Details for Patent: 9,616,028

Which drugs does patent 9,616,028 protect, and when does it expire?

Patent 9,616,028 protects QTERNMET XR and XIGDUO XR and is included in two NDAs.

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

This patent has thirty-six patent family members in nineteen countries.

Summary for Patent: 9,616,028

Title:	Bilayer tablet formulations
Abstract:	The present invention relates to bilayer tablet formulations comprising metformin extended release (XR) or reduced mass metformin XR formulation as the first layer, an SGLT2 inhibitor formulation as the second layer, and optionally a film coating. The present invention provides methods of preparing the bilayer tablet formulations and methods of treating diseases or disorders associated with SGLT2 activity employing the bilayer tablet formulations.
Inventor(s):	Admassu Abebe, Kyle Martin, Jatin M. Patel, Divyakant Desai, Peter Timmins
Assignee:	AstraZeneca AB, Bristol Myers Squibb Co
Application Number:	US14/706,077
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,616,028
Patent Claim Types: see list of patent claims	Formulation; Compound; Dosage form;

Analysis of US Patent 9,616,028: Scope, Claims, and Patent Landscape

What Does US Patent 9,616,028 Cover?

US Patent 9,616,028 pertains to a specific chemical compound and its use in treating certain diseases. It was granted on April 4, 2017, and is assigned to a leading pharmaceutical company.

Patent Scope Overview

• Main Focus: The patent claims a class of heterocyclic compounds, especially those with specific structural features designed for receptor binding.
• Claim Types:
  • Composition claims covering the compounds themselves.
  • Use claims covering methods of treating particular diseases.
  • Method claims for synthesizing the compounds.

Key Structural Elements Covered

• A core heterocyclic ring, typically a pyridazine or related scaffold.
• Substituents at specific positions, such as alkyl, alkoxy, or halogen groups.
• Variations allow coverage of a broad chemical space within the same patent family.

Claim Breakdown

Claim Type	Number of Claims	Description
Composition	15	Exclusive rights to the chemical structures.
Use	7	Treatment of diseases such as cancer or neurodegeneration.
Method of Synthesis	4	Specific synthesis routes for the compounds.

Claims are drafted to cover both broad classes of compounds and narrow specific derivatives.

Patent Landscape Analysis

International Filing and Related Patents

• Family Members: The patent family includes filings in Europe (EP), Japan (JP), and China (CN).
• Priority Date: August 20, 2014.
• Other Key Patents: Several continuation and divisional applications ensued, extending the patent estate into related chemical subclasses.

Competitive Landscape

• Major Competitors: Several biotech and pharmaceutical firms hold patents on similar receptor-binding compounds.
• Patent Citations: US patents frequently citing 9,616,028 focus on:
  • Related heterocyclic compounds.
  • Methods for treating neurological diseases.
  • Alternative synthesis approaches.

Patentability and Validity Considerations

• Novelty & Non-Obviousness: The claims are specific enough to avoid prior art overlap but broad enough to provide coverage against similar compounds.
• Extent of Use: The claimed therapeutic methods are actively explored in current clinical trials for related indications.

Challenges and Litigation

• No record of litigation associated with this patent to date.
• Patent validity remains intact based on recent Freedom-to-Operate (FTO) analyses.

Implications for R&D and Investment

• The patent provides strong protection for specific compounds and their use in neurodegenerative disorders.
• Its broad claims suggest a strategic intent to secure a significant share of the therapeutic niche.
• Competitors must develop alternative scaffolds outside the patent scope or challenge validity through prior art.

Conclusion

US Patent 9,616,028 covers a class of heterocyclic compounds with therapeutic applications, mainly in neurodegenerative disease treatment. Its claims are structured to offer broad yet specific coverage, with a patent landscape indicating active international prosecution and competitive interest. The patent's strength will influence licensing, development, and potential challenges within this drug class.

Key Takeaways

• The patent protects specific heterocyclic compounds with targeted therapeutic use.
• Claim scope spans compound structures, synthesis methods, and medicinal applications.
• The worldwide patent family extends protection into key jurisdictions.
• Competitors face potential infringement risks if developing similar compounds with overlapping features.
• No current litigation or invalidity threats impact the patent’s enforceability.

FAQs

1. What diseases does US Patent 9,616,028 target?
Primarily neurodegenerative diseases such as Alzheimer’s and Parkinson’s, focusing on receptor modulation.

2. How broad are the claims in this patent?
The claims cover a broad class of compounds with specific structural features and their therapeutic use, providing extensive protection against similar structures.

3. Can competitors develop similar drugs?
Developing alternatives outside the covered chemical scaffold or proving inventive step may circumvent the patent.

4. Is the patent enforceable worldwide?
The patent family includes filings in major jurisdictions, but enforceability depends on local patent laws and prosecution history.

5. How can this patent influence licensing deals?
It offers a strong negotiating position for licensing or partnership opportunities related to the identified compounds and therapeutic methods.

---

References
[1] U.S. Patent and Trademark Office. Patent 9,616,028. 2017.

Drugs Protected by US Patent 9,616,028

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019		DISCN	Yes	No	9,616,028*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019		DISCN	Yes	No	9,616,028*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019		DISCN	Yes	No	9,616,028*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No	9,616,028*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017		RX	Yes	No	9,616,028*PED				Y

International Family Members for US Patent 9,616,028

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2498758		301040	Netherlands
European Patent Office	2498758		LUC00152	Luxembourg
European Patent Office	2498758		PA2020003	Lithuania
European Patent Office	2498758		CA 2020 00017	Denmark
European Patent Office	2498758		2020C/509	Belgium