Abbott’s $1.6 Billion Settlement Stands as Cautionary Tale to Pharma Companies

The National Law Review recently published an article by David Deitch of Ifrah Law regarding Abbott’s Recent Settlement:

A recent settlement by global pharmaceutical giant Abbott Laboratories over its promotion of the drug Depakote shows that federal regulators remain prepared to pursue drug manufacturers for promoting unapproved uses of their products. Abbott has agreed to pay federal and state governments a total of $1.6 billion in criminal and civil fines and to plead guilty to a criminal misdemeanor violation of the Food and Drug Act to resolve allegations against it. This makes the case the second-largest in a series of multi-million dollar settlements of enforcement actions by the U.S. Department of Justice and state regulators against drug makers. Abbott will be subject to monitoring and reporting requirements as a condition of its plea.

When the Food and Drug Administration approves a drug as “safe and effective” for sale to the public, it specifies that the approval is for one or more defined medical purposes. It is a common practice among doctors, however, to prescribe drugs for other uses based on their understanding of other effects of use of the drug, and such “off label” prescriptions are not illegal.It is illegal, however, for drug manufacturers to promote off-label use of their products.

In the Abbott case, federal and state regulators and law enforcement agencies alleged that the company had promoted off-label use of Depakote, which the FDA has approved to treat epileptic seizures, migraines and the manic episodes suffered by people with bipolar disorder. As part of its settlement, Abbott has admitted that, beginning in 1998, it trained a portion of its sales force to promote Depakote to nursing home personnel as a way to control agitation and aggression in elderly patients suffering from dementia. Abbott continued to do so through 2006 even after it was forced to discontinue clinical trial testing in 1999 of the use of Depakote to treat patients with dementia because the drug caused increased drowsiness, dehydration and anorexia in the elderly test subjects.

The use of Depakote by nursing homes for the off-label use promoted by Abbott was attractive because, as Abbott’s sales force highlighted, Depakote was not covered by the Omnibus Budget Reconciliation Act of 1987 (OBRA) and its implementing regulations designed to prevent the use of unnecessary medications in nursing homes. Thus, use of the drug for this purpose could help nursing homes avoid the administrative costs and other burdens of complying with that law.

In some ways, the Abbott settlement is simply another reminder that pharmaceutical manufacturers that “misbrand” drugs by promoting off-label use will face scrutiny and enforcement from federal and state governments. On the other hand, the Abbott case is particularly egregious given the allegations that, after tests showed poor effectiveness and possible problems with the off-label use of Depakote, Abbott failed to disclose to its sales force the results of those studies. In highly regulated industries such as pharmaceutical manufacturing, the case is a reminder that companies that fail to adhere closely to legal and regulatory requirements do so at great risk.

ICC Institute Masterclass for Arbitrators

The National Law Review is pleased to bring you information about the upcoming ICC Conference Masterclass Arbitrators:

Join us for an intensive 2 1/2 day training for professionals interested in working as international arbitrators!

June 4-6, 2012 at ICC Headquarters in Paris.

Entrepreneur’s Guide to Intellectual Property – Blog Series: Trademark

An article by Laura M. Konkel of Michael Best & Friedrich LLP recently had an article regarding Trademarks published in The National Law Review:

What is a Trademark?

A trademark is any word, slogan, logo or other device that helps consumers identify and distinguish the source of a product or service. Even smells, sounds, colors, product shapes and packaging designs can be trademarks – e.g. the color brown applied to vehicles used for delivery services (owned by UPS), the musical notes G, E and C played on chimes when used in connection with television broadcast services (owned by NBC Universal) and the well-known shape of the curved COCA-COLA bottle. When consumers see or hear these unique trademarks, they know what company is offering the product or service without the need for words.

As a source indicator, a trademark helps consumers decide whether they want to buy or avoid a product or service based on their prior experiences with something else bearing that trademark. For example, a consumer who had a positive experience with a FORD vehicle may decide to buy another FORD vehicle in the future. Thus, a trademark that builds a positive reputation in the marketplace is an invaluable business asset.

Selecting Strong Trademarks

When developing a new brand name it’s tempting to pick a term that describes the product or service. For instance, if you are launching a new detergent, the name ULTRA CLEAN may be appealing because you want consumers to immediately understand that it is a superior cleaning product. However, as a general rule, terms that describe a characteristic of the product or service, or attribute quality or excellence to it (e.g. ULTRA), are very weak source identifiers that do little to set your product apart from those of your competitors. Descriptive and laudatory terms are also subject to little, if any, trademark protection, meaning it will be difficult to prevent competitors from using an identical or nearly identical product or service name.

More distinctive brand names generate more consumer recognition and are entitled to more protection. The strongest trademarks are fanciful or coined terms, which have no dictionary definition (e.g. KODAK film or EXXON petroleum). Arbitrary trademarks, which are comprised of terms with common meanings but not in relation to the product or service for which they are used (e.g. APPLE computers) are also very strong. Suggestive terms, which hint at a characteristic of the product or service without immediately describing it (e.g. COPPERTONE sunscreen), are also capable of trademark protection.

Clearing Trademarks for Use

Before adopting and investing money into a new trademark, you should first determine whether someone else is already using the same trademark, or a very similar trademark, in connection with a related product or service. If you use a trademark similar to one already used by a competitor, it may erode the source-indicating function of your competitor’s trademark and cause consumer confusion, subjecting you to a trademark infringement claim. If you infringe another’s trademark rights, you will have to rebrand your product or service and you may also be liable for monetary damages.

For this reason you should have a qualified attorney conduct a clearance search before adopting a new trademark. A clearance search typically involves a review of federal and state trademark databases, as well as other sources of information such as company name databases and the Internet. After completing a survey of current trademarks in the marketplace, your attorney will provide an opinion as to whether your new trademark poses an infringement risk. It is recommended that you conduct a clearance search in each country in which you intend to use your trademark.

Trademark Protection: Should I Register My Trademark?

In the U.S., rights in a trademark belong to the first person or business to use it. You need not have a federal registration to own trademark rights; however, without a registration, your rights will typically be limited to the geographic area in which your products or services are offered. For example, if you operate ABC BAKERY in Portland, Maine and sell your baked goods only in that area, and you do not own a federal registration for your ABC BAKERY trademark, then you may not be able to prevent someone else from operating an ABC BAKERY in San Diego, California. If you are granted a federal registration for ABC BAKERY, it will constitute a legal presumption of your ownership of that trademark and your exclusive right to use it nationwide as of the filing date of your federal trademark application. Other benefits of federal registration include public notice of your claim of trademark ownership, the ability to record your trademark with U.S. Customs and Boarder Protection Service to prevent importation of infringing or counterfeit products and the right to use the ® registration symbol.

There are many countries that, unlike the U.S., do not recognize unregistered trademark rights. In those countries, the first person or business to register a trademark acquires exclusive rights in it and can prevent others from using the same or similar trademark, even if that other party has already used the same mark in that country for many years. For this reason it is important to consult with a trademark attorney to determine where trademark applications should be filed in order to protect your valuable trademark rights.

Proper Trademark Use

Trademarks are adjectives. A trademark should never be used as a noun or a verb. It should always be used as an adjective that describes the common, generic name for the product or service.

Correct:

We use XEROX copy machines in our office.

I own ROLLERBLADE in-line skates.

My kids love OREO cookies.

Incorrect:

I made a XEROX.

Please XEROX these documents.

I’m going ROLLERBLADING.

My kids love OREOS.

If a trademark is used improperly as a noun or a verb it may become the generic description for, or synonymous with, a general class of products or services and lose its source-indicating function. Then, everybody will be free to use it. Examples of well-known terms that were once trademarks include “aspirin” and “escalator.” These terms lost their trademark significance through improper use.

Be consistent. Always use a trademark in the same manner, and if you registered it, use it exactly as shown in the registration certificate. Do not change punctuation or make a two-word mark into one word (e.g. X-Y-Z WisconsinDGET vs. XYZWisconsinDGET).

Use the appropriate trademark symbol. The TM symbol can be used to identify any trademark, registered or unregistered. It has no legal significance but indicates to others that you claim rights in the marked term. In contrast, the ® symbol can be used only to identify a federally registered trademark.

It is not necessary to mark every occurrence of a trademark with theTM or ® symbol, but it certainly doesn’t hurt. At a minimum, the first and/or most prominent use of a trademark on a product, on a package or in an advertising piece should be marked appropriately.

Distinguish trademarks from surrounding text. In addition to using theTM or ® symbol, you can also emphasize trademarks by printing them in all capital letters or in a bold, italic or other unique font. This helps make it clear to others that you are claiming trademark rights in a particular term.

Maintaining Trademark Rights

You must use a trademark to maintain rights in it. If you stop using a trademark for a period of time with no intention to use it again in the future, then you will abandon your rights in the trademark and it will become available for others to use.

Misuse of your trademark by others can also result in a loss of rights. If you don’t enforce your rights against infringers, your trademark will lose its source-indicating function, just as “aspirin” and “escalator” lost their trademark status (discussed above). If you discover that someone is infringing your trademark it is important to take action, or risk losing your rights.

Rainmaker Retreat: Law Firm Marketing Boot Camp

The National Law Review is pleased to bring you information about the upcoming Law Firm Marketing Boot Camp:

WHY SHOULD YOU ATTEND?

Have you ever gone to a seminar that left you feeling motivated, but you walked out with little more than a good feeling? Or taken a workshop that was great on style, but short on substance?

Ever been to an event that was nothing more than a “pitch fest” that left a bad taste in your mouth? We know exactly how you feel. We have all been to those kinds of events and we hate all those things too. Let me tell you right up front this is not a “pitch fest” where speaker after speaker gets up only trying to sell you something.

We have designed this 2 day intensive workshop to be content rich, loaded with practical content.

We are so confident you will love the Rainmaker Retreat that we offer a 100% unconditional money-back guarantee! At the end of the first day of the Rainmaker Retreat if you don’t believe you have already received your money’s worth, simply tell one of the staff, return your 70-page workbook and the CD set you received and we will issue you a 100% refund.

We understand making the decision to attend an intensive 2-day workshop is a tough decision. Not only do you have to take a day off work (all Rainmaker Retreats are offered only on a Friday-Saturday), but in many cases you have to travel to the event. As a business owner you want to be sure this is a worthwhile investment of your time and money.

WHO SHOULD ATTEND?

Partners at Small Law Firms (less than 25 attorneys) Solo Practitioners and Of Counsel attorneys who are committed to growing their firm. Benefits you will receive:

You will discover over 65 different marketing techniques that are proven to work in the real world environment of a fast moving law firm. Only practical techniques will be discussed here. We leave the theory for the classroom.
You will know the 5 critical numbers you need to be tracking in your law firm and how to measure your Return On Investment (ROI) for all your marketing efforts.
You will understand the core concepts of search engine optimization (SEO) and internet marketing for attorneys and how to create a dominant position on the internet.
You will study specific tools to automate your marketing system and “fix your follow up” to increase your conversion rates from prospects to paying clients.
You will be introduced to several advanced internet marketing strategies for lawyers.
You will leave with a Rainmaker Social Media Blueprint to help you fully leverage Facebook, LinkedIn, Twitter, YouTube, Avvo and JDSupra to drive new leads to your law firm.
You will learn from dozens of real world case studies of how attorneys have gone from a good 6 figure practice to a great “7 figure lifestyle law firm.”
You will learn how to focus your money on the most effective marketing strategies based on your specific practice area.
You will learn how to better select, train and motivate your partners and staff to do Rainmaking activities
You will learn where you can ‘cut the fat’ and reduce your costs by eliminating ineffective marketing strategies
You will create a written Marketing Action Plan (MAP) that will guide your law firm’s efforts and provide specific goals for your team to achieve in the next 6 months
You will have a realistic idea of how much money it will take to effectively market your law firm
You will start building a network of other attorneys across the country who are dedicated to building a 7 figure lifestyle law firm
You will understand how to utilize the 7 Rainmaker tools for generating more referrals and repeat business from current and former clients.

Solo practitioners who need to find more clients fast on a shoe-string budget. In addition to all the above benefits, solo attorneys will receive these massive benefits:

You will discover over 30 low cost (starting at $20/mo)and no cost marketing strategies to help you stretch your budget
You will learn software tools that will help you automate your marketing system
You will learn an easy to use system for tracking all your incoming leads
You will be introduced to specific tools to help you and your staff convert more prospects into paying clients.
You will create a written Marketing Action Plan (MAP) that will guide your law firm’s efforts and provide specific goals for your team to achieve in the next 6 months
You will see how other solo attorneys have leveraged internet marketing and social media networks to beat much bigger firms
You will hear about best practices in legal marketing and gain new insight into what has and has not worked for other solo attorneys all across the country
You will be introduced to several advanced internet marketing strategies for lawyers.
You will understand how to utilize the 7 Rainmaker tools for generating more referrals and repeat business from current and former clients.
You will learn what the most profitable practice areas are in this economy.
You will leave with a Rainmaker Social Media Blueprint to help you fully leverage Facebook, LinkedIn, Twitter, YouTube, Avvo and JDSupra to drive new leads to your law firm.

Law Firm Business Managers and Internal Legal Marketing Staff who are either responsible for marketing the law firm or manage the team who handles the law firm’s marketing. In addition to all the above benefits, Law Firm Business Managers and Internal Legal Marketing Staff will also receive these benefits:

You will understand what it takes to start marketing a practice from scratch.
You will walk out with a specific, step-by-step, written Marketing Action Plan (MAP) that your internal marketing team can implement in the next 30 days.
You will learn how to quickly evaluate potential legal marketing strategies to determine if they are a “good fit” for your attorney’s practice areas.
You will know how to integrate your offline legal marketing strategies, like referral development and cross selling the firm’s other services,with your online and internet marketing strategies.
You will have a simple guide for when it’s more beneficial and cost effective to outsource specific attorney marketing projects versus keeping it in house.
You will know the questions to ask when evaluating internet marketing and legal website development companies so you can make wise decisions.
You will grasp fundamental search engine optimization (SEO) techniques and understand how to evaluate potential providers of SEO services.
You will understand the “metrics of legal marketing”—how to track and measure the results and ROI of your law firm’s marketing campaigns using low cost tools.
You will discover a proven system for fixing the follow up of your attorneys and how to start tracking every lead, every prospect, and every referral source and automatically follow up with them frequently and consistently.
You will discover over a dozen low cost legal marketing strategies you can launch in 30 days or less.
You will have a paint-by-the-numbers approach to developing more referral sources for your law firm.
You will understand the basics of how to put together a reasonable law firm marketing budget.
You will know how to work better with the Managing Partner and law firm Partners to provide them with the data, the metrics and results they are looking for.

Of Counsel Attorneys who are paid on an “eat what you kill” basis. In addition to all the above benefits, Of Counsel attorneys will also receive these benefits:

You will learn how other Of Counsel Attorneys build their book of business.
You will understand how to walk the line between promoting your firm and promoting yourself.
You will learn low cost strategies to develop a stronger referral base.
You will realize how to apply a step-by-step approach to increasing your credibility in the marketplace.
You will recognize how to find more clients even without the support of your firm.
You will apply several specific strategies designed to improve your visibility.
You will leave with a game plan for finding more clients and building a sustainable book of business.

Associates who are either looking to grow their book of new clients in the next 6-12 months or want to launch their own private practice. In addition to all the above benefits, Associates will also receive these benefits:

You will understand what it takes to start marketing a practice from scratch.
You will learn the importance of building your own book of business now instead of just relying on senior attorneys to build it for you.
You will learn low cost techniques to find more clients with your limited time.
You will obtain a practical understanding of what it really takes to become a “Rainmaker.”

WHAT MAKES THIS SO DIFFERENT FROM EVERY OTHER LEGAL MARKETING SEMINAR?

1. Specifically Designed for Owners and Managing Partners at Small Law Firms and Solo Practitioners.While Associates, Of Counsel, and Partners at large firms (50+ attorneys) are welcome to attend and will receive benefit from attending, the Rainmaker Retreat is specifically designed to meet the needs, challenges, and financial budgets of solo practitioners and small law firms.

You won’t find any strategies that cost tens of thousands of dollars in this seminar. In fact, many of our strategies have little to no cost and with many of them we will tell you how to trade more of your time instead of spending your money if you’re marketing your practice on a shoe-string budget. Nor will you hear about generic marketing ideas that only work if you have a large staff or a separate marketing department.

2. This is an Advanced Legal Marketing Workshop. We work very hard to make the material easy to understand and simple to apply, but please understand this is an advanced, in-depth, hard-hitting law firm marketing course!

If you are just starting out or have never done legal marketing or business development before you will likely find the volume and depth of our strategies to be a little overwhelming at times.

A common remark we hear from experienced attorneys is that attending the Rainmaker Retreat is like “trying to drink from a fire hydrant” because we will provide you will dozens of time tested legal marketing strategies each day of the workshop.

At the Rainmaker Retreat, you will not hear any generic marketing advice like “just buy more Yellow Page ads” or “try to get more referrals from clients.” The Rainmaker Retreat focuses on in-depth discussions of cutting-edge strategies and revealing secrets of highly successful attorneys used by only an elite group of lawyers.

3. You will be taught How to Track and Measure Every Legal Marketing Effort! You will find a big emphasis on tracking the results of your attorney marketing efforts so if you are a numbers kind of person you will LOVE the Rainmaker Retreat!

There are 3 major areas you need to analyze and every one of your current challenges is directly related to problems in one or more of these 3 areas. We will teach you what the 3 areas are and how to use this tool to diagnose your problems and what “marketing treatment” you need to prescribe.

4. You will learn a Proven Lead Conversion System. The biggest area attorneys overlook in their legal marketing efforts is how to convert more prospects into paying clients. You will learn the 5 numbers you need to track in your law firm.

We will give you the tools and teach you how to use them so you can start tracking: (1) where every incoming lead is coming from, (2) how many of those leads turn into appointments, (3) how many appointments show up, (4) how many of those appointments retain at the initial consult, and (5) how many retain at a later date. We will introduce you to our Rainmaker Follow Up System that can be used to determine your Cost Per Lead (CPL) and Cost Per Client (CPC).

5. It is a Working Retreat. This means that several times each day you will be given specific marketing tasks to complete with step-by-step instructions. You not only come to listen, learn and discover, but also to practice and apply.

By the end of the Rainmaker Retreat you will:

Create a written 90-day Marketing Action Plan (MAP) for your law firm
Discover your firm’s Unique Competitive Advantage (UCA)
Identify a profile of your Ideal Target Market (ITM)
Have written strategies for improving your internet presence and search engine optimization
Develop your own plan for leveraging the power of blogging and social media following the Rainmaker Social Media Blueprint
Create a letter of introduction to potential Strategic Referral Partners (SRPs)

6. There is a Strong Focus on Return on Investment (ROI)! Everything about this workshop is focused on one goal—helping you achieve the best possible results by finding more and better clients in the least amount of time using the least amount of money possible!

For most attorneys,landing just 1 new client as a result of this workshop will more than pay for your attendance. But that’s not our goal! Our goal is to teach you how to gain dozens of new clients in the next 60-90 days.

Please note, ethically we cannot guarantee those kinds of results, but we work hard to provide you with all of the tools you will need to find more and better clients on a consistent basis. With that kind of Return on Investment, can you afford not to attend?

7. 100% Money Back Guarantee! We are so confident you will benefit from the Rainmaker Retreat that we offer a 100% money back guarantee. If you are not completely satisfied at the end of the first day, just let us know, turn your materials in and we will refund your money.

We guarantee you will come out of these 2 days with a step-by-step Marketing Action Plan (MAP) to make very specific changes to your marketing and how you go about building your legal practice.

Clash of the Generations – Age Discrimination in the United Kingdom in 2012

The National Law Review recently featured an article by Katie L. Clark of McDermott Will & Emery regarding Age Discrimination:

In Europe, many employers are currently caught in the middle of a conflict between older and younger employees. Many older employees want to work longer (whether by choice or necessity), while younger employees feel that an aging workforce is hampering their career progression. Both feel that that their age is being used against them. In the United Kingdom, the repeal of default retirement ages in April 2011 has only aggravated the problem.

UK employers may lawfully use age directly or indirectly in decision-making if “justified.” But where is the line drawn?

Two recent English Supreme Court cases provide some much-needed clarification for employers, particularly with regard to possible justifications for direct age discrimination.

Justifying Age Discrimination

Both direct and indirect age discrimination may be justified, that is, found to be lawful, if the employer can demonstrate that the discriminatory measure is “a proportionate means of achieving a legitimate aim”. The Supreme Court in the United Kingdom has now ruled that the “legitimate aims” that can justify direct age discrimination are narrower than those that can justify indirect age discrimination.

Legitimate Aims

Indirect age discrimination covers situations in which a workplace provision, criterion or practice puts people in a particular age group (young or old) at a disadvantage. A requirement of obtaining a degree to gain a promotion, for example, puts older people at a disadvantage because of lesser university access for prior generations. Keeping such a policy in place will be lawful if justified by individual reasons that are particular to that employer, such as cost reductions or improving competiveness. This gives employers flexibility to adopt legitimate measures that are appropriate to their individual business needs.

By contrast, the Supreme Court has now stated that direct age discrimination—treating an individual less favourably on grounds of his or her age or age group—may only be justified if an employer is implementing a legitimate public interest. The Supreme Court, in examining European case law, has identified two legitimate public interests that potentially justify direct age discrimination:

Inter-generational fairness—i.e., measures that promote the recruitment and retention of, and the sharing of limited opportunities between, different generations
Dignity—i.e., avoiding the need to dismiss older workers on the grounds of incapacity or under-performance, which may be humiliating for the employee or lead to disputes

Absent a legitimate aim that falls within one of those two categories, it is highly unlikely that an employer would be able to justify direct age discrimination, such as a mandatory retirement age forcing an individual out.

Even if an employer can point to a potentially legitimate public interest, it must establish that it is in fact pursuing the relevant interest. For example, improving the recruitment of young people is potentially a legitimate public aim, but it will not justify discriminating against older employees if the employer, in fact, has no difficulty in recruiting younger employees.

Proportionate Means

Once a legitimate aim has been established for direct or indirect discrimination, an employer will need to demonstrate that the measure adopted is proportionate. The Supreme Court has confirmed that to be proportionate, a measure must be both an appropriate means of achieving the legitimate aim and (reasonably) necessary in order to do so.

A measure will not be appropriate if it does not achieve the proposed aim, while a measure that goes further than is reasonably necessary to achieve the proposed aim will be disproportionate and impermissible.

It may be more difficult to show proportionality if the stated aim is to preserve the dignity of employees. Arguably, a retirement age of 65 insinuates that once employees turn 65, they are no longer able to do the jobs that they have been doing up to their 65th birthdays. If anything, this practice reinforces rather than dispels discriminatory stereotypes, which will make it difficult to justify.

What Does This Mean for Employers?

Direct discrimination claims are harder to defend than indirect discrimination claims. Managers need to understand that using mandatory retirement ages, while still possible, may lead to tough challenges.

The Supreme Court has provided clarification for employers on how to justify direct age discrimination, but not a definitive one-size-fits-all answer. The identification of legitimate aims is only half the problem, and questions of proportionality will continue to be difficult to answer.

Consequently, if imposing, continuing, or relying upon age-related criteria such as mandatory retirement ages is important to you as an employer, now is a good time to talk to us about the legitimate aim that will be relied upon and how this can be demonstrated for the particular workplace as a matter of fact.

Canadian International Trade Compliance Conference – August 21-23, 2012

The National Law Review is pleased to bring you information about the upcoming Canadian International Trade Compliance Conference:

Addressing the Global Trade Compliance Concerns Involving Export Controls, Custom Compliance and Cross Border Trade in Canada

Event Date: 21-23 Aug 2012
Location: Toronto, Ontario – VENUE TO BE CONFIRMED, Canada

Key conference topics

Assess the latest export permit requirements in Canada with Pratt and Whitney Canada

Address re-exports of U.S. origin goods from Canada to comply with both Canadian and U.S. export controls with Future Electronics

Integrate an effective anti-corruption compliance program as part of a global trade compliance program with Methanex Corporation

Analyze supply chain security concerns when dealing with cross border trade with Stanley Black & Decker, Inc.

Uncover the updates to the Export Controls List and their impact upon Canadian companies with Research in Motion Limited

Currently, international trade compliance professionals need to stay up to date on the changing regulations within Canada and also abroad. With the changes to the Export Controls List and the ever-complex nature of Canadian-U.S. cross border trade, companies need to be aware of how these changes affect their international trade compliance programs.

Canada’s relationship with the U.S. makes it imperative that the International Trade Compliance community is informed on the impact that U.S. rules and regulations can have on Canadian companies.

Building upon the success of the 2^nd Annual International Trade Compliance Conference, the marcusevans Canadian International Trade Compliance conference addresses the Global Trade Compliance Concerns involving export controls, customs compliance and cross border trade in Canada.

By attending this event, industry leaders will be able to overcome any potential challenges in crafting and sustaining a comprehensive trade compliance program.

Attending This Conference Will Enable You To:

1. Dissect the latest updates from the Department of Foreign Affairs and International Trade with Research in Motion Limited
2. Comprehend the U.S. Export Reform Initiative and the impact upon Canadian companies with Public Works and Government Services Canada
3. Develop and understanding of import value and transfer pricing with Ericsson Canada Inc.
4. Focus on NAFTA and other Free Trade Agreements with Plains Midstream Canada

Industry leaders attending this event will benefit from a dynamic presentation format consisting of workshops, panel discussions and case studies. Attendees will experience highly interactive conference sessions, 10-15 minutes of Q&A time after each presentation, 4+ hours of networking and exclusive online access to materials post-event.

Audience:

SVPs, VPs, Directors, Superintendents, Supervisors, Engineers, Specialists, Leaders and Managers from the Chemical, Petrochemical, and Refining Industries with responsibilities in:

EHS Environmental Health and Safety
Safety/Process Safety Management
Plant Management/Operations
Inspection/Reliability
Mechanical/Asset Integrity
Manufacturing/Technology
Training & Development

New “Stuxnet”- type Virus Discovered. What are the Security Implications for You?

Roy E. Hadley, Jr. of Barnes & Thornburg LLP recently published an article, New “Stuxnet”- type Virus Discovered. What are the Security Implications for You?, in The National Law Review:

A new, highly sophisticated computer virus has been discovered. No one has yet determined what it does but it appears to be related to the Stuxnet virus – the virus that specifically targeted Iran’s nuclear centrifuges.

Stuxnet was noteworthy because it was the first virus created for a specific purpose. It now appears that Stuxnet will not be alone.

As these types of specifically targeted “designer” viruses become more common, businesses should ask themselves “will I be targeted next?

This from MSNBC.com:

“Security experts have discovered a highly sophisticated computer virus in Iran and other Middle East countries that they believe was deployed at least five years ago to engage in state-sponsored cyber espionage.

Evidence suggest that the virus, dubbed “Flame,” may have been built on behalf of the same nation or nations that commissioned the Stuxnet worm that attacked Iran’s nuclear program in 2010, according to Kaspersky Lab, the Russian cyber security software maker that claimed responsibility for discovering the virus.

Kaspersky researchers said on Monday they have yet to determine whether Flame had a specific mission like Stuxnet, and declined to say who they think built it.

Iran has accused the United States and Israel of deploying Stuxnet.

Cyber security experts said the discovery publicly demonstrates what experts privy to classified information have long known: that nations have been using pieces of malicious computer code as weapons to promote their security interests for several years.

“This is one of many, many campaigns that happen all the time and never make it into the public domain,” said Alexander Klimburg, a cyber security expert at the Austrian Institute for International Affairs.”

5th Product and Pipeline Enhancement for Generics Conference, July 17-19, 2012

The National Law Review is pleased to bring you information about an upcoming conference:

5^th Product and Pipeline Enhancement for Generics Conference, July 17-19, 2012 in Washington, DC

The marcus evans 5th Product and Pipeline Enhancement for Generics Conference will host industry leaders within the Generic Pharmaceutical, Branded Pharmaceutical and API industries operating globally as they share best practices, strategies and tools on portfolio management and business strategy, as well as legal, intellectual property and patent issues.

Featuring case studies from leading generics experts, including:

Richard Dicicco, Chairman at Harvest Moon Pharmaceutical
Dr. Vijay Soni, Executive Vice President, IP, BD and Product Portfolio at Glenmark Pharmceuticals
Candis Edwards, Senior Vice President, Regulatory Affairs & Compliance at Amneal Pharmaceuticals
Gregory Fernengel, Senior Intellectual Property Counsel at Ben Venue Laboratories, Inc.
Markus H. Meier, Assistant Director, Health Care Division, Bureau of Compensation at Federal Trade Commission
Vishal K. Gupta, Chief Scientific Officer, Vice President, Research & Development at CorePharmaLLC
Sherri Leonard, VP, Business Development and Portfolio Management at OrchidPharma, Inc.

Attendees will leave this conference with a better understanding of:
1. Current and upcoming FDA proposals and regulations to ensure compliance
2. Innovation in the drug pipeline
3. Portfolio management and business development
4. How to protect the company’s patents’ and intellectual property
5. Expanding the commercial reach through biosimilars
6. Market changes and future industry developments

Testimonials:

“Great in-depth coverage of hot topics in an intimate setting that lent itself to excellent discussions.” – Novartis

”Terrific chance to connect with other industry traders to exchange ideas and explore solutions to the challenges we all face.” – OrchidPharma

The CFPB’s Consumer Complaint System: Key Points of Concern for Financial Services Companies

The National Law Review recently published an article by Stephanie L. Sanders and Richard Q. Lafferty of Poyner Spruill LLP regarding CFPB’s Consumer Complaint System:

The Dodd-Frank Act requires the Consumer Financial Protection Bureau (CFPB) to collect, investigate and respond to consumer complaints as part of its work in protecting consumers of financial products and services. Over the past year, CFPB’s Consumer Response team has gradually begun taking complaints on credit cards, mortgages, private student loans, other consumer loans, and other bank products and services. Because the complaint process could result in investigation or enforcement actions, financial services companies should be sure they understand the system and are prepared to respond promptly to complaints. Below is a list of recommendations for financial service companies to deal with the complaint system.

Know How to Use the Complaint System

CFPB’s website now prominently includes a “Submit a Complaint” portal. Consumers wishing to make a complaint in one of the above categories can simply click on the “Submit a Complaint” icon and follow the directions provided. In addition, CFPB accepts complaints by telephone, mail, email, and fax. The portal is the primary means of communication between CFPB and financial service companies, so companies should be familiar with the portal and establish procedures for fielding any complaints in a timely manner. CFPB has provided aCompany Portal Manual explaining how the portal and the complaint process works.

Once a complaint is submitted, CFPB screens it to determine whether it falls within the agency’s primary enforcement authority, whether it is complete, and whether it is a duplicate submission. If the complaint passes these tests, it is then forwarded to the company for response. The company is notified of the complaint and can log into the portal to view all active cases. Upon receipt of the complaint, the company must communicate with the consumer to determine the appropriate response. The company’s response is submitted via the portal, and the consumer is invited to review the response. The consumer can log onto the secure portal or call a toll-free number to receive status updates and review responses. The consumer is then given an opportunity to dispute the response.

Be Prepared to Respond Quickly

CFPB requests that companies respond to complaints within 15 calendar days and resolve complaints within 60 days. Failure to provide a timely response may trigger an investigation of the complaint by CFPB. Since a complete response requires that the company correspond with the complaining consumer, companies should pursue a response quickly to ensure they meet CFPB deadlines.

Understand that Complaints May Result in Investigations or Enforcement Actions by CFPB

The Consumer Response Team prioritizes review and investigation of complaints where a consumer disputes the response or the company fails to provide a timely response. In addition, the team analyzes groups of complaints to identify issue-specific trends. In some cases, complaints are referred to CFPB’s Division of Supervision, Enforcement, and Fair Lending and Equal Opportunity for further action. Financial services companies should thus be vigilant on the same matters, paying greater attention to disputed responses, ensuring that responses are timely, and monitoring for trends in the complaints received so that underlying problems are addressed before they are raised by the agency.

Understand that cCmplaints May Also Result in Investigations By Other Agencies

If a complaint is outside CFPB’s jurisdiction, it may be forwarded to the appropriate regulator (for example, while CFPB handles complaints on private student loans, it forwards complaints received about federal student loans to the Department of Education).

In addition, the Dodd-Frank Act requires CFPB to share consumer complaint information with the Federal Trade Commission (FTC) and other state and federal agencies. For example, if CFPB receives a complaint about identity theft, it may share that with the FTC, which is the agency that has historically investigated such complaints. As a result, financial services companies may need to anticipate receiving questions from the FTC about the effectiveness of their Red Flags program, which companies should have fully implemented in response to applicable FTC and other federal agency rules. In addition, CFPB currently shares its complaints with the FTC’s Consumer Sentinel system, an online database of consumer complaints maintained by the FTC that is accessible by law enforcement.

Be Prepared for an Increase in the Volume of Complaints

Consumer use of the complaint system is off to a strong start. CFPB recently issued a Consumer Response Annual Report summarizing the use of the complaint system from its launch in July 2011 through December 31, 2011. The report indicates that CFPB received 13,210 consumer complaints during that time, including 9,307 credit card complaints and 2,326 mortgage complaints. The most common credit card complaints involved billing disputes, identity theft, and APR or interest rates. The most common mortgage complaints involved situations in which the consumer was unable to pay (loan modification, collection, foreclosure). The complaint systems for bank products and services, private student loans, and other consumer loans only began in 2012, so the report did not cover those categories. By the end of 2012, the CFPB expects that the complaint system will cover all consumer financial products and services.

Financial services companies should monitor these trends to identify issues that may affect their business. They also should anticipate a significant increase in complaint volume as CFPB adds additional products to the complaint system and more consumers become aware of it. By comparison, the FTC Consumer Sentinel fielded 1.8 million complaints in 2011.

Retail Law Conference 2012

The National Law Review is pleased to bring you information about the upcoming Retail Law Conference:

at the Westin Galleria in Dallas, Texas

November 7-9, 2012

This event is the perfect opportunity to discuss the latest issues affecting the retail industry while obtaining important continuing legal education (CLE) credits.

Open to retail and consumer product general counsel, senior legal executives and in-house attorneys and their teams, the exceptional dialogue presented at this conference will help your organization navigate the current legal landscape of the industry.

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