United States Patent 7,105,152: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,105,152, titled "Suspension Aerosol Formulations," is a significant patent in the pharmaceutical industry, particularly in the development of inhalation therapies. This patent, issued to 3M Innovative Properties Corp. and later assigned to Norton Healthcare Limited, has been a focal point in several legal and industrial discussions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Issuance and Expiration
The patent was issued on September 12, 2006, and expired on September 12, 2023[2].
Assignees and Licensees
The patent was assigned to Norton Healthcare Limited, with Teva Branded Pharmaceutical Products R&D, Inc. and Teva Respiratory, LLC holding co-exclusive licenses to enforce the patent[2].
Scope of the Patent
Formulation Composition
The patent describes suspension aerosol formulations that contain a therapeutically effective amount of a drug and a propellant, specifically HFC 134a, HFC 227, or a mixture thereof. These formulations are designed for aerosol administration, typically through inhalation, and can be used to treat various conditions such as asthma, chronic obstructive pulmonary disease (COPD), allergic rhinitis, and other respiratory disorders[1].
Preferred Drugs
The preferred drugs for these formulations include formoterol, salmeterol, and their pharmaceutically acceptable salts, particularly formoterol fumarate. These drugs are chosen for their potency, allowing for effective therapeutic concentrations of less than 0.1%, preferably less than 0.08%, and most preferably less than 0.05%[1].
Propellants
The propellants used in these formulations are HFC 134a and HFC 227, which can be used individually or in any proportion as a mixture. The propellant is present in an amount sufficient to propel multiple doses from a metered dose inhaler (MDI)[1].
Delivery Methods
The formulations can be delivered via oral inhalation to effect bronchodilation or treat respiratory conditions. They can also be administered through nasal inhalation to treat conditions like allergic rhinitis or via topical (buccal) administration for other indications[1].
Claims of the Patent
Key Claims
- The patent claims cover suspension aerosol formulations containing a therapeutically effective amount of a drug and a propellant selected from HFC 134a, HFC 227, or a mixture thereof.
- It includes methods of preparing these formulations by combining the drug and propellant and dispersing the drug in the propellant.
- The patent also claims methods of treating mammals by administering these formulations through inhalation[1].
Formulation Characteristics
- The formulations preferably contain less than an effective stabilizing amount of surfactant and are substantially free of surfactants and other components.
- The concentration of the drug in the formulation is critical, with preferred concentrations being less than about 0.1%[1].
Patent Landscape
Litigation and Enforcement
The patent has been involved in several litigation cases, notably against Perrigo and Catalent, where Teva and its affiliates alleged infringement of the '152 patent. These cases highlight the importance of this patent in protecting intellectual property in the pharmaceutical industry[2].
Settlements and Agreements
Teva Pharmaceutical Industries Ltd. reached a settlement with Perrigo Pharmaceutical Co. and Catalent Pharma Solutions LLC in a patent case related to ProAir® HFA, which is a product covered under this patent. Such settlements indicate the ongoing negotiations and agreements within the industry to resolve patent disputes[5].
Impact on the Pharmaceutical Industry
Innovation and Competition
The patent has influenced the development of inhalation therapies, particularly those using HFC propellants. It has set a standard for the formulation and delivery of drugs via aerosol inhalers, impacting both innovation and competition in the market.
Generic Entry
With the expiration of the patent in 2023, generic versions of products covered under this patent can now enter the market, potentially increasing competition and reducing costs for consumers[4].
Metrics for Patent Scope
Independent Claim Length and Count
Studies on patent scope suggest that metrics such as independent claim length and count can provide insights into the breadth and clarity of patent claims. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Key Takeaways
- Formulation Composition: The patent covers suspension aerosol formulations with specific drugs and propellants.
- Preferred Drugs and Propellants: Formoterol, salmeterol, and HFC 134a/HFC 227 are preferred components.
- Delivery Methods: Oral, nasal, and topical administration methods are included.
- Litigation and Enforcement: The patent has been involved in significant litigation cases.
- Impact on Industry: It has influenced inhalation therapy development and will see generic entry post-expiration.
FAQs
What is the main focus of United States Patent 7,105,152?
The main focus is on suspension aerosol formulations containing a therapeutically effective amount of a drug and HFC 134a, HFC 227, or a mixture thereof.
Which drugs are preferred in these formulations?
Preferred drugs include formoterol, salmeterol, and their pharmaceutically acceptable salts, particularly formoterol fumarate.
What are the common propellants used in these formulations?
The common propellants are HFC 134a and HFC 227, which can be used individually or in any proportion as a mixture.
How are these formulations typically administered?
These formulations are typically administered through oral inhalation, but can also be delivered via nasal inhalation or topical (buccal) administration.
What is the current status of the patent?
The patent expired on September 12, 2023.
Who were the key parties involved in the litigation related to this patent?
Teva and its affiliates were involved in litigation against Perrigo and Catalent.
Sources
- US7105152B1 - Suspension aerosol formulations - Google Patents
- JURY TRIAL DEMANDED COMPLAINT - RPX Insight
- Patent Claims and Patent Scope - SSRN
- Pharmaceutical drugs covered by patent 7105152 - Drug Patent Watch
- Teva Reaches Settlement in ProAir® HFA Patent Case - Teva Pharmaceutical Industries Ltd.
