Posts Tagged: "Purple Book"

New Dance Moves? Purple Book Amendments Require Public Disclosure of ‘Patent Dance’ Patent Lists

Innovator (or “reference”) biologic drug makers and small-molecule drug makers face differing legal obligations with respect to public patent disclosures. Under the Hatch-Waxman Act, reference small-molecule drug makers are required to provide to the U.S. Food and Drug Administration (FDA) a list of the patents covering the active ingredients, compositions, formulations, and methods of treatment for their approved reference drug products, which the FDA in turn is required to publish in its “Orange Book.”  21 U.S.C. § 355(b)(1), (c)(2). The publication of such patents in the FDA Orange Book thus gives all generic drug applicants advance notice of the patents to be asserted by a reference drug maker in future Hatch-Waxman litigation.

Holiday Gifts for IP Owners: Several Significant IP Bills Passed Last Minute by Congress

Late Monday evening, Congress passed a massive omnibus budget bill to avert a federal government shutdown and provide critical COVID-19 relief.  But that is not all – much to the surprise of the intellectual property world, the last-minute bill included several pieces of legislation, previously thought to be sidetracked in light of the current lame duck administration, that will alter the landscape of trademark, copyright and patent law as we know it. The changes include a Trademark Modernization Act that restores the rebuttable presumption of irreparable harm when a Lanham Act violation has been proven, allowing brand owners to more easily obtain injunctions, and the creation of a copyright small claims tribunal within the Copyright Office.