Understanding the Scope and Claims of United States Patent 9,527,833
Introduction
The United States Patent 9,527,833, hereafter referred to as the '833 patent, is a critical component in the pharmaceutical patent landscape, particularly in the context of drug formulation and manufacturing. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The '833 patent, titled "Stable crystal form of tipiracil hydrochloride and crystallization method for the same," is associated with Taiho Pharmaceutical Co., Ltd. Tipiracil is a key component of the drug Lonsurf® (trifluridine/tipiracil tablets), used in the treatment of certain types of cancer, such as colorectal cancer.
Claims of the Patent
Independent Claims
The '833 patent includes several independent claims that define the scope of the invention. These claims typically focus on the stable crystal form of tipiracil hydrochloride and the methods for its crystallization. Here are some key aspects:
- Claim 1: This claim often defines the stable crystal form of tipiracil hydrochloride, specifying its physical and chemical properties.
- Claim 2: This might include the method for crystallizing tipiracil hydrochloride, detailing the steps and conditions necessary to achieve the stable crystal form[5].
Dependent Claims
Dependent claims build upon the independent claims, providing additional specifics or limitations. These could include variations in the crystallization process, different solvents used, or specific conditions under which the crystallization occurs.
Scope of the Patent
The scope of the '833 patent is determined by the language of its claims. Here are some key points:
Stable Crystal Form
The patent covers a specific stable crystal form of tipiracil hydrochloride, which is crucial for the stability and efficacy of the drug. This form is characterized by its unique physical and chemical properties, such as X-ray diffraction patterns and melting points[5].
Crystallization Method
The patent also includes claims related to the method of crystallizing tipiracil hydrochloride. This method is important for ensuring the consistent production of the stable crystal form, which is essential for pharmaceutical applications.
Patent Landscape
Related Patents
The '833 patent is part of a larger portfolio of patents related to Lonsurf®. Other patents, such as RE46,284, 10,138,223, and 10,456,399, also cover various aspects of the drug, including its composition, dosage, and administration schedule[2].
Litigation and Settlements
Patents related to Lonsurf® have been involved in several litigation cases. For example, Taiho Pharmaceutical Co., Ltd. v. Eugia Pharma Specialties Ltd. involved disputes over the validity and infringement of several patents, including the '833 patent. These cases often result in settlements that define the terms under which generic versions of the drug can be marketed[2].
Validity and Infringement
Obviousness and Written Description
Challenges to the validity of the '833 patent might include arguments of obviousness or lack of an adequate written description. For instance, in similar cases, defendants have argued that the claimed subject matter was already disclosed in prior art, such as clinical trials or earlier publications[1].
Infringement Analysis
Determining infringement involves a two-step analysis: claim construction and comparison of the accused product or process to the claims. For product-by-process claims, the focus is on whether the product was made by the process recited in the claim[4].
Impact on Pharmaceutical Industry
Innovation and Licensing
The '833 patent, along with other related patents, influences the landscape of pharmaceutical innovation. Patents with broad claims can increase licensing and litigation costs, potentially diminishing incentives for innovation. However, narrower claims, as seen in the '833 patent, can facilitate clearer boundaries and reduce legal disputes[3].
Generic Competition
The expiration or invalidation of patents like the '833 patent can open the door for generic competition. Generic manufacturers must navigate the patent landscape carefully, ensuring that their products do not infringe on valid patents. Settlements and Paragraph IV certifications are common mechanisms for resolving these issues[2].
Key Takeaways
- Specific Claims: The '833 patent includes specific claims related to the stable crystal form of tipiracil hydrochloride and its crystallization method.
- Patent Scope: The scope is defined by the claims, focusing on the physical and chemical properties of the crystal form and the crystallization process.
- Patent Landscape: The patent is part of a broader portfolio related to Lonsurf®, with ongoing litigation and settlements shaping the market.
- Validity and Infringement: Challenges to validity often involve obviousness and written description arguments, while infringement analysis is based on claim construction and comparison.
Frequently Asked Questions (FAQs)
Q1: What is the main subject matter of the '833 patent?
A1: The '833 patent covers the stable crystal form of tipiracil hydrochloride and the method for its crystallization.
Q2: How does the '833 patent impact the pharmaceutical industry?
A2: The patent influences innovation by setting clear boundaries for drug formulation and manufacturing, and it affects generic competition by defining what is protected and what is open for generic entry.
Q3: What are common challenges to the validity of the '833 patent?
A3: Common challenges include arguments of obviousness and lack of an adequate written description.
Q4: How is infringement of the '833 patent determined?
A4: Infringement is determined through a two-step analysis involving claim construction and comparison of the accused product or process to the claims.
Q5: What is the significance of settlements in patent litigation related to the '833 patent?
A5: Settlements define the terms under which generic versions of the drug can be marketed, often resolving disputes over validity and infringement.
Cited Sources
- District of Delaware, "19-2309.pdf" - [PDF]
- Robins Kaplan LLP Law Firm, "ANDA Litigation Settlements" - [Website]
- SSRN, "Patent Claims and Patent Scope" - [Paper]
- District of Delaware, "Civil Action No. 20-755-RGA" - [PDF]
- Google Patents, "US9527833B2 - Stable crystal form of tipiracil hydrochloride and crystallization method for the same" - [Patent]
