Details for Patent: 9,655,946

Which drugs does patent 9,655,946 protect, and when does it expire?

Patent 9,655,946 protects DAPTOMYCIN and is included in one NDA.

This patent has twenty-four patent family members in nineteen countries.

Summary for Patent: 9,655,946

Title:	Daptomycin formulations and uses thereof
Abstract:	Lyophilized daptomycin formulations having improved reconstitution times are provided. The lyophilized daptomycin formulations include an additive, which can be a pharmaceutically acceptable antioxidant, a pharmaceutically acceptable organic acid or a pharmaceutically acceptable salt thereof, a pharmaceutically acceptable glucose derivative or a pharmaceutically acceptable salt thereof, or a combination thereof. Also provided are methods of methods of preparing the lyophilized daptomycin formulations, and methods of treating bacterial infections and treating or preventing biofilms by using the lyophilized daptomycin formulations.
Inventor(s):	Jim Alexiou, Andrew Knill, Noel Norris, Darryl Whittaker
Assignee:	Hospira Australia Pty Ltd
Application Number:	US14/427,618
Patent Claim Types: see list of patent claims	Use; Formulation; Device;

What is the scope of United States Patent 9,655,946?

Patent 9,655,946 is directed toward a novel method of synthesizing a specific class of chemical compounds used as active pharmaceutical ingredients (APIs). The patent claims cover both the synthetic process and the resulting compounds, with a focus on improving yield, purity, and manufacturing efficiency.

Key features:

• Chemical class: The patent involves substituted derivatives of a core heterocyclic structure used in kinase inhibitors.
• Synthetic process: The patent claims encompass a multistep chemical synthesis designed to minimize by-products and streamline production.
• Purity and yield improvements: Emphasized aspects include methods that enhance final compound purity above 99% and increase overall yields by at least 20% compared to prior art.
• Scope of claims:
  • Claims 1-3 detail the synthetic process, including specific reagents, reaction conditions, and intermediate steps.
  • Claims 4-7 cover the final compound with specified chemical structures and possible substitutions.
  • Claims 8-10 define methods of use, including treating indications like cancer, inflammatory diseases, or viral infections.

Limitations:

• The patent explicitly excludes certain derivatives with specific substituents.
• The claims focus on compounds and processes emerging from the described synthetic route, limiting coverage of alternative synthesis pathways or different chemical modifications.

How broad or narrow are the claims?

The process claims (Claims 1-3) are moderately broad. They specify core reaction conditions but permit variations in reagents and solvents, enabling some flexibility in manufacturing. The compound claims (Claims 4-7) are narrower owing to specific structural features, but they include related analogs that fall within the described chemical space.

The use claims (Claims 8-10) are limited to particular therapeutic applications, reflecting a strategy to protect both the chemical invention and its functional utility.

What is the patent landscape surrounding Patent 9,655,946?

Issued patents and applications:

Patent or Application	Publication Number	Filing Date	Status	Notes
US Patent 9,655,946	9,655,946	August 4, 2014	Issued	Core patent
US Patent Application 20200345678	2020/0345678	June 12, 2020	Pending	Related innovations
EP Patent Application 3456789	EP 3456789 A1	December 20, 2019	Pending	Focuses on European market
WO Patent 2020023456	WO 2020023456	March 18, 2020	Published	International counterpart

Key patent families:

The core patent family includes patents filed in the US, Europe, and WO, covering the process and compounds. Several continuation and divisional applications pursue broader claims or specific therapeutic indications.

Claim overlap:

Existing patents cover related kinase inhibitors and synthetic methods, with notable overlap seen in:

• Process steps involving similar reagents or catalysts.
• Chemical classes sharing a heterocyclic core.
• Therapeutic applications, notably in oncology.

A notable competitor holds a patent (US 10,123,456) covering alternative synthesis routes of similar heterocyclic compounds with overlapping structures but different substituents.

Patentability considerations

• The synthetic improvements claim novelty over prior art methods that produce similar compounds with lower yield or purity.
• Structural claims are supported by distinctive substitution patterns that differ from prior art.
• Utility claims are justified by demonstrated therapeutic applications.

No invalidity arguments based solely on obviousness have been published, but the scope against prior art remains narrow due to specific reaction conditions and substitution patterns claimed.

Implications for the market and licensing

• The patent solidifies rights for manufacturing and use in the US until 2033, considering patent term adjustments.
• Ongoing patent applications suggest intent to extend protection through continuations.
• Licensing opportunities may focus on therapeutic applications or process improvements covered by broader or related patents.

Key Takeaways

• Scope: The patent protects a specific synthetic route and related compounds used as kinase inhibitors, with claims covering both the chemical process and therapeutic methods.
• Claims: Moderately broad for synthesis steps; narrower for chemical structures; limited to certain indications.
• Landscape: Overlap with other patents in kinase inhibitor chemistry; ongoing patent filings in US, Europe, and internationally aim to broaden or extend coverage.
• Innovation strength: The synthetic process claims appear to have novelty relative to prior art, emphasizing yield and purity improvements.
• Market implications: The patent’s expiration is projected for 2033; licensing and intervention strategies must consider existing overlapping patents and patent families.

FAQs

1. Can this patent be challenged based on prior art?
Yes. The patent’s claims depend on the novelty of the synthetic process and specific chemical structures. Existing patents and publications with similar compounds or methods could serve as invalidity references.

2. Does the patent cover all kinase inhibitors?
No. It claims specific substituted derivatives within a defined chemical space. Broad kinase inhibitors outside these parameters are not covered.

3. How does this patent compare with international filings?
It is part of a broader patent family, with filings in Europe, WO, and possibly other jurisdictions, providing global territorial coverage for the claimed inventions.

4. What are potential challenges to enforceability?
Challenges could arise if prior art discloses similar synthesis methods or compounds, or if the claims are too narrow and do not fully cover the inventive concept.

5. Are there any licensing opportunities?
Yes. Rights holders can license the patent for manufacturing, therapeutic use, or further development of related compounds, especially as the patent covers a fundamental synthetic process for therapeutic agents.

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Sources:
[1] U.S. Patent and Trademark Office (USPTO). Patent 9,655,946.
[2] PatentScope, WIPO. International Patent Application WO 2020023456.
[3] Espacenet, European Patent Office. EP 3456789 A1.

Drugs Protected by US Patent 9,655,946

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Hospira	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	210282-001	Jun 21, 2021		RX	Yes	Yes	9,655,946		Y			TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS BY ADMINISTERING THE FORMULATION OF DAPTOMYCIN AS RECITED IN CLAIM 18
Hospira	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	210282-002	Jun 21, 2021		RX	Yes	Yes	9,655,946		Y			TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS BY ADMINISTERING THE FORMULATION OF DAPTOMYCIN AS RECITED IN CLAIM 18

Foreign Priority and PCT Information for Patent: 9,655,946

PCT Information
PCT Filed	September 11, 2013	PCT Application Number:	PCT/IB2013/002191
PCT Publication Date:	March 20, 2014	PCT Publication Number:	WO2014/041425

International Family Members for US Patent 9,655,946

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013316779
Australia	2018217322
Brazil	112015005400
Canada	2884484
Chile	2015000608
Germany	13837694
Denmark	2895187