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Archive for the ‘Digest Note’ Category

On August 14, 2014, the U.S. Food and Drug Administration (FDA) issued Draft Guidelines on the direct de novo classification process, a means of accelerating the approval of new types of medical devices posing only low to moderate health risks.[1]  The FDA created de novo classification in 1997, but after the process failed to achieve its purpose of expediting approval, the FDA introduced an alternative de novo process called “direct” de novo.

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Posted On Jun - 16 - 2016 Comments Off READ FULL POST

Insuring Patents

By Yaping Zhang – Edited by Jennifer Chung and Ariel Simms

Despite its increasing availability, patent insurance—providing defensive protection against claims of patent infringement and funding offensive actions against patent infringers—continues to be uncommon. This Note aims to provide an overview of the patent insurance landscape.

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Posted On Apr - 27 - 2016 Comments Off READ FULL POST

The Court of Justice of the European Union Finds the Harbor No Longer Safe

Written by: Ann Kristin Glenster - Edited by: David Nathaniel Tan

This fall, the Court of Justice of the European Union delivered a landmark ruling,  holding that the Safe Harbor Agreement on the handling of personal data by U.S. companies in Europe was invalid. This article will give a brief overview of the case, and explore the salient issues to which the European Court took umbrage. Finally, it will attempt to sketch out some possible consequences of the ruling, and the options that now face E.U. and U.S. legislators.

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Posted On Jan - 4 - 2016 Comments Off READ FULL POST

Observing Mauna Kea’s Conflict

Written by: Aaron Frumkin

Edited by: Anton Ziajka

Believing the machinery desecrates their sacred summit and the scarce natural resources it shelters, native Hawaiians have opposed telescope development on Mauna Kea. While it seems that their beleaguered resistance to telescope development will fail yet again with the proposed Thirty Meter Telescope (TMT), this Note attempts to articulate their best arguments in hopes of properly framing the social costs associated with the great scientific and technological gains that TMT will surely provide.

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Posted On May - 19 - 2015 2 Comments READ FULL POST

Whack-a-troll Legislation

Written by Asher Lowenstein     —   Edited by Yaping Zhang

Patent assertion entities’ extensive litigation activities in different states enables to assess the efficacy of the proposed bills against legal strategies these trolls, such as MPHJ Technology, have engaged in. The legal battles confirm some of the concerns about the usefulness of proposed regulatory measures.

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Posted On Dec - 22 - 2014 Comments Off READ FULL POST
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