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Discovery Eli Lilly

WilmerHale

Stay Versus Stay: How Litigation Stays Pending IPRs Impact the 30-Month Regulatory Stay in Hatch-Waxman Litigation

WilmerHale on

Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of Food and Drug Administration approval...more

Dorsey & Whitney LLP

Cooperation, the SEC and FOIA

Dorsey & Whitney LLP on

A critical part of cooperating with an SEC or DOJ investigation for FCPA or other possible violations is the production of documents. In order for the company to assess what happened it must conduct an internal investigation...more

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