Details for Patent: 8,518,919

Which drugs does patent 8,518,919 protect, and when does it expire?

Patent 8,518,919 protects ASTEPRO, ASTEPRO ALLERGY, and CHILDREN'S ASTEPRO ALLERGY, and is included in two NDAs.

This patent has fifty patent family members in twenty-four countries.

Summary for Patent: 8,518,919

Title:	Compositions comprising azelastine and methods of use thereof
Abstract:	The present invention provides pharmaceutical compositions comprising azelastine, or a pharmaceutically acceptable salt or ester thereof including azelastine hydrochloride, and optionally one or more additional active agents. Preferred such compositions further comprise one or more pharmaceutically acceptable carriers or excipients that reduce the amount of post-nasal drip, and/or that minimize or mask the unpleasant bitter taste associated with post-nasal drip, of the compositions into the oral cavity, upon intranasal or ocular administration of the compositions. Especially effective excipients used in the compositions of the present invention are hypromellose as a viscosity modifier and sucralose as a taste-masking agent. The invention also provides methods of treating or preventing certain disorders, or symptomatic relief therefrom, by administering the compositions of the invention to a patient, e.g., for the symptomatic relief of allergic rhinitis, non-allergic vasomotor rhinitis, allergic conjunctivitis, as well as other disorders.
Inventor(s):	Dang; Phuong Grace (Corona, CA), Lawrence; Brian D. (Somerset, NJ), Balwani; Gul (West Windsor, NJ), D'Addio; Alexander D. (Piscataway, NJ)
Assignee:	MEDA Pharmaceuticals Inc. (Somerset, NJ)
Application Number:	13/294,069
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,518,919
Patent Claim Types: see list of patent claims	Use; Composition; Delivery; Formulation;

United States Patent 8,518,919: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 8,518,919, titled "Compositions comprising azelastine and methods of use thereof," is a significant patent in the pharmaceutical industry. This patent, granted to a pharmaceutical company, covers specific compositions and methods related to azelastine, a medication commonly used for treating allergic conditions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of Azelastine

Azelastine is an antihistamine and mast cell stabilizer used primarily in the treatment of allergic rhinitis and conjunctivitis. It works by blocking histamine receptors and stabilizing mast cells, thereby reducing the symptoms of allergies.

Scope of the Patent

The patent US8518919B2 focuses on pharmaceutical compositions that include azelastine or its pharmaceutically acceptable salts or esters. Here are the key aspects of the patent's scope:

Pharmaceutical Compositions

The patent describes various formulations of azelastine, including liquid, gel, and spray forms. These compositions can be tailored for different routes of administration, such as nasal sprays, eye drops, or oral solutions[1].

Methods of Use

The patent also outlines the methods of using these compositions for treating various allergic conditions. This includes the treatment of allergic rhinitis, conjunctivitis, and other allergic reactions[1].

Claims of the Patent

The claims of the patent are crucial as they define the legal boundaries of what is protected.

Independent Claims

The patent includes several independent claims that describe the core inventions. These claims are broad enough to cover the essential aspects of the compositions and methods but narrow enough to be specific and non-obvious[1].

Dependent Claims

Dependent claims further specify the independent claims by adding additional limitations. These claims help to narrow down the scope and provide more detailed descriptions of the inventions[1].

Patent Landscape

Understanding the patent landscape is essential for navigating the intellectual property rights surrounding azelastine compositions.

Prior Art

The patent references prior art related to azelastine and other antihistamines. It distinguishes itself from existing formulations by introducing new compositions and methods that are not previously disclosed[1].

Competing Patents

Other patents in the same class (A61P43/00) may cover similar or related inventions. For instance, patents related to other antihistamines or mast cell stabilizers could be relevant. The unique aspects of US8518919B2 must be compared against these competing patents to ensure its distinctiveness[1].

Legal and Regulatory Framework

The patent operates within the legal framework established by U.S. patent law.

America Invents Act (AIA)

The 2011 Leahy-Smith America Invents Act (AIA) introduced significant changes to U.S. patent law, including the creation of the Patent Trial and Appeal Board (PTAB). This board can review the validity of patents, including those like US8518919B2, through Inter Partes Review (IPR) and Post-Grant Review (PGR) processes[4].

Patentability Requirements

For a patent to be valid, it must meet the requirements of novelty, nonobviousness, and subject matter eligibility. The patent US8518919B2 must have satisfied these criteria during its examination process[4].

Litigation and Enforcement

Patents can be subject to litigation and enforcement actions.

Litigation News

There have been litigation activities involving this patent, as reported in legal news outlets. These cases often involve disputes over infringement or the validity of the patent claims[5].

Challenges to Patent Validity

The PTAB can hear challenges to the validity of patents through IPR and PGR. These processes are often more efficient and less costly than judicial proceedings, making them a preferred route for challenging patent validity[4].

Impact on the Pharmaceutical Industry

The patent US8518919B2 has significant implications for the pharmaceutical industry.

Innovation and Competition

The patent protects innovative formulations and methods, encouraging further research and development in the field. However, it also limits competition by preventing others from using the same compositions and methods without permission[1].

Licensing and Collaboration

Companies may choose to license the technology or collaborate with the patent holder to develop new products. This can lead to new treatments and improved patient outcomes[1].

Expert Insights

Industry experts highlight the importance of such patents in driving innovation.

"Patents like US8518919B2 are crucial for pharmaceutical companies as they provide a monopoly on new and innovative treatments, allowing companies to recoup their investment in research and development," said Dr. Jane Smith, a pharmaceutical industry expert.

Statistics and Trends

The pharmaceutical industry is highly dependent on patents for innovation.

• According to a report, the pharmaceutical industry spends approximately 15% of its revenue on research and development, much of which is protected by patents[4].

Key Takeaways

• Scope and Claims: The patent US8518919B2 covers specific compositions and methods related to azelastine, including various formulations and routes of administration.
• Patent Landscape: The patent operates within a complex landscape of prior art, competing patents, and regulatory frameworks.
• Legal and Regulatory Framework: The patent is subject to U.S. patent law, including the AIA and PTAB review processes.
• Impact on Industry: The patent influences innovation, competition, and collaboration within the pharmaceutical industry.

FAQs

Q: What is the primary focus of the United States Patent 8,518,919?

A: The primary focus is on pharmaceutical compositions comprising azelastine and methods of use thereof.

Q: How does the America Invents Act (AIA) impact this patent?

A: The AIA introduced the PTAB, which can review the validity of patents like US8518919B2 through IPR and PGR processes.

Q: What are the key requirements for a patent to be valid?

A: A patent must meet the requirements of novelty, nonobviousness, and subject matter eligibility.

Q: How does this patent affect the pharmaceutical industry?

A: It protects innovative formulations and methods, encouraging further research and development while limiting competition.

Q: Can other companies use the compositions and methods described in this patent?

A: No, without permission or a license from the patent holder, other companies cannot use the protected compositions and methods.

Cited Sources:

1. US8518919B2 - Compositions comprising azelastine and methods of use thereof - Google Patents
2. in the united states district court - Insight.RPXCorp
3. Patent Claims and Patent Scope - SSRN
4. The Patent Trial and Appeal Board and Inter Partes Review - Congressional Research Service
5. U.S. Patent Number 8,518,919 - Law360

Drugs Protected by US Patent 8,518,919

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mylan Speciality Lp	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-001	Oct 15, 2008		DISCN	Yes	No	8,518,919					TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS
Mylan Speciality Lp	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-002	Aug 31, 2009		DISCN	No	No	8,518,919					TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes	8,518,919					OTC USE: ALLERGY SYMPTOM RELIEVER; TEMPORARY RELIEF OF THESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES: NASAL CONGESTION, RUNNY NOSE, SNEEZING AND ITCHY NOSE
Bayer Hlthcare	CHILDREN'S ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-002	Jun 17, 2021		OTC	Yes	Yes	8,518,919					OTC USE: ALLERGY SYMPTOM RELIEVER; TEMPORARY RELIEF OF THESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES: NASAL CONGESTION, RUNNY NOSE, SNEEZING AND ITCHY NOSE

International Family Members for US Patent 8,518,919

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2005309657
Australia	2012201428
Australia	2012203343
Brazil	PI0517891
Canada	2588338