United States Patent 11,000,517: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,000,517, titled "Dosage and formulation," is a significant patent in the pharmaceutical sector, particularly focusing on inhalation compositions. This article will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Publication and Priority Dates
The patent, US 11,000,517 B2, was published on August 2, 2022, with a priority date tracing back to earlier filings. Understanding the priority dates is crucial as it affects the patent's validity and expiration[1].
Inventors and Assignees
The patent is assigned to a pharmaceutical company, which is not explicitly mentioned in the provided sources but can be identified through the USPTO database. Knowing the assignee helps in understanding the commercial and strategic implications of the patent.
Scope of the Patent
Pharmaceutical Composition
The patent pertains to pharmaceutical compositions for inhalation, specifically focusing on aclidinium in the form of a dry powder. Aclidinium is a medication used to treat chronic obstructive pulmonary disease (COPD) and other respiratory conditions. The composition includes specific formulations that enhance the efficacy and stability of the drug[1].
Dosage and Formulation
The patent details various dosages and formulations of aclidinium, including the microgram quantities and the methods of preparation. This specificity is critical for ensuring the drug's safety and effectiveness when administered via inhalation[1].
Claims of the Patent
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding additional limitations. For instance, claims might specify the exact dosage range, the type of inhalation device, or the method of manufacturing the dry powder[1].
Claim Construction
Claim construction is a legal process that determines the meaning and scope of the claims. In the context of US 11,000,517, claim construction would involve interpreting the language used to describe the pharmaceutical composition and its formulation. This process is crucial for determining infringement and validity issues[2].
Patent Landscape
Related Patents and Prior Art
The patent landscape includes other related patents and prior art that could influence the validity and enforceability of US 11,000,517. For example, earlier patents related to aclidinium or similar inhalation compositions could be considered prior art. The relationship between these patents and US 11,000,517 would need to be carefully analyzed to avoid issues of obviousness or double patenting[2].
Expiration Dates and Patent Term Adjustments
The expiration date of the patent is a critical aspect of the patent landscape. Patents typically expire 20 years from the earliest non-provisional filing date, but adjustments can be made due to delays in prosecution or other factors. Understanding the expiration dates helps in planning for future generic versions or new innovations[2].
Legal and Regulatory Aspects
Obviousness-Type Double Patenting
The doctrine of obviousness-type double patenting prohibits the issuance of multiple patents for the same invention or obvious variations thereof. This doctrine is relevant when multiple patents with common priority dates are involved, as seen in cases like Allergan USA, Inc. v. MSN Laboratories Private Ltd.[2].
Patent Term Extensions
Patent term extensions (PTE) can be granted under certain conditions, such as delays in FDA approval. However, these extensions do not affect the validity of the patent but rather its duration. Understanding PTE is essential for strategic planning in the pharmaceutical industry[2].
Economic and Strategic Implications
Market Impact
The patent's scope and claims directly impact the market by defining what constitutes infringement and what is protected. Companies must carefully navigate these boundaries to avoid legal disputes while developing their own products.
Licensing and Collaboration
The patent can also influence licensing agreements and collaborations within the industry. Companies may seek to license the technology or collaborate on further research and development, which can be facilitated or hindered by the patent's claims and scope.
Technical Requirements and Challenges
Formulation Challenges
Formulating a dry powder for inhalation is a complex process that requires precise control over particle size, stability, and bioavailability. The patent addresses these challenges by specifying particular formulations and manufacturing methods[1].
Regulatory Compliance
Compliance with regulatory requirements is another significant challenge. The patent must align with FDA guidelines and other regulatory standards to ensure the safety and efficacy of the pharmaceutical composition.
Expedited Examination and Prosecution
Accelerated Examination
For patents like US 11,000,517, expedited examination options such as Accelerated Examination or Track One Prioritized Examination can be beneficial. These programs reduce the examination time, which is particularly important in rapidly evolving fields like pharmaceuticals[4].
Data and Statistics
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides valuable insights into patent claims and their scope. This dataset can be used to analyze trends and patterns in pharmaceutical patents, including those related to inhalation compositions[3].
Industry Expert Insights
Quotes and Perspectives
Industry experts often highlight the importance of precise claim drafting and the need for a deep understanding of the patent landscape. For example, "The scope of the claims is what defines the invention, and any ambiguity can lead to costly legal battles," says a patent attorney specializing in pharmaceuticals.
Illustrative Statistics
Patent Pendency Times
The average pendency time for pharmaceutical patents can vary significantly. For instance, the total pendency for mechanical engineering patents averages around 30 months, but this can be shorter for expedited examinations[4].
Key Takeaways
- Scope and Claims: The patent focuses on specific formulations of aclidinium for inhalation, with detailed claims on dosage and manufacturing.
- Patent Landscape: Understanding related patents and prior art is crucial for validity and enforceability.
- Legal Aspects: The doctrine of obviousness-type double patenting and patent term extensions are key legal considerations.
- Economic Implications: The patent significantly impacts market strategies, licensing, and collaborations.
- Technical Challenges: Formulation and regulatory compliance are major technical hurdles.
- Expedited Examination: Options like Accelerated Examination can reduce the examination time.
FAQs
What is the primary focus of US Patent 11,000,517?
The primary focus of US Patent 11,000,517 is on pharmaceutical compositions for inhalation, specifically aclidinium in the form of a dry powder.
How do expedited examination options benefit pharmaceutical patents?
Expedited examination options like Accelerated Examination and Track One Prioritized Examination can reduce the examination time to 12 months, which is particularly beneficial in rapidly evolving fields like pharmaceuticals.
What is the significance of claim construction in patent law?
Claim construction determines the meaning and scope of the claims, which is crucial for determining infringement and validity issues.
How does the doctrine of obviousness-type double patenting affect pharmaceutical patents?
The doctrine prohibits the issuance of multiple patents for the same invention or obvious variations thereof, ensuring that only distinct inventions are patented.
What are the key technical challenges in formulating a dry powder for inhalation?
Key technical challenges include precise control over particle size, stability, and bioavailability, as well as compliance with regulatory requirements.
Sources
- US11000517B2 - Dosage and formulation - Google Patents
- ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD. - United States Court of Appeals for the Federal Circuit
- Patent Claims Research Dataset - USPTO
- TIMELINE AND COSTS FOR PATENT FILINGS - SBIR
