United States Patent 8,729,085: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 8,729,085, owned by Sumitomo Dainippon Pharma Co., Ltd. and Sunovion Pharmaceuticals Inc., is a critical patent in the pharmaceutical industry, particularly concerning the drug lurasidone, marketed under the brand name Latuda®. This patent is part of a broader patent landscape that protects various aspects of lurasidone formulations and methods of use.
Background of the Patent
Patent Overview
The patent 8,729,085 is directed to specific formulations of lurasidone hydrochloride, which is used in the treatment of schizophrenia and bipolar depression. This patent is one of several related to Latuda®, each covering different aspects such as methods of use, formulations, and composition[2][4].
Claim Construction and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are crucial in determining what is protected under the patent. For instance, the claims may specify particular formulations, such as the percentage of pregelatinized starch, which is a key component in the tablet formulation[5].
Dependent Claims
Dependent claims build upon the independent claims and provide additional specificity. For example, dependent claims might specify the range of pregelatinized starch (e.g., 20 to 50% wt/wt) that was narrowed during the prosecution of the parent patent to avoid prior art[5].
Claim Language and Scope
The language used in the claims is pivotal in defining the patent's scope. The Federal Circuit has emphasized that claim construction involves determining the meaning of the disputed claim terms based on the claim language itself, the specification, and the prosecution history of the patent[1][3].
Prosecution History
Amendments and Narrowing of Claims
During the prosecution of the '085 patent, the applicant made significant amendments to the claims. For instance, the range of pregelatinized starch was narrowed from 10 to 50% (wt/wt) to 20 to 50% (wt/wt) to avoid prior art. This narrowing was done for reasons related to patentability, which is a common practice to ensure the patent's validity[5].
Litigation and Enforcement
Hatch-Waxman Act and Generic Manufacturers
The '085 patent has been involved in several litigation cases under the Hatch-Waxman Act, which governs the approval of generic drugs. Generic manufacturers, such as Alkem Laboratories Limited, have sought to manufacture and distribute generic versions of Latuda®, leading to patent infringement actions by the patent holders[2][5].
Declaratory Judgment Actions
Companies like Par Pharmaceutical, Inc. have filed declaratory judgment actions seeking a determination of non-infringement of the '085 patent, among others. These actions highlight the ongoing legal battles in the pharmaceutical industry to protect intellectual property and to clear the path for generic drug entry[5].
Patent Landscape and Related Patents
Family of Patents
The '085 patent is part of a family of patents related to lurasidone, including U.S. Patent Nos. 8,883,794, 9,815,827, and 9,907,794. Each of these patents covers different aspects of lurasidone formulations, methods of use, and specific compositions[2][4].
Expiration Dates and Pediatric Exclusivity
The '085 patent has an expiration date of November 26, 2026, with pediatric exclusivity added. This extension is crucial as it delays the entry of generic competitors into the market[2].
Metrics for Patent Scope
Independent Claim Length and Count
Research has shown that metrics such as independent claim length and the number of independent claims can be used to measure patent scope. Narrower claims, as seen in the '085 patent after prosecution, are associated with a higher probability of grant and a shorter examination process[3].
Impact on Innovation and Litigation
Patent Quality and Litigation Costs
The scope and clarity of patent claims, such as those in the '085 patent, are significant concerns for patent quality. Broad or unclear claims can lead to increased litigation costs and may impede innovation by creating uncertainty and barriers to entry for other innovators[3].
Expert Insights
Judicial Perspectives
Judges and legal experts emphasize the importance of clear claim language and the need for a thorough examination of the entire patent record to determine the intended scope of the invention. This is evident in cases like Sumitomo Dainippon Pharma Co. v. Emcure Pharms. Ltd., where the court meticulously analyzed the claim terms and the specification to determine the meaning of disputed terms[1].
Key Takeaways
- Claim Construction: The meaning of claim terms is determined based on the claim language, specification, and prosecution history.
- Prosecution History: Amendments during prosecution can significantly narrow the scope of claims.
- Litigation: The '085 patent has been involved in several litigation cases under the Hatch-Waxman Act.
- Patent Landscape: The patent is part of a family of patents related to lurasidone formulations and methods of use.
- Metrics for Scope: Narrower claims are associated with a higher probability of grant and shorter examination processes.
- Impact on Innovation: Clear and narrow claims are crucial for maintaining patent quality and reducing litigation costs.
FAQs
What is the primary focus of U.S. Patent 8,729,085?
The primary focus of U.S. Patent 8,729,085 is on specific formulations of lurasidone hydrochloride, particularly the composition and percentage of pregelatinized starch in the tablet formulation.
Why was the range of pregelatinized starch narrowed during the prosecution of the '085 patent?
The range of pregelatinized starch was narrowed from 10 to 50% (wt/wt) to 20 to 50% (wt/wt) to avoid prior art and ensure the patent's validity.
What is the significance of the Hatch-Waxman Act in relation to the '085 patent?
The Hatch-Waxman Act governs the approval of generic drugs and has been the basis for several litigation cases involving the '085 patent, as generic manufacturers seek to enter the market with their versions of lurasidone.
How does the '085 patent fit into the broader patent landscape for lurasidone?
The '085 patent is part of a family of patents related to lurasidone, including other patents that cover different aspects such as methods of use and specific compositions.
What are the metrics used to measure the scope of a patent like the '085 patent?
Metrics such as independent claim length and the number of independent claims are used to measure patent scope, with narrower claims generally associated with a higher probability of grant and shorter examination processes.
How does the clarity of patent claims impact innovation and litigation costs?
Clear and narrow claims are crucial for maintaining patent quality, reducing litigation costs, and avoiding barriers to innovation that can arise from broad or unclear claims.
Sources
- Sumitomo Dainippon Pharma Co. v. Emcure Pharms. Ltd. - Casetext
- Lurasidone Hydrochloride Tablets - FDA
- Patent Claims and Patent Scope - Hoover Institution
- WO 2016/139683 A2 - World Intellectual Property Organization
- Declaratory Judgment Complaint (lurasidone) - Insight.RPXcorp.com
