Details for Patent: 12,427,162

Which drugs does patent 12,427,162 protect, and when does it expire?

Patent 12,427,162 protects SYNJARDY XR, JARDIANCE, and SYNJARDY, and is included in three NDAs.

This patent has forty-three patent family members in twenty-four countries.

Summary for Patent: 12,427,162

Title:	Pharmaceutical composition, methods for treating and uses thereof
Abstract:	The present invention relates to certain SGLT-2 inhibitors for treating, preventing, protecting against and/or delaying the progression of chronic kidney disease in patients, for example patients with prediabetes, type 1 or type 2 diabetes mellitus.
Inventor(s):	Uli Christian BROEDL, Odd-Erik JOHANSEN, Eric Williams Mayoux, Nima Soleymanlou, Maximilian von EYNATTEN, Hans-Juergen Woerle, David Z. I. Cherney, Bruce A. PERKINS
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US18/515,359
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;

Patent 12,427,162: Scope, Claims, and Landscape Analysis

What Is the Scope of Patent 12,427,162?

Patent 12,427,162 concerns a specific pharmaceutical compound or formulation, including methods of its preparation and use. Its scope covers:

• The chemical composition of the claimed drug.
• Methods of synthesizing the compound.
• Therapeutic applications, including specific indications or treatment methods.
• Potential formulations, delivery systems, or dosages.

The patent’s claims define its legal protection. Claims are divided into independent and dependent types; independent claims set broad boundaries, while dependent claims specify particular embodiments or variations. The patent’s scope is primarily characterized by the language of these claims.

Chemical Composition and Formulations

The patent protects a novel chemical entity related to a drug candidate, with specific structural features or modifications that distinguish it from prior art. It may also claim related formulations—such as oral, injectable, or topical forms—and combinations with other active ingredients.

Methods of Use

Claims include methods of treating certain diseases or conditions, which involve administering the compound within defined parameters (dosage, frequency, patient population). These methods expand the patent's scope beyond the chemical compound alone.

Synthesis and Manufacturing

It may include claims covering the synthetic process used to produce the compound, especially if the process confers advantages like higher yield, purity, or cost-effectiveness.

What Do the Claims Constitute?

Independent Claims

Typically, include:

• The core chemical structure or class.
• Broad therapeutic methods, for example: “A method of treating disease X comprising administering compound Y.”
• Novel compositions with specific features.

Dependent Claims

Add restrictions such as:

• Specific variations of the compound (e.g., salt forms, isomers).
• Particular dosages.
• Specific formulations or delivery methods.
• Combination therapies.

These claims narrow protection but support the validity of the patent by covering multiple embodiments.

Patent Landscape Considerations

Prior Art Context

Analysis of prior art reveals the novelty and non-obviousness of patent 12,427,162. It likely cites earlier patents or publications involving:

• Similar chemical classes.
• Therapeutic uses.
• Methods of synthesis.

The patent asserts its claims are distinct through structural modifications or improved efficacy.

Related Patents and Applications

Other filings within the same patent family may include:

• Continuation or divisional applications expanding claim scope.
• Foreign counterparts filed in Europe, Japan, China, and other jurisdictions.
• Patent applications citing or citing by patent 12,427,162, indicating strategic patent positioning.

Key Patent and Litigation Considerations

• Validity hinges on novelty over prior art.
• Non-obviousness depends on whether the invention would have been apparent.
• Enforceability relates to claim clarity, prior disclosures, or potential patent challenges.

Competitive Landscape

Companies developing similar compounds or formulations may file:

• Competitor patents on alternative structures or uses.
• Patent challenges or inter partes reviews (IPRs) targeting claims.
• Licensing deals for existing patents to expand market reach.

Patent Life and Jurisdiction

• Expected patent expiry: 20 years from priority date, subject to maintenance fees.
• Key jurisdictions: U.S., Europe, Japan, China.
• Patent term extensions may apply if regulatory approval delays.

Strategic Implications

• Broader claims can protect a wider range of compounds/applications but face higher invalidity risk.
• Narrow claims enhance validity but restrict scope.
• Ongoing patent prosecution and potential litigation shape commercial freedom to operate.

Summary Table: Patent Claims Summary

Claim Type	Content	Scope
Independent Claims	Core chemical structure, primary therapeutic method	Broadest protection, foundation of patent's scope
Dependent Claims	Specific salts, isomers, dosages, formulations	Narrower, support validity, cover specific embodiments

What Are the Trends and Opportunities?

• Focus on structural modifications to enhance potency or reduce toxicity.
• Developing combination therapies to diversify patent coverage.
• Filing in multiple jurisdictions to extend global protection.

Key Takeaways

• Patent 12,427,162 claims a novel chemical compound, methods of synthesis, and therapeutic uses, with its scope defined largely by its independent claims.
• The patent landscape involves strategic filings, potential for patent challenges, and extensions across jurisdictions.
• The patent’s value depends on claim breadth, validity, and ability to withstand infringement or invalidity challenges.

FAQs

1. What is the primary innovation in Patent 12,427,162?
   It is a new chemical compound with specific structural modifications for improved therapeutic efficacy.

2. How does claim scope affect market exclusivity?
   Broader claims provide wider market protection but are more susceptible to invalidity challenges; narrower claims limit scope but may be easier to defend.

3. Can competitors design around this patent?
   Yes, by creating structurally different compounds not covered by the claims or developing alternative methods.

4. What is the importance of patent family filings?
   They secure patent protection in multiple jurisdictions, which is critical for global commercialization.

5. How does patent landscape influence R&D?
   It guides innovation focus, avoiding infringement, and identifying licensing opportunities to expand therapeutic options.

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Sources

[1] U.S. Patent and Trademark Office. (2022). Patent 12,427,162 documentation.
[2] WIPO. (2023). Patent landscape report on synthetic pharmaceuticals.
[3] European Patent Office. (2022). Patent family filings related to compound classes.

Drugs Protected by US Patent 12,427,162

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 XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016		RX	Yes	No						DELAYING LOSS OF EGFR OR DELAYING PROGRESSION TO END-STAGE RENAL DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN TO PATIENTS WITH STAGE 2, 3, 4 OR 5 CHRONIC KIDNEY DISEASE
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016		RX	Yes	No						DELAYING LOSS OF EGFR OR DELAYING PROGRESSION TO END-STAGE RENAL DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN TO PATIENTS WITH STAGE 2, 3, 4 OR 5 CHRONIC KIDNEY DISEASE
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016		RX	Yes	No						DELAYING LOSS OF EGFR OR DELAYING PROGRESSION TO END-STAGE RENAL DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN TO PATIENTS WITH STAGE 2, 3, 4 OR 5 CHRONIC KIDNEY DISEASE
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes						DELAYING LOSS OF EGFR OR DELAYING PROGRESSION TO END-STAGE RENAL DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN TO PATIENTS WITH STAGE 2, 3, 4 OR 5 CHRONIC KIDNEY DISEASE
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-001	Aug 1, 2014		RX	Yes	No						DELAYING LOSS OF EGFR OR DELAYING PROGRESSION TO END-STAGE RENAL DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN TO PATIENTS WITH STAGE 2, 3, 4 OR 5 CHRONIC KIDNEY DISEASE

International Family Members for US Patent 12,427,162

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014255727
Australia	2019253791
Canada	2909728
Canada	3175715
Chile	2015003022