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The National Law Forum - Page 439 of 753 - Legal Updates. Legislative Analysis. Litigation News.

Serious Games Require Serious Attention to Marketing Statements

BrainLumos Labs recently paid $2 million to the Federal Trade Commission to settle claims that it deceived consumers about its brain training application’s ability to increase cognitive function. According to the FTC,  the company alleged that its app, called Lumosity, provided many beneficial effects including the ability to improve users’ school and work performance, delay the onset of age-related cognitive disorders and help restore brain function lost as a result of brain trauma and other health conditions.

According to the FTC, the company did not have sufficient scientific data to back up the claims made in its ads. The FTC also claimed that the company did not disclose that it solicited consumer testimonials about the effectiveness of the product via a contest that offered users the chance to win iPads and other prizes.

In a prepared statement, the company stood by the scientific basis for its brain-training methods and asserted that the settlement was a result of its marketing language that has since been discontinued.

The use of games for “good” causes, such as education, health and training is known as “serious games.” The potential for these types of games to help people in a variety of ways is immense. The number of these games is growing rapidly.

Makers of these games must be mindful not to overreach in the claims of what these games can do. The FTC has been active in policing unsupported claims by app makers.

Additionally, the FTC has been enforcing its endorsement guidelines which require disclosure when a company provides some compensation or financial incentive for endorsements or testimonials. Here, the fact that users had a chance to win valuable prizes in exchange for providing testimonials apparently was not disclosed.

Serious games and other apps have tremendous opportunity to provide beneficial results. However, it is important for makers of these games and apps to understand and comply with the various legal issues that are relevant to these offerings. It is advisable to seek legal review of all serious games and apps and their marketing plan before they are released to identify potential legal issues.

Article By James G. Gatto of Sheppard, Mullin, Richter & Hampton LLP
Copyright © 2015, Sheppard Mullin Richter & Hampton LLP.

Happy New Year: Looking Back and Looking Ahead at EEOC’s Strategic Plan

EEOCSealIn December 2012, the EEOC adopted its Strategic Enforcement Plan for Fiscal Years 2013-2016 (the “SEP”), in which it highlighted the agency’s enforcement priorities for the coming three years.  Now two years into the plan, the EEOC continues to refine its strategic enforcement efforts and employers are responding to them.

The EEOC’s SEP identified six priorities:

  1. Eliminating Barriers in Recruitment and Hiring.

  2. Protecting Immigrant, Migrant and Other Vulnerable Workers.

  3. Addressing Emerging and Developing Issues.

  4. Enforcing Equal Pay Laws.

  5. Preserving Access to the Legal System.

  6. Preventing Harassment Through Systemic Enforcement and Targeted Outreach.

In 2015, the EEOC continued its effort to pursue these stated priorities through systemic investigations and litigation arising from those investigations, despite a mixed record of success in the courts.  For example:

  • Background Check Litigation: Despite some notable setbacks, such as the Fourth Circuit’s affirmance of summary judgment against the EEOC and scathing rebuke of its litigation conduct in EEOC v. Freeman, the EEOC has continued to pursue cases involving background checks in furtherance of its stated priority of eliminating barriers in hiring.

  • Pregnancy and Disability Discrimination: Following the United States Supreme Court’s decision in Young v. UPS, the EEOC reissued its pregnancy discrimination guidance, noting that the “Court explained that employer policies that are not intended to discriminate on the basis of pregnancy may still violate the Pregnancy Discrimination Act if the policy imposes significant burdens on pregnant employees without a sufficiently strong justification.”  The EEOC also noted that the ADAAA does not require an impairment to “last a particular length of time to be considered substantially limiting,” thereby potentially including pregnancy.  The EEOC filed numerous ADA lawsuits in 2015, particularly focusing on reasonable accommodation issues.

  • Equal Pay: Although the EEOC continues to assert its pronounced attention to alleged violations of the Equal Pay Act, it has not expended litigation resources commensurate with its statements.  The EEOC may well monitor developments in equal pay protection under state law (e.g., California’s Equal Pay Act, effective January 1, 2016) to assess the value of its own litigation efforts.

  • Sexual Orientation or Gender Identity Discrimination: In an effort to address “emerging and developing issues,” the EEOC continues to include sexual orientation or gender identity discrimination in its definition of discrimination based on sex.  In its August 2015 fact sheet, the EEOC identified numerous private sector lawsuits initiated by the EEOC or in which the EEOC filed amicus briefs, addressing LGBT-discrimination-related issues.

The EEOC appears poised in 2016 to continue pursuing the SEP aggressively through the use of systemic investigations.  Employers can expect the EEOC to seek to expand investigations of individual charges, particularly in substantive areas aligning with the SEP.  Although the United States Supreme Court ruled in Mach Mining, LLC v. EEOC (2015) that the EEOC’s pre-suit obligation to attempt to conciliate alleged unlawful workplace practices is subject to judicial review, the EEOC will continue to test the limits of judicial review of EEOC’s investigations and attempts to conciliate.  As the new year begins, employers must remain vigilant when challenging failures by the EEOC to conciliate or properly investigate charges and pay particular attention to charges alleging disability, pregnancy and sexual orientation or gender identity discrimination.

Article By James J. Swartz, Jr. of Polsinelli PC

© Polsinelli PC, Polsinelli LLP in California

Legal Executive Institute 23rd Annual Marketing Partner Forum – January 20-22 Orlando

Join Thomson Reuters’ Legal Executive Institute this month as Marketing Partner Forum heads to Orlando for a three day summit on transformative value in law firm profitability and business development. Set against the Tuscan luxury of the Loews Portofino Bay Hotel, Marketing Partner Forum will welcome law firm marketing partners, rainmakers, practice group heads, business development leaders and esteemed corporate counsel for a dynamic and vibrant conference designed for the industry’s elite.

For more information and to register, call 1-800-308-1700.

Why You Should Attend

  • Hear from venerable thought leaders both within and outside of the legal industry.
  • Network with colleagues and enjoy the family-friendly adventure of Universal Orlando®.
  • Broaden your horizons through a number of interactive seminars that ask participants to collaborate.
  • Participate in a number of compelling sessions designed for law firm partnership.
  • Interact with clients and network for new business.
  • Focus on global business development and the impact of “glocalization” on legal services.
  • Depart the event with practical takeaways to share with peers and firm leadership.

Who Should Attend

  • Law Firm Partners
  • Managing Partners
  • Marketing Partners
  • Practice Group Heads
  • Chief Marketing Officers
  • Senior Business Development Professionals

New Year, New Wages : Minimum Wage Rates Around the States

After ringing in 2016, employers may want to skip the eggnog and check their wages to make sure they are properly paying their employees.  On Jan. 1, the minimum wage rates in 14 states went up and all are higher than the federal minimum wage.  These states and rate increases include:

Alaska

$9.75 per hour

Arkansas

$8.00 per hour

California

$10.00 per hour

Connecticut

$9.60 per hour

Hawaii

$8.50 per hour

Massachusetts

$10.00 per hour

Michigan

$8.50 per hour

Nebraska

$9.00 per hour

New York

$9.00 per hour

Rhode Island

$9.60 per hour

Vermont

$9.60 per hour

West Virginia

$8.75 per hour

The minimum wage rates in both Colorado and South Dakota will increase due to a cost of living adjustment tied to inflation.  For 2016, Colorado’s minimum wage is $8.31 per hour and South Dakota’s minimum wage now is $8.55 per hour.

Other notable minimum wage increases that will occur throughout 2016 include:

District of Columbia

$11.50 per hour, effective July 1, 2016

Maryland

$8.75 per hour, effective July 1, 2016

Minnesota

$9.50 per hour for large employers, effective August 1, 2016

$7.75 per hour for small employers, effective August 1, 2016

Finally, for employers who have federal service contracts, the minimum wage for employees has increased to $10.15 per hour.  These employers should pay close attention to the hourly rates in effect for the applicable contract as some rates will be higher than the minimum wage rate.

Article By Tina A. Syring of Barnes & Thornburg LLP

© 2015 BARNES & THORNBURG LLP

Year End Brings Major Changes to US Visa Waiver Program

Included in the 2016 Consolidated Appropriations Act (HR 2029), signed into law on December 18, 2015, were significant changes to the Visa Waiver Program (VWP). These changes will require “e-passports” of all VWP travelers and additional security standards. This follows “enhancements” to the program announced by the Obama Administration at the end of November.

The VWP permits visa-free travel for 20 million visitors per year to the United States for citizens of 38 program partner countries around the world. VWP visitors are admitted to the US as tourists or business visitors for 90 days. VWP countries include those in Western Europe, Australia, Chile, Japan, New Zealand, Singapore, South Korea and Taiwan. Every prospective VWP traveler undergoes counterterrorism screening and must receive approval through DHS’ Electronic System for Travel Authorization (ESTA).

The Consolidated Appropriations Act imposes new restrictions to VWP eligibility for certain individuals who:

  1. Have been present in Iraq, Syria, Iran or Sudan (or other countries designated by the Secretary of Department of Homeland Security (DHS) as supporting terrorism or countries “of concern” as designated by the Secretary) at any time on or after March 1, 2011. The law exempts those performing military service in the Armed Forces of VWP countries or those who carry out official duties in a full-time capacity in the employment of a VWP country government. DHS may also wave exclusion from the VWP program if it would be in the law enforcement or national security interest of the US.

  2. The Act also excludes VWP individuals who are nationals of Iraq, Syria, Iran or Sudan.

  3. All participating VWP countries must issue electronic- and machine-readable passports.

These new restrictions are more expansive than may be apparent and could result in unintended consequences for not only nationals of VWP countries, but US citizens, as well. It is important to note, nationality typically depends on the laws of the designated country. For example, an individual born in Iran but holding German nationality and a German passport may now be excluded from the VWP even if they have not visited Iran for many years and does not possess an Iranian passport.

As the impact of these changes play out over the next several weeks and months, we could see retaliation by VWP countries that restrict visa waiver travel for certain US citizens. Stay tuned and Happy New Year.

ARTICLE BY Gregory A. Wald of Squire Patton Boggs (US) LLP
 © Copyright 2015 Squire Patton Boggs (US) LLP

Happy New Year from the National Law Review

Happy New Year

Your friends at the National Law Review wish their readers a happy, safe, and healthy 2016!

  • Jennifer, Lane, Nicole, Eilene, Colleen and Marlene

Top Patent Law Stories In 2015

There was a lot of IP action in 2015 – much involving the Fed. Cir. and Supreme Court’s resolution of cases in progress in 2014. In no particular order, I pick:

top patent stories of 20151.  Ariosa v Sequenom. This Fed. Cir. decision that a method for isolating “cffDNA” from maternal blood is no more than a natural phenomenon was a big step backwards for the development of patent law in the area of “precision medicine” and clouds the future patent-eligibility of both natural products and methods of diagnosis and treatment. It is a pick to click with the Supreme Court. (There was also a PTO “July 2015 Update” of the December 2014 s. 101 Guidelines that really did not clarify anything.)

2.  Biosimilars Hit the Shelves. In April, the FDA finalized its biosimilars guidance and Sandoz soon launched the first biosimilar, a generic version of Neuprogen.

3.  Nautilus v Biosig. The Supreme Court redefined the “indefiniteness standard” of s. 112(2) so that a claim term must be reasonably certain to the POSA, not simply amenable to construction. In Dow v. Nova, this new standard compelled invalidation of the claims-in-suit.

4.  The Rise of the PTAB. While it seems clear that the Fed. Cir. does not want to review every decision made by the PTAB in IPR, it released important decisions relating to its authority. In re Cuozzo, the court preserved the application of the PTO’s broadest reasonable claim construction rule in IPRs. In Merck v. Gnossis, the court affirmed that it would review PTAB decisions under the deferential “substantial evidence” standard, and not review PTAB decisions for proper application of the preponderance of the evidence standard.

5.  Obviousness Post-KSR. With the Supreme Court’s rejection of the teaching-suggestion-motivation by the art requirement, the Fed. Cir. has been developing the legal standards around obviousness questions derived from decisions that the Supreme Court left intact. These include a greater reliance on evaluating whether or not the art “teaches away” from the claimed invention, and evidence tending to show that hindsight was employed by the lower court or the Board. Closer evaluations of secondary considerations such as commercial success, failure of others, long-felt need, etc. are appearing in recent decisions. For example, see Judge Newman’s dissent in Merck v. Gnossis, Appeal no. 2014-1779 (Fed. Cir. 2015); see also Shire v. Anneal.

6.  Teva v. Sandoz Reverses Cybor. Fed. Cir. can still review questions of law de novo, but must give deference to the lower court’s findings of fact.

7.  Kimbel v. Marvel. In this “Spiderman” decision, the S. Ct. upheld the viability of Brulotte v. Thys: “No royalties for you” patentee/licensee, after the patents have expired. Impact: not huge, since patentees have been designing work-arounds for years.

8.  The Gradual but Steady Demise of Invalidations Based on Inequitable Conduct. Even though the decisions on appeals post-Therasense affirmed findings of IC about half the time, there were no important decisions involving IC in 2015. Either it is being pled less or being dismissed earlier in the proceedings. The Fed. Cir. earlier had upheld the invalidation of an Apotex patent, and Apotex has petitioned for cert., calling the Therasense decision just one more rigid Fed. Cir. rule, but I don’t think the Supreme Court will bite.

9.  The Gaggle of Decisions on Divided Infringement. This includes Akami v. Limelight (direct infringement can involve multiple actors if one “mastermind” controls their actions), Commil v. Cisco (belief in invalidity does not negate intent to induce infringement), Life Techs. Corp. v. Promega (self-active inducement under 271(f)(1)) and others that never quite captured my interest.

10.  The Trans-Pacific Partnership. According to Republicans, one more thing that President Obama got wrong.

So Happy New Year to All! 2016 Promises to be equally interesting – as in the old Chinese curse – “May You Live in Interesting Times.”

Article By Warren Woessner of Schwegman, Lundberg & Woessner, P.A.
patents4Life blog

© 2015 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.

Year End 2015 Update – gTLD Sunrise Periods Now Open

New generic top-level domains (gTLDs, the group of letters after the “dot” in a domain name) have launched their “Sunrise” registration periods. As of the date of this newsletter, Sunrise periods are open for the following new gTLDs:

.OFFICE

.feedback

.family

.auto

.cars

.car

.lasalle

.cloud

.wine

.vin

.theatre

.SECURITY

.PROTECTION

.xn--tckwe (.コム – Japanese for “com”)

.YACHTS

.BOATS

.HOTELES

ICANN maintains an up-to-date list of all open Sunrise periods here. This list also provides the closing date of the Sunrise period. We will endeavor to provide information regarding new gTLD launches via this monthly newsletter, but please refer to the list on ICANN’s website for the most up-to-date information, as the list of approved/launched domains can change daily.

Because new gTLD options will be coming on the market over the next year, brand owners should review the list of new gTLDs to identify those that are of interest.

Article By Monica Riva Talley, Tracy-Gene G. Durkin & Shana L. Olson of
Sterne, Kessler, Goldstein & Fox P.L.L.C.

© 2015 Sterne Kessler

Extension of 2015 Affordable Care Act Reporting Deadlines

On December 28, 2015, the Internal Revenue Service issued Notice 2016-4 extending the deadline for information reporting requirements under the Patient Protection and Affordable Care Act (the “ACA”). The reporting requirements are intended to assist the IRS in application of ACA penalties and were two-fold: an initial disclosure to the employee and a final report to the IRS. These requirements were to be satisfied by the filing of Form 1095 (with different filings under Form 1095-B or 1095-C dependent on the type of insurance arrangement sponsored by the employer). The deadline for furnishing the form to the employee had been set for February 1, 2016. The deadline for filing Form 1095 with the IRS was to be February 29 for non-electronic filers and March 31 for all employers who are “electronic filers” (filing greater than 250 single 1095 forms).

Notice 2016-4 has now extended those deadlines as follows:

New deadline for furnishing Form 1095 to employees: March 31, 2016.

New deadline for filing Form 1095 with the Service:

Non-electronic filers: May 31, 2016.

Electronic filers: June 30, 2016.

Article By Nicole M. Hanna of Dinsmore & Shohl LLP

© 2015 Dinsmore & Shohl LLP. All rights reserved.

Center for Devices and Radiological Health (CDRH) Schedules January 2016 Cybersecurity Workshop

Center for Devices and Radiological Health, CDRH has scheduled a cybersecurity workshop entitled, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity,” on January 20-21, 2016 (see here for the Federal Register announcement).

Background and Workshop Context

As we discussed in a previous post, cybersecurity vulnerability is an increasing concern as medical devices are becoming more connected to the Internet, hospital networks, and other medical devices. Cybersecurity vulnerabilities may result in device malfunction, interruption of healthcare services including treatment interventions, inappropriate access to patient information, and breached electronic health record data integrity.

In the Federal Register announcement for the workshop, FDA states protecting the Healthcare and Public Health (HPH) critical infrastructure from attack by strengthening cybersecurity is a “high priority” of the Federal Government. For example, two recent Executive Orders (here and here) address enhancing cybersecurity infrastructure and increasing cybersecurity information sharing. Additionally, Presidential Policy Directive 21 states that the Federal Government shall work with the private sector to manage risk and strengthen the security and resilience of critical infrastructure against cyber threats.

Given this context, FDA, other governmental agencies, and public/private partnerships have sought to address cybersecurity vulnerability in recent years. For example, last year, CDRH finalized its guidance for industry entitled, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” Also in 2014, the National Institute of Standards and Technology (NIST) published a voluntary, risk-based framework focusing on enhanced cybersecurity. According to FDA, the HPH sector has utilized the framework to help manage and limit cybersecurity risks.

Workshop Objectives

At the public workshop, CDRH hopes to address vulnerability management throughout the medical device total product lifecycle. According to the Federal Register announcement, vulnerability management includes: analyzing how a vulnerability may affect device functionality, evaluating the vulnerability effect across product types, and selecting temporary solutions that may be employed until a permanent fix can be implemented. Vulnerabilities can be identified by the device manufacturer or external entities, including healthcare facilities, researchers, and other sectors of critical infrastructure.

The Agency believes an important component of vulnerability management is coordinated vulnerability disclosure (also known as responsible disclosure). Under coordinated vulnerability disclosure, all stakeholders agree to delay publicizing vulnerability details for a certain period of time, while the affected manufacturer works to rectify the vulnerability.

Further, CDRH states that one of the tools medical device manufacturers or healthcare facilities may use to evaluate and manage vulnerability is the Common Vulnerability Scoring System (CVSS). CVSS is a risk assessment tool that “provides an open and standardized method for rating information technology vulnerabilities.” CDRH notes, however, that CVSS does not directly incorporate patient risk and public health impact factors.

Workshop Themes

CDRH states that it hopes to address the following general themes during the workshop:

  • Envisioning a roadmap for coordinated vulnerability disclosure and vulnerability management as part of the broader effect to create a trusted environment for information sharing.

  • Sharing FDA’s current thinking on the implementation of the NIST framework in the medical device total product lifecycle.

  • Adapting cybersecurity and/or risk assessment tools such as CVSS for the medical device operational environment.

  • Adapting and/or implementing existing cybersecurity standards for medical devices.

  • Understanding the challenges that manufacturers face as they increase collaboration with external third parties (cybersecurity researchers, Information Sharing and Analysis Organizations (ISAOs), and end users), to resolve cybersecurity vulnerabilities that impact their devices.

  • Gaining situational awareness of the current activities of the HPH sector to enhance medical device cybersecurity.

  • Identifying cybersecurity gaps and challenges that persist in the medical device ecosystem and begin crafting action plans to address them.

Persons interested in attending the workshop must register online by January 13, 2016. Public comments concerning the workshop’s objectives or general themes can be submitted online or by mail.

Article By Christopher Hanson of Covington & Burling LLP

© 2015 Covington & Burling LLP