Latest Updates

Ireland's Department of Health is Requesting Comments Regarding Its National Biosimilars Medicines Policy

Ireland’s Department of Health (the “Department”) recently reported on its website that it is “developing a National Biosimilar Medicines Policy to promote the use of biosimilar medicines and to create a sustainable environment for… more

Corporate and Financial Weekly Digest - Volume XII, Issue 31

CFTC - CFTC Suspends Need of Formal Notice for Position Disaggregation Relief - On August 10, the Commodity Futures Trading Commission (the CFTC) issued no-action relief, eliminating the need for certain persons otherwise… more

North Carolina Governor Signs Law Creating Division to Investigate and Prosecute Employee Misclassification Claims

In 2015, a Raleigh newspaper ran a series of investigative articles focused on construction industry members that classified a large portion of their workers as independent contractors instead of employees. The articles alleged that… more

It's Not Etched in Stone that Sales-Tax-Free Weekends Be Held Only in August

This comes as no surprise to the people I work with (nor to my wife) but I was dead damn wrong in my last post, “Guv’s Sales Tax Holiday Bill Looks D.O.A. Appearances Are Deceiving,” 8-6-17. I thought Charlie Baker must have set… more

Pennsylvania Courts Split Over Sexual Orientation Discrimination

A recent decision by Judge Jan E. DuBois in Coleman v. Amerihealth Caritas, No. 16-3652, 2017 U.S. Dist. LEXIS 85319 (E.D. Pa. June 2, 2017) demonstrates that Pennsylvania courts remain divided as to whether Title VII of the Civil… more

Massachusetts Joins MTC Amnesty Program

Massachusetts Joins Multistate Tax Commission Amnesty Program - For Most States Amnesty Features Complete Tax Forgiveness - Urgent Action May Be Needed - Boston – On August 18, 2017 Massachusetts joined 22 other participating… more

NMFS issues final Atlantic sturgeon rule

U.S. fisheries regulators have issued a final rule designating nearly 4,000 river miles in Atlantic watersheds as critical habitat for endangered and threatened Atlantic sturgeon. The rule increases regulatory complexity and… more

Anti-Money Laundering and Countering Financing of Terrorism Amendment Act 2017

The Anti-Money Laundering and Countering Financing of Terrorism Amendment Act 2017 (Amendment Act) received Royal assent on 10 August 2017. The Amendment Act makes a number of changes to the Anti-Money Laundering and Countering… more

Corporate News – August 2017

FCA proposes a new premium listing category for sovereign controlled companies - On 13 July 2017, the Financial Conduct Authority published consultation paper CP 17/21 which proposes to create a new premium listing category for… more

Judge Oetken Construes Twenty-Nine Claim Terms in “Relatively Large” Markman Opinion

On August 10, 2017, District Judge Paul Oetken (S.D.N.Y.) construed 29 claim terms in a dispute between Defendant Comcast Corporation, et al. (“Comcast”) and Plaintiff Rovi Guides, Inc. and its subsidiaries (“Rovi”). The claim terms… more

New Executive Order on Infrastructure Ups the Ante on Streamlining the Environmental Review and Permitting Process

Since its earliest days, the Trump Administration has focused on eliminating delays in infrastructure projects, portraying environmental reviews and permitting as major choke points requiring change. On January 24, 2017, the White… more

Does Mayo Preclude the Patenting of Medical Diagnostics?

On August 4, 2017, the U.S. District Court in the District of Massachusetts found U.S. patent 7267820 (the ‘820 patent), owned by Athena Diagnostics, Inc., to be directed to non-patentable subject matter, and therefore invalid under 35… more

Skipping The Patent Dance: U.S. Supreme Court In Amgen V Sandoz Makes It More Difficult For Patent Owners To Delay Marketing Of Biosimilars

On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the complex statutory scheme that attempts to expedite resolution of patent disputes that… more

D.C. Circuit Provides Additional Support For Specialty Healthcare, Union-Friendly Micro-Units

The U.S. Court of Appeals for the D.C. Circuit has sided with the National Labor Relations Board in affirming the union-friendly practice of “micro-unit” organizing. The D.C. Circuit’s opinion issued in Rhino v. NLRB is unwelcome news… more

Taxpayers Bear The Tax Consequences Of Business Decisions

It is a basic precept of the tax law that the substance of a transaction, rather than its form, should determine its tax consequences when the form of the transaction does not coincide with its economic reality. This… more

5th Circuit Asked to Review ALJ Decision to Vacate “Controlling Employer” Doctrine Citation

Seyfarth Synopsis: As expected, OSHA has appealed an ALJ ruling that severely limits OSHA’s “controlling employer” enforcement policy. Acosta v. Hensel Phelps Constr. Co., No. 17-60543 (5th Cir. 8/4/17)… more

Projects and Energy Weekly Snippets

Weekly projects and energy updates in South Africa Electrification scheme in focus, says Eskom With 90% of South Africa now having access to electricity, the utility will now put special focus on the three provinces that are lagging… more

The enforcement of standard essential patents in Germany – a stocktaking

In July 2015, the European Court of Justice (CJEU) issued a long-awaited judgment answering questions as to the requirements an owner of a standard essential patent (SEP) is able to enforce its SEP without a breach of European… more

The Spokeo Saga Continues: Ninth Circuit Finds That Incorrect Consumer Report About Age, Marital Status, Wealth, Education Level, And Profession Gives Rise To Concrete Injury

Takeaway: In Spokeo, Inc. v. Robins, 136 S. Ct. 1540 (2016) (“Spokeo II”), the Supreme Court ruled that not every statutory violation gives rise to a concrete injury for standing purposes. An inaccurate report of a person’s zip code… more

Revisiting Rule 10b5-1 Trading Plans

I am sometimes surprised by the number of insiders who trade in their company’s stock outside of Rule 10b5-1 trading plans. It is often said, with some accuracy, that executive officers, directors and other insiders always possess… more

CA Supreme Court: Entity Ownership Change Can Trigger Documentary Transfer Tax

Many entities are formed for the sole purpose of buying and holding real estate. In this setup, legal title is held by the entity itself (not the entity’s owners), but the entity’s owners have a “beneficial interest” that can have tax… more

In Case You Missed It: Launch Links - August, 2017 #2

Some interesting links we found across the web this week: Why Startups Should Look for Opportunity Between the Coasts - Startups might consider an extended pit stop in the “flyover” states, where smaller cities are welcoming… more

I’m Saying, I’m Down with the I’MN Slogan

Love the new Minnesota State Lottery advertising slogan: I’MN. Or, as one of my college age sons often says, when he’s in agreement with someone’s idea or proposal, I’m down… more

Beltway Buzz - August 18, 2017

EEO-1 News . . . Maybe. Rumors are rampant that the White House’s Office of Management and Budget (OMB) may soon take action on the Equal Employment Opportunity Commission’s (EEOC) changes to its EEO-1 form, which will require… more

Future of CFPB’s Arbitration Rule Rests in Hands of Senate

On July 25, 2017, the U.S. House of Representatives voted to block the Consumer Financial Protection Bureau’s (CFPB) Arbitration Rule from becoming effective with a vote of 231 to 190. The vote was mostly down party lines and paves the… more

Regulatory reports, reviews and initiatives

The below provides a very brief and incomplete summary of government and regulatory initiatives with potential impact for the credit industry as at the date of this report… more

Canadian Securities Administrators Provide Guidance on the Review of Material Conflict of Interest Transactions

Transactions between related parties may create material conflicts of interest between an issuer and its directors, officers and related parties. In particular, material conflicts of interest may arise in the context of insider bids… more

Saudi Arabia moves to 100 percent foreign ownership for engineering consultants

The Saudi Arabian General Investment Authority (SAGIA) has recently been authorised to grant engineering consultancy licences, signalling a relaxation of foreign ownership restrictions in the Kingdom of Saudi Arabia (KSA). Effectively… more

Federal Lawmakers Consider IoT Security Standard

A new federal bill would regulate security for Internet of Things (IoT) devices by requiring government vendors to conform to standards and make sure that products can have security problems patched… more

FATCA, FCPA, AML and OFAC allow the US to regulate the world. But what does it really mean?

In the current environment of increased regulation, transparency, reporting and heightened compliance standards, the US and its Government Agencies have an arsenal of tools with extraterritorial application… more

Court Declines To Determine Whether Reinsurance Syndicate For Which A Company Fronted Should Be Involved In An Arbitration

The parties in this case presented to a court the issue of whether a reinsurance syndicate for which Federal Insurance acted as “a front” was a real party in interest and should be involved in an arbitration between Federal Insurance… more

Digital Health Companies May Find a Faster Path to Market Under the FDA's Digital Health Plan

It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the Center… more

SEC Staff Updates Revenue Recognition Guidance for New Standard

The SEC’s Office of the Chief Accountant and Division of Corporation Finance released Staff Accounting Bulletin (SAB) No. 116 that brings existing SEC staff guidance into conformity with the Financial Accounting Standard Board’s… more

A road map to successful life sciences transactions in France

U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions Team provide… more

Student Expulsion Upheld For Off-Campus, Online Activity

On July 26, 2017, the 5th Appellate District Court of Appeals (Richland County) issued a decision in N.Z. vs Madison Local Board of Education that should be read by every school administrator involved in student discipline. In… more

Key Regulatory Topics: Weekly Update - 11 August 2017 – 17 August 2017

BREXIT - ECB interview on Brexit preparations - On 16 August, the ECB published the transcript of an interview, given by Sabine Lautenschlager, ECB Executive Board Member and Supervisory Board Vice-Chair, on the preparatory work… more

Physicians Maintain High Standards

By the time this article goes to print, a lot could change, so there’s no apparent use in guessing what will come of the next Repeal and Replace efforts or what’s happening at Main Justice. Nobody knows. The only certainties from… more

No Good Deed Goes Unpunished

On August 7 Mission Hospital, in Asheville NC, learned the truth of Oscar Wilde’s observation that no good deed goes unpunished. That’s the day a federal court denied the hospital’s motion for summary judgment in a case brought against… more

Your Daily Dose of Financial News

A nearly $5 billion deal between French energy company Total and the oil and gas arm of Danish shipping giant Maersk is making waves this morning. Total will also assume a few tankers-full of Maersk Oil’s debt… more

Uber Settles FTC Dispute Over Consumer Data Privacy and Security Allegations

There are several key takeaways from a 20-year proposed consent order agreed to by Uber Technologies, Inc. (Uber) and the Federal Trade Commission (FTC)..… more

Soft Skills in Remediation: Part I – The Gatekeepers

Many Chief Compliance Officers (CCOs) came to the position from the legal department, internal audit or another professional discipline. These professions are technically focused and their training provides little to no soft skills… more

The European Commission opens a public consultation concerning EU legislation on Blood and, Tissues and Cells

The European Commission has opened an online stakeholders’ consultation for the evaluation of the European (“EU”) legislation regarding blood and, tissues and cells. The online consultation has the form of a questionnaire, and it will… more

Financing arbitration: Someone wants to pay your legal bills (??????:????????????)

Arbitration is quicker and more cost-effective than court. And no one likes paying legal bills. Life can be strange, however, and, in the arbitration context, perhaps neither of these “truisms” stands up any longer. It is now… more

[Video]FCPA Compliance Report-Episode 346, Mike Skopets on Miller’s Summer 2017 FCPA Report

In this episode, I visit with Mike Skopets, from Miller & Chevalier on the firm’s Summer 2017 FCPA Report. We discuss the background to the Report and begin with what macro trends the firm identified. We discuss the numbers of… more

Athena Diagnostics, Inc. v. Mayo (D. Mass., August 4, 2017) – “That’s all,” She Wrote.

Please read my recent post about stage 1 of this proceeding, in which the Judge in 2016 found that the claims to diagnosing Myasthemia Gravis (MG) by adding MuSk to a patient sample and detecting any IgG autoantibody complexes that are… more

Subcontractor Size Status Representations – Not Identical to Rules Governing Prime Contractors

If you are a prime contractor with a small business subcontracting plan, you may wonder “when” a small business subcontractor should render its size representation, and what are the subcontractor’s obligations to rerepresent its size… more

5 Key Takeaways: Protecting Your IP When Government Contracts Are Involved

Larry Prosen and Gunjan Talati, partners in Kilpatrick Townsend’s Government Contracts and Construction & Infrastructure Group, recently presented on an issue of growing importance -- “Protecting Your IP When Government Contracts Are… more

Second Circuit Issues Important Decision Strengthening the Enforceability of Digital Arbitration Agreements

Action Item: Businesses utilizing web or smart phone app-based contractual terms containing arbitration clauses made available by hyperlink should ensure that the link to the clause is reasonably conspicuous, and that the user is… more

Amazon 1-Click Patent About to Expire

Twenty years ago this September, Amazon filed for a patent on its new “1-click” on-line ordering idea. For those of you that were not around when it issued, or the several years following, there was quite a lot of complaining about… more

Chief Judge Stark Grants Defendants’ Motion For Invalidity Of ‘405 Patent For Nonenablement

By Memorandum Opinion entered by The Honorable Leonard P. Stark in Enzo Life Sciences, Inc. v. Abbott Laboratories et al., Civil Action No. 12-274-LPS (D.Del. August 18, 2017 (public version), the Court granted Defendants Abbott… more

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