In This Bulletin:
- Supreme Court Allows Generic Manufacturers to Challenge Overbroad Use Codes.…1
- Patent Reform: The Public Speaks …. 3
- Quick Updates ….5
- Criminal Liability for Cloud Storage Service Providers? .… 5
- Patent Litigation Settlement Negotiations Are Discoverable….6
- Federal Courts Address Question of Employer-Employee Ownership of Business-Related Social Media Accounts….7
Excerpt From: Supreme Court Allows Generic Manufacturers to Challenge Overbroad Use Codes
The United States Supreme Court ruled unanimously on April 17, 2012 that a generic drug manufacturer may file a counterclaim to force correction of an overbroad use code that encompasses unclaimed methods of using the drug at issue. In interpreting the text of 21 U.S.C. § 355(j)(5)(C)(ii)(I), the Court in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, No. 10-844, 132 S.Ct. 1670 (2012), gave substantial weight to ensuring that the Food and Drug Administration fulfills its statutory duty to approve non-infringing generics in accord with Congressional intent. Brand manufacturers are advised to review active use codes to ensure that they reasonably reflect the scope of any claimed methods of use.
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