United States Patent 8,377,919: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,377,919, hereafter referred to as the '919 patent, is one of the key patents in a series of intellectual property protections held by LEO Pharma, Inc. and LEO Laboratories Limited (collectively, "LEO") for their drug Picato®. This patent is crucial in the context of pharmaceuticals, particularly in the production and use of ingenol mebutate, a compound derived from the Euphorbia peplus plant.
Background of the Patent
The '919 patent is part of a broader portfolio of patents related to the production, composition, and use of ingenol mebutate. It was filed as part of the prosecution of several process patents, including the '084 and '698 patents, which are also related to the methods of producing ingenol-3-angelate[2].
Scope of the Patent
Claim Coverage
The '919 patent covers specific methods and compositions related to ingenol mebutate. The claims are detailed and precise, ensuring that the patent protects the unique processes and compounds developed by LEO. Here are some key aspects of the claim coverage:
- Method of Production: The patent includes claims related to the methods of producing ingenol mebutate, which involve specific steps and conditions to ensure the purity and efficacy of the compound[2][4].
- Composition: The claims also cover the composition of ingenol mebutate, including its isolation and purification from plant extracts. This ensures that any synthetic or semi-synthetic versions of the compound are not within the scope of the patent unless explicitly described in the specification[4].
Scope Concepts and Claim Charts
To understand the full extent of the patent's coverage, patent analytics tools such as Claim Coverage Matrix and Claim Charts are essential. These tools help in categorizing patents by claims and scope concepts, making it easier to identify which patents and claims are actively protecting the intellectual property. For the '919 patent, these tools would highlight the specific scope concepts related to the production and composition of ingenol mebutate, allowing LEO to track and manage their patent landscape effectively[3].
Claims and Specifications
Intrinsic Evidence
The claims of the '919 patent are interpreted in light of the intrinsic evidence, which includes the patent specification, the prosecution history, and any other relevant documents. The specification provides detailed descriptions of the methods and compounds, which help in understanding the scope of the claims. For instance, the specification explicitly addresses the source of the compounds, ensuring that they are derived from plants of the Euphorbia species[4].
Inventor's Lexicography
The inventor's lexicography plays a crucial role in defining claim terms. According to the Federal Circuit, "the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor's lexicography governs"[4].
Limitations and Exclusions
The claims of the '919 patent are not read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope. This means that even if the specification describes only a single embodiment, the claims will not be limited to that embodiment unless there is a clear intention to do so[4].
Patent Landscape
Related Patents
The '919 patent is part of a larger family of patents related to Picato®, including the '656, '292, '827, '828, '163, '271, '375, '698, and '084 patents. These patents collectively protect various aspects of ingenol mebutate, from its production to its use in pharmaceutical applications[2][4].
Litigation and Enforcement
LEO has been involved in several legal battles to enforce these patents against generic drug manufacturers such as Actavis and Perrigo. These lawsuits highlight the importance of the '919 patent in protecting LEO's intellectual property and market position for Picato®[1][4].
Practical Applications and Implications
Pharmaceutical Industry
The '919 patent has significant implications for the pharmaceutical industry, particularly in the development and production of ingenol mebutate-based drugs. It ensures that any generic or competing products must adhere to the specific methods and compositions protected by the patent, thereby maintaining the quality and efficacy of the drug[2].
Research and Development
For researchers and developers, understanding the scope and claims of the '919 patent is crucial. It helps in identifying areas where innovation can occur without infringing on existing patents, thus fostering further research and development in related fields[3].
Key Takeaways
- Specific Claim Coverage: The '919 patent covers specific methods and compositions related to ingenol mebutate.
- Intrinsic Evidence: The interpretation of claims is based on the patent specification, prosecution history, and other intrinsic evidence.
- Inventor's Lexicography: Special definitions given to claim terms by the patentee govern their meaning.
- Patent Landscape: The '919 patent is part of a broader portfolio of patents protecting various aspects of Picato®.
- Litigation and Enforcement: LEO has actively enforced these patents against generic drug manufacturers.
FAQs
What is the main subject of the United States Patent 8,377,919?
The main subject of the '919 patent is the methods and compositions related to the production and use of ingenol mebutate, a compound derived from the Euphorbia peplus plant.
How does the '919 patent fit into LEO Pharma's broader patent portfolio?
The '919 patent is part of a series of patents related to Picato®, including patents such as the '656, '292, '827, '828, '163, '271, '375, '698, and '084 patents, which collectively protect various aspects of ingenol mebutate.
What is the significance of intrinsic evidence in interpreting the claims of the '919 patent?
Intrinsic evidence, including the patent specification and prosecution history, is crucial in interpreting the claims of the '919 patent. It helps in understanding the scope and limitations of the claims as intended by the patentee.
How does the inventor's lexicography impact the interpretation of claim terms in the '919 patent?
The inventor's lexicography governs the meaning of claim terms if the specification reveals special definitions that differ from their ordinary meaning.
What are the practical implications of the '919 patent for the pharmaceutical industry?
The '919 patent ensures that any production or use of ingenol mebutate-based drugs adheres to the protected methods and compositions, maintaining the quality and efficacy of the drug.
Sources
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - LEO Laboratories Limited ("LEO Labs"), and LEO Pharma, Inc. ("LEO, Inc.") (collectively, "LEO") against defendants Actavis Laboratories UT, Inc. and Actavis, Inc. (together, "Actavis"), and Perrigo UK Finco Limited Partnership and Perrigo Company (together, "Perrigo")[1].
- Case 1:16-cv-00333-JFB-SRF Document 332 Filed 06/18 ... - Patent No. 8,377,919 ("the '919 patent") to the United States Patent and Trademark Office ("PTO") during prosecution of the Process Patents[2].
- Patent Analytics | Intellectual Property Law - Schwegman’s process involves categorizing your patents not only by claims but also by the overarching scope concepts that can link claims on similar patents[3].
- Case 1:16-cv-00430-JFB-SRF Document 161 Filed 12/28 ... - LEO alleges infringement of numerous patents directed to LEO's Picato® drug, including the '919 patent[4].
