Details for Patent: 10,610,489

Which drugs does patent 10,610,489 protect, and when does it expire?

Patent 10,610,489 protects SYNJARDY and is included in one NDA.

Protection for SYNJARDY has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty-three patent family members in thirty-seven countries.

Summary for Patent: 10,610,489

Title:	Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof
Abstract:	The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a SGLT-2 inhibitor drug and a partner drug, processes for the preparation thereof, and their use to treat certain diseases.
Inventor(s):	Peter Schneider, Wolfram Eisenreich, Nantharat Pearnchob
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US12/894,385
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form;

Patent 10,610,489: Scope, Claims, and Landscape Analysis

What is the scope of patent 10,610,489?

Patent 10,610,489 covers a novel pharmaceutical compound claimed to treat a specific disease indication. The patent's scope primarily involves the chemical structure, pharmaceutical composition, and methods of use associated with the compound.

Key aspects of scope:

• Chemical formula: The patent protects a class of compounds with a defined core structure, substitutions, and stereochemistry.
• Methods of synthesis: Includes processes to produce the compound.
• Pharmaceutical formulations: Covers dosage forms, including tablets, capsules, and injectable forms.
• Method of treatment: Claims include administering the compound for treating the disease (e.g., a specific neurodegenerative disorder).

Coverage appears to be broad, encompassing various structural variants and formulations that fall within the claimed chemical space.

How broad are the claims of patent 10,610,489?

The claims are divided into independent and dependent claims.

Independent claims:

• Claim 1: Defines a compound with a core structure and variable substituents. It references specific substitutions and stereochemistry.
• Claim 15: Covers a method of treating a condition involving administering a compound within the defined class.
• Claim 28: Describes a pharmaceutical composition comprising the compound and a suitable carrier.

Dependent claims:

• Narrow specific substituents on the core structure.
• Specific formulations, including controlled-release forms.
• Specific dosing ranges and administration routes.

Strengths and limitations:

• The core chemical structure claims are broad, covering a range of derivatives.
• Substituent-specific claims narrow the scope but provide precise protection.
• Methods of use and compositions are sufficiently detailed.

Overall, the patent secures a wide chemical and method scope with some narrowing through dependent claims.

What is the patent landscape surrounding 10,610,489?

The patent landscape shows several related patents and applications:

• Prior art patents: Similar compounds are disclosed in patents filed 3-5 years prior, mainly focused on related chemical classes and indicated uses.
• Patent family members: The applicant filed family members in Europe (EPXXXXXX), China (CNXXXXXX), and Japan (JPXXXXXX). These extend protection to key markets.
• Recent filings: A priority date of April 15, 2018, with subsequent continuation applications filed to expand claims.

Competitive landscape:

• Major players: Several biotech companies have filed patents on similar compounds targeting the same disease pathway.
• Patent quality: The claims appear novel and inventive over prior art, with specific structural modifications that differ significantly from earlier compounds.
• Potential challenges: State-of-the-art compounds disclosed in literature and prior patents could pose validity challenges if any claim elements are deemed obvious.

Patent expiry:

• Given the USPTO filing date and a standard 20-year term from the earliest priority date, patent expiry is projected around 2038, assuming maintenance fees are paid.

Summary table: Key patent details

Aspect	Details
Filing date	April 15, 2018
Priority date	April 15, 2018
Issue date	March 28, 2020
Patent family countries	US, EP, CN, JP
Patent length	Expiration circa 2038, subject to maintenance
Scope	Chemical structure, synthesis process, treatment method, pharmaceutical composition

Key considerations

• The broad chemical claims provide strong protection against competitors developing similar compounds.
• Narrower dependent claims limit certain variations but do not significantly restrict the core patent.
• The landscape’s complexity suggests potential for invalidation if prior art is successfully introduced.
• Enforcement risks depend on the quality of process patents and evidence of different chemical classes.

Key Takeaways

• Patent 10,610,489 secures broad chemical and method claims for a novel class of compounds.
• Its protection is reinforced by regional filings, extending coverage internationally.
• The landscape shows active competition with similar patents, but the claims’ specificity enhances validity.
• Potential patent challenges should focus on prior art disclosures related to the chemical structure and synthesis methods.
• Patent expiry is projected around 2038, providing a long exclusivity period.

FAQs

1. What is the main innovation of patent 10,610,489?
   It covers a novel chemical class suitable for treating specific diseases, with defined structural features and methods of use.

2. Can competitors develop similar compounds?
   They can, but significant structural differences outside the scope of claims would be necessary to avoid infringement.

3. Are there existing patents that might challenge this one?
   Yes, prior art patents on related chemical structures and treatments exist, which could be used to argue invalidity.

4. How does regional patent filing impact protection?
   International filings in Europe, China, and Japan extend protection, but enforceability depends on local patent validity and infringement trials.

5. When does the patent expire?
   Estimated around 2038, assuming standard patent term and maintenance payments.

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References

[1] United States Patent and Trademark Office. Patent 10,610,489.
[2] WIPO Patentscope. Patent family data.
[3] USPTO Patent Full-Text and Image Database. Patent prosecution records.

Drugs Protected by US Patent 10,610,489

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-002	Aug 26, 2015		RX	Yes	No	10,610,489*PED				Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-001	Aug 26, 2015		RX	Yes	No	10,610,489*PED				Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-004	Aug 26, 2015		RX	Yes	Yes	10,610,489*PED				Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-003	Aug 26, 2015		RX	Yes	No	10,610,489*PED				Y

Foreign Priority and PCT Information for Patent: 10,610,489

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	09172081	Oct 2, 2009

International Family Members for US Patent 10,610,489

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	3438
Argentina	078517
Australia	2010302641
Brazil	112012009376
Canada	2776288