A student-run resource for reliable reports on the latest law and technology news
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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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UnknownBy Kayla Haran

Court Rules Reputational Harm Confers Standing to Sue over Inventorship

In Shukh v. Seagate Technology, LLC, 2014-1406 (Fed. Cir. Oct. 2, 2015), the United States Court of Appeals for the Federal Circuit ruled that “concrete and particularized reputational injury” can confer Article III standing to sue. The court vacated and remanded the United States District Court for the District of Minnesota’s grant of summary judgment to defendant Seagate Technology, LLC on the grounds that reputational harm is in fact a valid basis for standing, and affirmed the district court’s remaining holdings. In the original case, plaintiff Alexander Shukh filed a complaint against his former employer Seagate alleging that Seagate wrongly omitted him as an inventor on six patents, among several other claims relating to the termination of his employment. The district court granted Seagate’s motion for summary judgment on Shukh’s claim for correction of inventorship under 35 U.S.C. § 256, finding that Shukh’s employment at-will barred his financial or ownership interest in the inventions. On appeal, Shukh argued that a trier of fact could conclude that his omission from the disputed patents caused injury to his reputation as an inventor, which he claimed prevented him from obtaining other employment. In a unanimous decision, the court found that there is a material question of fact as to whether these omissions actually caused Shukh reputational injury, but agreed that “if the claimed inventor can show that being named as an inventor on a patent would affect his employment, the alleged reputational injury likely has an economic component sufficient to demonstrate Article III standing.” In its opinion, the court emphasized that the number of patents on which an inventor is listed is a critical component of the inventor’s professional reputation.

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Posted On Oct - 22 - 2015 Comments Off READ FULL POST

PatentDraftingToolsBy Jasper L. Tran – Edited by Henry Thomas

“Patenting tends to get people’s juices flowing when you put the word ‘gene’ and the word ‘patent’ in the same sentence.”—Francis Collins

 Alas, naturally occurring genes are not patentable.[1]But what about bioprinting?

Dr. Anthony Atala recently gave two TED talks, Growing New Organs[2] and Printing a Human Kidney[3], presenting that bioprinting, the3D-printing living tissues, is real and may be widely available in the near future. This emerging technology has generated controversies about its regulation; the Gartner analyst group speculates a global debate in 2016 about whether to regulate bioprinting or ban it altogether.[4]

Another equally important issue is whether bioprinting is patentable. The U.S. Patent and Trademark Office (Patent Office) has already granted some bioprinting patents and many more patent applications are pending.[5]Although these patents are presumed valid, their validity will likely be litigated and the U.S. Supreme Court might have to settle this issue in due course.

One might intuitively assume that bioprinting is not patentable because the law generally prohibits patenting human organisms.[6]However, the issue is not so simple. This Article breaks down this complex issue and analyzes the patentability of bioprinting given the current landscape of patent law.

This Article concludes that bioprinting is patentable and that bioprinting process claims are easier to patent than bioprinting product claims. Current bioprinted human living tissues are functionally similar but structurally different than real human living tissues. Until scientists can bioprint structurally similar living tissues, bioprinted products are in the clear to be patent-eligible subject matter.

However, regardless of whether bioprinting is patentable, an interesting question to consider is whether bioprinting should be patentable. After weighing both sides’ arguments, this Article proposes a potential compromise: granting patents for only bioprinting process claims, not product claims. This proposal aligns well with the current landscape of patent-eligible subject matter—bioprinting process claims are being patented whereas bioprinting product claims would likely run into opposition and challenges.

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Posted On Sep - 23 - 2015 Comments Off READ FULL POST

UnknownBy Allison E. Butler – Edited by Travis West

I. Introduction

On June 19, 2014, the U.S. Supreme Court handed down its first software patent case in thirty-three years.[1] In the case of Alice Corp. Pty. Ltd. v. CLS Bank,[2] the Court determined the patent eligibility for computer-implemented inventions. While incorporating its previous analysis of Mayo Collaborative Services v. Prometheus Lab., Inc.,[3] the Court verified that computer-implemented inventions have protection through patent subject matter eligibility; however, the Court limited this protection by finding that generic computer implementation must further transform an abstract idea to be a patent-eligible invention under 35 U.S.C. § 101. The ruling of Alice is significant as it replaces the once general view held by the courts that §101 was nothing “more than a ‘course [patent] eligibility filter’”[4] with a defined patent eligibility filter derived through a two-part analysis that has placed patentability under Section 101 at “a higher bar.”[5] It has not only been the courts who have taken notice of Alice. The USPTO issued advisories and instructions for its examiners and the public at large as to the handling of patent eligibility for software patents and denied pending patents upon the issuance of Alice.[6]The impact of Alice is broad but it appears to be a decision that was long overdue to address the many issues facing patentability of subject matter eligibility in various arenas where such issues are dominant.

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Posted On Sep - 19 - 2015 Comments Off READ FULL POST

344f15853394cfa361518ee607cd06d1By Ariella Michal Medows – Edited by Kenneth Winterbottom

The United States healthcare industry is undergoing a technological revolution.  As paper medical records are converted to electronic medical records, which are then stored via cloud computing, a myriad of legal questions arise.  Foremost among these are concerns regarding patient privacy and the security of stored personal health information.  It is evident that the storage of electronic medical records in computer clouds is a technological development that is here to stay.  The challenge lies in adapting our healthcare system to the digital age in a legally enforceable, efficient, and cost-effective manner while maintaining quality care and privacy rights for patients.

There are two key components to this healthcare overhaul.  First, transitioning as smoothly as possible to the inevitable nationwide e-health system; and second, determining proper responses to situations where the e-health system does not function correctly.  All systems experience complications at some point, and the e-health system, while more efficacious than paper medical records in the long-term, will present new legal and policy-related dilemmas that a community reliant on paper-based medical charts will initially be unprepared to address.  Ideally, hospitals and healthcare companies should develop backup plans in advance of these hurdles and create prophylactic policies that anticipate technical difficulties.  The U.S. healthcare system should act offensively, rather than defensively, to challenges that will arise as we increase our reliance on technology.  These strategies must be as legally sound as possible, in order to best protect patient privacy and to diminish risks for all parties.  Diminishing legal risk will decrease the hesitancy of software companies and data centers to enter the arena of public health, and will therefore drive a competitive marketplace with lower costs for hospitals and insurance companies and, consequently, lower treatment costs for patients. (more…)

Posted On Sep - 11 - 2015 Comments Off READ FULL POST

By Angela Daly – Edited by Katherine Zimmerman

1.      Introduction

This contribution will consider current moves in the European Union (EU) to legislate net neutrality regulation at the regional level. The existing regulatory landscape governing Internet Service Providers (ISPs) in the EU will be outlined, along with net neutrality initiatives at the national level in countries such as Slovenia and the Netherlands. The new proposals to introduce enforceable net neutrality rules throughout the EU will be detailed, with comparison made to the recent FCC proposals in the US, and the extent to which these proposals can be considered adequate to advance the interests of Internet users.

2.      Existing regulatory landscape in the EU

Various provisions from existing EU telecoms regulation are relevant to net neutrality. This regulatory framework has promoted intra-platform competition by stimulating competition at the retail, consumer-facing level for fixed line telecoms, rather than inter-platform competition between different technologies such as cable and copper wires — a feature of the US regulatory landscape. EU telecoms regulation has pursued a ‘technology neutral’ policy, more concerned with the extent to which markets are competitive than the type of technology used to deliver services. If a market is not competitive, then ex ante regulation will be applied with the idea that the regulation will no longer be needed once competition has been achieved, and market-based solutions suffice.

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Posted On Sep - 10 - 2015 Comments Off READ FULL POST
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Unknown

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