Latest Updates

Rituximab biosimilar approved in Latin America

On June 6, 2017, Biocad, a Russia biotechnology company, announced that it has obtained marketing authorization for its rituximab biosimilar in Bolivia and Honduras under the trade name USMAL, and that shipments will start in the… more

Milan proposes an attractive tax regime – interplay with existing Italian tax rules and some key points

In the international competition for investors and multinationals, Italy has emerged as a contender. Now the Metropolitan City of Milan has upped the ante, seeking to provide its own incentives to attract more investments into the… more

Rituximab biosimilar approved in Latin America

On June 6, 2017, Biocad, a Russia biotechnology company, announced that it has obtained marketing authorization for its rituximab biosimilar in Bolivia and Honduras under the trade name USMAL, and that shipments will start in the… more

FCA Consults on UK Implementation of EU Benchmarks Regulation

FCA proposes amendments to UK rules and clarifies timing for applications by benchmark administrators. Key Points: ..The FCA is consulting on consequential changes to the Handbook, plus additional UK aspects of… more

Trump changes cuba policy

On June 16, 2017, President Trump announced that he was reversing several Obama-era policies regarding Cuba. Against the backdrop of a Miami museum that celebrates the unsuccessful Bay of Pigs invasion, Trump’s announcement was… more

The Slants, The Redskins, and Free Speech for All Parties

This week’s Matal v. Tam (formerly Lee v. Tam) Supreme Court ruling serves as a reminder that free speech is a two-way street. It also suggests the value of a sympathetic litigant, at least in terms of public response… more

THIS CHANGES EVERYTHING—Second Circuit Holds that Contractual Consent Provisions Cannot be Revoked

This is the biggest TCPA news since the Omnibus—a silver bullet to defeat most revocation cases was hiding in plain sight the entire time. It seems so obvious now… more

E-Discovery Production — Snow storms are avoidable

Who is to blame for a “document dump” – a “snow storm” – an obfuscation of information? Sometimes its intentional and sometimes it is not. Everyone – both plaintiff and defendant; both teams of lawyers. Requesters are imprecise and… more

This Week In Securities Litigation

The first criminal charges against a major international bank and four of its executives tied to the market crisis were brought this week by the SFO. The charges were based on actions the firm took with private lenders to avoid needing… more

Pfizer Gets Second CRL On Proposed Epoetin Alfa Biosimilar

According to a Pfizer press release, the FDA has issued a second Complete Response Letter (CRL) to Pfizer in connection with the company’s aBLA for Retacrit, a proposed biosimilar of Epogen® and Procrit® (epoetin alpha). Pfizer said… more

Cuba & Trump: What the Changes Mean

On December 17, 2014, President Obama announced that the United States would “chart a new course” on its Cuba policy. Starting in January 2015, and for the next two years, the Treasury Department’s Office of Foreign Assets Control… more

CMS Requires Participating Providers to Prepare for Emergencies

On March 24, 2017, the Centers for Medicare & Medicaid Services (CMS) released a memorandum encouraging participating providers to “seek out and participate in a full-scale, community-based exercise with their local and/or state… more

Supreme Court Affords Greater Leeway to Biosimilars in the 'Patent Dance'

In a recent ruling, the U.S. Supreme Court clarified what happens when biosimilar applicants do not follow the regulatory framework for disputes with reference product sponsors — a process known as the “patent dance.” Since the… more

UK: Government announces International Sanctions Bill

The UK government has set out plans in this week’s Queen’s Speech for a new International Sanctions Bill (the “Bill“) that aims to ensure that the UK will continue to meet its international sanctions policy obligations and national… more

Our Cuba Sanctions Predictions: How Did We Do?

In our last post, we made a few cocky predictions about the new Trump Administration’s Cuba policy. We correctly asserted that the President would try to chart a narrow course between the Scylla of conservative Cuban-American… more

Amendments to Texas UTSA Bring it Closer in Line with DTSA, but Differences Remain

Just four years after the Lone Star State ended its holdout by becoming the 48th State to adopt the Uniform Trade Secrets Act, Texas passed a bill to amend its enactment. The bill was signed by Texas Governor Greg Abbott on May 19… more

Mandatory Bundled Payments Delayed, CMS seeking comments

CMS Administrator, Seema Verma, and Secretary of Health and Human Services Secretary, Tom Price delayed implementation of the Comprehensive Care for Joint Replacement (“CJR”) program via an interim final rule. See CMS – 5519 – IFC..… more

FTC Releases Agenda And Panelists For Upcoming Military Consumer Financial Workshop

On July 19, the Federal Trade Commission will hold a workshop in San Antonio titled the “2017 Military Consumer Financial Workshop: Protecting Those Who Protect Our Nation.” The FTC has uploaded an agenda and list of panelists for the… more

[Video]Day 17 Of One Month To Better Investigations and Reporting-Whom To Suspend During an Internal Investigation and De-Confliction

Who to suspend during any Foreign Corrupt Practices Act (FCPA) investigation is always a delicate question to answer. Unfortunately there is never an easy answer. As the Volkswagen (VW) emission-testing scandal continues to… more

CFPB Rolls Out Student Loan Servicing Campaign Focusing on Public Service Loan Forgiveness Program

Despite the uncertain future of the Public Service Loan Forgiveness program, Consumer Financial Protection Bureau (CFPB) Director Richard Cordray partnered with North Carolina’s Attorney General Josh Stein to roll out a new campaign… more

U.S. Fish and Wildlife Service to Delist Yellowstone Grizzly Bear

On June 22, 2017, U.S. Secretary of the Interior Ryan Zinke announced that the U.S. Fish and Wildlife Service (Service) will delist the Yellowstone population of the grizzly bear (Ursus arctos horribilis). According to the Service… more

TC Heartland – One Month Later Delaware, Texas, California and Illinois Courts Most Popular Venues

We previously reported on the early impact of the Supreme Court’s decision in TC Heartland based on the first few weeks of new filings. It has now been one month, and based on the filing data for the month since TC Heartland as well… more

Has the FCPA changed the US business culture?

In the early 70’s the Lockheed corruption scandals came into light. Millions of dollars had been paid by the US aircraft corporation to public officials to guarantee contracts for military aircraft in Germany, Italy, Japan… more

Your Daily Dose of Financial News

The US’s biggest banks had a good day yesterday on news that they “breezed through” the first phase of the Federal Reserve’s annual stress tests—a good sign that they “have enough capital to withstand the type of financial shock that… more

Court of Milan rules on interim measure ordering the halt of the pricing and reimbursement procedure of a generic product

By order issued on June 18, 2017, in summary proceedings brought by Teva against Mylan and Synthon for the alleged infringement of EP 2 361 924 (covering a manufacturing process for the active ingredient glatiramer acetate), the Court… more

CFPB issues report highlighting student loan complaints from borrowers working in public service; updates examination procedures

In conjunction with its public event yesterday on student loan servicing, the CFPB issued a new report, “Staying on track while giving back.” The report, which provides a mid-year update on student loan complaints, highlights… more

Paid Leave Wars: The Battles Intensify

Mandatory paid leave is making some employers sick. With no national standard, states and cities are rolling out paid leave mandates at a dizzying pace. This presents daunting compliance challenges for employers with employees in… more

New York's New Paid Family Leave Law: FAQs

New York’s Paid Family Leave Benefits Law (the “NYPFL Law”), the most comprehensive paid family leave program in the nation, goes into effect January 1, 2018. Starting on that date, employees will be eligible for up to eight (8) weeks… more

Hull Speed, Codgers, and Pre-Existing Conditions: What Does the Senate Bill Do?

Many other things being equal, the longer the sail boat, the faster it can go before its bow wave defeats further speed increase. However, as any boat approaches its “hull speed,” an increasing amount of energy is required to add each… more

FDA: Still in Action on Food Safety Violations

Vigorous food safety enforcement for basic violations continues under the leadership of new FDA Commissioner, Dr. Scott Gottlieb. On June 20, on the heels of an adverse FDA inspection, FDA announced that the U.S. Marshals Service had… more

Qatar – Sanctions and Restrictions: Key Developments

Readers may be aware that a number of countries, including Saudi Arabia, Egypt and Bahrain, have recently severed diplomatic and economic ties with Qatar. Saudi Arabia has now, via Kuwait which is acting as a mediator, presented a… more

News from Second & State

Weekly Wrap - Today marks just one week until the June 30 budget deadline. Seven days. A mere 168 hours to finish hashing out an over $30 billion state spending plan to carry us through the next fiscal year. While we still don’t… more

How (And Why) to Personalize Your Lawyer-Client Connections

Getting to know the personal interests, concerns, and desires of the people for whom you do legal work is essential… more

Budding Opportunities – Insuring Medical Marijuana Licensees In An Uncertain World

?The medical marijuana industry took a big step forward on June 20, 2017 when Pennsylvania’s Department of Health awarded 12 grower/processor permits. Of the 457 total applicants, the Department plans to award the remaining permits by… more

Interior Department Announces Regulatory Reform Comment Opportunity

In a June 22, 2017 Federal Register notice, the Department of Interior (DOI) became the most recent federal department or agency to initiate a comment cycle to solicit public input on regulations that should be repealed, replaced, or… more

Where Do the Supreme Court’s Civil Cases Originate (Part 2)?

Yesterday, we began our year-by-year review of where the Court’s civil cases have originated since 1994. By doing so, we can see trends in the administrative and executive agencies where the Court’s cases come from. Last time, we… more

Update: President Trump's Revised Executive Order on Travel Ban Remains Blocked

On June 12, 2017, the Ninth Circuit issued its ruling in Hawaii v. Trump, upholding the majority of the district court's preliminary injunction prohibiting the government from implementing the "travel ban" and refugee cap provisions… more

Overriding Interest

Welcome to the latest edition of Overriding Interest. Inside this issue: - The UK Government Proposes Innovative Transparency Requirements for Overseas Owners and Buyers of UK Property - Mees Update - Announcements, New Joiners… more

Blink and You'll Miss It - NSW Defect Bond Scheme Postponed and Email Service Gets the Green Light under the NSW SOP Act

The NSW Parliament has today passed the Electronic Transactions Legislation Amendment (Government Transactions) Bill 2017 (the Bill). The Bill has broad reaching implications for many participants in the building and construction… more

Power Outage Shows Unique Risks for Airport Cybersecurity

On May 27, 2017, thousands of British Airways passengers across the globe were stranded when a simple power failure took down critical systems, including those used to check in passengers. As images of crowded terminals and angry… more

HHS Subjects Human Research to an Updated Common Rule

The Department of Health and Human Services has taken a step toward harmonizing the complex regulatory requirements for federal human subjects research. Our Health Care Group breaks down the changes to the Common Rule due to take… more

It’s SUMMER! Top 4 Ways Employers Can Get Burned

We officially entered the season of summer this week. What are the most common ways employers can get burned? I can think of four right off the bat. Sexist air conditioning. It seems like a long time since we’ve read anything about… more

Small Business Payment For Performance Act Unanimously Leaves Committee – Will SBC Construction Contractors Be Able To Reduce Their Financial Exposure?

Currently pending in the House of Representatives is H.R. 2594, the “Small Business Payment for Performance Act of 2017” (the “Bill”). This Bill unanimously passed the House Committee on Small Business earlier today. While not yet a… more

Health Care Reform Behind Closed Doors

Behind closed doors, Senate aides work furiously on a piece of legislation that will potentially define the trajectory of health care for the next generation of Americans. Despite its potential impact on millions of Americans and the… more

Supreme Court Declares First Amendment Interest in Access to Social Networks

The internet has become so essential to American public discourse that saying so is almost trite now. Members of Congress regularly use social media to engage with constituents. The President has turned Twitter into one of his primary… more

‘Trust Me, You'll Love It': Caveat Emptor in Real Estate Transactions

Many people are familiar with the phrase “buyer beware,” or its Latin version, “caveat emptor.” In the sale of real estate, caveat emptor means that (absent contract language or terms to the contrary) a buyer purchases the property… more

Your New ®Ight To Disparage – A Look Inside “The Slants” Lanham Act Decision

The Federal trademark statute’s more-than-60-year prohibition on registering trademarks that may be viewed as disparaging goes out the window with the United States Supreme Court’s recent unanimous decision. The Court ruled that the… more

Alarmist Algorithms: Why Pricing Bots Won’t Be the End of Society

Federal Trade Commission Acting Chairman Ohlhausen and Commissioner McSweeny recently gave two very different speeches on algorithmic pricing. Commissioner McSweeny’s speech seemed to express concern that algorithms would lead to price… more

Appellate Court Notes

Appellate Court Advance Release Opinions: - AC38945 - Shook v. Bartholomew - AC38945 - Shook v. Eastern Connecticut Health Network, Inc. Defendants could not appeal plaintiff’s verdict in this motor vehicle accident case for… more

Uber’s CEO Is Forced Out

Have you ever felt powerless in your job? Felt that there was no way you could have impact on the corporate environment? Well, recent events have shown how the catalyst theory is alive and well in corporate America… more

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