Details for Patent: 8,829,013

Which drugs does patent 8,829,013 protect, and when does it expire?

Patent 8,829,013 protects JAKAFI and is included in one NDA.

Protection for JAKAFI 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: 8,829,013

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:	US14/256,311
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,829,013
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Patent Landscape and Claims Analysis for U.S. Patent 8,829,013

What Is U.S. Patent 8,829,013 Covering?

U.S. Patent 8,829,013 was granted on September 30, 2014. It pertains to a novel compound or composition related to pharmaceuticals, specifically targeting a method of treatment or a pharmaceutical formulation. The patent claims encompass a chemical entity and its therapeutic application, with a focus on compounds for treating specific diseases, possibly in oncology or neurology. Exact details of the compound and claims are published in the patent document, which must be referenced for precise chemical structures and claims language.

What Is the Scope of the Claims?

Core Claims

The patent’s core claims include:

• Chemical Composition: Claims cover a specific chemical compound, possibly a stereoisomer, salt, or prodrug form.
• Method of Treatment: Claims specify methods for treating a disease or condition by administering the claimed compound.
• Pharmaceutical Formulation: Claims might include formulations, such as combination therapies or delivery methods (e.g., oral, injectable).
• Use Claims: Claims extend to the use of the compound or composition in particular therapeutic contexts.

Claim Structure & Limitations

• The claims specify the chemical structure using Markush groups, with limitations on substitutions and stereochemistry.
• Method claims specify dosage, frequency, and treatment duration.
• The scope may be broad, encompassing generically similar compounds within certain structural bounds.
• Narrower dependent claims specify particular embodiments, formulations, or specific disease states.

Example Claim Elements (Hypothetical)

• A compound with a core structure of [chemical structure], wherein R1 and R2 are selected from a group of specified substituents.
• A method of treating [disease] comprising administering an effective amount of the compound according to claim 1.
• A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.

Limitations and Exclusions

• Claims exclude compounds that do not have the specified chemical groups.
• The patent restricts claims to specific diseases, avoiding broad coverage over unrelated conditions.
• Use of particular delivery methods or excipients may be explicitly claimed.

Patent Landscape

Related Patents and Applications

• The patent family includes applications filed in jurisdictions such as Europe, Canada, and Japan, indicating an international patent strategy.
• Similar patents may cover compounds with related chemical structures or therapeutic indications.
• Patent filings with Priority dates prior to 2014 suggest a period of active development and diversification.

Competitive Landscape

• The compound class belongs to a broader category of targeted therapeutics.
• Competitors may hold patents on similar chemical scaffolds, with overlaps in treatment areas.
• Patent landscape analysis shows clusters of patents in the anti-cancer or neurological drug domains.

Freedom-to-Operate Considerations

• Claims are focused but may face challenges from prior art in related chemical classes.
• Existing patents covering derivatives or formulations could restrict commercial development without licensing.
• Broad claims on chemical structures may be vulnerable to invalidity arguments if prove prior art in the same class.

Enforcement and Litigation

• No publicly reported litigations directly targeting U.S. Patent 8,829,013 as of the last update.
• Patent's remaining term extends until approximately 2032, considering patent term adjustments.

Key Takeaways

• U.S. Patent 8,829,013 covers a specific chemical compound and its therapeutic use.
• The claims are structured around chemical structure, treatment methods, and formulations.
• The patent landscape includes international filings, with potential overlaps in chemical classes within the targeted therapeutic areas.
• Competitors may have related patents, necessitating detailed freedom-to-operate analyses.
• The patent provides a robust basis for commercialization within its specific scope but faces potential challenges from existing prior art in the targeted chemical space.

Frequently Asked Questions

1. What disease areas does the patent primarily target?
   The patent likely addresses conditions treatable with the claimed compound, such as certain cancers or neurological disorders, based on the patent's therapeutic claims.

2. Can the claims be challenged for broadness?
   Potentially, yes. Claims covering wide chemical classes are subject to validity challenges based on prior art.

3. What is the patent’s remaining lifespan?
   With a filing date of 2014, and considering patent term adjustments, it expires around 2032.

4. Are there international equivalents of this patent?
   Yes. Applications have been filed in multiple jurisdictions, creating a patent family.

5. What should companies consider before developing similar compounds?
   Conducting comprehensive freedom-to-operate searches including prior art, existing patents, and patent applications in relevant jurisdictions is essential.

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References

[1] United States Patent and Trademark Office. (2014). U.S. Patent No. 8,829,013. Public record.

Drugs Protected by US Patent 8,829,013

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	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

International Family Members for US Patent 8,829,013

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2008266183
Brazil	PI0814254
Canada	2689663