Will Brexit Undermine U.K. Participation in the General Data Protection Regulation and the U.S./E.U. Privacy Shield?

The June 23, 2016 Brexit referendum outcome in the U.K. does create uncertainty about whether the U.K. will continue to follow EU data protection laws, including implementation of the E.U.’s new General Data Protection Regulation (“GDPR”), scheduled to become effective on May 25, 2018. Furthermore, the recently negotiated new U.S./E.U. Privacy Shield, intended to replace the E.U.-invalidated Safe Harbor, faces an uncertain future in the U.K. as well if it is not an available framework for multinational businesses to do business in the U.K. For example, Microsoft stated in an open letter in May, 2016 to its 5000 U.K. employees before the Brexit vote that the U.K.’s EU membership was one of the factors that attracted Microsoft to make investments in the U.K., including in a new data center. One important future signal will be whether the U.K. opts to join the European Economic Area, or otherwise maintains significant trade with the EU, in which case the U.K. would necessarily need to comply with EU privacy regulations. If not, the U.K. would still need to develop its own data protection network. However, because at least two years must elapse before the U.K. can formally exit the EU under Article 50 of the Treaty of Lisbon, and even that two year period does not commence until formal notice is given, both the GDPR (in May 2018) and the Privacy Shield are likely to be in place in the U.K. before any actual exit from the EU occurs. And many observers believe that any law that Britain adopts will likely be similar to the GDPR, since a non-member country’s data protection regime must be deemed “adequate” by the EU for businesses in that non-member country to exchange data and to do business within the EU. In short, nothing is going to change immediately, and because Brexit won’t likely be completed for years, the Privacy Shield could well be implemented in the U.K. for personal data transfers from the U.K. to the U.S. well before actual withdrawal is completed. It also may take years to negotiate and complete agreements, and enactment of alternative U.K. data privacy laws.

See our previous post regarding the text of the U.S./EU Privacy Shield…

Article by Douglas Bonner of Womble Carlyle Sandridge & Rice

Federal Circuit Requires 180 Day Notice For All Biosimilars, Even After Patent Dance

In Amgen v. Apotex, the Federal Circuit rejected Apotex’s arguments that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” process of the Biologics Price Competition and Innovation Act (“BPCIA”), expanding on its decision in Amgen v. Sandoz that 42 USC § 262(l)(8)(A) is a mandatory, stand-alone requirement. The Supreme Court has asked the Solicitor General to weigh in on whether it should grant certiorari in Amgen v. Sandoz. Will this decision make the Court more or less likely to review the Federal Circuit’s interpretation of this important biosimilar statute?

The Biosimilar Patent Dance

The biologic product at issue is Amgen’s Neulasta® (pegfilgrastim) product. Amgen describes pegfilgrastim as “a recombinantly expressed, 175-amino acid form of … human granulocyte-colony stimulating factor (‘G-CSF’) conjugated to a 20 kD monomethoxypolyethylene glycol (m-PEG) at the N-terminus.” After Apotex filed a Biologic License Application (BLA) seeking FDA approval to market a biosimilar version of Neulasta® (pegfilgrastim), the parties followed several steps of the patent dance procedures, which resulted in Amgen asserting U.S. Patent Nos. 8,952,138 and 5,824,784 in the U.S. District Court for the Southern District of Florida. Those infringement claims are being litigated, although the ‘784 patent has been dropped since it expired.

The Biosimilar 180-Day Notice Dispute

As noted in the Federal Circuit decision, Apotex sent Amgen a letter on April 17, 2015, stating that it was “providing notice of future commercial marketing pursuant to 21 USC § 262(l)(8)(A), though Apotex lacked (as it still lacks) an FDA license.” Amgen sought a preliminary injunction to “require Apotex to provide … notice if and when it receives a license and to delay any commercial marketing for 180 days from that notice.” The district court granted that motion, citing the Federal Circuit decision in Amgen v. Sandoz that notice cannot be given before the biosimilar product is approved. Apotex appealed.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Taranto and joined by Judge Wallach and Judge Bryson. The bottom line of the court’s decision is this:

The [§ 262(l)](8)(A) requirement of 180 days’ post-licensure notice before commercial marketing … is a mandatory one enforceable by injunction whether or not [the biosimilar applicant provided a copy of its biosimilar application to the reference product sponsor in accordance with § 262(l)(2)(A)].

As it had in Amgen v. Sandoz, the court emphasized the “categorical” language used in the statute:

The subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).

The court noted that § 262(l)(8)(A) “contains no words that make the applicability of its notice rule turn on whether the applicant took the earlier step of giving the [§ 262(l)](2)(A) notice that begins the § 262(l) information-exchange process,” and stood by its holding in Amgen v. Sandoz that the statute is “‘a standalone notice provision’ not dependent on the information-exchange processes that begin with [§ 262](l)(2)(A).”

Further justifying its decision, the court emphasized that the BPCIA created a “two stage” patent litigation process, and found that the 180-day pre-marketing notice is essential to the second stage. In that regard, it explained that the 180 day period “gives the reference product sponsor time to assess its infringement position for the final FDA-approved product as to yet-to-be-litigated patents,” and “gives the parties and the district court the time for adjudicating such matters without the reliability-reducing rush that would attend actions for requests for relief against immediate market entry that could cause irreparable injury.”

The court also considered and rejected Apotex’s arguments based on the relationship between § 262(l)(8)(A) and other sections of the BPCIA, such as § 262(l)(9)(B) and § 262(l)(9)(C), which give the reference product sponsor the right to bring delcaratory judgment actions when the biosimilar applicant fails to follow some or all of the patent dance procedures.

Requiring 180-Days Notice Does Not Extend The 12-Year Exclusivity Period

Perhaps Apotex’s most compelling argument was that the court’s interpretation of 262(l)(8)(A) effectively gives original biologic products 12.5 years of exclusivity rather than the 12 years provided by Congress in § 262(k)(7). The court dealt with this argument in two ways. First, the court noted that “§ 262(k)(7) by its terms establishes the 12-year date only as an earliest date, not a latest date, on which a biosimilar license can take effect” (emphasis added). Second the court hypothesized that the FDA could implement the 12-year exclusivity period by “issu[ing] a license before the 11.5-year mark and deem[ing] the license to take effect on the 12-year date.” In that case, the 180-days notice could be given in time to expire when the 12-year exclusivity period expires.

(The FDA has not yet issued guidance or regulations on this issue, and is not bound by the Federal Circuit decision. Indeed, the U.S. Court of Appeals for the District of Columbia is the appellate court most likely to review the FDA’s interpretation of § 262(k)(7).)

What Will the Supreme Court Do?

As noted above, the Supreme Court has asked the Solicitor General to weigh in on whether it should grant certiorariin Amgen v. Sandoz. Since this decision is consistent with that one, it is not clear that it will make the Court more or less likely to hear the case. The opinion here provides a detailed summary of the patent litigation procedures of the BPCIA and the related sections of the patent infringement statute, 35 USC § 271. That analysis may make the Court more comfortable with the Federal Circuit’s interpretation, or could lead the Court to try its own hand at deciphering a statutory scheme that Judge Lourie characterized as deserving of “a Pulitzer Prize for complexity.”

ARTICLE BY Courtenay C. Brinckerhoff of Foley & Lardner LLP

Voluntary Product Registry: Dietary Supplement Update

Leading dietary supplement trade association makes strides in developing product registry.

As previously covered, a leading dietary supplement trade association — the Council for Responsible Nutrition (CRN) — has been pursuing the goal of creating a Voluntary Product Registry for Dietary Supplements. According to CRN, the goal of the registry is to increase transparency and give regulators greater access to information about the composition of supplement products currently on the market.
At a recent conference, CRN announced that it had retained the global science safety firm, UL, to develop and administer the product registry. The current plan is to implement a two-tiered database. Tier one will permit companies to add basic information about their products at no cost, and the information will be accessible to any interested party. Tier two will provide companies with a fee-based opportunity to add more detail about their products, and access will be restricted to specific audiences (e.g., regulatory authorities, retailers).
CRN anticipates that the registry will be operational by the end of 2016, and member companies will be required as a condition of membership to input all their product labels into the registry by July 2017.

ARTICLE BY Food and Drug Law at Keller and Heckman LLP

First Reported Tesla Autopilot Fatality in Central Florida

In a recent blog post, Tesla revealed that the Model S vehicle that was involved in a fatal accident on May 7 in Williston, Florida was in Autopilot mode at the time of the collision. This marks the first known fatality in a Tesla vehicle where Autopilot was active. The National Highway Transportation Safety Administration is currently in the midst of an investigation of the cause of the collision which is believed to include a determination of whether the Autopilot system was working properly at the time of the accident.

According to various news sources, the accident occurred when a tractor trailer drove across a divided highway and in front of the Tesla vehicle. Due to the height of the trailer, the Model S actually passed under the trailer with the initial impact occurring to the vehicle’s windshield. Tesla CEO Elon Musk stated on Twitter that the radar system used by the Autopilot feature did not help in this case because of the height of the trailer. According to Musk, the system “tunes out what looks like an overhead road sign to avoid false breaking events.” Tesla believes that the Autopilot system would have prevented the accident if the impact had occurred to the front or rear of the trailer.

This accident represents the first in what will undoubtedly be many similar accidents that will raise questions regarding the safety of Autopilot systems. Tesla is one of the first automakers to utilize such technology and they have reiterated that they require customers to sign an agreement acknowledging that the system is in a “public beta phase” before they can use it. Some driving experts have criticized Tesla for introducing an Autopilot feature too early believing that the system gives drivers the false impression that the car can handle anything it encounters. By way of contrast, GM has only tested their Autopilot feature privately and Volvo has indicated that they intend to take full liability for their cars when the feature is activated.

ARTICLE BY Ian S. Abovitz of Stark & Stark

How Will the Exit of the United Kingdom from the European Union (“Brexit”) Affect U.S. Corporations Doing Business in the UK?

On June 23, 2016, the UK voted in a referendum to leave the EU. The UK government will now initiate the procedure under Article 50 of the Lisbon Treaty leading to the UK’s withdrawal from the EU. The UK will be immediately excluded from the European Council and the Council of Ministers, and a negotiation period of two years will commence during which the terms of its withdrawal and of its future relationship with the EU will be determined. No member state has initiated this procedure before, and so it is impossible to predict what this future relationship will be. Furthermore, the UK’s relationships with non-EU states will have to be independently reestablished, as it will no longer be entitled to rely on the bilateral treaties with those states it enjoyed whilst an EU member state.

This Client Alert will focus on the likely impact of Brexit on the laws of the UK influencing key business areas for U.S. corporations doing business in the UK.

M&A

The UK Companies Act 2006, which embodies UK law as it relates to both public and private companies, has been significantly influenced by EU directives, however, it is highly unlikely that Brexit will result in any changes to UK company law, so the basic mechanics of acquisitions and disposals of UK companies will remain the same. The vast majority of M&A transactions in Europe take place between private companies, either by means of an acquisition of shares or of assets, and Brexit will not affect the laws governing such transactions.

The EU Takeover Directive harmonises public company takeovers in the EU and is modelled on the UK Takeover Code, which regulates takeovers of public limited companies in the UK. Brexit is therefore unlikely to have any significant impact on takeovers.

The EU Cross-Border Mergers Directive enables a private or public company in one EU member state to merge with a company in another member state. Brexit means that UK companies will cease to benefit from this regime.

Brexit may possibly affect competition law in the longer term. Currently anti-competitive agreements and abuses of dominant positions in the UK are policed by the Competition and Markets Authority under laws and procedures which mirror EU regulations. In the case of mergers, however, larger transactions are dealt with by the European Commission on a “one-stop-shop” basis to save the parties having to file in several states. Brexit could lead to a decoupling of UK competition law from that of the EU and the end of the “one-stop-shop,” at least for UK mergers.

Commercial Contracts

Existing contracts which continue beyond Brexit could be affected in a number of ways, for example:

Depending on how the contract is drafted, Brexit might constitute a “material adverse change,” entitling the parties to terminate;
Provisions which have EU territorial scope, such as restrictive covenants or exclusive sales rights, will no longer include the UK;
If import duties are imposed as a result of Brexit, contractual pricing mechanisms may operate to shift the burden of such additional costs onto one of the parties making performance more costly.

New contracts should take such matters into account, and now that Brexit is a reality, parties should negotiate how its consequences will be dealt with and who bears the risk.

Debt and Equity Financing

Similar considerations apply to financing transactions on Brexit as apply to M&A deals and commercial contracts. Generally the effect on such transactions will be insignificant.

In the case of loan facility documents, EU territorial clauses may be affected by the UK’s departure from the EU, and Brexit may trigger an event of default in the case of particularly harsh “material adverse change” provisions. The imposition of tariffs and duties and the consequences of market disruption as a result of Brexit might lead to lenders passing on increased costs to borrowers. Brexit might also cause a UK borrower to make an inadvertent misrepresentation (for example, that it is in compliance with EU laws and regulations). It is difficult to see how Brexit would prejudice English law security taken under a security document (with the one exception of intellectual property rights – see below).

Equity financing documents, such as placing and underwriting agreements and prospectuses, will be similarly affected. In addition, the possible loss of the “passporting” regime for the sale and distribution of securities throughout the European Economic Area (EEA) would adversely affect fundraising outside the UK. On an IPO or bond issue, issuers should consider a Brexit-related risk factor disclosure in their prospectuses, especially if their business is likely to be adversely affected by Brexit.

Funds and Asset Management

Brexit could have potentially significant adverse consequences for funds and asset managers in the UK.

Initially, UK fund managers will be treated as non-EEA alternative investment fund managers and lose their managing and marketing passports into the EU. Currently, thanks to the “passport” regime, under the Alternative Investment Funds Management Directive (AIFMD), both UK and non-UK funds can be managed by UK-regulated fund managers operating out of the UK, and such fund managers can market and distribute the fund throughout the EU. Such fund managers will cease to qualify for a passport on Brexit. Under current rules, they could only market such funds as alternative investment funds to EEA investors under local private placement arrangements, if applicable.

Also, as undertakings for collective investment in transferable securities (UCITS) must be EU domiciled and managed by an EU management company, Brexit could be potentially disastrous for a UK-domiciled UCITS fund.

UCITS funds are subject to strict investment rules, including a maximum investment of 30 percent of their assets in non-UCITS collective investment schemes. Brexit will result in many such funds having to alter their investment mandates to take account of the UK no longer being a member of the EU. Similarly, even non-UCITS funds, whose investment policies are to invest in EU securities, will have to readjust their portfolio investments in UK companies or amend their policies.

Employment

The vast majority of UK employment law is “home grown,” such as protection against unfair dismissal, the right to a payment on redundancy, protection against sex, race, nationality, ethnic origin and disability discrimination, and the right to a minimum wage. EU directives have contributed to UK employment law in areas such as the protection of employment rights on the transfer of undertakings, the obligation to consult with employees in the case of mass redundancies, working time limits and minimum holiday pay.

These EU-derived employment laws have become so integral to UK employment law that it is unlikely that Brexit will affect them.

In fact, previous UK governments have tended to “gold plate” EU directives and regulations (for example, the Working Time Directive allows full-time employees 20 days of paid annual leave, but the UK application of that law allows 28 days). It is possible that, outside the EU, a future UK government will review certain aspects of the legislation which have not sat well with UK businesses since their inception, including in particular, the weekly limit on working hours, regulations relating to agency workers and work councils and even those in respect of collective consultation with employees in general.

As in the case of commercial contracts, employment agreements with EU territorial scope may be affected (for example, in the case of covenants not to compete or solicit customers or employees in the EU after termination of employment).

Brexit may deny the UK access to the “single market” of the EU, including the right of free movement of workers between the UK and the remaining EU member states. This will adversely affect the ability of UK companies to manage a cross-border skilled and experienced workforce.

Trade

Many UK trade laws derive from EU law such as the following:

Product safety
Consumer protection
Laws on unfair contracts
The rights of commercial agents
On-line shopping
Payment services
Laws on hazardous chemicals
Certification of electrical and medical devices

Most of these laws have become enshrined in UK law for many years and are unlikely to be affected by Brexit. However some, which derive from secondary legislation, would lapse unless a post-Brexit government were to preserve them (for example, the regulations governing consumer protection from unfair trading, general product safety, and consumer contracts in respect of “distance” sales of goods and services to consumers).

The withdrawal of the UK from the EU “single market” could entail import duties on the export of products and services from the UK to the EU. Also institutions, such as banks, trading companies and professional firms, such as lawyers and accountants, would cease to enjoy the single market in the provision of services, which could lead to the restructuring or even relocation of their EU-based offices.

Intellectual Property

As one of the largest creators of intellectual property in the EU, the UK and its entrepreneurial innovators could be significantly affected by Brexit.

The Community Trade Mark would cease to apply in the UK. This would require trade marks to be registered both in the UK and as CTMs, incurring additional costs and potentially adversely affecting existing trade mark licenses and security over trade marks.

Currently UK patents are protected and registered under UK legislation, and so Brexit will not affect them (or European patents designating the UK). From 2017, a new EU patent system, the Unitary Patent, is scheduled to be launched, with its new court, the Unified Patents Court, expected to take its seat in London. Brexit would exclude UK patents from this unified system, and London will lose its new court.

Data Protection

The UK law on data protection is based on EU law but dates back to 1998, and so it is unlikely to be significantly affected by Brexit. There are current EU proposals to strengthen the law under the General Data Protection Regulation, and it is likely that the UK will now adopt this.

Post-Brexit cross-border transfers of personal data to the UK are unlikely to be automatically permissible from EU member states. The UK would have to apply to the European Commission for a decision that its data protection standards are adequate to protect the privacy of EU residents (which means the EU standards would have to be met in any event). In the recent case of Schrems, the European Court of Justice held that the United States had not complied with European data protection standards (as Facebook had allegedly transferred consumers’ data to the NSA) and abolished the “safe harbour” rules which had hitherto permitted such transfers from the EU to the United States. If the EC were to deny or restrict the terms of its adequacy decision, the UK could find itself in a similar position to that of the United States after Brexit, which could seriously adversely affect technology providers with UK-based data centres offering services to EU clients.

Conclusion

The legal consequences of Brexit are difficult to quantify. Much will depend on the exit terms negotiated between the UK and the remaining EU member states and the status of the continuing relationship between the UK and the EU after Brexit. Such matters will not be known for at least two years. In the interim the status quo will survive.

ARTICLE BY Jonathan Maude, Richard L. Thomas & Sam Tyfield of Vedder Price

Senate Judiciary Introduces CREATES Act To Expedite Access To Affordable Drugs

Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of affordable generic drugs” and biosimilar products. The bill, entitled the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, S. 3056, would punish the strategic refusal of “innovator” companies to (1) share drug samples needed for generic and biosimilar regulatory testing and approval; and (2) agree on a shared safety protocol for so-called “REMS products.” The CREATES Act is the latest in a string of legislative efforts around the country focusing on drug affordability and price transparency.

A. Regulatory Background

When and how a generic or biosimilar product (or brand drug or biologic) enters the pharmaceutical supply chain varies depending on whether the product is subject to Risk Evaluation and Mitigation Strategies (“REMS”) requirements. REMS originated with the FDA Amendments Act of 2007, which authorizes distribution restrictions and other REMS for medicines with higher toxicity and risk potential. A REMS may include Elements to Assure Safe Use (“ETASU”), such as restricted distribution, physician and patient education, and/or evidence of safeuse conditions.

By law (21 U.S.C. § 355-1(f)(8)), REMS requirements cannot be used to “block or delay” generic approval. Nevertheless, FDA has publicly stated“we have found cases in which sponsors have tried to use the REMS to block generics.” Such efforts have been challenged in private antitrust litigation and generated more than 100 inquiries to FDA. The Federal Trade Commission has told Congress it “continue[s] to be concerned about potential [REMS] abuses . . . to impede generic competition,” which “may violate the antitrust laws.” Enter the CREATES Act.

B. The CREATES Act

Section 3 of the CREATES Act would establish causes of action for “delays of generic drugs and biosimilar biological products.” An “eligible product developer,” i.e., an ANDA applicant or 351(k) applicant, could bring a federal civil action against the license holder for a “covered product”—defined as an approved drug or biological other than one for which there is a short-term shortage—alleging the license holder

(1) “has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable, market-based terms”; or

for products subject to a REMS with ETASU

(2) (i) “failed to reach agreement with respect to a single, shared system of elements to assure safe use with respect to the covered product[] or . . . at least 120 days have elapsed since the developer first initiated an attempt to reach an agreement”; or

(ii) “refused to allow the eligible product developer to join a previously approved system of elements to assure safe use with respect to that product.”

The Act would authorize judges to award injunctive relief and damages “sufficient to deter” similar delaying conduct. Damages could not exceed the revenue earned from sale of the drug during the refusal period, however.

The CREATES Act would exempt innovators from liability from “the failure of an eligible product developer to follow adequate safeguards to assure safe use of the covered product during development or testing activities.” Additionally, innovators would not be liable if, in fact, they “had [no] access to inventory of the covered product to supply to the eligible product developer on commercially reasonable, market-based terms” or if “the covered product could be purchased by the eligible product developer in sufficient quantities on commercially reasonable, market-based terms from the agents, distributors, or wholesalers of the license holder.”

C. Reactions and Implications

The CREATES Act enjoys broad support from the generic industry, physicians, pharmacists, hospitals, consumer advocacy groups, antitrust experts, and insurers. During a recent Congressional hearing, the CREATES Act waspraised for confronting anticompetitive regulatory manipulation by promoting competition and, in turn, improving consumer choice and welfare. The hearing’s lone dissenter, the Pharmaceutical Research and Manufacturers of America (“PhRMA”), claimed the bill “uses a blunt instrument to address a narrow issue.” Among other things, PhRMA objected to litigation as the mechanism for resolving product safety concerns and breakdowns in complex, multiparty REMS negotiations.

These criticisms raise legitimate issues. Reliance on litigation to remedy delays in generic entry risks a slow, expensive, and unpredictable enforcement process. Determining if a “term” is “commercially reasonable,” for example, presents fact-bound, context-specific questions typically reserved for a finder of fact. What legal consequence, if any, flows from a generic’s failure to engage in good faith negotiations to join the brand’s shared REMS?

The law also could leave innovators facing conflicting statutory obligations. It would allow “[a]n eligible product developer [to] submit . . . a written request for the eligible product developer to be authorized to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU,” in which case “provision of the covered product by the license holder under the terms of [an] authorization will not be a violation of the REMS for the covered product.” Yet, it (currently) does not amend the statutory provisions governing the enforcement of REMS programs (21 U.S.C. § 355(p)(1)(B); 21 U.S.C. § 333(f)(4)(A)). Without a legislative fix, sharing samples of a drug with REMS with ETASU could expose a brand company to civil and criminal penalties.

Some or all of these matters may be mooted by amendments to the CREATES Act as it makes it way through the legislative process. Time will tell.

D. Striking A Balance

The CREATES Act seeks to tweak the elusive balance between encouraging development and continued research for new drugs and biologics while ensuring timely availability of lower-cost generic and biosimilar drugs. While the fate of the CREATES Act remains uncertain, its impact on the American healthcare system would be significant for stakeholders on all sides of the public debate over drug affordability.

ARTICLE BY James W. Matthews, David L. Rosen, Katy E. Koski & Jason L. Drori of

Foley & Lardner LLP

Happy Independence Day!

Happy 4th of July!

From your friends at the

National Law Review

12 Tips for Getting the Most Business Out of Speaking Events

Speaking provides credibility and visibility, both of which are very helpful in terms of acquiring new clients. Yet, despite the significant time and effort that it takes to prepare presentations, many attorneys find that speaking events are not producing as much business as they had hoped. The following tips are intended to help lawyers identify areas to fine-tune their approach, in order to produce better results going forward.

Find the Best Audience – Speaking to a wide range of groups just to get experience can be a very good idea. However, once an attorney becomes more comfortable and skilled at communicating to groups and managing the dynamics of a room, it is important to start actively seeking the ideal audience. This may take some trial and error. The best organizations for reaching a particular niche may not be as obvious as one might think. If you are not getting the business you want, this is the first place to look.
Choose a Critically Important Topic – Even if you are speaking to an ideal audience, you may not be addressing an issue that would inspire them to hire you. They may attend simply because they are curious about the subject and want to be prepared for the future, rather than because they view the issue as a serious concern on which they are willing to spend money. It may take some experimentation in order to identify topics that hit the sweet spot, both resonating with the audience, and showcasing your passion and expertise.
Choose an Enticing Title – A well-crafted title increases attendance and enthusiasm for the topic dramatically. On one hand, this could be seen as superficial; but on the other hand, if a speaker goes out of her way to choose an amusing or compelling title, it is reasonable to assume that she made similar effort with the entire presentation.
Make Sure the Description Accurately Represents the Content of the Presentation – There are two major ways this can go awry. First, sometimes an event organizer will write the program description for you. If you do not control the way the program is being advertised, it is very likely that the “wrong” people will attend or that they will come with expectations that are at odds with what you actually provide. This can lead to a confused or disappointed audience and a lot of frustration for the speaker. The second common way this happens is when the speaker writes a program description before designing the presentation. While content may evolve through the preparation process, it is important to keep the program in alignment with the description.
Come Across as Personable – While an attorney’s experience and expertise are important, clients are a lot more interested in doing business with those whom they like. Public speaking does not come naturally to everyone, and even people who are usually genuine and charming may not come across as their usual likeable selves, due to nervousness, a believe that they “should” act a certain way in front of a group, etc. Some of this comes with practice, but getting feedback and simply putting greater attention on connecting with the audience can be immensely helpful.
Put Aside the Perfectionism – There are a lot of variables at play when speaking to a group, and circumstance will not always go as planned. If you are at a conference, the previous breakout session can run late, cutting into your perfectly timed presentation. The audience may turn out to have a dramatically different level of knowledge about the subject than you expected. There could be an unusually difficult audience member who won’t shut up about his own agenda. You could fall suddenly ill and have intense nausea or a hoarse voice. The list of unexpected challenges is long. Flexibility is your friend.
Make Sure Your Biographical Descriptions are Consistent – If your biographical descriptions say different things about your expertise, you may be inadvertently undermining your credibility. Audience members frequently research speakers on the Internet and through social media to determine whether or not to attend a presentation, or to evaluate a speaker’s level of expertise. Thus, it is important that your law firm biography, speaker’s biography, and LinkedIn and other social media profiles all send a consistent message.
Tell Them the Types of Law You Practice – Based on your presentation topic, audiences often make inaccurate assumptions about the scope of work that you do. If you offer a presentation about regulation of the electric grid, they may not realize that you also work on other types of energy or regulatory issues. Simply telling them at some point in your presentation, or using a range or examples, helps people recognize opportunities for working with you.
Have a Structure for Gathering Contact Information – Asking for business cards from those who wish to receive client alerts, or offering to send out slides or other supplementary materials related to your topic is a great way to gather contact information from audience members. It is important to know the policies and procedures for the particular host organization, as some provide materials to participants electronically, others will offer the speaker a list of attendees, etc. Once you know the particulars, you can make a plan for how to request contact information from participants in way that is both inviting and appropriate.
Follow up – The people who attend your program are leads, and turning them into clients generally requires follow-up. While some people who attend your presentation may immediately express interest in hiring you, most will not be shopping for an attorney right away. However, that could easily change down the line, and you want to still be in contact when it does. Therefore, it is important to have a good system in place for following up and staying in touch.
Offer Insights as Well as Information – Lawyers are great at providing information on developments in the law and other technical details, but often do not offer the type of insights and generalizations that audiences find most valuable. Such comments may require caveats, but this is where your expertise becomes most evident. In a world where it’s not that hard to look up regulations, it is the context and broader implications for which clients are paying you.
Make Content as Engaging as Possible – It is not always obvious how to liven up a presentation on a dry legal topic. However, one of the best ways is to use stories. Every case has a story behind it, and although the exact details may not be relevant to your audience, simply fleshing out the situation, and explaining a little bit about the characters, groups or context helps people to process and later recall the information. Don’t be scared to err on the side of being a little too interesting. If the audience can’t stay awake, they are a lot less likely to remember, let alone hire you.

Even highly effective and experienced speakers will likely be able to identify areas for improvement. Becoming truly great at anything, from football to parenting to business development, requires constant practice, evaluation and adjustment. The key is to just choose one or two areas to focus on at time. Progress in any of these areas is likely to increase the number or quality of your prospects.

ARTICLE BY Anna H. Rappaport of Excelleration, LLC

Huge Increase In OSHA And Certain MSHA Fines Announced

OSHA announced an increase to its penalties today of nearly 80 percent and some MSHA fines will increase by several thousand dollars as well. The new civil penalty amounts, courtesy of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, are applicable only to civil penalties assessed after Aug. 1, 2016, whose associated violations occurred after Nov. 2, 2015.

OSHA’s maximum penalties, which have not been raised since 1990, will increase by 78 percent. The top penalty for serious violations will rise from $7,000 to $12,471. The maximum penalty for willful or repeated violations will increase from $70,000 to $124,709.

MSHA’s penalties will increase in some areas and decease in others. The new minimum penalty for a 104(d)(2) Order will be $4,553 rather than $4000 and the maximum penalty for a flagrant violation will rise to $250,433 from $242,000. However, the maximum penalty for most other MSHA violations will decrease to $68,300 from $70,000.

A Fact Sheet on the Labor Department’s interim rule is available here. A list of each agency’s individual penalty adjustments is available here.

ARTICLE BY Matthew Linton of Holland & Hart LLP

DOJ Announces Dramatic Increase in False Claims Act Penalties

On May 6th, we posted about the possibility that the Department of Justice (“DOJ”) might dramatically increase False Claims Act penalties after the Railroad Retirement Board (“RRB”) nearly doubled the per-claim penalties it imposed under the FCA. After nearly two months of anticipation, DOJ published an Interim Final Rule yesterday announcing that it intended to increase the minimum per-claim penalty under Section 3730(a)(1) of the FCA from $5,500 to $10,781 and increase the maximum per-claim penalty from $11,000 to $21,563. These adjusted amounts will apply only to civil penalties assessed after August 1, 2016, whose violations occurred after November 2, 2015. Violations that occurred on or before November 2, 2015 and assessments made before August 1, 2016 (whose associated violations occurred after November 2, 2015) will be subject to the current civil monetary penalty amounts.

The penalty increases proposed by DOJ are the same as those proposed by the RRB back in May. The RRB’s increase resulted from a section of the Bipartisan Budget Act of 2015, called the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the “2015 Adjustment Act”), which required federal agencies to update civil monetary penalties (“CMPs”) within their jurisdiction by August 1, 2016. The 2015 Adjustment Act amended the Federal Civil Penalties Inflation Adjustment Act of 1990—which is incorporated into the text of the FCA—and enacted a “catch-up adjustment.” Under the “catch-up adjustment,” CMPs must be adjusted based on the difference between the Consumer Price Index (“CPI”) in October of the calendar year in which they were established or last adjusted and the CPI in October 2015.

DOJ last raised the civil penalty amounts under the FCA to their current levels in August 1999, but because the 2015 Adjustment Act repealed the legislation responsible for the 1999 adjustment, DOJ looked back to 1986 when civil penalties were set at a minimum of $5,000 and a maximum of $10,000. This calculation resulted in a CPI multiplier of more than 215% resulting in the new minimum per-claim penalty of $10,781 ($5,000 x 2.15628) and a maximum per-claim penalty of $21,563 ($10,000 x 2.15628). Under the 2015 Adjustment Act, the increases are required unless DOJ, with the concurrence of the Director of the Office of Management and Budget, makes a determination to increase a civil penalty less than the otherwise required amount. As to the FCA civil penalty, as well as scores of other civil penalties under DOJ’s jurisdiction, DOJ declined to seek this exception.

DOJ is providing a 60-day period for public comment on this Interim Final Rule. Like the rest of the health care industry, we will be watching closely to see if commenters are able to convince the Department to reconsider these astronomical penalty amounts.

ARTICLE BY Samantha P. Kingsbury & Laurence J. Freedman of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

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