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Last Updated: January 2, 2025

Details for Patent: 4,911,932


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Summary for Patent: 4,911,932
Title: Skin care compositions
Abstract:A skin care composition having improved effectiveness in preventing and treating acute inflammatory skin conditions comprising miconazole nitrate and zinc oxide.
Inventor(s): Clum; Charles E. (Kingston, NJ), Isaacson; David M. (East Brunswick, NJ)
Assignee: Johnson and Johnson Consumer Products, Inc. (New Brunswick, NJ)
Application Number:06/700,165
Patent Claim Types:
see list of patent claims
Composition; Compound; Use;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 4,911,932

Introduction

United States Patent 4,911,932, issued on March 27, 1990, is a significant patent in the pharmaceutical sector, particularly concerning the development and approval of drug products. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background: New Drug and Biological Product Approval

Before diving into the specifics of the patent, it is crucial to understand the regulatory framework governing new drug approvals in the United States. The FDA requires extensive testing and approval processes, which can be time-consuming and costly. This process involves premarket testing, which can significantly impact the effective patent life of a drug[4].

Patent Overview: 4,911,932

The patent in question claims the human drug product VUSIONO Ointment, which contains the active ingredients miconazole nitrate, zinc oxide, and white petrolatum. Here is a detailed look at its key components:

Claims

The patent claims specifically cover the composition and formulation of the VUSIONO Ointment. The claims are structured to protect the unique combination of active ingredients and their proportions, ensuring that any similar product would infringe on this patent. For instance, the patent might claim:

  • "A topical ointment composition comprising miconazole nitrate, zinc oxide, and white petrolatum."
  • "A method of treating skin infections using the ointment composition of claim 1."

Scope

The scope of the patent is defined by its claims and the description provided in the patent specification. It includes the specific formulation, the method of preparation, and the intended use of the ointment. The scope is narrow, focusing on a particular combination of ingredients rather than a broad range of formulations[2].

Patent Term and Exclusivity

One of the critical aspects of drug patents is the patent term and how it is affected by regulatory requirements. Drug inventors often file patent applications before starting clinical trials, which means the patent may issue before the trials are completed and the drug is approved. This can lead to a significant reduction in the effective patent life, a phenomenon known as "patent distortion"[4].

Patent Term Restoration

In 1984, Congress introduced provisions for patent term restoration to mitigate the impact of lengthy regulatory approval processes. However, changes in patent term calculations in the 1990s have complicated this process. Today, achieving the intended 14 years of effective patent life often requires securing new, original patents that issue late in clinical trials[1][4].

Patent Landscape: Pharmaceutical Patents

The pharmaceutical patent landscape is complex and highly regulated. Here are some key points:

Patent Quality and Scope

Debates over patent quality often focus on the breadth and clarity of patent claims. Narrower claims are generally associated with a higher probability of grant and a shorter examination process. The examination process tends to narrow the scope of patent claims, ensuring that patents are not overly broad or vague[3].

Regulatory Challenges

Drug companies face significant regulatory hurdles, including lengthy and costly clinical trials. These challenges can skew research incentives away from more complex diseases, such as Alzheimer's and certain types of cancer, due to the extended time required for premarket testing[1][4].

Impact on Innovation

The patent system is designed to incentivize innovation by providing a period of exclusivity. However, the unique challenges faced by drug inventors can diminish these incentives. The distortion of patent terms due to regulatory requirements can lead to less time for commercialization, potentially discouraging investment in more complex and time-consuming research projects[4].

Public Policy Implications

The high prices of new drugs and the wait for cheaper generic versions have sparked public policy debates. Proposals include imposing price controls or limiting the number of patents a company can secure for a single drug. However, these measures must balance the need for affordable drugs with the necessity of incentivizing innovation in the pharmaceutical sector[1][4].

Examples and Statistics

  • The number of people diagnosed with Alzheimer's dementia is projected to reach 7.1 million by 2025, highlighting the need for effective treatments[1].
  • Certain cancers, such as pancreatic cancer and glioblastoma multiforme, remain essentially untreatable, underscoring the importance of continued innovation[1].

Quotes from Industry Experts

"The federal government’s gatekeeping mechanism protects public health by ensuring that new drugs are, on average, more beneficial than harmful for the patients for whom they are intended. However, this comes at a price: the research required by the U.S. Food and Drug Administration (FDA) is not only expensive and time-consuming but also risky."[4]

Key Takeaways

  • Patent Scope and Claims: The patent claims a specific formulation of VUSIONO Ointment, protecting the unique combination of active ingredients.
  • Patent Term and Exclusivity: The effective patent life is affected by regulatory requirements, and patent term restoration provisions aim to mitigate this impact.
  • Regulatory Challenges: Lengthy clinical trials and regulatory approvals can skew research incentives and reduce the effective patent life.
  • Impact on Innovation: The patent system's ability to incentivize innovation is compromised by the unique challenges faced by drug inventors.
  • Public Policy Implications: Balancing affordable drug prices with the need to incentivize pharmaceutical innovation is a critical public policy issue.

FAQs

Q: What are the active ingredients in the VUSIONO Ointment covered by Patent 4,911,932? A: The active ingredients are miconazole nitrate, zinc oxide, and white petrolatum.

Q: How does the FDA approval process affect the patent term of drug inventions? A: The FDA approval process can significantly reduce the effective patent life due to the time spent in clinical trials and regulatory review.

Q: What is patent term restoration, and how does it impact drug patents? A: Patent term restoration is a provision that aims to restore a portion of the patent term lost due to premarket research and FDA review, helping to ensure a more meaningful period of exclusivity for drug inventors.

Q: Why are narrower patent claims often preferred in the pharmaceutical sector? A: Narrower claims are associated with a higher probability of grant and a shorter examination process, ensuring clarity and validity.

Q: How do regulatory challenges impact research incentives in the pharmaceutical industry? A: Regulatory challenges can skew research incentives away from more complex diseases due to the extended time and resources required for premarket testing.

Citations

  1. Distorted Drug Patents - University of Missouri School of Law[1]
  2. USPTO Patent 4,911,932 - United States Patent and Trademark Office[2]
  3. Patent Claims and Patent Scope - SSRN[3]
  4. Distorted Drug Patents - University of Washington School of Law[4]

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Drugs Protected by US Patent 4,911,932

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
No data available in table
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Patented / Exclusive Use>Submissiondate
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International Family Members for US Patent 4,911,932

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Australia 3775885 ⤷  Subscribe
Australia 569602 ⤷  Subscribe
Austria 42039 ⤷  Subscribe
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 3 of 3 entries

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