Science, Computers & Technology Updates

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Humira Biosimilar Approved As Litigation Gets Going

The FDA on Friday approved the first U.S. biosimilar of Humira (adalimumab), AbbVie’s best-selling biologic for treatment of inflammatory conditions. The biosimilar, Amgen’s Amjevita (adalimumab-atto), received approval for...more

Health Alert (Australia) 26 September 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland - 10 September 2016 - Inquest into the death of C - C was a 14 year old girl with multiple physical and...more

Judge Approves LifeLock’s $68M Proposed Settlement with Class and $10.2M with Lawyers

On Tuesday, September 20, 2016, a federal judge in California granted approval of the $68 million settlement between LifeLock and a class of plaintiffs that alleged it made false statements about the services it provides to...more

Mind Reading Infringement Contentions

Order Regarding Discovery Letter Briefs, InteraXon Inc. v. NeuroTek, LLC, Case No. 15-cv-05290 (Magistrate Judge Kandis A. Westmore) - InteraXon, maker of a mind reading meditation aid, is not required to read the...more

Blockchain and Public Securities: Shedding Light on 'Going Dark'

The application of blockchain technology to the securities market could prove to be a game changer by adding transparency, reducing costs and speeding up settlements. Initially known as the technology underlying the...more

Vanda v. Roxane Labs. – Are Two Natural Laws Better Than One?

As you will recall, in Prometheus v. Mayo, the Supreme Court held that a claim reciting a natural law had to have other non-conventional steps to pass muster under s. 101. The natural law in Mayo was the correlation between...more

Former SEC Commissioner Louis A. Aguilar Describes Corporate Directors' Cybersecurity Duties

When Louis A. Aguilar was a commissioner at the Securities and Exchange Commission, he helped organize the SEC’s March 2014 roundtable to discuss the cyber risks facing public companies. The numerous data breaches that have...more

Considering E-Discovery in Cloud Contracts

Earlier this year, I predicted that 2016 would be a year of increased focus on e-discovery from cloud-based sources and postulated that many organizations would demand better e-discovery solutions and increased cooperation...more

Federal Automated Vehicles Policy: 6 Key Issues for the Automotive Supply Chain

The U.S. Department of Transportation (“DOT”) and the National Highway Traffic Safety Administration (“NHTSA”) last week finally issued the long-awaited Federal Automated Vehicles Policy (the “HAV policy”). The HAV...more

3D Printing: What it Means To Manufacturers Who Want To Sell Replacement Parts in a Digital Ecosystem

Among the next generation of 3D printing patents that will soon expire are key patents for metal-based printing processes. The patents’ expiration will almost certainly result in significant price reductions for 3D printers...more

FDA Holding its First Public Meeting on Drug Product Identification Requirements in October

Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA). The meeting will take place on October 14, 2016 at the Agency’s campus in...more

Tridim Innovations LLC v. Amazon.com, Inc. (N.D. Cal. 2016)

"Computer Display System" Patent Found Invalid under § 101 - Tridim Innovations LLC sued Amazon.com, Inc. for patent infringement of U.S. Patent Nos. 5,838,326 and 5,847,709 in the U.S. District Court for the Northern...more

Apotex Prevails in Neulasta Biosimilar Litigation, Files for Cert on 180-Day Issue

Among the first generation of biosimilar litigation under the Biologics Price Competition and Innovation Act (BPCIA) is a dispute between Amgen and Apotex over Apotex’s proposed biosimilar versions of Amgen’s Neupogen...more

Congressman introduces fintech bill

Republican Congressman Patrick McHenry, Vice Chair of the House Financial Services Committee, has introduced the “Financial Services Innovation Act of 2016,” which is intended to provide a streamlined regulatory process for...more

Consumer Fraud Allegations For A Prescription Medical Device Do Not Pass The Test

When we think of prescription medical devices, we usually think of the sorts of devices that are implanted during surgery and tend to end up in litigation—artificial joints, pacemakers, surgical meshes, and bone cements, to...more

[Event] Nonprofits in the Digital Age - October 18th, Seattle, WA

Please join us for a complimentary seminar focused on the critical legal issues facing nonprofits as they increasingly engage supporters, raise funds, and create change online and through digital technology....more

Samsung Bioepis Seeks Regulatory Approval for an Adalimumab Biosimilar in Europe and South Korea

Samsung Bioepis is reportedly seeking regulatory approval to sell a biosimilar version of Humira® (adalimumab) in South Korea. Also, in July 2016, Samsung Bioepis reported that the EMA had accepted its Marketing Authorization...more

FDA Denies AbbVie Citizen Petition on Fifth Amendment Takings

On September 23, the FDA denied a citizen petition from AbbVie submitted to the FDA on April 2, 2012, requesting that the FDA not implement the BPCIA as to any applications for biosimilar products referencing Humira...more

Social Links: Yelp’s Communications Decency Act claim; Twitter loosens its character limit; building a Snapchat audience

The California Supreme Court agreed to hear Yelp’s case arguing that requiring the company to remove a one-star review of a law firm “creates a gaping hole” in the immunity that shields internet service providers from suits...more

Yahoo Announces Large Data Breach

On September 22, 2016, Yahoo issued a statement confirming that hackers infiltrated its systems in late 2014 and lifted account data tied to at least 500 million users. In its press release, Yahoo said that a recent...more

The Ping FCPA Enforcement Action: Lessons for the Compliance Practitioner

The Securities and Exchange Commission (SEC) settled a Foreign Corrupt Practices Act (FCPA) enforcement action against an individual earlier this month when it announced the resolution of a matter involving Jun Ping Zhang,...more

UPDATE: Got Data? Actual Harm Not Required for FTC Enforcement Action for Lax Security Measures

As anticipated, things are getting even more exciting with the case previously covered in Password Protected. Specifically, LabMD is appealing the landmark data security case between it and the Federal Trade Commission...more

Key Legal Issues in Privacy and Data Security on Display in Sixth Circuit Data Breach Class Action Decision

A September 12, 2016 decision out of the U.S. Court of Appeals for the Sixth Circuit adds new fuel to an ongoing legal debate: when a data breach places a business’s sensitive customer information into the hands of hackers,...more

Blog: The FCA’s approach to cyber security in financial services firms

Nausicaa Delfas, the FCA’s Director of Specialist Supervision has delivered a speech at the FT’s Cyber Security Summit, about the FCA’s approach to cyber security in financial services firms. There are 3 short takeaways...more

Yuba Sutter Medical Center Hit With Ransomware

Yuba Sutter Medical Center in California (Yuba Sutter) has notified its patients that it has suffered a recent ransomware attack that caused parts of its network to be incapacitated. As a result, patient files were unable to...more

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