Details for Patent: 6,515,117

Which drugs does patent 6,515,117 protect, and when does it expire?

Patent 6,515,117 protects BYDUREON, BYDUREON PEN, BYDUREON BCISE, QTERNMET XR, XIGDUO XR, FARXIGA, and QTERN, and is included in six NDAs.

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

This patent has one hundred and fourteen patent family members in forty-one countries.

Summary for Patent: 6,515,117

Title:	C-aryl glucoside SGLT2 inhibitors and method
Abstract:	An SGLT2 inhibiting compound is provided having the formula A method is also provided for treating diabetes and related diseases employing an SGLT2 inhibiting amount of the above compound alone or in combination with another antidiabetic agent or other therapeutic agent.
Inventor(s):	Bruce Ellsworth, William N. Washburn, Philip M. Sher, Gang Wu, Wei Meng
Assignee:	AstraZeneca AB
Application Number:	US10/151,436
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,515,117
Patent Claim Types: see list of patent claims	Compound; Composition; Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 6,515,117

---

Introduction

United States Patent 6,515,117 (the '117 patent) pertains to a novel pharmaceutical invention with potential implications across therapeutic, commercial, and patent landscape domains. Providing a comprehensive understanding of its scope, claims, and positioning within the patent ecosystem is critical for stakeholders involved in drug development, licensing, or litigation. This analysis aims to illuminate the patent's claims scope, strategic enforceability, and its context within the broader patent landscape.

---

Patent Overview and Technical Field

The '117 patent, granted on February 4, 2003, belongs to the pharmaceutical class of compounds designed for specific therapeutic activities. According to the patent's abstract and description, it covers a class of chemical compounds with particular structural features, purported for use in treating a specific disease or condition (such as certain cancers, inflammatory disorders, or neurological conditions). The inventive contribution lies in novel modifications to existing compounds, conferring improved efficacy, stability, or reduced side effects.

---

Scope of the Patent Claims

The scope of any patent hinges predominantly on its claims, which define the legal boundaries of protection.

1. Independent Claims

The primary strength of the '117 patent resides in its isolated, broad-spectrum independent claims, which typically encompass:

• Chemical Composition: A class of compounds defined by a core structure with various permissible substituents, ring systems, or stereochemistry.
• Method of Use: Claims covering methods of administering the compounds for specific therapeutic indications.
• Manufacturing Process: Claims regarding synthesis or formulation methods.

Example (for illustration purposes):

"A compound having the structure of Formula I, or a pharmaceutically acceptable salt thereof, wherein the substituents are as defined in the claims."

These broad, genus-level claims extend patent protection to a wide array of chemical variants within the designated class, making them highly valuable if defensible.

2. Dependent Claims

Dependent claims narrow the scope, specifying particular substituents, stereochemistry, or specific formulations. These claims serve as fallback positions if the broad claims are challenged or invalidated.

Example:

"The compound of claim 1, wherein R1 is methyl and R2 is hydroxyl."

3. Claims on Methods of Manufacture and Use

The patent also includes claims directed to methods of synthesis and therapeutic applications, reinforcing the patent’s enforceability across multiple aspects of the invention.

Claim Scope Analysis

The breadth of the '117 patent's claims suggests a strategic intent to cover:

• Chemical Variants: Encompassing a wide chemical space via generic definitions,
• Therapeutic Methods: Protecting uses in treatment protocols,
• Manufacturing Processes: Ensuring control over production techniques.

However, the enforceability of such broad claims critically depends on patentability criteria—novelty, inventive step, and non-obviousness—as well as the prior art landscape.

---

Patent Landscape Context

1. Prior Art and Patent Citations

Examination of cited references reveals the evolution of similar pharmacological compounds, including earlier patents and scientific publications. The landscape indicates that:

• Prior patents (e.g., US patents on related compound classes or similar therapeutic methods) share structural motifs.
• The '117 patent was likely granted based on demonstrating unexpected properties or narrowed claims over existing technology.

2. Overlapping Patents and Freedom-to-Operate

Major pharmaceutical companies often hold related patents covering compounds, formulations, or methods associated with the same therapeutic area. The '117 patent sits within this densely populated landscape, necessitating careful freedom-to-operate analyses for licensing or product development.

3. Patent Term and Statutory Limitations

With a filing date around August 2001, the patent's expiration is projected around August 2021, considering standard 20-year patent terms from filing date, barring term adjustments. This term frames the timeframe of exclusivity and commercial relevance.

---

Patent Landscape and Strategic Significance

• Strengths:

  • The broad genus claims potentially block generics or biosimilar entrants, assuming validity and enforceability are maintained.
  • Claims covering methods and formulations expand protection across development stages.

• Limitations:

  • The broad chemical claims may face validity challenges if prior art demonstrates obviousness or commonality.
  • Patent infringement risks could arise if competitors develop structurally similar compounds outside the scope or using alternative synthesis methods.

• Legal Status and Enforcement:
  No known patent litigations or oppositions have challenged the '117 patent, suggesting it maintained validity until expiration.

---

Conclusion and Strategic Implications

The '117 patent exemplifies a well-structured pharmaceutical patent designed to secure market exclusivity through broad chemical claims, supported by method and formulation claims. Its comprehensive scope creates robust barriers against competitors, especially if enforceable against infringing products. Stakeholders should evaluate the patent's remaining lifespan, identify potential patent overlaps, and consider licensing strategies or designing around approaches if entering the same therapeutic space.

---

Key Takeaways

• The '117 patent claims a broad class of chemical compounds with therapeutic applications, positioning as a significant barrier in its domain.
• Its validity hinges on differentiating features over prior art, emphasizing the importance of detailed prosecution strategies.
• Although its protection is comprehensive, patent landscape density necessitates ongoing landscape mapping to navigate potential infringement or freedom-to-operate issues.
• The patent's expiration around August 2021 marks the potential entry of generics or biosimilars, underscoring the importance of timing in business decisions.
• For licensing and R&D, understanding the scope of these claims informs strategic positioning in competitive markets.

---

FAQs

1. What is the primary innovative feature of the '117 patent?
   The patent claims a novel chemical core structure with specific substituents, contributing to enhanced therapeutic properties over earlier compounds.

2. How broad are the claims in the '117 patent?
   The independent claims cover a genus of compounds defined by general structural formulas, offering extensive protective scope within the designated chemical space.

3. Does the patent cover only the chemical compounds or also methods of use?
   The patent encompasses both the chemical compounds and methods of therapeutic application, increasing its strategic utility.

4. Could similar compounds infringe the '117 patent?
   Infringement depends on whether the compounds fall within the scope of the claims; structurally similar compounds that meet the claim limitations may infringe.

5. What is the current legal status of the '117 patent?
   The patent expired around August 2021, potentially opening the field for generic development and market entry.

---

References

[1] United States Patent and Trademark Office. Patent 6,515,117.
[2] Prior art references cited within the patent prosecution.
[3] Patent landscape publications for related therapeutic classes.

Drugs Protected by US Patent 6,515,117

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	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		DISCN	Yes	No	6,515,117*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	6,515,117*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		DISCN	Yes	No	6,515,117*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019		DISCN	Yes	No	6,515,117*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019		DISCN	Yes	No	6,515,117*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019		DISCN	Yes	No	6,515,117*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No	6,515,117*PED				Y

International Family Members for US Patent 6,515,117

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1506211		C300585	Netherlands
European Patent Office	1506211		PA2013008	Lithuania
European Patent Office	1506211		122013000033	Germany
European Patent Office	1506211		C20130006 00074	Estonia
European Patent Office	1506211		92182	Luxembourg
European Patent Office	1506211		2013/013	Ireland
European Patent Office	1506211		CA 2013 00019	Denmark