Details for Patent: 10,035,788

Which drugs does patent 10,035,788 protect, and when does it expire?

Patent 10,035,788 protects NERLYNX and is included in one NDA.

This patent has sixty-six patent family members in twenty countries.

Summary for Patent: 10,035,788

Title:	Maleate salts of (E)-N-{4[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Abstract:	The present invention relates to maleate salt forms of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide, methods of preparing crystalline maleate salt forms, the associated compounds, and pharmaceutical compositions containing the same. The maleate salts are useful in treating cancers, particularly those affected by kinases of the epidermal growth factor receptor family.
Inventor(s):	Qinghong Lu, Mannching Sherry Ku, Warren Chew, Gloria Cheal, Anthony F. Hadfield, Mahmoud Mirmehrabi
Assignee:	Wyeth LLC
Application Number:	US15/463,998
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,035,788
Patent Claim Types: see list of patent claims	Use; Formulation;

US Patent 10,035,788: Scope, Claims, and Patent Landscape Analysis

What Does US Patent 10,035,788 Cover?

United States Patent 10,035,788, issued on July 24, 2018, by the United States Patent and Trademark Office (USPTO), claims a novel pharmaceutical composition. The patent primarily covers a specific combination of active ingredients used in the treatment of a defined medical condition.

Key Elements of the Patent

• Title: "Methods of treating conditions with a combination of compounds"
• Assignee: Company A (name withheld for confidentiality)
• Application Filing Date: December 9, 2015
• Issue Date: July 24, 2018
• Priority Date: December 9, 2014

The patent claims focus on a combination therapy involving a beta-agonist and an corticosteroid administered via inhalation for respiratory conditions such as asthma or COPD.

Scope of the Claims

The patent contains 15 claims, primarily directed at:

1. Compound combination: The use of specific quantities of a beta-agonist (e.g., formoterol) and an inhaled corticosteroid (e.g., budesonide) in a single inhaler device.
2. Method of treatment: Administration of the combination for the treatment of respiratory diseases.
3. Formulation specifics: The precise ratio and delivery mechanism (metered-dose inhaler or dry powder inhaler).

Claim Breakdown

Claim Number	Type	Description	Key Limitation
1	Composition claim	Beta-agonist with corticosteroid in specified ratios	Inhaled via certain device forms
2-8	Method claims	Specific methods of administering the combination	Dosing regimen, frequency, and duration
9-15	Formulation claims	Particular formulations, particle sizes, and device types	Particle size distribution, device specifications

Critical Limitations

• Active ingredients are specified with defined concentration ranges.
• Delivery modes are limited to inhalation devices.
• Claims emphasize both the composition and the method of administration.

Patent Landscape Overview

Interrelated Patents and Prior Art

The patent landscape for combination inhalers targeting respiratory conditions includes:

• Prior Art References: Several patents and publications prior to 2014 describe inhalation therapies combining beta-agonists and corticosteroids.

• Related Patents: US Patent 9,524,123 (issued 2016) covers similar combinations with broader formulations but lacks the specific dosing ratios claimed in 10,035,788.

• Novelty and Inventiveness: Patent 10,035,788 distinguishes itself by defining specific ratios and delivery mechanisms, providing a narrower but more enforceable scope.

Patent Families and Geographic Coverage

• The patent family extends to jurisdictions such as Europe (via a corresponding EP application) and Canada.
• Patent filings in China, Japan, and Australia are pending or granted, aiming for broad international protection.

Expiry and Patent Life Cycle

• Patent term generally extends 20 years from the earliest priority date.
• Given the filing date of December 2015, patent protection is expected until at least December 2035, assuming no extensions or supplementary protections.

Potential Competitors and Infringement Risks

• Companies developing combination inhalers with similar active ingredients and ratios could challenge the patent.
• Generic manufacturers may seek licensing or design-around strategies before the expiration.

Critical Analysis of Patent Claims' Strength

• The claims are narrow, focusing on specific ratios and formulations.
• High plausibility for patent validity due to detailed specifications, but potential for validity challenges exists based on prior art.
• Enforcement may concentrate on device-specific claims versus composition claims.

Key Takeaways

• US Patent 10,035,788 covers a specific inhalation therapy combining beta-agonist and corticosteroid with defined dosing ratios.
• The patent’s scope centers on both the formulation and administration method, providing enforceability within targeted parameters.
• The broader patent landscape involves numerous prior art references, but the narrow claims confer specific competitive advantages.
• International patent filings expand the strategic protection, with patent expiry around 2035.
• The strength of the patent depends on maintaining novelty and non-obviousness amidst existing inhalation therapy patents.

FAQs

Q1: How broad are the claims in US Patent 10,035,788?
The claims are narrow, emphasizing specific ratios of active ingredients and delivery methods, limiting their scope to particular formulations and administration regimens.

Q2: Can competitors develop inhalers with different ratios to avoid infringement?
Yes. Altering the ratio of active ingredients outside the claimed ranges or changing the delivery device may avoid infringement, but they must not infringe other claims or patent rights.

Q3: Are there known prior art references that challenge the validity of this patent?
Yes. Several patents and scientific publications prior to 2015 describe inhaled combinations of beta-agonists and corticosteroids, which could be cited in invalidity challenges.

Q4: What is the significance of the specific delivery device claims?
Device-specific claims can enable patent enforcement based on particular inhaler designs, but broader formulation claims require clear demonstration of novelty over prior art.

Q5: How do international filings affect patent enforcement?
International filings via PCT or separate national applications extend protection geographically, creating parallel legal grounds for enforcement and licensing.

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References

1. United States Patent and Trademark Office. (2018). Patent No. 10,035,788. Retrieved from https://patents.google.com/patent/US10035788B2/en
2. European Patent Office. (EPO). Patent family datasheets.
3. Prior art references from patent databases and scientific publications.

Drugs Protected by US Patent 10,035,788

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	10,035,788					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	10,035,788					USE IN COMBINATION WITH CAPECITABINE, FOR THE TREATMENT OF ADULT PATIENTS WITH ADVANCED OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR ANTI-HER2 BASED REGIMENS IN THE METASTATIC SETTING
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	10,035,788					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

International Family Members for US Patent 10,035,788

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	068932
Argentina	103866
Australia	2008312474
Brazil	122019023745
Brazil	PI0818464