Detailed Analysis of the Scope and Claims of United States Patent 9,283,174
Introduction
The United States Patent 9,283,174, issued on March 15, 2016, is a crucial patent in the pharmaceutical industry, particularly for the treatment of pain associated with post-herpetic neuralgia (PHN) using a non-aqueous patch. This patent is held by Scilex Pharmaceuticals Inc. and is central to their product ZTlido®. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Inventors and Assignees
The patent was invented by Tatsuya Mori and Naoyuki Saida and is assigned to ITOCHU CHEMICAL FRONTIER Corporation and OISHI KOSEIDO CO., LTD.[4].
Patent Description
The patent describes a non-aqueous patch for the treatment of pain, specifically designed for the relief of pain associated with post-herpetic neuralgia in adults. The patch contains lidocaine, a local anesthetic, and is applied topically to the affected area.
Claims of the Patent
Claim Structure
The patent includes multiple claims, with Claim 1 being particularly significant. Claim 1 of the '264 patent, which is closely related to the '174 patent, covers "[a] method of treating pain in a human comprising applying a non-aqueous patch to the human, the non-aqueous patch comprising lidocaine"[2].
Key Claims
- Claim 1: This claim specifies the method of treating pain using a non-aqueous patch containing lidocaine.
- Dependent Claims: These claims further detail the composition of the patch, the concentration of lidocaine, and the method of application.
Scope of the Patent
Breadth of Claims
The scope of the patent is a subject of contention, particularly in the context of patent infringement cases. The defendant, Aveva Drug Delivery Systems, Inc., argued through their expert witness, Dr. Maureen Donovan, that the claims of the Asserted Patents (including the '174 patent) are extremely broad and not enabled because they would require undue experimentation to practice the claims[1].
Metrics for Measuring Scope
Research on patent scope suggests that metrics such as independent claim length and independent claim count can be used to measure the breadth of patent claims. Narrower claims are generally associated with a higher probability of grant and a shorter examination process[3].
Patent Landscape
Related Patents
The '174 patent is part of a family of patents that include U.S. Patent Nos. 9,925,264 and 9,931,403. These patents collectively cover various aspects of the non-aqueous patch, including its composition, method of application, and therapeutic uses[2].
Litigation and Challenges
The patent has been subject to litigation, particularly with Aveva Drug Delivery Systems, Inc.'s filing of an Abbreviated New Drug Application (ANDA) for a generic version of ZTlido®. Scilex Pharmaceuticals Inc. has alleged patent infringement, leading to a legal battle over the validity and enforceability of the Asserted Patents[1][2].
Patent Expiration and Generic Availability
Patent Expiration Dates
The patent is set to expire on May 10, 2031. Currently, there is no therapeutically equivalent generic version of ZTlido® available in the United States[5].
Impact of Expiration
The expiration of the patent will open the market for generic versions of the non-aqueous lidocaine patch, potentially increasing competition and reducing costs for patients.
Expert Opinions and Legal Rulings
Expert Witness Testimony
Dr. Maureen Donovan's testimony highlighted the broad nature of the claims, which she argued were not enabled due to the requirement of undue experimentation. However, the court refused to exclude her opinions, allowing them to be considered in the trial[1].
Legal Rulings
The court's decision to allow Dr. Donovan's testimony underscores the complexity and challenges in determining the validity and scope of pharmaceutical patents. This case illustrates the rigorous scrutiny that patent claims undergo in legal proceedings.
Conclusion on Patent Scope and Claims
The United States Patent 9,283,174 is a significant patent in the pharmaceutical industry, particularly for pain management. The scope and claims of this patent are critical in defining the intellectual property rights of Scilex Pharmaceuticals Inc. and in determining the legitimacy of generic versions of ZTlido®.
Key Takeaways
- Patent Description: The patent covers a non-aqueous patch containing lidocaine for treating pain associated with PHN.
- Claims: Claim 1 specifies the method of treating pain using the patch, with dependent claims detailing composition and application.
- Scope: The breadth of claims is a subject of contention, with metrics like independent claim length and count used to measure scope.
- Patent Landscape: Part of a family of patents, with ongoing litigation over infringement and validity.
- Expiration: Set to expire on May 10, 2031, with no current generic equivalent available.
FAQs
Q: What is the main purpose of the United States Patent 9,283,174?
A: The main purpose of the patent is to cover a non-aqueous patch containing lidocaine for the treatment of pain associated with post-herpetic neuralgia.
Q: Who are the inventors of the patent?
A: The inventors are Tatsuya Mori and Naoyuki Saida.
Q: What is the significance of Claim 1 in the patent?
A: Claim 1 specifies the method of treating pain using a non-aqueous patch containing lidocaine.
Q: Why is the breadth of the patent claims a subject of contention?
A: The breadth of the claims is contested because it may require undue experimentation to practice the claims, as argued by Dr. Maureen Donovan.
Q: When is the patent set to expire?
A: The patent is set to expire on May 10, 2031.
Sources
- Expert Witness Profiler: Court refuses to exclude Pharmaceutical Expert Witness' Opinions regarding breadth of asserted claims.
- Insight.RPXCorp: SCILEX PHARMACEUTICALS INC., ITOCHU CHEMICAL FRONTIER CORPORATION, et al.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: United States Patent Mori et al.
- Drugs.com: Generic ZTlido Availability.
