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Medical Devices › Food and Drug Administration (FDA) › Patent Term Extensions

Offit Kurman

Patents and the FDA: Four Critical Considerations Medical Device Companies Must Know to Successfully Introduce New Products into...

Offit Kurman on

The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen intellectual property (IP)...more

MoFo Life Sciences

Patent Term Extension For Medical Devices

MoFo Life Sciences on

Patent term extension (PTE) under 35 U.S.C. § 156 is a statutory program that restores to a patent at least a portion of the term that was effectively lost while the covered product was undergoing regulatory review and could...more

Troutman Pepper Locke

Not So Simple Math: Calculating the Regulatory Review Period for Patent Term Extension

Troutman Pepper Locke on

This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more

Troutman Pepper Locke

Patent Term Extension for Drugs Not Limited to New Chemical Entities

Troutman Pepper Locke on

Patent term extension is a valuable tool that drug manufacturers should consider, even when their products are not new entities. Recent decisions from the U.S. Patent and Trademark Office, coupled with various court...more

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