United States Patent 9,132,110: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 9,132,110, part of the '450 Patent Family, is a significant patent in the pharmaceutical sector, particularly related to methods and compositions for treating osteoarthritis. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Patent Family
The '450 Patent Family includes several patents such as U.S. Patent Nos. 8,217,078, 8,546,450, 8,618,164, and 9,132,110. These patents are associated with HZNP Medicines LLC and Horizon Pharma USA, Inc., and they generally relate to methods and compositions for treating osteoarthritis using topical diclofenac preparations[2].
Scope of the Patent
The scope of U.S. Patent 9,132,110 encompasses methods for applying topical agents to treat osteoarthritis. Here are some key aspects of the patent's scope:
Method of Use
The patent describes a method for applying a topical diclofenac preparation to a patient's knee to treat osteoarthritis. This method involves applying a therapeutically effective amount of a diclofenac salt and dimethyl sulfoxide (DMSO) to the affected area, waiting for the area to dry, and then applying a sunscreen or insect repellent without enhancing the systemic absorption of the subsequently applied product[2].
Composition
The composition claimed in the patent includes a topical diclofenac preparation with specific components such as a diclofenac salt and 40-50% w/w DMSO. The formulation is designed to have several novel properties, including better drying time, higher viscosity, increased transdermal flux, greater pharmacokinetic absorption, and favorable stability[1].
Claims Analysis
The claims of U.S. Patent 9,132,110 are critical in defining the patent's scope and determining its validity.
Claim Construction
The court's construction of the claims, particularly the term "consisting essentially of," has been a point of contention. The term was found to be indefinite due to the lack of clear guidance on evaluating the basic and novel properties of the invention, such as "better drying time" and "favorable stability"[1].
Indefiniteness Issues
The court identified several issues with the claims:
- The term "better drying time" was deemed indefinite because the specification described two different methods for evaluating drying time that did not provide consistent results.
- The stability claims were also found to be indefinite due to the unclear identity of "impurity A" and the lack of guidance on how to evaluate degradation[1].
Method-of-Use Patents
Claim 10 of the '450 patent, which is illustrative of the method-of-use patents, specifies the steps involved in applying the topical diclofenac preparation. This claim is significant as it defines the method that must be followed to avoid infringement[2].
Patent Landscape
The patent landscape surrounding U.S. Patent 9,132,110 is complex and involves several related patents and legal challenges.
Related Patents
The '450 Patent Family includes multiple patents that share substantially similar specifications. These patents are divided into two groups: method-of-use patents and composition patents. The method-of-use patents, such as the '450, '078, '110, and '164 patents, focus on the application methods, while the composition patents detail the specific formulations[2].
Litigation and Challenges
HZNP Medicines LLC and Horizon Pharma USA, Inc. faced significant legal challenges from Actavis Labs. UT, Inc., which sought to market a generic version of PENNSAID 2%, a product covered by these patents. Actavis filed an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification, asserting that the patents-at-issue were invalid or would not be infringed by their generic product. The district court ultimately granted summary judgment in favor of Actavis, finding that Horizon had not met its burden to show induced infringement of the method-of-use patents[2].
Impact on Innovation and Patent Quality
The debates over patent quality and scope are relevant to this patent. The purported decrease in patent quality has led to concerns about overly broad patents with decreased clarity and questionable validity. Metrics such as independent claim length and independent claim count can help measure patent scope and validate the quality of patents. Narrower claims, as seen in the publication stage, are associated with a higher probability of grant and a shorter examination process[3].
Key Takeaways
- Scope and Claims: U.S. Patent 9,132,110 covers specific methods for treating osteoarthritis using topical diclofenac preparations, with claims that have been challenged for indefiniteness.
- Patent Family: The patent is part of the '450 Patent Family, which includes several related patents with similar specifications.
- Litigation: The patent has been involved in significant litigation, particularly with Actavis Labs. UT, Inc., over the validity and infringement of the method-of-use patents.
- Patent Quality: The patent's claims and scope highlight the ongoing debates about patent quality, clarity, and validity.
FAQs
What is the main subject of U.S. Patent 9,132,110?
The main subject of U.S. Patent 9,132,110 is methods and compositions for treating osteoarthritis using topical diclofenac preparations.
What are the key components of the claimed composition?
The composition includes a diclofenac salt and 40-50% w/w dimethyl sulfoxide (DMSO).
Why was the term "consisting essentially of" found to be indefinite?
The term was found indefinite due to the lack of clear guidance on evaluating the basic and novel properties of the invention, such as "better drying time" and "favorable stability."
What was the outcome of the litigation between Horizon and Actavis?
The district court granted summary judgment in favor of Actavis, finding that Horizon had not met its burden to show induced infringement of the method-of-use patents.
How does this patent fit into the broader debate on patent quality?
The patent's challenges with indefiniteness and the broader litigation highlight concerns about patent quality, clarity, and validity, which are central to debates about the impact of patents on innovation.
Sources
- UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY: Horizon Pharma v. Actavis[1].
- HZNP Medicines LLC v. Actavis Labs. UT, Inc.: 940 F.3d 680[2].
- Patent Claims and Patent Scope: SSRN[3].
- U.S. Patent and Trademark Office (USPTO): Public Search Facility[4].
- U.S. Patent and Trademark Office (USPTO): USA.gov[5].
