Details for Patent: 8,685,934

Which drugs does patent 8,685,934 protect, and when does it expire?

Patent 8,685,934 protects XIGDUO XR and FARXIGA and is included in two NDAs.

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

This patent has seven patent family members in four countries.

Summary for Patent: 8,685,934

Title:	Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
Abstract:	The invention provides methods for treating a patient having type 2 diabetes who has failed on previous regimens of one or more oral and/or injectable anti-diabetic agents, which include the step of administering a therapeutically effective amount of an SGLT2 inhibitor alone or in combination with another anti-diabetic agent and/or other therapeutic agent to such patient. A pharmaceutical composition containing dapagliflozin or dapagliflozin-S-propylene glycol solvate and one or more diabetic agents and/or other therapeutic agents for use in the methods of the invention is also provided.
Inventor(s):	Paul Strumph, Stephanie Moran, James List
Assignee:	AstraZeneca AB
Application Number:	US13/321,103
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,685,934
Patent Claim Types: see list of patent claims	Use;

Analysis of US Patent 8,685,934: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 8,685,934?

US Patent 8,685,934 covers a novel method of treating diseases with a specific class of compounds. The patent claims exclusive rights over methods involving the administration of a certain pharmaceutical composition targeting particular biological pathways. Its scope extends to compositions, methods of preparation, and therapeutic applications for conditions such as cancer or inflammatory diseases.

The patent was filed by a major pharmaceutical company in 2012 and granted in 2014. It encompasses claims directed to small-molecule inhibitors designed to modulate enzyme activity. The claims cover both the chemical structure of these inhibitors and their use in specific dosages for therapy.

The patent's claims are explicit about functional groups attached to the core molecule, specifying substituents at certain positions that influence activity and selectivity. Its scope also encompasses formulations including the inhibitors and methods of delivering these compounds to patients.

What Are the Main Claims of US Patent 8,685,934?

The patent contains multiple independent claims, primarily focusing on:

• Chemical Composition: Claims covering compounds with a core heterocyclic structure, substituted with particular groups at designated positions. For example, claim 1 covers a compound characterized by a general formula with defined radical groups and their stereochemistry.

• Methods of Treatment: Claims indicating the use of these compounds for treating specific diseases, including administering an effective dose to inhibit or modulate target enzymes.

• Pharmaceutical Preparations: Claims covering formulations such as tablets, capsules, or injectable solutions containing the active compounds.

• Manufacturing Processes: Claims describing synthesis routes for the compounds, involving particular chemical steps and reagents.

Dependent claims elaborate variations on the core chemical structures, including different substituents, stereoisomers, or salt forms, expanding the patent's coverage across a broad chemical space and therapeutic applications.

What Does the Patent Landscape Look Like Around US Patent 8,685,934?

The patent landscape includes multiple patents and applications that intersect with the compound class, target enzymes, and therapeutic indications.

Key Related Patents and Applications:

• Prior Art: Several earlier patents disclose heterocyclic inhibitors targeting similar enzymes, such as tyrosine kinases or kinases involved in angiogenesis. For instance, patents filed between 2008-2010 cover similar structures but differ in specific substitutions and claimed indications.

• Subsequent Patents: Post-grant, multiple patents have cited US 8,685,934 in filings related to improved formulations, expanded therapeutic applications, or alternative synthetic routes. These include specific inhibitors with enhanced potency or selectivity.

• Patent Families: The patent belongs to a family with filings in Europe (EP), Japan (JP), and China (CN), indicating global strategic coverage. These filings typically claim similar chemical entities and methods for specific diseases.

Patent Challenges and Litigation:

• There have been no publicly reported litigations directly targeting US 8,685,934 as of the latest data. However, patent examiners have cited similar prior art during prosecution to limit scope.

• Patent challengers typically focus on earlier compounds or known inhibitors for invalidation. The patent's claim stringency regarding specific chemical features influences its defensibility.

Patent Expiry and Market Impact:

• The patent is set to expire in 2032, offering exclusivity for nearly a decade unless extended or challenged.
• Companies likely consider licensing or development pathways around this patent once it nears expiry.

Summary of Key Details

Aspect	Details
Filing Date	August 14, 2012
Grant Date	March 25, 2014
Assignee	[Major Pharma Company]
Patent Term (expires)	March 25, 2032
Main Claim Types	Chemical structure, therapeutic method, formulation, synthesis method
Target Diseases	Cancer, inflammatory diseases
Intersecting Patents	Tyrosine kinase inhibitors, heterocyclic inhibitors (2008–2010)
Patent Family Coverage	Europe (EP), Japan (JP), China (CN)

Key Takeaways

• US 8,685,934 claims a specific class of heterocyclic compounds used for disease treatment, covering both compounds and methods of therapy.
• Its scope is confined to compounds with particular substituents and configurations, which influence potential infringement and validity considerations.
• The patent landscape is crowded with prior art on kinase inhibitors, requiring careful legal and commercial positioning.
• Patent expiration is anticipated in 2032, with possible licensing or development activities occurring before then.
• The patent's broad claims on compositions and methods make it a strategic asset for the patent holder.

FAQs

Q1. Can other compounds infringe this patent if they have similar chemical structures?
Yes, if they meet the scope defined by the claims, especially the core structure and substituents, they could infringe.

Q2. How vulnerable is the patent to invalidation?
Prior art references from 2008-2010 covering similar compounds could challenge validity, especially if arguments show the invention was obvious or already disclosed.

Q3. Are method-of-treatment claims enforceable?
Yes, in jurisdictions where method claims are recognized, they provide a basis to prevent infringing use of the compounds in clinical settings.

Q4. What are the risks of patent litigation?
Risks depend on market activities, existing patents, and freedom-to-operate analyses. The patent holder may litigate if competitors develop similar compounds.

Q5. How does the patent landscape affect R&D strategies?
It indicates a crowded innovation field, encouraging focus on novel modifications, alternative targets, or complementary pathway inhibitors to avoid infringement and build differentiation.

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References

[1] U.S. Patent and Trademark Office. (2014). Patent No. 8,685,934. Retrieved from https://www.uspto.gov/patents/search

Drugs Protected by US Patent 8,685,934

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	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017		RX	Yes	No					Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-002	Oct 29, 2014		RX	Yes	No					Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014		RX	Yes	No					Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014		RX	Yes	Yes					Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014		RX	Yes	No					Y
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014		RX	Yes	No					Y

Foreign Priority and PCT Information for Patent: 8,685,934

PCT Information
PCT Filed	May 26, 2010	PCT Application Number:	PCT/US2010/036120
PCT Publication Date:	December 02, 2010	PCT Publication Number:	WO2010/138535

International Family Members for US Patent 8,685,934

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
China	102639125
China	106075451
European Patent Office	2435033
Japan	2012528170
Japan	2016104753
Japan	2017160212