The National Law Forum

Senate Democrats Continue To Push For A Budget Deal; House And Senate Continue Appropriations Markups

Senate Democrats Continue to Push for a Budget Deal

In the coming weeks, Senate Democrats will implement a strategy intended to force Republicans into a budget deal. Senate Democratic leadership does not want to rely on President Obama’s vetoes of appropriations bills to force Republicans into negotiations, and will likely prevent any appropriations bills that retain the sequester’s spending limits from reaching the Senate floor. Senate Appropriations Committee Ranking Member Barbara Mikulski (D-MD) said Democrats intend to be at the table during any budget deal negotiations between President Obama and Senate and House Republicans, noting Senate Democrats “are doing everything to force this issue.” Additionally, Senate Democratic Whip Dick Durbin (D-IL) said the plan is to force Republicans to make a deal now, rather than wait until the end of the fiscal year after the President vetoes appropriations measures. He noted that “as long as the Republicans need 60 votes in the Senate and don’t have them, they’ll need Democratic cooperation.”

While the House has been moving appropriations measures at a quick pace, and the Senate has been making progress on their Appropriations Committee markups, the appropriations process could slow down in the coming weeks as Senate Republicans try to bring the Defense Appropriations Bill to the floor (as of the time of writing this report, Senate Majority Leader Mitch McConnell (R-KY) had not yet scheduled floor time for the Defense Appropriations Bill). Democrats are expected to block the measure, as it increases defense spending without increasing non-defense discretionary spending. If Democrats are successful, it could effectively stop further Senate appropriations efforts on the floor, though the Senate Appropriations Committee will likely continue to pass appropriations bills out of committee, laying the groundwork for an omnibus bill later in the year.

This Week’s Hearings:

Wednesday, June 17: The Senate Budget Committee will hold a hearing titled “CBO’s Long Term Fiscal Outlook for the Nation.”
Wednesday, June 17: The House Budget Committee will hold a hearing titled “Why Congress Must Balance the Budget.”

FY 2016 Appropriations Committee/Subcommittee Markup Hearings

Tuesday, June 16: The Senate Appropriations Homeland Security Subcommittee will hold a markup of the FY 2016 Homeland Security Appropriations Bill.
Tuesday, June 16: The Senate Appropriations Interior, Environment, and Related Agencies Subcommittee will hold a markup of the FY 2016 Interior and Environment Appropriations Bill.
Tuesday, June 16: The House Appropriations Committee will hold a markup of the FY 2016 Interior and Environment Appropriations Bill.
Wednesday, June 17: The House Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee will hold a markup of the FY 2016 Labor, Health and Human Services, and Education Appropriations Bill.
Wednesday, June 17: The House Appropriations Committee will hold a markup of the FY 2016 Financial Services and General Government Appropriations Bill.

ARTICLE BY Timothy W. Drake & Pamela K. Welsh of Squire Patton Boggs (US) LLP

On National Bourbon Day, Maker’s Mark Toasts to Consumer Protection Reform

June 14th is National Bourbon Day, so it’s a nice time to highlight the resolve of the recent class action lawsuit filed against Maker’s Mark, one of America’s favorite whiskeys, by two consumers who said the company falsely advertised its product as “handmade.”

The suit seized on the word “handmade” used in Maker’s Mark advertising, claiming consumers had been misled. U.S. District Judge Robert Hinkle ruled on behalf of Maker’s Mark, stating that “no reasonable person would understand ‘handmade’ in this context to mean literally made by hand.”

This case is representative of an increasingly common national trend. Similar suits have recently been filed against Tito’s Handmade Vodka and Jim Beam Bourbon.

Consumer advocates say that these class action lawsuits are the most effective way to hold companies accountable for what they allege to be misleading marketing. But real-life consumers, those the litigation is supposed to protect, are often harmed as defendants’ legal costs and sometimes multimillion-dollar verdicts or settlements are passed on in the form of higher prices and fewer choices.

So all across the country, state policymakers are rethinking and reforming their respective consumer protection acts (CPAs) to their original mission of preventing and punishing truly deceptive business practices.

Most state CPAs were modeled on the Federal Trade Commission Act when they were first enacted in the 1960s and 1970s. But since then, many of these laws have come to include expansive amendments and judicial interpretations that now allow lawsuits like the one aimed at Maker’s Mark.

Emory University law professor Joanna Shepherd’s white paper, Consumer Protection Acts or Consumer Litigation Acts?, was published last year and demonstrates this devolution. It begins with the origins of the federal law a century ago when “Congress first sought to define and deter” a “new class of consumer harms” that arose as “the merchant-consumer relationship” evolved rapidly, along with new products and services, retail models, and credit-based payment systems. “Unfair and deceptive acts or practices in or affecting commerce” were prohibited by the broadly worded new law.

But to prevent litigious mischief, Congress purposely limited enforcement of the law to its newly created FTC, prohibiting private lawsuits out of fear that “a certain class of lawyers” would otherwise “arise to ply the vocation of hunting up and working of such suits,” the number of which “no man can estimate,” warned Sen. William J. Stone (D-MO) prior to the act’s 1914 passage.

Fifty years later, the states were no longer willing to leave consumer protection entirely to the federal government. Eventually all 50 states and the District of Columbia adopted their own consumer protection statutes and authorized state attorneys general to enforce them.

By the 1980s, however, many state CPAs were being expanded well beyond their original scope. No longer were these laws enforced primarily by state attorneys general seeking injunctive relief in the public interest. Now they permitted and even promoted private lawsuits seeking significant awards for sometimes theoretical damages and inflated attorney’s fees. Incredibly, some plaintiffs no longer have to prove injuries, demonstrate that they relied on allegedly deceptive representations, or even behaved reasonably in order to prevail in lawsuits.

But here’s to judges like Judge Hinkle who require plaintiffs to explain precisely how they were misled by innocuous advertising terms like “handmade.” And here’s to those state lawmakers working to refocus their consumer protection laws in the interest of consumers who were truly misled into making a purchase and suffered an actual injury as a result.

Happy National Bourbon Day, everyone.

ARTICLE BY Sherman Joyce of American Tort Reform Association

Ariosa Diagnostics, Inc. v. Sequenom, Inc. – Another Diagnostic Patent Meets its End

On Friday, June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015) finding that the claims of U.S. Patent No. 6,258,540 (the ‘540 patent) did not meet the patent-eligibility requirements of 35 U.S.C. §101.

The ‘540 patent

The ‘540 patent claims certain methods of using cell-free fetal DNA (cffDNA). In 1996, the inventors, Doctors Dennis Lo and James Wainscoat, discovered cffDNA in material plasma and serum. Traditionally, this portion of maternal blood samples was discarded by researchers as medical waste. As a result, the inventors developed a method for detecting a small fraction of paternally inherited cffDNA in maternal plasma or serum to determine certain fetal characteristics, such as gender. The method was commercialized by Sequenom as the MaterniT21 test. An advantage provided by the test is that it created an alternative for prenatal diagnosis of fetal DNA that avoided the risks of widely-used techniques that took samples from the fetus or placenta.

In addition to claiming methods of using cffDNA, the ‘540 patent also provides for making a diagnosis of certain fetal characteristics based on the detection of paternally inherited cffDNA. According to the specification, a pregnant woman carrying a fetus with certain genetic defects has more cffDNA in her blood than a woman with a normal fetus.

Claims 1, 24 and 25 of the ‘540 patent recite:

1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises:

amplifying a paternally inherited nucleic acid from the serum or plasma sample, and

detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

24. A method for detecting a paternally inherited nucleic acid on a maternal blood sample, which method comprises:

removing all or substantially all nucleated and a nucleated cell populationS from the blood sample,

amplifying a paternally inherited nucleic acid from the remaining fluid and subjecting the amplified nucleic acid to a test for the paternally inherited fetal nucleic acid.

25. A method for performing a prenatal diagnosis on a maternal blood sample, which method comprises:

obtaining a non-cellular fraction of the blood sample,

amplifying a paternally inherited nucleic acid from the non-cellular fraction,

and performing nucleic acid analysis on the amplified nucleic acid to detect paternally inherited fetal nucleic acid.

The remaining claims describe how the method of detection occurs or how it can be used. For example, claim 2, which depends from claim 1, recites amplification by polymerase chain reaction (PCR). Claim 4, which also depends from claim 1, recites detection by a sequence specific probe.

District Court Proceedings

Ariosa Diagnostics, Inc. (Ariosa) and Natera, Inc. (Natera) make and sell alternative non-invasive tests that compete with Sequenom’s MaterniT21 test. Specifically, Ariosa sells the Harmony Test, a non-invasive test used for prenatal diagnosis of certain fetal characteristics, and Natera sells the Non-Invasive Paternity Test, which is used to confirm the paternity or non-paternity of a gestating fetus from genetic information in fetal DNA available in the blood of a pregnant female.

In response to letters threatening claims of infringement, from December 2011 through early 2012, Ariosa and Natera each filed separate declaratory judgment actions against Sequenom alleging non-infringement of the ‘540 patent. Sequenom counterclaimed alleging infringement. Sequenom filed a motion seeking an preliminary injunction to enjoin Ariosa from selling the Harmony Prenatal test. In July 2012, the district court denied the motion finding that there was a substantial question over whether the subject matter of the asserted claims was directed to eligible subject matter. Sequenom appealed to the Federal Circuit.

In August 2013, the Federal Circuit vacated and remanded the case, holding that the district court erred in certain respects not relevant to this appeal. Additionally, the Court did not offer any opinion regarding the subject matter eligibility of the asserted claims.

After remand, the parties filed cross motions for summary judgment regarding invalidity under 35 U.S.C. §101. The district court found that the ‘540 patent was directed to the natural phenomenon of paternally inherited cffDNA and that the claims did not add enough to the natural phenomenon to make the claims patent eligible under §101. According to the district court, at the time of the filing of the ‘540 patent in 1997, the steps of amplifying and detecting were well-understood, routine, or conventional. Thus, the district court concluded that the ‘540 patent was not directed to patentable subject matter finding that the only “inventive concept of the processes of the ‘540 patent is to apply those well-understood, routine processes to paternally inherited cffDNA, a natural phenomenon”. Additionally, the district court also found that the claimed processes posed a risk of preempting a natural phenomenon. Sequenom appealed.

Federal Circuit Decision

The Federal Circuit began its decision by setting forth the two-prong patent-eligibility test (citing Mayo Collaborative Services v. Prometheus Laboratories, Inc. (March 2012)). The first prong is to determine whether the claims at issue are directed to a patent-ineligible concept. If answered in the affirmative, the second prong is to determine whether the elements of each claim, both individually and as an ordered combination, recite additional elements that transform the nature of the claim into a patent-eligible invention that amounts to significantly more than the ineligible concept itself.

Regarding the first prong, the Federal Circuit noted that the claims of the ‘540 patent were method claims, which generally constitute eligible subject matter. However, upon further inspection, the Court further noted that the claims were directed to a multistep method that began with cffDNA taken from a maternal plasma or serum sample. cffDNA was naturally occurring and circulated freely in the blood stream of a pregnant woman. As a result, the existence of cffDNA in maternal blood was a natural phenomena. The Court further noted that the method ended with paternally inherited cffDNA, which was also a natural phenomena. Therefore, because the method began and ended with a natural phenomenon, the Federal Circuit held that the claims were directed to naturally occurring matter. The Court stated that the specification supported its conclusion. For example, column 1, lines 50-51 states: “[i]t has now been discovered that foetal DNA is detectable in maternal serum or plasma samples”, column 13, line 11-13 states: “[t]hese observations indicate that maternal plasma/serum DNA may be a useful source of material for the non-invasive prenatal diagnosis of certain genetic disorders,” and column 16, lines 12-14 states: “[t]he most important observation in this study is the very high concentration of foetal DNA in maternal plasma and serum”.

Regarding the second prong, the Federal Circuit concluded that the practice of the method claims did not result in an inventive concept that transformed the natural phenomena of cffDNA into a patentable invention. Specifically, the Court stated that for process claims that encompass natural phenomenon, the process steps must recite additional features that are new and useful. According to the Court:

“The method at issue here amounts to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA. Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA is not new and useful. The only subject matter new and useful as of the date of the application was the discovery of the presence of cffDNA in maternal plasma or serum.”

With respect to the preparation and amplification steps, the Court noted that the specification confirmed that in 1997 that these steps were well-understood, routine, conventional activities performed by doctors. Additionally, Sequenom’s expert testified that PCR and other methodologies for amplifying DNA were well known in 1997. The Court further found that the detecting steps were also similarly well-understood, routine and conventional.

Regarding the dependent claims, the Court found that these claims were broad examples of how to detect cffDNA in maternal plasma. The Court noted that these claims were focused on the use of the natural phenomenon in combination with well-understood, routine and conventional activity.

The Court concluded stating

“Thus in this case, appending routine conventional steps to a natural phenomenon, specified at a high level of generality, is not enough to supply an inventive concept. Where claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible subject matter if the methods themselves are conventional, routine and well understood applications in the art.”

Regarding preemption, Sequenom argued that there were numerous other uses of cffDNA aside from those claimed in the ‘540 patent and as a result, the ‘540 patent did not preempt all uses of cffDNA. The Federal Circuit disagreed. The Court noted that while preemption might signal patent ineligible subject matter, the absence of complete preemption did not demonstrate patent eligibility. Specifically, in this case, the Court noted that Sequenom’s attempts to limit the breadth of the breadth of the claims by showing alternative uses of cffDNA outside the scope of the claims did not change the conclusion that the claims were directed to patent ineligible subject matter.

At the end of the opinion, the Court addressed Sequenom’s arguments that before the ‘540 patent that “no one” was using plasma or serum of pregnant mothers to amplify and detect paternally-inherited cffDNA. Moreover, Sequenom noted that the 1997 Lancet publication of the inventors had been cited over a thousand times and that the claimed method utilized the man-made tools of biotechnology in a new way that revolutionized prenatal care. The Court agreed but noted, citing to Ass’n for Molecular Pathology v. Myriad Genetics, Inc. (June 2013), that just because a discovery is groundbreaking, innovative or brilliant does not by itself satisfy §101. The Court stated:

“While Drs. Lo and Wainscoat’s discovery regarding cffDNA may have been a significant contribution to the medical field, that alone does not make it patentable. We do not disagree that detecting cffDNA in maternal plasma or serum that before was discarded as waste material is a positive and valuable contribution to science. But even such valuable and contributions can fall short of statutory patentable subject matter, as it does here”.

ARTICLE BY Lisa L. Mueller of Michael Best & Friedrich LLP

The July 2015 Visa Bulletin Brings Little Change

The Department of State’s July Visa Bulletin announced only a few modest changes in employment-based visa processing. Most significantly, the EB-3 subcategory for professionals and skilled workers will become unavailable for the Philippines.

Additionally, Indian nationals seeking classification under the EB-2 preference category will see no change from the month of June. Those seeking classification under the EB-3 and other workers categories will see a very small change from January 22, 2004 to February 4, 2004. This means the government is virtually experiencing a “delay” of 11 years. Priority dates for Chinese nationals share lack of progress. Individuals under EB-2, advanced only four months to October 1, 2013, while EB-3 and other workers remained the same.

Those individuals who have been impacted by a visa retrogression of any kind are encouraged to check the DOS Visa Bulletin each month in order to see if visa processing dates have moved under their approval category.

Employment-Based	All Chargeability Areas Except Those Listed	China – Mainland Born	India	Mexico	Philippines
1st	C	C	C	C	C
2nd	C	10/1/2013	10/1/2008	C	C
3rd	4/1/2015	9/1/2011	2/1/2004	4/1/2015	U
Other Workers	4/1/2015	1/1/2006	2/1/2004	4/1/2015	U
4th	C	C	C	C	C
Certain Religious Workers	C	C	C	C	C
5th Targeted Employment Areas/Regional Centers and Pilot Programs	C	9/1/2013	C	C	C

ARTICLE BY Courtney B. Noce of Greenberg Traurig, LLP

New Draft EMA-Guideline On Clinical Development Of Fixed Combination Medicines

The European Medicines Agency (EMA) has recently published for public consultation its draft guideline on clinical development of fixed combination medicinal products (Draft Guideline), which is intended to replace CHMP/EWP/240/95 Rev. 1 (Existing Guideline). The Draft Guideline applies to fixed combination medicinal products containing two or more active substances within a single pharmaceutical form. The active substances may be known active substances or substances that have yet to be authorised in the EU.

An EMA concept paper on the Existing Guideline suggested that it be revised in order to suppress regulatory aspects and restrict it to the scientific requirements for clinical development of fixed combination products. The Draft Guideline therefore contains a number of changes from the Existing Guideline, including:

It no longer describes the applicable legal basis for approving marketing authorisation applications for fixed combination products. The Existing Guideline places a strong link between Article 10b of Directive 2001/83/EC and the development of fixed combination products. However, the Draft Guideline provides that “The legal basis for applications concerning fixed combination medicinal products may vary depending on the particularities of the active substances in combination and the development undertaken. The choice of legal basis lies with the applicant…” The Draft Guideline, as is the case with the Existing Guideline, does not discuss data exclusivity in respect of fixed combination products. The European Commission’s guidance contained in its Notice to Applicants, Volume 2 A continues to apply in this regard. It is worth noting that Teva has recently withdrawn its application and has discontinued proceedings in litigation before the General Court of the European Union (Case T-547/12) concerning regulatory data exclusivity for fixed combination products.

The Draft Guideline no longer addresses requirements for combination packs (i.e., where active substances are included in separate pharmaceutical forms marketed in the same package). The Existing Guideline states that scientific principles applicable to fixed combination products will also be applied in the assessment of combination pack medicinal products. However, the EMA has subsequently recognised that from a regulatory point of view combination packs are not the same as fixed-dose combinations. As such, reference to combination packs has been removed from the Draft Guideline.

The Draft Guideline contains more detail on the scientific aspects relevant for approval of fixed combination products. In summary, it provides that the basic requirements for a marketing authorisation application for a fixed combination product are: (1) justification of the pharmacological and medical rationale for the combination, (2) establishment of the evidence base for the: (a) relevant contribution of all active components to the desired therapeutic effect; and (b) positive risk-benefit for the combination, and (3) verification that the evidence base presented is relevant to the product applied for.

The deadline for submitting comments on the Draft Guideline is 15 November 2015. Comments should be sent to FDCguideline@ema.europa.eu, and should be submitted using this template.

ARTICLE BY Sarah Cowlishaw of Covington & Burling LLP

Congratulating A Celebrity Could Cost You A Lawsuit re: Right of Publicity and False Endorsement

When a celebrity does a good deed or a sports figure achieves a major accomplishment, companies may feel like sending a public “shout out” to that individual – whether it be through a tweet, a Facebook post, or some other media. However, companies need to be very careful that such a reference to the public figure does not suggest any type of endorsement of or association with its products or services, which could constitute a right of publicity violation. The right of publicity is generally understood to be the right of a person to control the commercial exploitation of his or her identity, and prevent commercial appropriation of his or her identity by others without permission. Generally, a right of publicity violation consists of unauthorized use of a protected aspect of identity (i.e. name, image, likeness) for commercial purposes, such as use on commercial products and in commercial advertising.

Last year we mentioned basketball legend Michael Jordan’s right of publicity lawsuit against Jewel Food Stores. In 2009, Jewel Food Stores ran an advertisement in Sports Illustrated magazine containing congratulatory text about Jordon’s induction in the Basketball Hall of Fame along with a photo of Jordan’s namesake basketball shoes. However, the advertisement also featured Jewel’s trademarks: its red and white logo and the slogan “Good Things Are Just Around the Corner.” The ad copy played on the slogan to refer to Jordan as a “fellow Chicagoan who was ‘just around the corner’ for so many years.”

In response, Jordan filed suit against Jewel for right of publicity violation, false endorsement under the Lanham Act, and unfair competition, seeking $5 million in damages. Jewel argued that the notice was non-commercial speech and should be protected by the First Amendment, and the district court agreed. However, the Court of Appeals held that although the advertisement had a celebratory theme, there was an unmistakable commercial function also. Even though it did not purport to sell any specific product, it served to enhance the store’s brand in the minds of consumers. Specifically, the court noted it was

image advertising, aimed at promoting goodwill for the Jewel-Osco brand by exploiting public affection for Jordan at an auspicious moment in his career.

There has been some activity by the court since our last post and the suit’s remand. In response to Jewel filing third-party claims against Time Inc. (publisher of Sports Illustrated) for contribution and indemnification, the district court ruled that Time could not be held liable, as state law would prevent Jewel from imposing contribution liability on Time. Additionally, the court has denied Jordan’s request for summary judgment on his claim under the Illinois Right of Publicity Act, stating that the appellate court’s conclusions about the function of the ad under the First Amendment did not answer the question as to whether Jordan’s identity was used for a commercial purpose under state law. Finally, just last week the court ruled that Jordan has a statutory right to sue Jewel, in response to Jewel’s assertion that Jordan had transferred his publicity rights to his loan-out company, rendering him the improper plaintiff.

A jury trial for this case is set for December 8.

Companies who may be considering using a celebrity’s name or likeness in any contextwithout permission should think again, especially in light of lawsuits like this one.

ARTICLE BY Beth L. Goldstein of Squire Patton Boggs (US) LLP

New York City Council Passes Ban-the-Box Legislation

Joining many other jurisdictions, the New York City Council has passed the Fair Chance Act, an ordinance restricting when employer inquiries about applicants’ criminal histories may be made during the application process and imposing significant obligations on employers who intend to take action based on such information.

The Council passed the ordinance on June 10, 2015. The ordinance will become effective 120 days after receiving Mayor Bill de Blasio’s signature, which is expected shortly, as the Mayor has expressed support for the legislation.

Like other ban-the-box laws, the ordinance generally prohibits an employer with at least four employees from making an inquiry about an applicant’s pending arrest or criminal conviction record until after a conditional offer of employment has been extended. Limited exceptions are provided.

Under the ordinance’s definition of inquiry, employers are prohibited not only from asking an applicant prohibited questions — verbally or in writing — but also are prohibited from searching publicly available sources to obtain information about an applicant’s criminal history.

Exceptions

The main exception applies when an employer, under applicable federal, state, or local law, is required to conduct criminal background checks for employment purposes or to bar employment in a particular position based on criminal history.

Other exceptions remove prospective police officers, peace officers, and law enforcement agency and other law-enforcement-related employees from coverage. Therefore, these are unlikely to affect positions and employers in the private sector.

Notification Process

Employers who make inquiries into an applicant’s criminal history after a conditional offer of employment has been extended and determine that the information warrants an adverse employment action must follow a rigorous process. Specifically, employers must:

Provide the applicant with a “written copy of the inquiry” which complies with the City’s Commission on Human Right’s required (but not-yet-issued) format;
Perform the analysis required by Article 23(a) of the New York Correction Law, “Licensure and Employment of Persons Previously Convicted of One or More Criminal Offenses”;
Provide the applicant with a copy of its analysis, also in a manner which complies with the Commission’s required format, which includes supporting documents and an explanation of the employer’s decision to take an adverse employment action; and
Allow the applicant at least three business days to respond to the written analysis by holding the position open during this time.

Of course, for employers who conduct background checks through consumer reporting agencies, if such information is obtained from a background check, the above process must be integrated with the Fair Credit Reporting Act (FCRA) pre-adverse action requirements.

Supporters view the ordinance as ending discrimination against applicants with low-level arrests and providing assurance that applicants will be considered solely based on their qualifications. Critics see the ordinance as adding to the already-onerous mandates imposed on employers in New York City by favoring ideology over practicality, sending a bad message to employers doing business — or desiring to do business — in New York City.

The one undeniable fact is that all covered New York City employers must develop measures to ensure compliance with the ordinance.

ARTICLE BY Richard Greenberg, Daniel J. Jacobs, Susan M. Corcoran, Christopher M. Valentino & Ellen Bandel of Jackson Lewis P.C.

China Proposes “RoHS 2” Framework for Comment

On May 15, 2015, China’s Ministry of Industry and Information Technology (“MIIT”) released a latest Draft for Comments (“May 2015 Draft”) of the “Management Methods for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products” (“Methods”) (Draft for Comments in Chinese). The new Methods is designed to replace the existing regime, promulgated in 2006 and commonly referred to as “China RoHS.” The May 2015 Draft is now open for public comments until June 17, 2015. It makes several important proposed changes to the existing China RoHS regulation.

Since 2010, the Chinese government has attempted to push forward an updated RoHS regulation, and MIIT has released several draft revisions, but none have been enacted. The May 2015 Draft generally retains the requirements on both materials restrictions and information disclosure, but makes several important changes:

It aligns its scope with the EU RoHS 2. The new open scope of covered “Electrical and Electronic Products” (“EEP”) is not limited to “electronic information products” but would now extend to all electrical and electronic equipment (“EEE”) that meets voltage specifications. The definition is almost identical to that of EEE in the EU RoHS 2 Directive, except that it excludes “devices involved in electrical power production, transmission and distribution.”;
The May 2015 Draft will remove the current “manufactured for export” scope exclusion;
The renamed “Compliance Management Catalogue” will likely, once issued in the future, include the hazardous-substance content limits (to date not yet imposed under China RoHS 1).
With respect to certification, the May 2015 Draft proposes a new, multi-agency, two-step system to replace the current program. Products on the “Compliance Management Catalogue” will first go through a “conformity assessment” process. After the conformity assessment, that assessment will be subject to a subsequent verification mechanism, which will be developed later by MIIT along with Finance and other ministries.

It remains unclear how the new conformity assessment and the following verification mechanism will operate in practice. The language implies that the MIIT may need to take further actions to specify the details of these programs;

The May 2015 Draft will remove the disclosure requirement for product packaging materials from the existing regulation.

It remains to be seen whether this May 2015 Draft will be finalized as the new China RoHS 2 regulation and whether the above changes will remain in the enacted rules. Parties that are interested in submitting comments on this Draft may do so via either of the two approaches listed here (in Chinese).

Mr. LaMotte graciously acknowledges the assistance of Shengzhi Wang, a summer associate with the Firm, in the preparation of this Alert.

ARTICLE BY K. Russell LaMotte of Beveridge & Diamond PC

Want to Build Business? Here’s How to Be a Better Networker

Few would argue that networking always has been and likely always will be an important aspect of building and maintaining a successful law practice. Networking is how lawyers connect with prospective clients and referral sources, build trust and loyalty, and develop the types of individual relationships that can lead to new business.

It’s also time-consuming and, for most of us, not particularly easy or fun.

So, it is not surprising that more and more busy lawyers have embraced social media and digital marketing to expand their network of contacts. While these tools give us a platform for making connections on a large scale, the relationships we develop this way typically are not as deep as those we nurture through in-person contact.

6 Lawyer Networking FAQS

When coaching attorneys on their business development activities, I frequently am asked for pointers for how to make in-person networking less time-consuming and more effective. Answers to a few key questions can put this into perspective.

1. It seems there are events I could attend nearly every day. How do I know which are the best?

• Revisit your goals. The best events are those that help you reach your marketing and business development goals. If you are looking to raise your profile in a particular industry, attend events where people involved in the industry will be. If you want to cement your relationship with a key client, ask them which events they would recommend you attend to learn more about their business or their industry. If you are a younger attorney who needs to develop a profile and a network, attend as many different types of events as you can.

• Review attendee lists. Some events will make the attendee list available in advance of the meeting. Request a copy, and review it to get an idea of whether there are people attending who would be worth meeting. If the event is predominantly attended by people you already know or those whose positions or employers are not in your business development “sweet spot,” you may want to find another event, unless, of course, you can use the event to hone your networking skills. An event where less is at stake can make you feel more comfortable.

• Remember why you’re there. You network to develop relationships, which takes time and goes beyond one brief conversation. The best professional networking groups operate as business information, idea and support exchanges, providing opportunity for you to really get to know someone. Sometimes, this might be more easily accomplished by attending a meet-up of a group of people with the same hobbies than through a bar association meeting.

2. Most of these events last a couple of hours. How do I make sure I am not wasting my time?

• Set three attainable goals. Do not let yourself become overwhelmed because there are 500 people attending a convention in one of your targeted industries. Go into the event with a few attainable goals, such as meeting specific individuals, meeting five new people, speaking with the host or chairperson about assisting with a future event, introducing a colleague to one of your contacts, or meeting a high-profile speaker.

• Set a realistic time limit. Instead of feeling as though you have to stay for the duration of the event, take some of the pressure off by committing to being engaged for one hour, or some other realistic and comfortable period of time. Not only will this keep you fresh and engaged, you are more likely to attend more events if you set boundaries on the amount of time you commit.

3. I find it difficult to initiate a conversation with a stranger. How do I start?

• Arrive early. If you get there early, the room will walk into you, whereas if you walk in late, people will already be mid-conversation when you arrive.

• Look for an opportunity to engage someone. If the room is crowded and there seem to be many conversations underway, look for people who are standing alone. One-on-one may be more comfortable and can make for effective networking.

• Don’t be afraid to admit that you don’t know anyone there. Approach a group with a smile on your face, and simply ask, “May I join you?” No one ever replies, “No, we don’t want you.”

4. What do I talk about? If I don’t know someone well, it can be a challenge to find something to discuss.

• Your primary job is to listen. The worst thing you can do when networking is turn it into a sales pitch. Networking should be about building a quick rapport – it should be informal, brief, interesting and leave people wanting to know more. People bond over commonalities. Sales pitches have the opposite effect.

• Build a bank of conversation starters. Catching up on current events and being knowledgeable in a variety of general topics will help you make meaningful contributions to conversations.

• Follow the event on social media. Many organizations will set up a Twitter feed with a specific hashtag as a way to share information about the event and engage attendees in discussion before and after.

5. I know I shouldn’t talk to the same few people the entire time. How do I make a graceful exit from a conversation?

• It’s OK, indeed, appropriate to move on. Unless the conversation is very promising, plan to spend no more than four to six minutes with any one individual. After that, you should be prepared to move on. You also don’t want to take up too much of the other person’s time. They are there for the same reasons you are. Remember, you feel more uncomfortable about leaving the interaction than the other person. It’s acceptable to say that you have to make a phone call, get a drink, go to the restroom or say hello to someone you haven’t seen.

• Make an introduction. Offer to introduce someone you’ve met to someone else you met or know in the room. This allows you to gracefully move on while also helping others expand their network.

• Glass half full. Literally. Carry a half glass of beverage and order only half a glass of beverage to more easily facilitate separation.

6. I attended four events this month. Why haven’t I gotten any new work?

• Relationships take time. It takes time for people to have confidence in you and form a relationship with you. You cannot expect someone to send you work just because they met you at an event. Instead, focus on investing in others. Find ways to be helpful, provide information, tell them of an opportunity that might interest them or introduce them to others beneficial to their own network. The rest will come.

• Follow up, and keep at it. If you have followed your networking plan for the event, you are on your way to developing a relationship. That said, you should not consider the event to be “over” until you have followed up. Send an email to those you met, following up on your conversation or providing information you promised to send. If you would like to develop a stronger relationship with a few particular people you met, consider giving them a call rather than sending an email.

The key to successful networking is to remember that you are building real, deep relationships with your contacts. What good is a network full of people who don’t know you very well? The more you foster trust and rapport with those you meet, the more you can begin forging new avenues of business.

ARTICLE BY Joi Scardo of Jaffe

SEVIS and SEVP System Outage – J, F, and M Students Travel Warning: Student and Exchange Visitor Information System

The Student and Exchange Visitor Information System (SEVIS) is used by the Department of State and The Student and Exchange Visitor Program (SEVP) to monitor nonimmigrant exchange visitors and students during their time in the United States. SEVIS is a web-based system used for critical processes such as issuance of documentation necessary to obtain visas, payment of fees required to participate in exchange programs, and evidence of maintenance of status required to re-enter the United States after travel.

A SEVIS system update is scheduled to be released on Friday, June 26, 2015. While the planned update/upgrade will provide improved functionality for users, it will also result in a service outage from 8:00 p.m. EDT Friday, June 26, 2015, to 8:00 pm EDT, Sunday, June 28, 2015. During the outage it will not be possible to access the system to input and/or update records. It will also not be possible for immigration officers to verify active SEVIS records. For this reason, it is recommended that J, F, and M visa holders refrain from non-essential travel requiring their re-entry to the United States during the outage. Visa holders who must travel during the outage should be prepared for long waits at the airport upon re-entry. Finally, it will not be possible to pay SEVIS fees necessary for the J visa program. J visa sponsors are recommending that these fees be paid prior to the outage in order to avoid any delays in proceeding with visa issuance.

ARTICLE BY Courtney B. Noce of Greenberg Traurig, LLP

The National Law Forum

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1. It seems there are events I could attend nearly every day. How do I know which are the best?

2. Most of these events last a couple of hours. How do I make sure I am not wasting my time?

3. I find it difficult to initiate a conversation with a stranger. How do I start?

4. What do I talk about? If I don’t know someone well, it can be a challenge to find something to discuss.

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6. I attended four events this month. Why haven’t I gotten any new work?

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SEVIS and SEVP System Outage – J, F, and M Students Travel Warning: Student and Exchange Visitor Information System

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