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New Guidance Patents Regulatory Oversight

ArentFox Schiff

USPTO Expands on ‘Settled Expectations’ as Basis for PTAB Discretionary Denials

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The US Patent and Trademark Office (USPTO) recently issued a Director Discretionary Denial decision expanding on the “settled expectations” ground for discretionary denial of a post-grant review proceeding...more

Polsinelli

FDA Publishes Industry Guidance Document for Amendments to Abbreviated New Drug Applications

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In early July 2018, the United States Food and Drug Administration (FDA) issued a final guidance document titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA – Guidance for Industry." A...more

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