|
Patent landscape, scope, and claims: |
United States Patent 9,295,657: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,295,657, titled "Epinephrine Formulations," is a significant patent in the pharmaceutical industry, particularly in the context of epinephrine-based medications. This patent, owned by entities such as Par Pharmaceutical, Inc., and its affiliates, plays a crucial role in the development and marketing of epinephrine injection products.
Patent Overview
The patent 9,295,657 pertains to specific compositions of epinephrine, methods of administration, and methods of manufacturing these compositions. Here are some key aspects:
Composition
- The patent describes pharmaceutical compositions that include epinephrine as the active agent, along with various additives such as pH raising agents, antioxidants, transition metal complexing agents, pH lowering agents, tonicity regulating agents, preservatives, and solvents[1][4].
pH Control
- The compositions often include a buffer system to maintain a stable pH, which is crucial for the stability and efficacy of the epinephrine. This buffer system can resist significant pH changes caused by strong acids or bases[1].
Impurity Control
- The patent emphasizes the importance of minimizing impurities, such as D-epinephrine and epinephrine sulfonic acid (ESA), to ensure the quality and stability of the epinephrine formulations[1].
Claims
The claims of the patent are detailed and specific, covering various aspects of the composition and its manufacturing process.
Independent Claims
- The patent includes independent claims that define the scope of the invention. These claims are critical in determining the patent's breadth and validity. For instance, claims may specify the concentration of epinephrine, the presence of specific additives, and the methods of preparing the composition[4].
Dependent Claims
- Dependent claims further narrow down the scope by adding additional limitations to the independent claims. These could include specific ratios of components, methods of administration, or storage conditions[4].
Patent Scope and Quality
The scope and quality of the patent are important factors in its validity and enforceability.
Metrics for Patent Scope
- Research has shown that patent scope can be measured using metrics such as independent claim length and the number of independent claims. Narrower claims are often associated with a higher probability of grant and a shorter examination process[3].
Examination Process
- The examination process at the USPTO tends to narrow the scope of patent claims, making them more specific and less broad. This process is crucial in ensuring the patent's clarity and validity[3].
Litigation and Enforcement
The patent has been involved in several legal disputes, which highlight its significance and the challenges in enforcing it.
Par Pharmaceutical, Inc. v. Hospira, Inc.
- In this case, Par Pharmaceutical, Inc. asserted that Hospira's ANDA (Abbreviated New Drug Application) product infringed on their patents, including 9,295,657. The court's decision and the subsequent litigation provide insights into the patent's enforceability and the strategies employed by pharmaceutical companies to protect their intellectual property[4][5].
Paragraph IV Certifications
- The FDA's approval process for generic drugs involves paragraph IV certifications, where the generic drug applicant must certify that the patents are invalid, unenforceable, or will not be infringed. This process was relevant in the case involving Luitpold Pharmaceuticals, Inc., where the court found that Luitpold did not infringe on the patents in question[4].
Expiration and Exclusivity
The patent's expiration date and exclusivity periods are critical for understanding its impact on the market.
Expiration Date
- The patent 9,295,657 is set to expire on March 13, 2035, which marks the end of its exclusive protection period[4].
Generic Drug Exclusivity
- The first ANDA applicant to submit a substantially complete application with a paragraph IV certification for a generic version of the drug may be granted 180-day generic drug exclusivity. This exclusivity period can significantly impact the market dynamics and competition[4].
Regulatory Compliance
Compliance with FDA regulations is essential for any drug product, including those covered by this patent.
ANDA Submissions
- The FDA requires ANDA submissions to be in the electronic Common Technical Document (eCTD) format, and these submissions must adhere to specific guidelines to avoid rejection[4].
Postmarketing Reporting
- Postmarketing reporting requirements are in place to ensure the ongoing safety and efficacy of the drug product. These requirements include submitting reports to the FDA and maintaining certain labeling and technical standards[4].
Key Takeaways
- Composition and Stability: The patent emphasizes the importance of specific compositions and additives to maintain the stability and efficacy of epinephrine formulations.
- Patent Scope and Claims: The patent's scope is defined by its independent and dependent claims, which have been subject to scrutiny and litigation.
- Litigation and Enforcement: The patent has been involved in significant legal disputes, highlighting the challenges and strategies in enforcing pharmaceutical patents.
- Regulatory Compliance: Compliance with FDA regulations, including ANDA submissions and postmarketing reporting, is crucial for maintaining market approval.
Frequently Asked Questions (FAQs)
What is the primary focus of United States Patent 9,295,657?
The primary focus of this patent is on specific compositions of epinephrine, including methods of administration and manufacturing, to ensure stability and efficacy.
What role do buffer systems play in the patent?
Buffer systems are used to maintain a stable pH in the epinephrine compositions, resisting significant pH changes caused by strong acids or bases.
How does the patent address impurities?
The patent emphasizes minimizing impurities such as D-epinephrine and epinephrine sulfonic acid (ESA) to ensure the quality and stability of the formulations.
What is the significance of paragraph IV certifications in the context of this patent?
Paragraph IV certifications are crucial in the FDA's approval process for generic drugs, where applicants must certify that the patents are invalid, unenforceable, or will not be infringed.
When is the patent set to expire?
The patent 9,295,657 is set to expire on March 13, 2035.
Sources
- US20170189352A1 - Epinephrine formulations - Google Patents
- Par Pharm., Inc. v. Hospira, Inc. - Casetext
- Patent Claims and Patent Scope - Hoover Institution
- ANDA 207568 - accessdata.fda.gov
- PAR PHARMACEUTICAL INC LLC LLC v. HOSPIRA INC (2020) - FindLaw
More… ↓
⤷ Subscribe
|
