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In a recent study published in the Expert Review of Medical Devices, researchers investigated the utilization of patent term extensions (PTEs) to extend regulatory timeframes for medical devices in the United States. Here are the key takeaways from their findings:
- Low Utilization: The study highlights a notable difference in the adoption of PTEs between pharmaceuticals and medical devices. While PTEs are commonly used in the pharmaceutical industry, their utilization in the medical device sector remains comparatively low.
- Increasing Trend: Despite the low adoption rates, there has been a significant increase in the number of PTE applications over the past decade. This trend suggests a growing awareness or recognition of the benefits of PTEs among medical device companies.
- Product Code Analysis: The research analyzed PTE applications across different medical specialties and product codes. Findings reveal that about half of the product codes had only one instance of PTE application, indicating a varied distribution of PTE utilization across different device types and specialties.
- Competitive Markets: PTE filings are particularly heightened for medical devices entering highly competitive markets. Companies seem to strategically pursue PTEs to gain a competitive advantage and protect their investments in innovative products.
- Challenges and Limitations: The study acknowledges challenges in data availability and captures data related to regulatory submissions made before 2023. Additionally, it suggests the need for further research to understand industry stakeholders’ views and experiences regarding the usefulness of PTEs.
Key Points:
- PTE utilization in medical devices lags behind pharmaceuticals.
- Significant increase in PTE applications over the last decade.
- Varied distribution of PTE applications across different medical specialties.
- Heightened PTE filings in highly competitive markets.
- Challenges exist in data availability and understanding stakeholder perspectives.
Overall, the study provides valuable insights into the evolving landscape of PTE utilization for medical devices and underscores the need for further research and industry engagement to maximize the benefits of this regulatory pathway.
