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Life Sciences Draft Guidance Patents

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FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision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As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more

A&O Shearman

Biden Administration Releases New Proposed Framework for the Exercise of “March-In” Rights under Bayh-Dole

A&O Shearman on

The Biden Administration’s recent publication of the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights and its request for comments on the draft guidance will impact how march-in rights...more

Smart & Biggar

2019 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more

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