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Patents › Patent Term Extensions › Federal Food Drug and Cosmetic Act (FFDCA)

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

Goodwin

FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision

Goodwin on

As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Patent Term Extension Considerations for BioPharma Patents

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

Time spent on securing marketing approval for regulated products, such as pharmaceuticals, medical devices and agrochemicals effectively shortens the term of patent protection during which an innovator can recover its...more

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