United States Patent 8,927,574: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 8,927,574, titled "Crystalline Pharmaceutical and Methods of Preparation and Use Thereof," was granted to SARcode Bioscience, Inc. on January 6, 2015. This patent is significant in the pharmaceutical industry, particularly in the treatment of dry eye disease. Here is a detailed analysis of its scope, claims, and the surrounding patent landscape.
Background and Inventor
The patent was invented by John Burnier and assigned to SARcode Bioscience, Inc., which is now part of Novartis Pharmaceuticals Corporation. The application was filed on December 13, 2012, as a continuation of a previous application filed on October 21, 2010[1].
Scope of the Patent
The patent covers crystalline forms of lifitegrast, a medication used to treat dry eye disease. Specifically, it describes methods of preparing and using these crystalline forms, which are crucial for the stability and efficacy of the drug.
Crystalline Forms
The patent details various crystalline forms of lifitegrast, including their physical and chemical properties. These forms are essential for ensuring the drug's stability and bioavailability, which are critical factors in pharmaceutical development[1].
Methods of Preparation
The patent outlines several methods for preparing these crystalline forms. These methods include crystallization techniques, purification processes, and formulation strategies that ensure the drug meets the required standards for pharmaceutical use[1].
Methods of Use
The patent also covers the methods of using lifitegrast for treating dry eye disease. This includes the administration routes, dosages, and treatment regimens that are effective for managing the condition[1].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention.
Independent Claims
The independent claims are broad and cover the core aspects of the invention, such as the crystalline forms of lifitegrast and the methods of their preparation and use. For example, Claim 1 might describe a specific crystalline form of lifitegrast, while Claim 2 might detail a method for preparing this form[1].
Dependent Claims
The dependent claims are narrower and build upon the independent claims. They provide additional details and specific embodiments of the invention, such as particular solvents used in crystallization or specific dosages for treatment[1].
Patent Landscape
The patent landscape surrounding US 8,927,574 is complex and involves multiple related patents.
Related Patents
Several other patents are associated with lifitegrast and its use in treating dry eye disease. These include patents such as US 8,084,047, US 8,168,655, US 8,367,701, and others, which collectively form a robust patent portfolio for Novartis Pharmaceuticals Corporation[2][5].
Litigation and Infringement
The patent has been involved in several litigation cases, particularly under the Hatch-Waxman Act. Novartis has filed complaints against generic drug manufacturers like Aurobindo Pharma Ltd. and Ingenus Pharmaceuticals, LLC, alleging patent infringement related to their Abbreviated New Drug Applications (ANDAs) for generic versions of Xiidra (lifitegrast ophthalmic solution)[2][5].
Impact on the Pharmaceutical Industry
The patent has significant implications for the pharmaceutical industry, especially in the development and commercialization of dry eye treatments.
Innovation and Competition
The patent protects Novartis's exclusive rights to lifitegrast, allowing the company to maintain market dominance in the treatment of dry eye disease. This can influence innovation by encouraging other companies to develop alternative treatments rather than generic versions of existing drugs[3].
Licensing and Litigation Costs
The breadth and validity of the patent can affect licensing and litigation costs. Broader patents with clearer claims can reduce litigation costs but may also increase licensing fees, impacting the overall cost of drug development and commercialization[3].
Expiry and Pediatric Extension
The patent is estimated to expire on November 12, 2030, although it may be extended due to pediatric exclusivity or other regulatory provisions. This expiry date is crucial for generic manufacturers planning to enter the market with their own versions of lifitegrast[4].
Key Takeaways
- Crystalline Forms: The patent covers specific crystalline forms of lifitegrast essential for its stability and efficacy.
- Methods of Preparation and Use: Detailed methods for preparing and using these crystalline forms are outlined.
- Claims: The patent includes broad independent claims and narrower dependent claims.
- Patent Landscape: The patent is part of a larger portfolio related to lifitegrast and has been involved in several litigation cases.
- Impact: The patent influences innovation, competition, and costs in the pharmaceutical industry.
FAQs
Q: What is the main subject of United States Patent 8,927,574?
A: The main subject is the crystalline forms of lifitegrast, a medication used to treat dry eye disease, along with methods of their preparation and use.
Q: Who is the inventor and assignee of the patent?
A: The inventor is John Burnier, and the assignee is SARcode Bioscience, Inc., now part of Novartis Pharmaceuticals Corporation.
Q: What is the significance of the patent in the pharmaceutical industry?
A: The patent protects Novartis's exclusive rights to lifitegrast, influencing innovation, competition, and costs in the development and commercialization of dry eye treatments.
Q: What are some related patents to US 8,927,574?
A: Related patents include US 8,084,047, US 8,168,655, US 8,367,701, and others that form a robust patent portfolio for Novartis.
Q: When is the patent estimated to expire?
A: The patent is estimated to expire on November 12, 2030, although it may be extended due to regulatory provisions.
Cited Sources
- United States Patent and Trademark Office, "United States Patent US 8,927,574 B2," January 6, 2015.
- RPX Insight, "Case 1:20-cv-01426-LPS Document 37 Filed 09/07/21 Page 1 of 70."
- SSRN, "Patent Claims and Patent Scope," September 29, 2016.
- DrugBank Online, "Lifitegrast: Uses, Interactions, Mechanism of Action."
- RPX Insight, "in the united states district court - RPX Insight."
