Understanding the Scope and Claims of United States Patent 7,838,027
Introduction
United States Patent 7,838,027, titled "Pantoprazole multiparticulate formulations," is a significant patent in the pharmaceutical industry, particularly for the drug Protonix, which is used to treat gastroesophageal reflux disease (GERD) and other conditions. This patent, held by Wyeth Pharmaceuticals (now part of Pfizer), covers specific formulations of pantoprazole sodium.
Patent Overview
Patent Number and Title
- Patent Number: US7838027B2
- Title: Pantoprazole multiparticulate formulations[4].
Publication and Priority Dates
- Publication Date: The patent was published on September 28, 2010.
- Priority Date: The application was filed on December 19, 2004[4].
Scope of the Patent
Invention Description
The patent describes pantoprazole sodium multiparticulates designed to avoid sticking to nasogastric and gastrostomy tubes. This is a critical innovation because it enhances the ease of administration and reduces the risk of clogging these tubes, which is a common issue with traditional formulations[4].
Claims
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
- Claim 1: This claim describes the multiparticulate formulation of pantoprazole sodium, including the composition and the method of preparation.
- Subsequent Claims: These claims detail various aspects of the formulation, such as the use of specific excipients, the particle size distribution, and the method of coating the multiparticulates to prevent sticking[4].
Patent Claims Analysis
Independent Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth and quality. For US7838027B2, the independent claims are detailed but not overly broad, suggesting a well-defined scope that is less likely to be challenged for being too vague or overly broad[3].
Claim Language
The claim language is specific and technical, ensuring that the patent covers the exact formulation and method of preparation without leaving room for ambiguity. This specificity is crucial for maintaining the patent's validity and preventing generic entry based on minor variations[3].
Patent Landscape
Related Patents
The patent landscape for pantoprazole sodium includes several related patents, each covering different aspects of the drug's formulation and use. For example:
- US7544370: Covers pantoprazole multiparticulate formulations with a focus on pediatric use.
- US7550153 and US7553498: Also cover multiparticulate formulations with specific expiration dates[5].
Patent Expiration Dates
- US7838027B2: The patent is set to expire on September 30, 2024, although there are pediatric extensions that could extend the exclusivity period until March 30, 2025[2][5].
Patent Term Extension (PTE)
Regulatory Review and Clinical Trials
The patent term extension (PTE) is a critical aspect of pharmaceutical patents, allowing firms to restore up to five years of patent protection for time spent in clinical trials and regulatory review. For US7838027B2, any PTE would have been calculated based on the time spent in these phases, up to a maximum of five years[1].
PTE Eligibility
To be eligible for PTE, the patent must be in force when the drug is approved by the FDA and must cover the product or substance, a method of using the product, or a method of manufacturing the product. In this case, the patent covers the specific formulation and manufacturing process of pantoprazole sodium multiparticulates[1].
Impact on Generic Entry
Exclusivity Periods
The expiration of the patent and any associated exclusivity periods are crucial for generic manufacturers. Once the patent expires, generic versions of the drug can enter the market, provided they do not infringe on any remaining patents or exclusivity rights. For pantoprazole sodium, several generic applications have been filed, with the first generic version approved by the FDA[2][5].
Competitive Landscape
The approval of generic versions will significantly impact the competitive landscape for Protonix. Generic entry typically leads to a reduction in prices and increased competition, which can erode the market share of the brand-name drug. However, the specific formulation and manufacturing process covered by US7838027B2 may still offer some competitive advantages until all related patents expire[2].
Conclusion
United States Patent 7,838,027 is a key patent in the pharmaceutical industry, particularly for the treatment of GERD and related conditions. The patent's scope and claims are well-defined, covering a specific formulation of pantoprazole sodium that enhances its administration. Understanding the patent landscape, including related patents and expiration dates, is crucial for both the patent holder and potential generic manufacturers.
Key Takeaways
- Patent Scope: The patent covers pantoprazole sodium multiparticulate formulations designed to avoid sticking to nasogastric and gastrostomy tubes.
- Claims Analysis: The claims are specific and technical, ensuring a well-defined scope.
- Patent Landscape: Several related patents cover different aspects of pantoprazole sodium formulations.
- Patent Expiration: The patent is set to expire on September 30, 2024, with potential pediatric extensions.
- Generic Entry: Generic versions can enter the market after patent expiration, significantly impacting the competitive landscape.
FAQs
-
What is the main innovation covered by US7838027B2?
- The main innovation is the development of pantoprazole sodium multiparticulates that avoid sticking to nasogastric and gastrostomy tubes.
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When is the patent set to expire?
- The patent is set to expire on September 30, 2024, with potential pediatric extensions until March 30, 2025.
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What is the impact of patent term extension (PTE) on pharmaceutical patents?
- PTE allows firms to restore up to five years of patent protection for time spent in clinical trials and regulatory review.
-
How does the expiration of US7838027B2 affect generic entry?
- Once the patent expires, generic versions of the drug can enter the market, provided they do not infringe on any remaining patents or exclusivity rights.
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What are the competitive implications of generic entry for Protonix?
- Generic entry typically leads to a reduction in prices and increased competition, which can erode the market share of the brand-name drug.
Sources
- NBER Working Papers Series: THE NBER ORANGE BOOK DATASET
- Drugs.com: Generic Protonix Availability
- SSRN: Patent Claims and Patent Scope
- Google Patents: US7838027B2 - Pantoprazole multiparticulate formulations
- Pharsight: Drug Patents containing Pantoprazole Sodium
