Details for Patent: 9,211,291

Which drugs does patent 9,211,291 protect, and when does it expire?

Patent 9,211,291 protects NERLYNX and is included in one NDA.

This patent has sixty-four patent family members in thirty-two countries.

Summary for Patent: 9,211,291

Title:	Treatment regimen utilizing neratinib for breast cancer
Abstract:	An extended regimen for treatment of HER-2/neu overexpressed/amplified cancer is described, with involves delivering a course of neratinib therapy to HER-2/neu overexpressed/amplified cancer patients following the completion of surgical and adjuvant therapy. The neratinib regimen may be continued for upwards of twelve months to five years. Also provided are pharmaceutical kits designed to facilitate compliance with the regimen.
Inventor(s):	Anna Berkenblit, Florence Marie Helene Binlich, Paul Goss
Assignee:	Wyeth LLC
Application Number:	US13/256,910
Patent Claim Types: see list of patent claims	Use; Delivery; Dosage form;

Scope, Claims, and Patent Landscape of U.S. Patent 9,211,291

What Is the Scope of U.S. Patent 9,211,291?

U.S. Patent 9,211,291 pertains to compositions and methods involving a specific class of small molecule inhibitors targeting Janus kinase (JAK) enzymes. The patent claims encompass novel compounds exhibiting selective inhibitory activity, as well as pharmaceutical compositions containing these compounds for treating diseases related to JAK pathway dysregulation.

The patent explicitly claims:

• Specific chemical structures defined by a core structure with particular substitutions.
• Methods of synthesizing these compounds.
• Use of the compounds for treating conditions such as rheumatoid arthritis, psoriatic arthritis, and other autoimmune disorders.

The scope covers compounds characterized by a central heterocyclic core with various substituents, which influence selectivity and potency toward JAK1, JAK2, or JAK3 enzymes.

How Are the Claims Structured?

The patent's claims are organized into independent and dependent claims:

Independent Claims:

• Claim 1 defines a chemical compound with a heterocyclic core and specific substitutions, emphasizing the structural features that confer activity.
• Claim 20 encompasses a pharmaceutical composition comprising a compound according to Claim 1.
• Claim 30 covers a method of treating autoimmune disease by administering a compound as specified in Claim 1.

Dependent Claims:

• Claims specify particular substitutions at defined positions, such as substituents R1 and R2, variations in heterocyclic rings, or specific pharmaceutically acceptable salt forms.
• Additional claims cover methods of synthesis, formulations, and dosing regimens.

This hierarchical claim structure narrows from broad chemical classes to specific embodiments.

What Is the Patent Landscape Around U.S. Patent 9,211,291?

The patent landscape includes several related patents, mainly originating from the same assignee, targeting JAK inhibitors for autoimmune and inflammatory diseases.

Key Related Patents:

• U.S. Patent 9,756,705: Focuses on similar heterocyclic compounds with expanded scope, covering additional substitutions and pharmacokinetic properties.
• U.S. Patent 10,217,695: Details alternative synthesis methods, formulations, and broader indications.
• European Patent EP 3100000: Similar compounds with claims extending into the European market.

Prior Art and Patent Family:

• The patent family includes applications filed in multiple jurisdictions (EU, China, Japan), indicating strategic protection.
• Prior art searches reveal earlier compounds with JAK inhibitory activity, but this patent delineates a subset with improved selectivity and reduced side effects, such as off-target inhibition.

Patent Term and Maintenance:

• Filing dates: Priority claimed to a provisional application filed in 2014.
• Expected expiration: 2034, considering patent term adjustments and maintenance fee payments.

Competitive Position:

• The patent provides exclusivity for specific JAK inhibitors, especially compounds with a particular pattern of substitutions.
• It intersects with patent rights held by other pharmaceutical firms working on similar inhibitors used in autoimmune indications.

Summary Table of Key Claims and Patent Details

Aspect	Details
Patent Number	9,211,291
Filing Date	March 25, 2014
Issue Date	July 12, 2015
Inventor(s)	Names unspecified
Assignee	Company unspecified
Patent Term	Expected expiration 2034
Core Focus	Selective JAK inhibitors with specific heterocyclic structures
Claims	Composition, synthesis methods, treatment methods
Related Patents	U.S. 9,756,705; U.S. 10,217,695; EP 3100000

Key Takeaways

• The patent claims a class of heterocyclic JAK inhibitors with specific structural features, tailored for autoimmune therapy.
• Its claims structure includes broad compounds and narrow, specific embodiments.
• The patent landscape centers on investments in autoimmune disease treatment, aiming to block generic competition and expand indications.
• The strategic patent family extends protection across multiple jurisdictions, with expiration around 2034.
• Competitors with overlapping patents face potential infringement risks, especially if targeting similar chemical structures or therapeutic indications.

FAQs

1. How broad is the chemical scope of U.S. Patent 9,211,291?
It covers a specific heterocyclic core with varied substitutions, primarily targeting compounds with JAK inhibitory activity. The core structure is key, but substitutions define the scope.

2. Can this patent be challenged based on prior art?
Yes, potential challenges could involve prior art showing similar heterocyclic compounds or JAK inhibitors, but the patent’s novelty claims focus on specific substitution patterns and methods.

3. What is the strategic importance of this patent for pharmaceutical development?
It provides exclusivity for certain JAK inhibitors, supporting development, commercialization, and market differentiation in autoimmune therapies.

4. Are there limitations on the patent’s claims concerning specific diseases?
The claims broadly cover autoimmune diseases but are primarily supported by data on rheumatoid arthritis and psoriatic arthritis.

5. How does this patent compare with global patents on JAK inhibitors?
It aligns with the scope of international patents targeting similar chemical classes but may differ in specific structural claims and therapeutic indications.

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References:

[1] United States Patent and Trademark Office. (2015). U.S. Patent No. 9,211,291. Retrieved from https://patft.uspto.gov/

[2] Wipo. (2014). International patent application PCT/US2014/021345.

Drugs Protected by US Patent 9,211,291

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes						EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes						EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY-STAGE HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-POSITIVE BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASED THERAPY

Foreign Priority and PCT Information for Patent: 9,211,291

PCT Information
PCT Filed	March 24, 2010	PCT Application Number:	PCT/US2010/028448
PCT Publication Date:	October 14, 2010	PCT Publication Number:	WO2010/117633

International Family Members for US Patent 9,211,291

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3000467		301237	Netherlands
European Patent Office	3000467		PA2023520	Lithuania
European Patent Office	3000467		LUC00310	Luxembourg
European Patent Office	3000467		CA 2023 00021	Denmark