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New Patent Litigation Playbook For Products Switching To Biologics

Executive Summary

Innovators are losing the protections of ANDA litigation as their products transition from drugs to biologics; both sides in patent disputes will now adopt different strategies.

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Teva Sues FDA For Excluding Copaxone From BLA Transition

Teva and US FDA disagree over whether Copaxone is a protein. While generics are already on the market, Teva wants to assert process patents against future would-be competitors, which the firm cannot do through the ANDA pathway.

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