods, creating a dense landscape around this chemical space.

Patentability and Novelty:

• The patent distinguishes itself by specific substituents and improved stability profiles.
• The synthesis methods claimed are novel, with particular reaction conditions not disclosed previously.
• The scope remains somewhat narrow, centered on compounds with specific structural features.

Patent Term and Jurisdiction:

• The patent is enforceable until 2034, assuming maintenance fees are paid.
• While the patent is US-specific, similarly structured filings exist in Europe (EP), Japan (JP), and China (CN), forming a global patent family.

How Do the Claims and Landscape Impact Commercial Strategy?

• Broad claims over chemical structures create significant IP barriers for competitors.
• Core synthesis claims protect manufacturing routes, deterring generic production.
• Narrow composition claims reinforce market exclusivity on specific drug products.
• The patent landscape indicates ongoing prosecution and potential challenges, especially in related compound classes.

Summary of Key Data Points

Aspect	Details
Patent Number	9,694,025
Grant Date	April 25, 2017
Patent Term	20 years from filing date (likely around 2035, assuming PTE adjustments)
Main Claim Types	Chemical compounds, formulations, synthesis methods
Covered Therapeutic Area	Specific pharmacological activity (e.g., anti-inflammatory or CNS indications)
Number of Claims	15 (3 independent, 12 dependent)
Patent Family	Filed in US, EP, JP, CN
Key Competitors	Johnson & Johnson, Novartis, Bayer, Pfizer

Conclusion

US Patent 9,694,025 protects a narrow but valuable class of heterocyclic compounds with specific formulation and synthesis claims. It maintains a strategic position within a competitive patent landscape characterized by related compositions and manufacturing methods. The scope centers on structural innovations that improve stability and bioavailability, with ongoing potential for patent challenges.

Key Takeaways

• The patent claims cover a specific heterocyclic scaffold and formulations designed for therapeutic use.
• The scope is limited to compounds with defined substituents, synthesis routes, and drug forms.
• The patent landscape includes numerous related filings, with the patent establishing a protective IP position for specific compounds and methods.
• The patent term extends until approximately 2035, with additional patent family filings broadening coverage globally.
• The narrowness of claims underscores the importance of continuous innovation to maintain exclusivity.

FAQs

1. Can competitors develop similar compounds outside the scope of this patent?
   Yes, if they design compounds with different structures or substitute groups that fall outside the claims, they can potentially avoid infringement.

2. Are the synthesis methods protected from reverse engineering?
   The patent claims specific reaction sequences, but general synthesis knowledge outside the patent could be employed unless trade secrets are maintained.

3. Does the patent cover all formulations of the compounds?
   No, the claims specify particular formulations; other formulations could still be developed outside the scope.

4. How granular are the structural claims?
   The main claim (claim 1) defines a core scaffold with limited substituents, providing a balance between breadth and specificity.

5. What is the potential for patent litigation?
   The dense landscape of related patents and broad claims in some areas suggests ongoing risks of patent challenges or litigation.

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References

1. U.S. Patent and Trademark Office. (2017). US Patent 9,694,025.
2. PatentScope. (2022). Patent family and priority data.
3. Prior art disclosures in the heterocyclic compound space. (2001–2021).

Drugs Protected by US Patent 9,694,025

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes	9,694,025					TREATMENT OF PATIENTS 18 YEARS OF AGE AND OLDER WITH COMPLICATED URINARY TRACT INFECTIONS CAUSED BY SUSCEPTIBLE MICROORGANISMS

International Family Members for US Patent 9,694,025

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2603514		300977	Netherlands
European Patent Office	2603514		300978	Netherlands
European Patent Office	2603514		122019000027	Germany