United States Patent 8,722,679: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 8,722,679, titled "Controlled release sterile injectable aripiprazole formulation and method," is a significant patent in the pharmaceutical industry, particularly in the context of psychiatric medications. This patent, held by Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S, is central to several ongoing patent infringement disputes.
Background of the Patent
The patent in question pertains to a controlled release sterile injectable formulation of aripiprazole, a medication used primarily for the treatment of schizophrenia and bipolar disorder. Aripiprazole is marketed under the brand name ABILIFY MAINTENA® by Otsuka Pharmaceutical Co., Ltd.[2].
Scope of the Patent
The scope of the patent is defined by its claims, which describe the specific aspects of the invention that are protected. Here are some key aspects:
Claim Structure
The patent includes multiple claims that outline the composition and method of the controlled release formulation. These claims are divided into independent and dependent claims, each specifying different elements of the invention.
Independent Claims
Independent claims are standalone and define the broadest scope of the invention. For example, Claim 1 of the patent describes a controlled release sterile injectable aripiprazole formulation composed of aripiprazole particles of a desired mean particle size and a vehicle[4].
Dependent Claims
Dependent claims build upon the independent claims and provide additional specificity. These claims may include specific particle sizes, vehicle compositions, and methods of preparation.
Claims Analysis
Claim Language and Scope
The claims in this patent are crafted to ensure a clear and specific description of the invention. For instance, the patent specifies that the aripiprazole particles have a mean particle size that is critical for the controlled release mechanism. This specificity helps in distinguishing the invention from prior art and other similar formulations[4].
Patent Scope Metrics
Research on patent scope suggests that metrics such as independent claim length and independent claim count can be used to measure the breadth of a patent. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Patent Landscape
Litigation and Infringement
The patent is currently involved in several litigation cases, notably against Mylan Laboratories Limited, Viatris Inc., and Mylan Pharmaceuticals Inc. These defendants have filed Abbreviated New Drug Applications (ANDAs) seeking FDA approval for generic versions of ABILIFY MAINTENA®, which the plaintiffs allege infringe on the '679 patent among others[1][2].
Paragraph IV Certifications
In the context of ANDA filings, the defendants have submitted Paragraph IV certifications, alleging that the claims of the patents in suit are invalid, unenforceable, and/or not infringed. This is a common strategy in Hatch-Waxman litigations, where generic manufacturers challenge the validity of brand patents to expedite market entry[2].
Patent Quality and Clarity
Critiques and Debates
There are ongoing debates about patent quality, particularly regarding the clarity and breadth of patent claims. The '679 patent, with its detailed and specific claims, avoids some of the criticisms associated with overly broad or unclear patents. However, the litigation surrounding it highlights the complexities and challenges in patent enforcement[3].
Examination Process
The examination process for this patent would have involved a thorough review to ensure that the claims are clear, specific, and novel. The fact that the patent has been granted suggests that it met the criteria set by the USPTO, although the ongoing litigation indicates that its validity and enforceability are still under scrutiny[3].
Industry Impact
Innovation and Licensing
Patents like the '679 patent play a crucial role in incentivizing innovation in the pharmaceutical industry. However, they also contribute to licensing and litigation costs, which can be substantial. Viatris, for example, has noted in its SEC filings that it incurs significant litigation expenses related to patent disputes[2].
Market Competition
The approval of generic versions of ABILIFY MAINTENA® could significantly impact the market dynamics, potentially reducing costs for consumers and increasing competition. However, the ongoing litigation aims to protect the exclusivity of the brand product until the patent expires[1][2].
Key Takeaways
- Specific Claims: The '679 patent has specific claims that define the controlled release formulation of aripiprazole.
- Litigation: The patent is involved in several litigation cases against generic manufacturers.
- Patent Quality: The patent's clarity and specificity are crucial in distinguishing it from prior art and other formulations.
- Industry Impact: The patent affects innovation, licensing, and market competition in the pharmaceutical industry.
FAQs
What is the main subject of United States Patent 8,722,679?
The main subject of this patent is a controlled release sterile injectable formulation of aripiprazole, used in the treatment of psychiatric conditions.
Who are the current holders of this patent?
The patent is held by Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S.
What is the significance of the mean particle size in the patent claims?
The mean particle size of aripiprazole particles is critical for the controlled release mechanism of the formulation.
Why is this patent involved in litigation?
The patent is involved in litigation due to ANDA filings by generic manufacturers who seek to market generic versions of ABILIFY MAINTENA®, which the plaintiffs allege infringe on the patent.
How does this patent impact the pharmaceutical industry?
This patent impacts the industry by protecting the exclusivity of the brand product, influencing innovation and licensing costs, and affecting market competition.
Cited Sources
- IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF WEST VIRGINIA OTSUKA PHARMACEUTICAL CO., LTD. AND H. LUNDBECK A/S, Plaintiffs, v. MYLAN LABORATORIES LIMITED, VIATRIS INC. AND MYLAN PHARMACEUTICALS INC., Defendants. - RPX Insight.
- Case 1:22-cv-00032-TSK Document 1 Filed 04/08/22 Page 1 of 37 - RPX Insight.
- Patent Claims and Patent Scope - Hoover Institution.
- US8722679B2 - Controlled release sterile injectable aripiprazole formulation and method - Google Patents.
