United States Patent RE42,353: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent RE42,353, a reissue of the original U.S. Patent 6,414,148, is a significant intellectual property asset for AstraZeneca UK Limited. This patent pertains to the drug product Vandetanib, which was approved by the FDA on April 6, 2011. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The patent in question, RE42,353, was originally issued as U.S. Patent 6,414,148 on July 2, 2002, and was later reissued on May 10, 2011. The inventors listed include Andrew Peter Thomas Craig Johnstone, Edward Clayton, Elaine Sophie Elizabeth Stokes, and Jean-Jacques Marcel Lohmann, among others[1].
Scope of the Patent
The patent covers Vandetanib, a drug used for the treatment of certain types of cancer. Specifically, it encompasses the active ingredient Vandetanib, which had not been previously approved for commercial marketing or use under the Federal Food, Drug, and Cosmetic Act prior to the approval of the New Drug Application (NDA) 022-405 on April 6, 2011[1].
Active Ingredient and Use
Vandetanib is a tyrosine kinase inhibitor used primarily in the treatment of medullary thyroid cancer. The patent claims include the drug itself, as well as methods of using and manufacturing it. This broad coverage ensures that the intellectual property rights of AstraZeneca are well-protected across various aspects of the drug's lifecycle[1].
Claims of the Patent
The claims of U.S. Patent RE42,353 are crucial in defining the scope of protection. The patent includes multiple claims that read on the approved product, its use, and its manufacturing process.
Claims Coverage
Claims 1-7 and 13-22 of both the reissued patent RE42,353 and the original patent 6,414,148 encompass the approved product. These claims are detailed and specify the composition, method of use, and method of manufacturing Vandetanib. The claims are designed to ensure that any infringement would be clearly identifiable and actionable[1].
Patent Term Extension
AstraZeneca UK Limited requested an extension of the patent term under the Drug Price Competition and Patent Term Restoration Act of 1984. This request was made within the sixty-day period permitted after the FDA approval of Vandetanib. The extension is based on the regulatory review period, which can significantly impact the patent's expiration date and the company's market exclusivity[1].
Compliance with Patent Reissue Requirements
For a patent to be reissued, it must comply with 35 U.S.C. § 251, which requires that the reissue claims cover "the invention disclosed in the original patent." The reissue claims in RE42,353 must be supported by the original disclosure, ensuring that they do not broaden the scope of the invention beyond what was originally described[2].
Patent Landscape and Analytics
Understanding the patent landscape is essential for managing intellectual property effectively. Patent analytics tools can help identify which patents and claims are actively protecting the product and where gaps or opportunities exist.
Claim Coverage Matrix
A Claim Coverage Matrix can categorize patents by claims and scope concepts, providing a clear view of the patent landscape. This tool helps in filtering, searching, and analyzing large numbers of patent claims concurrently, making it easier to determine if there are gaps in the current coverage and highlighting future design opportunities[3].
Interactive Claim Charts
Interactive claim charts generated by tools like ClaimScape® software can be reviewed by technical experts to determine whether a particular scope concept is applicable to a target product or method. These charts help in identifying areas where claim coverage is lacking and can be updated as new patents are filed or as development avenues are explored[3].
Regulatory and Legal Framework
The America Invents Act (AIA) and the Patent Trial and Appeal Board (PTAB) play significant roles in the post-grant proceedings of patents. The AIA guidelines help determine whether patent claims are directed to ineligible subject matter, such as laws of nature, natural phenomena, or abstract ideas. If the claims are directed to such subject matter, they must contain an "inventive concept" to be patentable[4].
Potential Challenges and Infringement
Patents like RE42,353 can face challenges through inter partes review (IPR) or other post-grant proceedings. Allegations of patent infringement or invalidity can arise, as seen in cases like Rain Gutter Pros, LLC v. MGP Manufacturing, LLC, where declaratory judgment actions are filed to determine the validity and enforceability of patents[5].
Key Takeaways
- Scope and Claims: The patent covers Vandetanib, including its composition, use, and manufacturing process.
- Patent Term Extension: The patent term was extended under the Drug Price Competition and Patent Term Restoration Act of 1984.
- Compliance with Reissue Requirements: The reissue claims must be supported by the original disclosure.
- Patent Landscape: Tools like Claim Coverage Matrix and interactive claim charts help in managing and analyzing the patent landscape.
- Regulatory Framework: The AIA and PTAB play crucial roles in post-grant proceedings.
FAQs
What is the primary subject matter of U.S. Patent RE42,353?
The primary subject matter is Vandetanib, a tyrosine kinase inhibitor used in the treatment of medullary thyroid cancer.
Why was the patent term extended for RE42,353?
The patent term was extended under the Drug Price Competition and Patent Term Restoration Act of 1984 to account for the regulatory review period.
What are the key claims covered by RE42,353?
The claims cover the composition of Vandetanib, methods of using it, and methods of manufacturing it.
How does patent analytics help in managing patents like RE42,353?
Patent analytics helps in identifying which patents and claims are actively protecting the product, where gaps or opportunities exist, and in categorizing patents by claims and scope concepts.
What regulatory framework governs post-grant proceedings for patents like RE42,353?
The America Invents Act (AIA) and the Patent Trial and Appeal Board (PTAB) govern post-grant proceedings, ensuring that patent claims are valid and enforceable.
Sources
- U.S. Patent RE42,353 - Regulations.gov
- In Re FLOAT'N'GRILL LLC - Court of Appeals for the Federal Circuit
- Patent Analytics - SLWIP
- The Patent Trial and Appeal Board and Inter Partes Review - Congressional Research Service
- Rain Gutter Pros, LLC v. MGP Manufacturing, LLC - Casetext
