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Biogen Dodges IPR Bullet on Key Tysabri® Patents

On Monday, the PTAB issued its ruling denying institution of three IPRs challenging Biogen’s patents claiming formulations and methods of treatment using natalizumab. Specifically, the PTAB denied institution of IPR2016-00912…more

AGG Food and Drug Newsletter - October 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and…more

Abandoning Bolam: a new standard for advising on investment risk

There has been a change in how the court will assess whether a financial advisor has used reasonable care and skill when giving investment advice. Following Supreme Court case law in the medical negligence field, Kerr J declined to…more

WV District Court: EPA Has A Non-discretionary Duty Under The CAA To Evaluate Economic Losses Resulting From Government Action

On October 17, the U.S. District Court for the Northern District of West Virginia coalgranted summary judgment to Murray Energy Corporation, which sued the Environmental Protection Agency (EPA) seeking declaratory and injunctive relief…more

CTFC Approves Proposed Rules Addressing Application of Certain CEA Regulations to Cross-Border Transactions

On October 11, 2016, the U.S. Commodity Futures Trading Commission (“CFTC“) unanimously approved proposed rules relating to the application of certain swap provisions of the Commodity Exchange Act (CEA) and CTFC to cross-border…more

Hong Kong Arbitration Week Triumphs Despite Weather

Hong Kong woke up this morning to a battering from Typhoon Haima. With much of the global arbitration community currently in the city for the fifth annual Hong Kong Arbitration Week, this force majeure event was no doubt an…more

The Problem With The BIC

The biggest hallmark for the new Fiduciary Rule is the best interest contract exemption and the need for brokers to get those signed with their retirement plan and IRA clients. Getting legalese written on paper isn’t going to be such a…more

Wolverine Status Review Reinitiated

The distinct population segment of the North American wolverine (Gulo gulf luscus) has had a long and difficult history with the Endangered Species Act (ESA). However, things appeared to be changing in 2013, when, after denying a…more

The 5% Solution: IRS Revenue Procedure 2016-42 Provides Relief for the Probability of Exhaustion Test

Charitable Remainder Annuity Trusts (CRATs) can be a very effective charitable planning tool. Choosing to fund a CRAT can remove assets from the estate of the donor, provide a reliable income stream for a family member and result in…more

CFPB Mortgage Servicing Rule Amendments Published in Federal Register

The CFPB Mortgage Servicing Rule Amendments were published in the Federal Register yesterday, starting the clock for the effective date of the amended provisions.  Most of the provisions are effective on October 19, 2017.  The…more

Telework Under The ADA & Other Nondiscrimination Laws

A workforce that adheres to a traditional work style, or a consistent eight-hour workday in the same location – with no offsite work or interaction with business colleagues or customers – is increasingly becoming a relic in many…more

The FAA’s New Drone Regulations

The use of small unmanned aircraft systems (sUAS or, colloquially, drones) is becoming more prolific. In the oil and gas context, drones can play a key role in conducting risky oilfield operations. The uses for drones in the oil patch…more

Enforcement Date Of OSHA Rule Delayed Again — Until December 1

The Occupational Safety and Health Administration has delayed for a second time the enforcement date of its new “Reasonable Reporting Procedure” rule as it pertains to post-accident drug testing and safety incentive programs. The new…more

Federal Circuit Finds Three Intellectual Venture’s Patents Invalid under the Mayo/Alice Framework

The Federal Circuit recently decided a case concerning three patents owned by Intellectual Ventures I LLC (“IV”). Intellectual Ventures I LLC v. Symantec Corp., Case Nos. 2015-1769, 2015-1770, 2015-1771 (Fed. Cir. Sept. 30, 2016). The…more

China Simplifies Its Legal Administration of Foreign Direct Investments

In order to implement the State Counsel’s decision issued on September 3, 2016 (State Counsel’s Decision), which simplifies the original substantive review and approval process (Approval System) to a new simple filing system (Filing…more

Philadelphia Beverage Tax Scheduled to Take Effect January 1, 2017

On June 16, 2016, The Philadelphia City Council voted to approve a so-called "soda tax" making Philadelphia the first major city poised to implement such a tax. Despite the simple sounding nickname for the new tax, it now appears that…more

Iran Issues Pre-qualification for Upstream Tenders

Iran is said to be targeting an increase in oil production from 3.85 to 4 million barrels per day by the end of 2016. Iran is also hoping to start export of a new heavy oil, called West Karun, and which is expected to compete with…more

SEC's Focus on Private Equity Firms Continues with Recent Action

A settled enforcement action, announced by the U.S. Securities and Exchange Commission (SEC) on September 14, 2016, continues the trend of increased SEC scrutiny of private equity advisers concerning the allocation and disclosure of…more

A Look Through The Crystal Ball: The EEOC’s Updated 2017-2021 Strategic Enforcement Plan

Seyfarth Synopsis: On October 17, 2016, the EEOC unveiled its updated Strategic Enforcement Plan (“SEP”) for Fiscal Years 2017-2021. It ought to be required reading for every employer and their executive teams. The New SEP…more

Augmented Reality, and the Inevitable Regulations, Go!

Well before Pokémon Go burst onto the mobile gaming scene in July, we had written about some of the pitfalls associated with AR gaming. When the game netted some 45 million daily users in just a few weeks, we talked about Pokémon Go…more

Monster Movie Month: Episode III – Son of Frankenstein and Evolution From Yates Memo and FCPA Pilot Program

Welcome to my third installment in this month’s classic monster movie festival. This year I am revisiting the Frankenstein series. Today I want to explore the final movie where Boris Karloff starred as Frankenstein’s Monster; Son of…more

Changes to FLSA White Collar Exemptions Raise Questions About Service Contract Act Compliance

The U.S. Department of Labor (DOL) rule that updates the overtime regulations for executive, administrative and professional employees (the "white collar exemptions") under the Fair Labor Standards Act (FLSA) is set to take effect on…more

Federal Banking Agencies Propose New Requirements for Managing Cyber Risk

Three federal banking agencies have announced plans to develop new rules that would establish cyber risk management and resiliency standards for large interconnected entities under the agencies' supervision, as well as those entities'…more

Rating Agency Developments

On October 11, 2016, S&P published its methodology for surveilling ratings of U.S. residential mortgage-backed securities principal only strip securities. Report. On October 7, 2016, Moody’s published its rating methodology for…more

More Than the Leaves Are Changing: Clinical Trial Research Regulations and Policies Get a Fall Makeover

The Food and Drug Administration (FDA) and National Institutes of Health (NIH) have recently finalized or signaled intent to finalize numerous proposals that promise to change the landscape of clinical trial reporting, clinical…more

4 More Things to Know About Transgender Rights in the Workplace

“Bathroom Bills” Apply to All Public Facilities, Including Showers and Locker Rooms. Despite being commonly referred to as “bathroom bills,” the laws and policy statements regarding transgender individual’s bathroom access apply…more

The SEC Has Data Fever, and the Only Prescription Is More Data (Analytics)

Companies are increasingly investing in enterprise governance, risk, and compliance (eGRC), largely in response to an uptick in regulatory action and enforcement. Between the enactment of laws such as the Dodd-Frank Wall Street Reform…more

HUD Advocates Broad “Disparate Impact” Liability for P&C Insurers

In February 2013, the U.S. Department of Housing and Urban Development adopted a “Discriminatory Effects Rule,” which established liability under the Fair Housing Act for conduct that is otherwise lawful, but which has a…more

Reminder: Comments to revised RAD forms due October 28th and RAD Report out for review

On September 28, 2016, HUD published a notice in the Federal Register to solicit comments to revised form documents used in the Rental Assistance Demonstration (“RAD”). This notice follows a 60-day comment period on earlier draft…more

Foreign request for legal assistance disclosable

The appellant companies successfully sought inspection of a mutual legal assistance request from the U.S. Department of Justice to the National Crime Agency (NCA) to obtain a prohibition order from an English court on the basis that…more

Understanding How Insurance Policy Conditions Apply When There is an Assignment of Benefits

Florida first-party property insurers have seen a dramatic rise in assigned insurance claims. In the typical scenario, an insured assigns her rights to receive insurance proceeds from a loss to a contractor in return for the…more

FCC Flexes Muscle: T-Mobile to Pay $48 Million for Failing to Disclose Limits on ‘Unlimited’ Data

Showing that it’s not about to slow down its aggressive enforcement of its open Internet regulations, the Federal Communications Commission (FCC) announced a settlement yesterday resolving claims that T-Mobile USA Inc. (T-Mobile)…more

Alert: New US Debt-Equity Rules Target Earnings Stripping

On October 13, 2016, the IRS and the Treasury Department issued new rules largely designed to prevent highly related corporate taxpayers from claiming the tax benefits of “earnings stripping,” or the payment of excessive deductible…more

New Use for Drones on Australian Beaches

In Western Australia’s South West beaches surveillance drones will hit the skies to increase swimmer safety by spotting sharks in the water. This project will take place over a three-month period (from November to January) and will…more

Workplace Investigations And The Case Of The Planted Peanut Butter

I’m a week late with this follow-up. (Sorry.) - Two weeks ago, I posted about an employee (fictionally named “Zoey”) who had a peanut allergy. After she asked a peanut-butter-loving co-worker (“Addison”) to be considerate, Zoey…more

EPA is Extending Its Refrigerant Management Regulations to Non-Ozone Depleting Refrigerants

The U.S. Environmental Protection Agency (EPA) has signed and is submitting for publication in the Federal Register an update to its Refrigerant Management Regulations under Section 608 of the Clean Air Act (CAA) to further reduce…more

[Video]This Week in FCPA-Episode 27, the Walla Walla Edition

Show Notes for Episode 27, week ending October 21, 2016-the Walla Walla Edition 1. Lennox Industries self-reports a $425 bribe; 2. Another guilty plea in FIFA corruption scanda; 3. Public Citizen letter to DOJ/SEC re: Wal-Mart…more

Locksmith Locked Out By Communications Decency Act

The Communications Decency Act (“CDA”) provides broad immunity for “providers of interactive computer services.” In essence, if an internet service provider falls within certain parameters, it is entitled to immunity against certain…more

401(k) Sponsors Say Their Plan is OK, but They Really Have No Idea

When I was dating my wife, she asked me if I had a good credit score and I said I did. I never checked my credit score, but I paid all my bills in full and on time. Of course when I got a copy of my credit report, my credit score…more

How to Address and Prevent Systemic Sexual Harassment in the Workplace

With sexual harassment suits carrying multimillion-dollar price tags, what can employers do to avoid the sting of litigation?…more

Derivatives In Review - October 2016

CFTC Delays Reduction in Swap Dealer De Minimis Exception Threshold - On October 13, 2016, the Commodity Futures Trading Commission approved an Order delaying for one year the reduction of the threshold for determining whether an…more

Update: EB-5 Regional Center Program Receives Short-Term Extension

On September 29, 2016, as part of recently enacted federal spending legislation, the EB-5 Regional Center Program received a short-term extension through December 9, 2016. The Program has been similarly extended, with no change in…more

Illinois District Court Denies Motion to Certify TCPA Class Action

In the consolidated cases Espejo v. Santander Consumer USA Inc., No. 11 C 8987, 2016 WL 6037625 (N.D. Ill. Oct. 14, 2016) and Levins v. Santander Consumer USA Inc., No. 12 C 9431, 2016 WL 6037 (N.D. Ill. Oct. 14, 2016), the U.S…more

Fund Restructurings: How to Navigate a Conflict-Rich Environment

The number of private equity fund restructurings is likely to rise in the coming years. The current economic expansion will inevitably come to an end (at 87 months and counting, this expansion is already the third longest post-WWII)…more

Recognising foreign insolvency proceedings arising in jurisdictions other than the place of incorporation - A case study of Re Opti-Medix Ltd (in liquidation) and another matter [2016] SGHC 108.

The central question in the case of Re Opti-Medix Ltd (in liquidation) and another matter [2016] SGHC 108 (Opti-Medix) was whether insolvency proceedings in a jurisdiction other than the place of incorporation could be recognised by…more

Your Daily Dose of Financial News

Federal regulators unveiled a proposal yesterday that would push the country’s biggest banks and other “critical financial companies” to shore up cybersecurity protocols, to prevent hacks, and to have a recovery plan at the ready…more

Bank Regulators Issue Notice of Proposed Rulemaking on Enhanced Cyber Risk Management Standards

Three federal banking regulatory agencies have approved an advance notice of proposed rulemaking (ANPR) inviting comment on a set of potential enhanced cybersecurity risk-management and resilience standards that would apply to large…more

How Certain Can You Be Of A General Partner’s Authority?

In this post, Professor Douglas K. Moll attacks the question of whether a partner has “actual authority, simply as a matter of his ‘partner’ status, to bind the partnership to an ordinary business transaction”..…more

Revision of limitation periods in future employment contracts required: Amendment of sec. 309 no. 13 German Civil Code (BGB)

As of October 1, 2016 employment contracts may only require text form, not the more formal written form, for all notices or statements issued by employees. Text form is met e.g. by an email. Any clause in an employment contract…more

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