Understanding the Scope and Claims of United States Patent 9,238,076
Introduction
The United States Patent 9,238,076, hereafter referred to as the '076 patent, is a significant intellectual property asset in the pharmaceutical sector. To analyze its scope and claims, it is crucial to delve into the patent's specifics, the broader patent landscape, and the regulatory environment in which it operates.
Patent Overview
The '076 patent, titled "Dapagliflozin Tablets," is associated with the drug Dapagliflozin, which is used in the treatment of type 2 diabetes. This patent is part of a larger portfolio of patents related to Dapagliflozin, each covering different aspects of the drug, such as its composition, method of use, and manufacturing process[5].
Claims and Scope
Claim Structure
The claims of the '076 patent are critical in defining the scope of protection. Patent claims can be broadly categorized into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims. The '076 patent likely includes a combination of these to ensure comprehensive protection for the specific formulation and uses of Dapagliflozin[3].
Metrics for Measuring Patent Scope
Research suggests that patent scope can be measured using metrics such as independent claim length and independent claim count. Narrower claims, as indicated by shorter lengths and fewer counts, are often associated with a higher probability of grant and a shorter examination process. This implies that the '076 patent, if it follows this trend, would have claims that are precisely defined to avoid broad and potentially invalid claims[3].
Patent Landscape
Related Patents
The '076 patent is part of a family of patents related to Dapagliflozin. Other patents in this family include the '117, '254, '502, '598, '786, '648, '972, '685, '105, '698, '934, '251, '615, and '851 patents. These patents cover various aspects such as different formulations, methods of use, and expiration dates, creating a complex web of intellectual property protection around Dapagliflozin[5].
Expiration Dates
The '076 patent is set to expire on April 15, 2024. This expiration date is significant as it marks the end of the exclusive rights granted to the patent holder, allowing generic or biosimilar versions of the drug to enter the market. Other related patents have different expiration dates, extending the protection period for various aspects of Dapagliflozin until as late as 2030[5].
Regulatory Environment
FDA Approvals
The '076 patent is linked to the FDA's approval process for generic versions of Dapagliflozin. The FDA determines bioequivalence and therapeutic equivalence of generic drugs to the reference listed drug. For instance, the FDA has approved ANDA (Abbreviated New Drug Application) submissions for Dapagliflozin tablets, which include certifications regarding the validity and enforceability of related patents[2][5].
Paragraph IV Certifications
Generic drug applicants often submit Paragraph IV certifications, which state that the patents covering the brand-name drug are invalid, unenforceable, or not infringed by the generic version. These certifications can lead to patent litigation and are a critical aspect of the regulatory landscape surrounding the '076 patent[5].
Patent Enforcement and Litigation
Terminal Disclaimers
In the context of patent enforcement, terminal disclaimers can be relevant. These disclaimers are used to avoid double patenting issues, where multiple patents cover the same invention. The USPTO has the authority to impose conditions on terminal disclaimers, ensuring that claims in a terminally disclaimed continuation patent remain enforceable only if precedent claims are valid[1].
Obviousness-Type Double Patenting Rejections
Patent applicants can use various tools to address obviousness-type double patenting rejections, such as traversing these rejections or using reissuance to ensure the validity of claims. This flexibility allows patentees to optimize their claim strategies, even in complex patent families like those surrounding Dapagliflozin[1].
Industry Impact
Innovation and Competition
The '076 patent and its related patents play a significant role in the pharmaceutical industry by protecting innovative drugs and formulations. However, the expiration of these patents can lead to increased competition from generic and biosimilar products, which can drive down prices and improve access to medications.
Key Takeaways
- Patent Scope and Claims: The '076 patent's claims are crucial for defining its scope of protection, with narrower claims often associated with higher grant probabilities and shorter examination processes.
- Patent Landscape: The '076 patent is part of a larger family of patents covering various aspects of Dapagliflozin, with different expiration dates extending protection until 2030.
- Regulatory Environment: FDA approvals and Paragraph IV certifications are key components of the regulatory landscape, influencing the enforcement and litigation of the '076 patent.
- Industry Impact: The expiration of the '076 patent and related patents will impact the pharmaceutical industry by allowing generic and biosimilar competition.
FAQs
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What is the '076 patent related to?
The '076 patent is related to Dapagliflozin tablets, a medication used in the treatment of type 2 diabetes.
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When does the '076 patent expire?
The '076 patent is set to expire on April 15, 2024.
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How do terminal disclaimers affect patent enforcement?
Terminal disclaimers can be used to avoid double patenting issues, and the USPTO can impose conditions on these disclaimers to ensure that claims remain enforceable only if precedent claims are valid.
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What are Paragraph IV certifications?
Paragraph IV certifications are statements submitted by generic drug applicants claiming that the patents covering the brand-name drug are invalid, unenforceable, or not infringed by the generic version.
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How do narrower patent claims impact the examination process?
Narrower claims are often associated with a higher probability of grant and a shorter examination process, as they are more precisely defined and less likely to be challenged.
Sources
- Letterhead DC Office - Regulations.gov
- ANDA 211414 - accessdata.fda.gov
- Patent Claims and Patent Scope - SSRN
- US9238076B2 - Polymer-based sustained release device - Google Patents
- Dapagliflozin Tablets - accessdata.fda.gov
