Science, Computers & Technology Updates

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EPA Releases First Determinations for New Chemicals under New TSCA

On July 22, 2016, the U.S. Environmental Protection Agency (EPA) posted on its website the first four Section 5(a)(3) determinations for premanufacture notices (PMN) under the Toxic Substances Control Act (TSCA) as amended by...more

Scottrade data breach class action case dismissed for lack of standing

We previously reported that Scottrade was hit with a class action case within 24 hours of notifying customers of a data breach. According to the Complaint, the data compromised included the names, addresses, telephone...more

OCR Announces First HIPAA Enforcement Action against a Business Associate

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced an agreement with Catholic Health Services of the Archdiocese of Philadelphia (CHCS), settling allegations that CHCS violated the Health...more

What Does The Loss Of “Green Chemistry” Provision From Amended TSCA Mean For Biochemicals?

On July 15, 2016, Environmental Leader published "What Does the Loss of 'Green Chemistry' Provision from Amended TSCA Mean for Biochemicals?," featuring comments by Lynn L. Bergeson, Managing Partner of Biobased and Renewable...more

Induced Infringement Becomes More Difficult To Defend

In Warsaw Orthopedic, Inc. v. NuVasive, Inc. (June 3, 2016) 2016 U.S. App. LEXIS 10092, the Federal Circuit Court of Appeals broadly interpreted the Supreme Court’s test for induced infringement, finding irrelevant the...more

Major League Baseball investigating Cardinals-Astros hacking

Promptly following the sentencing of Christopher Correa on July 18, 2016, Major League Baseball Commissioner Rob Manfred announced that Major League Baseball (MLB) is looking further into the hacking incident involving...more

The Economic Development Toolbox: Downtown Redevelopment Districts Provide Additional Economic Development Tools for Ohio...

On May 6, 2016, Governor Kasich signed Am. Sub. House Bill 233 (“H.B. 233”) authorizing Ohio municipalities to create Downtown Redevelopment Districts (“DRDs”) to encourage the rehabilitation of historic buildings and...more

FDA Adjustment to Orphan Drug Review May Indicate Increased Scrutiny of Designations

In recent years, applications for orphan drug designations have flooded into FDA at a rapid pace, and this year appears to be no exception. Orphan drug applications received by FDA rose by approximately 30% over the previous...more

Privacy Shield is final: What it means for businesses

The US Department of Commerce announces that it will begin accepting applications for Privacy Shield certifications beginning on August 1. For US organizations collecting personal data from the EU, the past year has been...more

European Parliament Passes Landmark Data Protection Regulation

On April 14, 2016, the European Parliament passed the General Data Protection Regulation (GDPR) and its companion, Data Protection Directive for Police and Criminal Justice Authorities. The GDPR is a comprehensive regulation...more

ThisWeek in FCPA-Episode 14, the Wolf of Wall Street Edition [Video]

In this episode, Jay Rosen and I talk about the SFO investigation into Unaoil, the forfeiture lawsuit filed in the 1MDB scandal, the possible JP MorganChase sons and daughters FCPA settlement, the new Standard Law School FCPA...more

On the Move and At Risk: Safeguards for Mitigating Mobile Device Vulnerabilities While Traveling Overseas

Employees use their smartphones as a key tool for accessing information during a work day – especially when outside the office and traveling on business. While smartphones, tablets, laptops and other devices may increase...more

New rules for vat taxation of e-commerce services in Russia

On 3 July 2016 Russian President Vladimir Putin signed Federal Law No. 244-FZ introducing rules for VAT taxation of e-commerce services in Russia (Law)....more

Wearable Medical Devices Market Trending Upwards

New reports, such as the Global Diagnostic Wearable Medical Devices Market 2016-2020 Report, bring good news to the rapidly growing wearable medical device market. According to the Report, the diagnostic wearable medical...more

Amgen and Allergan Report Progress in Herceptin® Biosimilar Clinical Trial

In the late 1980's, Dennis Slamon discovered a new oncogene, Her2/neu,that was amplified in 25-33% of human beast cancers. Slamon et al., "Studies of the HER2/neu ProtoOncogene in Human Breast and Ovarian Cancer," Science...more

Put a Fork in it: What’s Happening with the DAO?

If you have an interest in bitcoin, you’ve undoubtedly heard people refer to “The Blockchain.” Because the term “blockchain” can refer to any distributed ledger where “blocks” are added to the ledge by solving complex...more

Supreme Court Reinvigorates Effectiveness of Obtaining an Opinion of Counsel to Defend against Potential Enhanced Damages for...

On June 13, 2016, the U.S. Supreme Court again reversed a decision of the Federal Circuit—the Circuit specially designated to hear all patent appeals—this time, in articulating the test for determining whether to award...more

Next-Generation Sequencing: FDA Issues New Guidance for Genetic Tests

On July 6, 2016, the U.S. Food and Drug Administration (“FDA” or “Agency”) released the following two draft guidance documents on the oversight of next-generation sequencing (“NGS”) tests...more

Self-Regulatory Actions Signal Warning for Mobile Apps that Allow Third Parties to Collect Information for Interest-Based...

Recent actions against two prominent mobile app developers serve as a warning for companies that authorize third parties to collect and use information over time for advertising in mobile apps (known as interest-based...more

Software Inventions See More Help in Bascom Decision

Since the Supreme Court decided Alice Corp. v. CLS Bank International, patent examiners and the courts have been working to better define patent eligibility. Following closely on the heels of their Enfish, LLC, v. Microsoft...more

En Banc CAFC Requires UCC Sale For On Sale Bar

In an en banc decision issued in The Medicines Company v. Hospira, Inc., the Federal Circuit determined that in order for a commercial transaction to trigger the on-sale bar of § 35 USC 102(b), it must “bear the general...more

A One-Two Punch Case With An Off-Label Twist

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense. For more important stuff, we find qualifiers like “vague” and...more

Utah votes to let authorities disable drones near wildfires

This week, in Salt Lake City, lawmakers approved a bill that would allow Utah authorities (i.e., firefighters or law enforcement) to disable and down drones if they are being flown too close to wildfires. Governor Gary...more

Can FDA Implement The BPCIA As The CAFC Suggested?

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

Your daily dose of financial news - The Brief – 7.22.16

EU financial watchdog ESMA has fined rating agency Fitch Ratings Ltd. $1.5 million for reportedly violating the EU’s rules for rating agencies relating to the 12-hour requirement, internal controls, and unauthorized...more

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