Detailed Analysis of the Scope and Claims of United States Patent 8,008,338
Introduction
United States Patent 8,008,338, titled "Ketorolac Tromethamine Compositions for Treating or Preventing Ocular Pain," was issued on August 30, 2011, to inventors Christopher A. Muller, Janet K. Cheetham, Teresa H. Kuan, and David F. Power. This patent is crucial for understanding the formulation and use of ketorolac tromethamine in ophthalmic solutions, particularly in the context of Allergan's ACULAR LS® product.
Background and Invention Overview
The patent focuses on compositions of ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), designed to treat or prevent ocular pain. The invention is significant because it addresses the common adverse events associated with higher concentrations of ketorolac, such as ocular irritation, burning, and stinging upon instillation[4].
Claims and Scope
Claim Construction
The patent includes several claims that define the scope of the invention. A critical aspect of these claims is the interpretation of the term "ketorolac." The court has ruled that in the context of the '338 patent, "ketorolac" must mean "ketorolac tromethamine" to align with the patent's specification and the preferred embodiment described therein[1].
Key Claims
- Claim 1: This claim specifies a composition comprising ketorolac tromethamine, which is interpreted as the tromethamine salt of ketorolac.
- Claims 3-5: These claims are dependent on claim 1 and describe specific concentrations and formulations of the ketorolac tromethamine solution. The court has determined that these claims logically depend on the interpretation of "ketorolac" as "ketorolac tromethamine"[1].
Preferred Embodiment
The preferred embodiment of the invention is a 0.4% ketorolac tromethamine solution, which is described extensively in the patent specification. Any claim construction that excludes this embodiment is considered illogical and unlikely to be correct[1].
Patent Landscape Analysis
Importance of Patent Landscape
Patent landscape analysis is essential for understanding the technological and competitive landscape surrounding a patent. This analysis involves analyzing vast amounts of patent data to extract legal, business, and technical insights[3].
Relevant Sources
- USPTO, WIPO, and EPO Databases: These databases are crucial for collecting relevant patent and non-patent data.
- Technical Literature: Preliminary searches of technical literature and collaboration with technical teams and market experts help in identifying relevant keywords, patent class codes, and organizations operating in the field[3].
Legal Status and Expiry Dates
Understanding the legal status (alive, pending, lapsed, revoked, or expired) and expected expiry dates of patents is vital for decision-making. For the '338 patent, it is listed in the FDA's Orange Book and is associated with the New Drug Application (NDA) No. 21-528 for ACULAR LS®[2].
Market and Competitive Insights
Market Developments
Patent landscape studies reveal market developments such as mergers and acquisitions, in/out-licensing, and litigation activities. In the case of the '338 patent, Allergan has been involved in several litigation cases against generic manufacturers, such as Akorn, Inc., to protect its intellectual property rights[2].
Litigation Activities
The patent has been the subject of several court cases, including Allergan Sales, LLC v. Lupin Ltd. and Allergan Sales, LLC v. Akorn, Inc. These cases highlight the importance of the patent in the ophthalmic pharmaceutical market and the efforts to enforce its claims against generic competitors[1][2].
Technical Insights
Formulation and Administration
The patent describes specific formulations of ketorolac tromethamine that are designed to minimize adverse events. The 0.4% solution is particularly noted for its reduced ocular irritation compared to higher concentrations like the 0.5% solution[4].
Clinical Significance
The compositions described in the patent are clinically significant because they provide an effective treatment for ocular pain with fewer side effects. This makes the product more patient-friendly and enhances its market viability.
Business Implications
Protection of Intellectual Property
The '338 patent is a key asset for Allergan, and the company has taken significant steps to protect it. The patent's listing in the FDA's Orange Book and its association with NDA No. 21-528 underscore its importance in maintaining market exclusivity for ACULAR LS®[2].
Competitive Advantage
The unique formulation and the patent protection provide Allergan with a competitive advantage in the ophthalmic pharmaceutical market. This advantage is crucial for maintaining market share and preventing generic competition.
Key Takeaways
- Interpretation of Claims: The term "ketorolac" in the '338 patent must be interpreted as "ketorolac tromethamine" to align with the patent's specification and preferred embodiment.
- Preferred Embodiment: The 0.4% ketorolac tromethamine solution is the preferred embodiment and a critical aspect of the invention.
- Patent Landscape: Understanding the patent landscape is essential for navigating technological and competitive domains.
- Market and Competitive Insights: The patent is a significant asset for Allergan, providing protection against generic competition and maintaining market exclusivity.
- Technical Insights: The formulations described in the patent are clinically significant, offering effective treatment for ocular pain with reduced side effects.
FAQs
What is the main focus of United States Patent 8,008,338?
The main focus of the patent is on compositions of ketorolac tromethamine for treating or preventing ocular pain, particularly emphasizing a 0.4% solution that minimizes adverse events.
How is the term "ketorolac" interpreted in the '338 patent?
The term "ketorolac" is interpreted as "ketorolac tromethamine" to align with the patent's specification and the preferred embodiment described therein.
What is the preferred embodiment of the invention described in the '338 patent?
The preferred embodiment is a 0.4% ketorolac tromethamine solution, which is extensively described in the patent specification.
Why is patent landscape analysis important for this patent?
Patent landscape analysis helps in understanding the technological and competitive landscape, providing insights into market developments, litigation activities, and the legal status of related patents.
What is the significance of the '338 patent in the ophthalmic pharmaceutical market?
The patent is significant because it protects Allergan's ACULAR LS® product, providing a competitive advantage and maintaining market exclusivity against generic competitors.
Sources
- Allergan Sales, LLC v. Lupin Ltd. - Casetext
- IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS MARSHALL DIVISION ALLERGAN SALES, LLC, Plaintiff, v. AKORN, INC., Defendant. - Insight.RPXCorp
- Navigating Technological Domains with Patent Landscape Analysis - Sagacious Research
- US8008338B2 - Ketorolac tromethamine compositions for treating or preventing ocular pain - Google Patents
- US8946281B2 - Ketorolac tromethamine compositions for treating or preventing ocular pain - Google Patents
