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:

5th 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

Ninth Circuit Holds Statistics Alone Can Establish Prima Facie Case of Age Discrimination in a RIF

The National Law Review recently published an article about Age Discrimination written by Michael T. Chin of Schiff Hardin LLP:

On May 29, 2012, the Ninth Circuit Court of Appeals issued a decision clarifying the standard for plaintiffs to establish a prima facie disparate treatment discrimination claim. In Schechner v. KPIX-TVNo. 11-15294, 2012 U.S. App. LEXIS 10766 (9th Cir. May 29, 2012), the court held that a plaintiff’s initial burden of proof is relatively low and can be met by the introduction of statistics showing an adverse impact on a protected category — in this case, older workers. While the plaintiffs met their initial burden here, the Ninth Circuit nevertheless affirmed the district court’s grant of summary judgment in the employer’s favor on plaintiffs’ age discrimination claims under the California Fair Employment and Housing Act (“FEHA”).

In March 2008, like many employers at the time and even now, defendant KPIX-TV (“KPIX”) was faced with the task of having to reduce its annual budget. As part of its cost-cutting measures, KPIX implemented a reduction in force (“RIF”), resulting in the termination of five members of the “on-air” news team, including both plaintiffs. Each member of the RIF group was male and over the age of forty. Plaintiffs filed suit, claiming that their terminations were the product of age and gender discrimination in violation of the FEHA. Plaintiffs submitted reports by an expert statistician who concluded that the age disparity between the RIF group and the group of individuals that KPIX decided to retain was “statistically significant” and age “correlated closely” with the decision to terminate.

The Ninth Circuit held that “statistical evidence that shows a stark pattern of age discrimination” is sufficient to establish a prima facie case, even though “it does not address the employer’s proffered non-discriminatory reasons for the discharge.”Id. at *14-15. The Ninth Circuit proceeded to consider the legitimate, non-discriminatory reasons for the RIF offered by KPIX. Here, KPIX presented evidence of reasons for layoff decisions unrelated to age, such as that news anchors generally would not be subject to termination because they were the “face” of the station, that specialty reporters would not be subject to termination because they were being promoted to push the brand of the station, and that general assignment reporters would be subject to termination based on their respective dates of contract expiration. The Ninth Circuit concluded that KPIX had established non-discriminatory reasons for its RIF decisions, and that the plaintiffs were unable to show pretext.

This case highlights the importance of establishing a set of reasoned, job-related factors to be considered in deciding which employees to include in a RIF. Numbers suggesting an adverse impact on protected classes can be problematic, but not necessarily fatal.

© 2012 Schiff Hardin LLP

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.

Continued Uncertainty Surrounding the Future of the SEC’s “Neither Admit Nor Deny” Settlement Practice

The Securities Litigation Group of Vedder Price recently had an article regarding the SEC published in The National Law Review:

Since US District Court Judge Jed S. Rakoff of the Southern District of New York rejected a $285 million settlement between the Securities and Exchange Commission (SEC) and Citigroup Global Markets Inc. (Citigroup) last fall, both the SEC and federal courts have grappled with the future of what had been the SEC’s long-standing practice of permitting companies to settle cases without admitting any liability. However, the Second Circuit’s recent decision to stay the proceedings before the Southern District of New York, pending the resolution of the SEC and Citigroup’s appeals of Judge Rakoff’s settlement rejection, suggests that the appellate court may eventually set aside Judge Rakoff’s rejection of the parties’ settlement.

In SEC v. Citigroup, Judge Rakoff held that the proposed consent judgment between the SEC and Citigroup was “neither fair, nor reasonable, nor adequate, nor in the public interest” because Citigroup had not admitted or denied the allegations set forth by the SEC1. Per Judge Rakoff, the proposed settlement did “not serve the public interest, because it ask[ed] the Court to employ its power and assert its authority when it does not know the facts.”2

In the immediate aftermath of Judge Rakoff’s ruling, Robert Khuzami, the Director of Enforcement at the SEC, issued a statement, noting that Judge Rakoff’s decision “ignore[d] decades of established practice throughout federal agencies and decisions of the federal courts.”3Further, Khuzami stated that “[r]efusing an otherwise advantageous settlement solely because of the absence of an admission also would divert resources away from the investigation of other frauds and the recovery of losses suffered by other investors not before the court.”4

Notwithstanding Khuzami’s criticism of Judge Rakoff’s decision, in early January 2012, the SEC announced a policy change involving cases in which parallel criminal proceedings result in convictions or admissions of securities law violations. In such situations, per the new SEC policy, the “neither admit nor deny” language is no longer available, and the conviction or admission would be incorporated into the civil disposition. This policy change will likely have little impact on most defendants, since the bulk of cases brought by the SEC do not involve criminal proceedings.

In recent months, other US district courts have mimicked the reasoning employed by Judge Rakoff in rejecting no-admit, no-deny settlements. For example, in December 2011, US District Court Judge Rudolph T. Randa of the Eastern District of Wisconsin took issue with a proposed settlement between the SEC and Kass Corp. CEO, Michael Koss, and requested that the SEC provide additional information showing why the settlement was in the public interest.  In response, the SEC redrafted the proposed settlement agreement. More recently, US District Court Judge Richard A. Jones of the Western District of Washington rejected a proposed no-admit, no-deny settlement between the SEC and three individual defendants. Judge Jones criticized the SEC for seeking judgments against the defendants while reserving the right to request disgorgement remedies and civil penalties in the future.5

On March 15, 2012, in a per curiam opinion, a three-judge panel of the Second Circuit granted the motions of the SEC and Citigroup to stay district court proceedings, pending the resolution of their interlocutory appeals that seek to set aside Judge Rakoff’s decision rejecting the parties’ proposed settlement.6Although the panel did not hold that Judge Rakoff’s settlement rejection was improper, the Second Circuit concluded that the SEC and Citigroup had shown a likelihood of success on the merits of their appeals, which justified staying the lower court proceedings. Notably, the panel wrote that Judge Rakoff was likely incorrect in rejecting the proposed settlement on public policy grounds, stating that it is not “the proper function of federal courts to dictate policy to executive administrative agencies.”7

While the lower court proceedings remain stayed, on March 31, 2012, the Second Circuit scheduled oral arguments on the pending appeals for late September 2012.  Until then, the future of the SEC’s long-standing “neither admit nor deny” settlement practice will continue to remain unsettled.


SEC v. Citigroup Global Markets, Inc.,__ F. Supp. 2d __, 2011 WL 5903733, at *6 (S.D.N.Y. Nov. 28, 2011).

Id.

Robert Khuzami, Public Statement by SEC Staff: Court’s Refusal to Approve Settlement in Citigroup Case (Nov. 28, 2011), available at:http://www.sec.gov/news/speech/2011/spch112811rk.htm.

Id.

SEC v. Merendon Mining (Nevada), Inc. et al., No. 10 CV 00955 (Mar. 5, 2012).

SEC v. Citigroup Global Markets, Inc., __ F. 3d __, 2012 WL 851807 (2d Cir. Mar. 15, 2012).

Id. at

© 2012 Vedder Price

8th Annual FCPA & Anti-Corruption Compliance Conference

The National Law Review is pleased to bring you information about the upcoming 8th FCPA & Anti-Corruption Compliance Conference:

8th FCPA and Anti-Corruption Compliance Conference
Identifying Changes to the Global Anti-Corruption Compliance Landscape to Maintain and Upgrade Your Existing Compliance Program

Event Date: 12-14 Jun 2012
Location: Washington, DC, USA

Beyond dealing with the FCPA and UK Bribery Act, there are upcoming changes to global Anti-Compliance initiatives being enacted by other major countries. It is imperative that organizations are made aware of these new rules and regulations to be able to meld them all into their organization’s anti-corruption compliance program. Maintaining a robust global compliance program along with performing proper and detailed 3rd party due diligence is of the upmost importance.

Marcus Evans invites you to attend our 8th Annual Anti-Corruption & FCPA Conference. Hear from leading executives within various industries on how to identify new areas of concern when dealing with bribery or working within a company to update an anti-corruption compliance program.

Attending this event will allow you to learn how to mitigate the effects of any possible instances of corruption and bribery both at home and abroad. Discuss solutions and best practices that companies have found when dealing with their anti-corruption compliance programs. This conference will not only review the newest enforcement cases, but also highlight practical solutions to problems dealing with FCPA and global anti-corruption measures.

Attending this conference will allow you to:

-Overcome the issues in dealing and conducting an internal investigation with Dell
-Identify anti-corruption liability concerns for US companies when engaging in Joint Ventures and Mergers and Acquisitions with Crane Co.
-Perform anti-corruption audits to better identify gaps in the compliance program with SojitzCorporation of America
-Promote 
a culture of ethics within an organization to combat non-compliance with Morgan Stanley
-Assess
 the continued challenges in conducting a 3rd party due diligence program with Parker Drilling

The marcus evans 8th Annual Anti-Corruption & FCPA Conference is a highly intensive, content-driven event that includes, workshops, presentations and panel discussions, over three days. This conference aims to bring together heads, VP’s, directors, chief compliance officers, and in-house counsel in order to provide an intimate atmosphere for both delegates and speakers.

This is not a trade show; our 8th Annual Anti-Corruption & FCPA Conference is targeted at a focused group of senior level executives to maintain an intimate atmosphere for the delegates and speakers. Since we are not a vendor driven conference, the higher level focus allows delegates to network with their industry peers.

NLRB’s Acting General Counsel Releases Another Report on Social Media Policies

An article by Steve L. Hernández of Barnes & Thornburg LLP recently had an article regarding NLRB’s Social Media Policies in The National Law Review:

On May 30, 2012. Lafe Solomon, the NLRB’s Acting General Counsel (the “AGC”), released a third report on social media cases brought before the Board. This report deals with seven different cases involving social media policies, covering topics such as the use of social media and electronic technologies, confidentiality, privacy, protection of employer information, intellectual property, and contact with the media and government agencies. In the first six policies reviewed, the AGC concluded that at least some of the provisions in the employers’ policies and rules were overbroad and, accordingly, unlawful, under the National Labor Relations Act (NLRA). Importantly, the Board found that the savings clauses in these otherwise unlawful policies did not save the policies. Only the final social media policy reviewed by the AGC was found to be entirely lawful. In finding the final reviewed policy lawful, the AGC pointed to the policies substantial use of examples of allowed and proscribed behavior. Specifically, the AGC stated that “rules that clarify and restrict their scope by including examples of clearly illegal or unprotected conduct, such that they could not reasonably be construed to cover protected activity, are not unlawful.”

© 2012 BARNES & THORNBURG LLP

Upcoming Summer 2012 CLE National Institutes

The National Law Review is pleased to bring you information about the ABA’s Upcoming Summer 2012 CLE National Institutes:

Learn and network at these in-person,full-day or multi-day seminars held live in various locations across the country that draw lawyers from across the nation.

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.

© 2012 Ifrah PLLC

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.

© MICHAEL BEST & FRIEDRICH LLP