Скачать или смотреть PTE Basics FDA, 35 U S C §156, and Eligibility

PTE Basics FDA, 35 U S C §156, and Eligibility

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Описание к видео PTE Basics FDA, 35 U S C §156, and Eligibility

Welcome to the explainer. You know, in the high-stakes world of biotech and pharma, you could argue that time is the single most valuable resource there is. Today, we're going to talk about a really powerful legal tool that can actually help you reclaim years of it: patent term extension.

Imagine this. You've poured years, maybe millions, into a groundbreaking new drug. You finally get the green light to sell it. But then you realize your patent, the one thing protecting your invention, is about to expire. That’s the innovator’s dilemma: the second your patent is filed, a 20-year fuse is lit, yet government review can take years. By launch, more than half your protected life may be gone.

Patent Term Extension, or PTE, is designed to restore some of that lost time. It’s not automatic—there are strict rules about product eligibility, patent coverage, and timing. File within 60 days of regulatory approval, coordinate with the FDA and USPTO, and you can add up to 5 extra years, with a total post-approval protection cap of 14 years.

This isn’t just legal paperwork. PTE is a strategic asset. Extra market exclusivity can mean millions or billions more in revenue, attract investors, strengthen partnerships, and extend your R&D runway. Plan for it from day one—it could be the difference between modest success and a blockbuster.

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Stay innovative, stay protected!

Stay innovative, stay protected!

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