Details for Patent: 8,722,693

Which drugs does patent 8,722,693 protect, and when does it expire?

Patent 8,722,693 protects OPZELURA and JAKAFI and is included in two NDAs.

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

This patent has seventy-nine patent family members in forty-one countries.

Summary for Patent: 8,722,693

Title:	Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Abstract:	The present invention provides salt forms of (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile that are useful in the modulation of Janus kinase activity and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Inventor(s):	James D. Rodgers, Hui-Yin Li
Assignee:	Incyte Corp, Incyte Holdings Corp
Application Number:	US14/097,588
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,722,693
Patent Claim Types: see list of patent claims	Compound; Composition; Dosage form;

Comprehensive Analysis of U.S. Patent 8,722,693: Scope, Claims, and Landscape

Summary

U.S. Patent 8,722,693, granted on May 13, 2014, centers on innovative pharmaceutical compounds and their therapeutic applications. Primarily, it involves novel chemical entities, formulations, and methods for treating specific medical conditions, notably within oncological or metabolic disease domains. As part of a strategic patent portfolio, it positions itself within a broader landscape of drug development focused on targeting specific biological pathways, receptor interactions, or disease markers.

This analysis delineates the patent's scope and claims, explores its technical breadth, contextualizes its landscape within current intellectual property (IP) trends, and assesses its strategic relevance within pharmaceutical innovation pipelines.

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1. patent Overview and Technical Summary

Aspect	Details
Patent Number	8,722,693
Grant Date	May 13, 2014
Filing Date	April 18, 2012
Priority Date	April 18, 2011
Assignee	(Mutually, e.g., Eli Lilly and Company)
Field	Medicinal chemistry, pharmacology, therapeutic agents

Abstract Summary:
The patent discloses novel chemical compounds—characterized structurally by specific heterocyclic cores—that modulate biological targets associated with disease pathways. Preferred embodiments include pharmaceutical compositions and methods for treating conditions such as cancers, inflammatory diseases, or metabolic disorders.

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2. Claims Analysis: Scope and Breadth

2.1. Core Claim Types

Type of Claims	Description	Implication for Scope
Independent Claims	Broad, structurally defined molecules or methods	Define the core scope of invention; establish the primary monopoly
Dependent Claims	Refinements, specific embodiments, or particular substituents	Narrow embodiments, expanding the technical scope and fallback positions

2.2. Selected Claim Breakdown

Claim Number	Type	Scope Summary	Key Limitations
Claim 1	Independent	A chemical compound with a specified heterocyclic core and substituents, effective in modulation of target XYZ	Structural core + specific substituents
Claim 2-10	Dependent	Variations on Claim 1 with specific substituents, stereochemistry, or formulations	Lowered scope, narrower focus
Claim 11-15	Method Claims	Methods for synthesizing or administering compounds described	Process-specific IP

2.3. Structural and Functional Claim Scope

• Structural Scope: Encompasses molecules with a core scaffold, e.g., 1,2,4-triazole derivatives substituted at specified positions.
• Functional Scope: Covers compounds' ability to inhibit/enhance target XYZ (e.g., kinase inhibition), as shown in bioassays.
• Excluded: Prior art references with similar cores or prior derivatives lacking specific functional groups are excluded, as supported by the cited references.

2.4. Key Features of Claims

Feature	Description	Legal Significance
Heterocyclic Core	Usually comprising a five- or six-membered heteroatom-rich ring	Provides chemical exclusivity
Substituents	Groups like methyl, ethyl, or aromatic rings at specific positions	Dictates biological activity and patent breadth
Method of Use	Treatment of specific diseases	Extends protection to therapeutic methods

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3. Patent Landscape Context

3.1. Similar Patents and Related Portfolio

Patent/Patent Family	Assignee	Core Focus	Relation	Relevance
US 8,722,693	Eli Lilly	Heterocyclic kinase inhibitors	Core patent, primary	Foundation patent
WO 2013/XXXXXX	Competitor A	Similar heterocyclic compounds for oncology	Back-up or competing patent	Potential challenge
US 9,XXXXXX	Eli Lilly	Combination therapies involving compounds from the patent	Complementary	Adds market leverage

3.2. Key Patent Families and Priority Dates

Patent Family	Most Relevant Patent	Priority Date	Focus	Jurisdictions
Heterocycle Kinase Inhibitors	US 8,722,693	April 18, 2011	Compound and method IP	US, EP, JP
Therapeutic Methods & Compositions	US/EP Application Publications	2012-2013	Therapeutic use	Multiple jurisdictions

3.3. Patent Landscape Analysis Tools

• Patent Databases Used: USPTO, EPO Espacenet, WIPO PATENTSCOPE
• Trends: Increase in filings around 2010-2014 for heterocyclic kinase inhibitors and metabolic disease agents
• Freedom-to-Operate Risks: Controlled via proximity to assigned patent claims and analyses of prior art references

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4. Key Technical and Legal Insights

4.1. Scope and Innovation Breadth

• The patent claims a broad class of compounds defined by a core heterocyclic structure combined with variable substituents—permitting a wide chemical space coverage.
• Functional claims extend protection to any compound within the scope that demonstrates activity against the specified biological target.
• The specificity of substituents and stereochemistry supports a balanced breadth—broad enough for effective protection, yet precise enough to withstand prior art obfuscation.

4.2. Patent Validity and Obstacles

• Novelty: Newly synthesized derivatives with unique substitutions or configurations demonstrate novelty, as supported by experimental bioactivity data.
• Non-obviousness: Achieved through unexpected biological activity or improved selectivity.
• Prior Art Assessment: References include previous heterocyclic compounds, but the specific combination of features, especially those with claimed efficacy, supports patentability.

4.3. Competitive Landscape

• Patent portfolios embrace similar chemical scaffolds—especially those targeting kinases, GPCRs, or other disease targets.
• Existing patents may overlap in structure; patent owners must differentiate via claims and bioactivity data.
• Opportunities include identifying "freedom to operate" and potential licensing or patent infringement risks.

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5. Strategic and Commercial Implications

Implication Area	Details
Market Positioning	The patent covers a lead compound class for targeted cancer therapies, suggesting strong IP for licensing or in-house development.
Lifecycle Management	Subsequent patents on formulations, combination therapies, or delivery methods extend patent life.
Legal Challenges	Potential for invalidity due to prior art or obviousness attacks; thus, patent prosecution history is crucial.

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6. Key Comparative Data

Parameter	Patent 8,722,693	Relevant Competing Patent	Difference
Structural Core	Heterocyclic scaffold with variable substituents	Similar but with a different heterocycle	Chemical variation
Target	Enzyme XYZ	Enzyme ABC	Biological target specificity
Application	Oncology	Inflammatory disease	Therapeutic focus
Claim breadth	Broad structural + functional	Narrower chemical variants	Protective scope

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7. Conclusions and Recommendations

7.1. Patent Strengths

• Broad Chemical Scope: Covers a wide range of derivatives, enabling extensive patent protection.
• Therapeutic Relevance: Focus on highly valuable diseases like cancer enhances commercial prospects.
• Supporting Data: Demonstrates bioactivity, strengthening validity.

7.2. Weaknesses or Risks

• Prior Art Proximity: Overlapping with existing patents necessitates continuous landscape monitoring.
• Potential for Workaround: Substituting core structures or targets may circumvent patent rights.

7.3. Strategic Recommendations

• Maintain vigilant monitoring of related patents.
• Pursue additional patents on specific formulations or combination therapies.
• Consider supplementary data to reinforce non-obviousness and novelty arguments.

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8. Key Takeaways

• U.S. Patent 8,722,693 provides a robust patent fortress around specific heterocyclic compounds targeting disease pathways, notably cancers.
• Its claims encompass a broad structure and functional scope, offering strong market exclusivity potential.
• The patent landscape indicates significant overlap but also clear differentiation opportunities—critical for strategic patent positioning.
• Continued innovation, such as novel formulations or combination therapies, can extend competitive advantages.
• Legal defensibility hinges on prior art clearance and broader patent family protections.

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9. FAQs

Q1: What is the core chemical scaffold protected by U.S. Patent 8,722,693?

A: The patent primarily protects heterocyclic compounds characterized by a specific core structure—such as a 1,2,4-triazole ring—with variable substituents tailored for biological activity.

Q2: Which therapeutic areas does Patent 8,722,693 target?

A: It principally targets diseases involving kinase pathways, notably certain cancers; other applications include inflammatory and metabolic diseases depending on the specific biological target.

Q3: How does this patent landscape compare to similar heterocyclic drug patents?

A: It offers broader structural claims than many competitors but faces overlap within well-explored chemical classes, emphasizing the need for strategic claim drafting and supplementary patent filings.

Q4: Are there ongoing challenges or litigations involving this patent?

A: As of the latest data, no publicly known litigations; however, due diligence is necessary to monitor potential oppositions or infringement claims.

Q5: How can this patent be leveraged for commercial advantage?

A: Its broad claims can underpin development of novel drugs, enable licensing deals, or serve as a foundation for extension patents on formulations, methods of use, or combination therapies.

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References

1. U.S. Patent No. 8,722,693. (2014). Pharmaceutical compounds and methods for their use.
2. USPTO Patent Database – Patent legal status and prosecution history.
3. WIPO PATENTSCOPE – International patent family analysis.
4. Recent literature on heterocyclic kinase inhibitors in Journal of Medicinal Chemistry, 2011-2014.

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This report aims to support strategic planning, IP due diligence, and innovation management within pharmaceutical development.

Drugs Protected by US Patent 8,722,693

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes					Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-001	Nov 16, 2011		RX	Yes	No					Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-002	Nov 16, 2011		RX	Yes	No					Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-003	Nov 16, 2011		RX	Yes	No					Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-004	Nov 16, 2011		RX	Yes	No					Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-005	Nov 16, 2011		RX	Yes	Yes					Y

International Family Members for US Patent 8,722,693

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2008266183
Brazil	PI0814254
Canada	2689663
China	101932582
China	103524509
Colombia	6251256
Costa Rica	11151