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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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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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Defend Trade Secrets Act of 2016 Seeks to Establish Federal Cause of Action for Trade Secrets Misappropriation

By Suyoung Jang – Edited by Mila Owen

Following the Senate Judiciary Committee’s approval in January of the Defend Trade Secrets Act of 2016, the Committee has released Senate Report 114-220 supporting the bill. The bill seeks to protect trade secret owners by creating a federal cause of action for trade secret misappropriation.

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Federal Circuit Flash Digest

By Evan Tallmadge – Edited by Olga Slobodyanyuk

The Linked Inheritability Between Two Regions of DNA is an Unpatentable Law of Nature

HP Setback in Challenging the Validity of MPHJ’s Distributed Virtual Copying Patent

CardPool Fails to Escape an Invalidity Judgment But Can Still Pursue Amended Claims

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Amicus Brief by EFF and ACLU Urging Illinois State Sex Offender Laws Declared Unconstitutional under First Amendment

By Yaping Zhang – Edited by Mila Owen

With the Illinois Supreme Court gearing up to determine the constitutionality of the state’s sex offender registration statute, two advocacy non-profits have filed amicus briefs in support of striking the law down.

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The Harvard Journal of Law & Technology recently released its Fall 2011 issue, now available online.  Jane Yakowitz, author of “Tragedy of the Data Commons” has written an abstract of her article for the Digest, presented below.

- The Digest Staff

JOLT Print Preview: Tragedy of the Data Commons
Jane Yakowitz

The data that fuels most of the quantitative health and policy research in this country is publicly available data that has undergone some sort of anonymization process. This is the data commons, and unwittingly, we are all in it. Our tax returns, medical records, and school records, among other things, seed its pastures and facilitate a wide range of empirical studies.

In theory the data commons gives us the best of both worlds by allowing researchers to test hypotheses and produce generalizable results without exposing anybody’s personal information. But in practice, we all shoulder some risk that a bad actor might use auxiliary information to reidentify us, and discover our private information. The looming policy question, raised by Paul Ohm and the Federal Trade Commission, is whether current data privacy policies in the United States strike the right balance between the risks of reidentification attacks and the utility of data-sharing. Paul Ohm and other scholars believe the risk is too high, that we need stronger privacy laws to protect data subjects. This article comes to the exact opposite conclusion: the utility of public research data is so great, and the realistic risks so small, that the law should foster the sharing of anonymized data.  (more…)

Posted On Jan - 30 - 2012 Comments Off READ FULL POST

The Harvard Journal of Law & Technology recently released its Fall 2011 issue, now available online.  Sonia K. McNeil, author of “Privacy and the Modern Grid” has written an abstract of her article for the Digest, presented below.

- The Digest Staff

JOLT Print Preview: Privacy and the Modern Grid
Sonia K. McNeil

The American electrical grid is in bad shape. Because of chronic underinvestment in research and development, a digital nation now relies on an infrastructure created before the invention of microprocessors that is beginning to show its age. Power quality problems and system disturbances cost the United States nearly $150 billion each year, regional blackouts aggravate and endanger millions of residents, and structural insecurities tempt hackers and terrorists around the globe.

To address these problems, the modern grid is being transformed from an outmoded, centralized network dominated by energy producers to a flexible, decentralized system that is more secure, more reliable, and better able to respond to and interact with consumers. The updated “smart grid” will permit “a two-way flow of electricity and information” in near-real time, creating an adaptive, interactive energy matrix. For consumers, the most visible part of the smart grid will be “smart meters,” advanced electrical meters that collect highly granular data on individual electricity consumption and allow users to monitor and remotely control their electrical use in response to fluctuating energy prices. At the level of an individual home, the goal is to use data to encourage consumers to conserve energy by showing them its cost as they consume it, rather than days or weeks later in an energy bill. System-wide, this information will be harnessed to spur economic growth, conserve the environment, increase electrical service reliability, strengthen national security, and develop derivative technologies.  (more…)

Posted On Jan - 26 - 2012 Comments Off READ FULL POST

Written by Laura Fishwick
Edited by Adam Lewin
Editorial Policy

Introduction

The most recent U.S. Supreme Court case to address the legality of school-imposed punishment for student expression was more than forty years ago in Tinker v. Des Moines Indep. Cmty. Sch. Dist., 393 U.S. 503 (1969). In that seminal case, the Supreme Court found that a state’s interest in maintaining its educational system can justify limitations on students’ First Amendment rights to the extent necessary to maintain an effective learning environment. Id. In Tinker, school officials suspended students for wearing black arm bands to protest the Vietnam War. Articulating the standard still used by courts today,[1] the Court held that a school may regulate student speech or expression if school officials can reasonably conclude that such speech caused or is likely to cause a “material and substantial” disruption to school activities. Id. at 513 (finding no substantial disruption because the protests were non-violent and did not interfere with class activities).

Tinker and subsequent Supreme Court cases have not addressed whether a school may regulate student speech that occurs off campus or online and is not connected to a school event, but that nonetheless causes disruption on campus or in the classroom. Further complicating the analysis of on campus, off campus, and online speech are additional factors such as the location where recorded activity takes place before it is posted online, and the location of the computer used to upload data onto the Internet. This comment explores the recent lower court decisions applying the Tinker standard to school-enforced limits on student speech made on the Internet. In cases of off campus or online speech, some courts have responded to the fact that Tinker involved on campus speech by requiring the school to show a substantial nexus between the speech and the school before applying Tinker. Beyond the nexus inquiry, courts move onto Tinker and examine the intensity of on campus discussions surrounding the expression, the burden the expression places on the administration, and whether the expression contains violent content.  (more…)

Posted On Jan - 12 - 2012 2 Comments READ FULL POST

Written by Julia Mas-Guindal
Edited by Heather Whitney
Editorial Policy

I. Introduction

The doctrine of moral rights in copyright law has been a source of strain in domestic and comparative legal scholarship for decades. This strain is greater in the U.S. than in countries employing a continental legal system, where moral rights are widely recognized. This is because U.S. law and European law are built on different foundations: while for the U.S. Copyright Act the encouragement of economic investments is the top priority, continental countries prioritize protecting the artistic work and the creators. This fact has made it difficult for U.S. law to adequately account for moral rights, as I will argue in this comment. This issue is particularly acute in the realm of film. While the U.S. has made progress in establishing moral rights for paintings, drawings, sculptures and certain photographic images through the Visual Artist Rights Act of 1990 (“VARA”), the U.S. system continues to exclude filmmakers.

In this comment, I will review what moral rights are and compare the moral rights landscapes of the U.S. to those of continental countries. This will shed light on why filmmakers’ moral rights have been excluded and how exclusion is not inevitable, as other countries with bustling film industries, like India, have moral rights for filmmakers.

Finally, I will address the arguments made by the likes of producers and studios for why directors should not have moral rights. In the end, I argue for a way to meet the needs of producers and studios while also making room in U.S. law for recognition of moral rights in the filmmaking field.

(more…)

Posted On Dec - 31 - 2011 Comments Off READ FULL POST

The Digest will be taking a short break from our regular coverage over the coming weeks as our Staff Writers go on holiday.

While we take our hiatus from regular coverage, we have the pleasure of re-introducing our Comments feature. Comments are longer opinion pieces on especially significant issues. These pieces are written entirely by members of our staff, on topics they believe warrant closer examination and study. From now until late January, we will publish one Comment every one to two weeks. We have great pieces this year and we hope you enjoy them!

We’ll be back sometime in January with our usual coverage.

We sincerely hope you’ve enjoyed our work this year!

The Digest Staff

Posted On Dec - 22 - 2011 Comments Off READ FULL POST
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