Tag: Regulatory

U.S. Citizenship and Immigration Services (USCIS) EB-5 Engagement with Securities and Exchange Commission

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On April 3, 2013, representatives from the Staff of the Securities and Exchange Commission (SEC) participated with the U.S. Citizenship and Immigration Services (USCIS) in an EB-5 stakeholder conference call opened by Rob Silvers, counsel to the USCIS Director Mayorkas.  Present from the Staff were representatives from four Divisions – Corporation Finance, Trading and Markets, Investment Management and Enforcement.  The call was intended to provide general information to stakeholders.

In general, the Staff members confirmed the application of various securities laws to EB-5 programs.  For many in the EB-5 industry, the views expressed will be unwelcome news, as many have been operating under the assumption that some or all of the securities laws that apply to other investment programs do not apply to EB-5 programs.  For experienced securities lawyers working on EB-5 programs, however, the call broke no new ground but did serve as a confirmation of the advice we have been giving our clients.

Some notes about SEC Staff Interpretations

The Staff members on the call provided the standard disclaimer given in every public talk — that the views expressed represented their own and not necessarily those of the Commission as a whole.  Despite this disclaimer, Staff members are careful in their public speaking, and generally speak only considered views that have been adopted by the senior leadership of the SEC.

When considering Staff interpretations, it is important to note the structure of United States securities laws.  Federal securities laws represent various statutes passed by Congress and amended from time to time.[1] These laws frequently call upon the SEC to adopt formal implementing regulations.  In addition, the SEC Staff routinely provides informal interpretations of the securities laws and the regulations through various means.  In addition, all fifty states have their own securities laws, known as blue sky laws, and except in limited instances of federal preemption, these blue sky laws apply in addition to the federal laws.  Experienced securities lawyers will advise clients based on all of these sources of law.  However, not all of these sources of law have the same legal weight, and in particular, the views of the Staff do not necessarily represent positions that would ultimately prevail in a civil lawsuit brought by the SEC or a private plaintiff, or in a criminal action brought by the Department of Justice.  Nonetheless, the Staff’s views are often persuasive in court, and at a minimum, one can expect substantial legal expenses and regulatory entanglement from operating in a manner contrary to Staff interpretations.

Various speaker notes

The Division of Corporate Finance representative confirmed that federal securities laws apply to transactions in securities.  The SEC noted that the definition of “securities” is very broad, and likely includes most if not all of the investment vehicles used in the EB‑5 program.  The Securities Act of 1933 provides that all offers and sales of securities must be registered with the SEC unless an exemption from registration applies.  EB-5 offerings are frequently conducted in accordance with two exemptions — Regulation D, applicable to private placements of securities, and/or Regulation S, applicable to sales to non-U.S. persons.[2] Each of these exemptions has a number of requirements that must be satisfied.  The representative discussed an important condition of Regulation D – the prohibition on general solicitation (for example, advertising, publicly accessible web sites or conducting seminars where the general public is invited).  The representative noted that the SEC has proposed regulations under the JOBS Act to lift the ban on general solicitation in certain circumstances, but until such regulations are adopted, general solicitation will disqualify an offering from Regulation D.  The representative could not predict when such regulations will be adopted.  The representative noted an important caveat that an exemption from registration requirements does not mean that the offering is exempt from other provisions of the securities laws.  In particular, exempt offerings are subject to the anti-fraud provisions of the securities laws.

The Trading and Market Division representative focused on the laws requiring persons engaged in the business of engaged in the business of effecting transactions in securities for the account of others to register as broker-dealers.  The representative expressed a broad view of the types of conduct that trigger the requirement to register as a broker-dealer.  The representatives stated that in general, if someone is involved in the sale and offering of EB-5 investments and is compensated based on the success of the offering – a “salesman’s interest” in the program – that person is most likely engaging in brokerage activities which trigger the obligation to register as a broker-dealer under the Securities Exchange Act of 1934 (1934 Act).  The representative also provided a very broad view of the jurisdiction of the SEC to enforce broker-dealer requirements for persons soliciting foreign investments.  In the view of the SEC Staff, any activities using United States means of commerce, such as telephone calls made from the U.S., are likely sufficient to invoke U.S. jurisdiction for activities that require broker-dealer registration, regardless of whether the investors are foreign persons.  In response to questions, the Staff representatives noted that:

  • the Staff does not believe that the Supreme Court’s decision in Morrison v. National Australia Bank, Ltd. limiting the extra-territorial application of another section of the 1934 Act is an impediment to their enforcement activities, and
  • the broker-deal registration laws apply equally to solicitation of issuers (as opposed to investors) from within the United States.

The Trading and Market Division representative also discussed the applicability of broker-dealer registration laws to persons employed by Regional Centers to conduct offerings for the account of the Regional Center, and the availability of Rule 3a4-1 as a non-exclusive exemption from registration requirements for such persons.

The Investment Management Division representative addressed applicability of the Investment Advisers Act of 1940 and the Investment Company Act of 1940 to EB-5 programs.  The representative noted that individuals and entities that do not fall into the broker-dealer category will often be required to register under the Investment Advisers Act if they provide investment advice for compensation.  The representative noted that anti-fraud provisions apply to investment advisors, and investment advisers have fiduciary duties to their clients, including the duty to disclose all conflicts of interest.

The representative also stated that Regional Centers which pool investments for third parties and that hold securities likely are investment companies that need to register under the Investment Company Act absent an available exemption.  The representative discussed three exemptions that might be available to Regional Centers:

  • the 3(c)(1) exemption for an investment company with no more than 100 investors that is not making a public offering;
  • the 3(c)(7) exemption for qualified purchases, who must meet a significantly higher net worth standard than accredited investors; and
  • the 3(a)(2) exemption for government securities, which may apply if the Regional Center is sponsored by a governmental agency.

The Division of Enforcement representative discussed the February 2013 enforcement action brought against the Chicago Convention Center project.  The representative focused on the allegations in that case that the defendants made false representations to USCIS as part of a scheme to defraud investors.  He noted that false statements about the ability of a project to create jobs may be fraudulent under the securities laws.  He also noted that anti-fraud provisions apply not only to misstatements but also to omissions of material information.

[1] Examples of amendments include the Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act and the Jumpstart Our Business Startups (JOBS) Act.

[2] The SEC did not speak about state blue sky laws, as those are outside the SEC’s jurisdiction.  However, we note that some states do not have any exemption for programs that are excluded from federal registration requirements under Regulation S.  This is currently a significant issue for programs that do not comply with Regulation D, such as by employing general solicitation in the offer and sale of the securities.

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The Legal Challenge to the SEC’s Conflict Minerals Reporting Regulations

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In the 2010 Dodd-Frank Act, the United States Congress required, inter alia, the SEC to promulgate regulations requiring certain manufacturers to trace the sources of tin, tantalum, tungsten and gold that are contained in products they manufacture or contract to manufacture to allow them to report yearly to the SEC whether the products are “not DRC [Democratic Republic of the Congo] conflict free.” Conflict free was defined by Congress as meaning the products do not contain minerals that finance or benefit violent armed groups in the DRC or adjoining countries. Congress required the SEC action because “it [was] the sense of Congress” that the exploitation of conflict minerals from that region was financing armed groups that engaged in “extreme levels of violence” creating “an emergency humanitarian situation.”

Various industry groups lobbied heavily against the passage of the Dodd-Frank Act and later submitted comments during the SEC’s rulemaking challenging the proposed regulations’ due diligence and reporting obligations as unduly burdensome and costly. After considering the comments, the SEC, where it would not run afoul of the Congressional mandate, did reduce some of the burdens that would be imposed on industry. However, the SEC acknowledged that compliance with Congress’s intent precluded reduction of other burdensome aspects of the regulations. The SEC promulgated the regulations in August 2012.

In October, 2012, the National Association of Manufacturers, along with the U.S. Chamber of Commerce, commenced a legal challenge to the conflict minerals regulations. Since then, voluminous briefs have been filed by NAM and the SEC along with briefs by numerous interested groups. These briefs outline the parameters of the dispute and suggest that NAM faces an uphill battle.

The crux of the industry’s challenge is that the SEC failed to properly quantify the benefits and costs associated with the regulations and thereby acted arbitrarily and capriciously in promulgating them. NAM claims the reporting requirements will not aid the DRC and could cripple the region economically. It also claims that the SEC failed to agree to certain revisions that would have lessened the burdens and costs on business, like carving out a de minimus exemption for manufacturers whose products used only trace amounts of conflict minerals and predicating a burdensome due diligence requirement on whether a manufacturer had “reason to believe” that their products contained conflict minerals that may have originated in the DRC as opposed to whether the products “did originate” there. NAM asks the court to strike the entire regulation and send the SEC back to square one.

The SEC responds that it was not its responsibility to quantify the benefits of the regulations, noting that Congress had made that calculation and had determined that the benefits justified the reporting requirement Congress mandated. In fact, the SEC admitted it could not quantify the benefits because it lacked data to do so. Rather it performed a qualitative analysis. It also defends its rejection of NAM’s proposed revisions that would have reduced the costs of compliance. The SEC noted, and various members of Congress agreed, that Congress had considered and rejected the de minimus exemption because it would defeat the purpose of the rule. Congress concluded that thousands or millions of trace amounts can add up to a significant amount, the trade in which would undercut the rule’s purpose of stopping the flow of money to armed insurgents in the region. The second NAM proposal was rejected because in the SEC’s view, it would encourage willful blindness by industry. That is, if a business encountered a red flag suggesting the sources of its minerals were not conflict-free, it would investigate no further, so as to avoid a determination that they did originate there.

An interesting issue concerns the regulation’s imposition of the reporting requirements not just on manufacturers but also to those who contract for the manufacture of goods. NAM believes that this extension of the reporting requirements is contrary to the express language of Dodd-Frank. It supports its position through application of rules of construction routinely used in interpreting statutes and its argument is logical. However, former and current members of Congress came to the SEC’s aid on this issue claiming in their brief that they intended to include those who contract for the manufacturer of goods, again to prevent exemptions that would significantly undercut what the regulations sought to achieve.

Oral arguments are scheduled for May 15, 2013. It will be very interesting to see how receptive the panel from the DC Circuit is to NAM’s arguments. Asking the court to scuttle the entire regulation, the parameters of which Congress as a matter of policy framed, makes NAM’s challenge all the more difficult.

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Replication without Human Intervention: Lessons from Monsanto v. Bowman

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Until now, the practicing of an invention needed some direct form of human action; someone was needed to “do something” to bring the invention into existence, as well as replicate it by making more (in the case of a physical object) or performing it again (in the case of a method). However, this may no longer be necessary in all instances. At least in the case of some biological technologies, once an invention has been created by a human, further human intervention may no longer be needed for replicating the invention. In these instances, does a patent owner lose the right to exclude future uses, sales, offers for sale or importations of such an invention?

In Monsanto v. Bowman, the Supreme Court is poised to bring some clarity to this question. Monsanto Company designs and manufactures herbicide-resistant soybean seeds and related technology. Monsanto sold patented seeds to farmers for growing and resale as commodity items to be used in such things as public-school lunches and animal feed. Such sales were made under license agreements that allowed the beans to be sold without any ongoing restrictions on the use of those beans.

Vernon Bowman is a soybean farmer. Bowman purchased these beans and replanted them as second-generation seeds, which were the products of seeds purchased from a licensed Monsanto technology distributor.

Monsanto sued Bowman for patent infringement, arguing that the beans were products of Monsanto’s patented herbicide-resistant seeds and that, by planting them instead of purchasing new seeds, Bowman violated the Monsanto Technology Agreement for the seeds. The U.S. District Court found that Bowman’s activities infringed upon Monsanto’s patent and awarded damages to Monsanto for violation of its patented technology. The Federal Circuit agreed and upheld the decision, holding that Monsanto’s patent covered both the original seeds and a product of the original seeds, such as those second-generation beans grown by Bowman.

Bowman appealed, arguing that, under the doctrine of patent exhaustion, Monsanto’s patent rights were exhausted upon its initial sale of the seeds that Bowman later purchased from the licensed distributor, and that use of progeny seeds is an expected use of the product. In response, Monsanto argued that in the case of self-replicating technologies, such as seeds that grow and produce more seeds, the patent extends to the underlying technology (i.e., herbicide resistance) and not only to the seed itself.

The important question raised in this case is whether an exception to the doctrine of patent exhaustion for self-replicating technologies is needed and/or warranted. While this question is clearly important to the biotechnology and agricultural industries, it also has the potential to significantly affect the software and robotics industries. For example, as robotics and artificial intelligence become increasingly sophisticated in their abilities to adapt and “grow,” it does not seem too outlandish to think that, one day, these may also become self-replicating technologies.

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National Labor Relations Board (NLRB) Issues Guidance on Lawful Confidentiality Language

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On July 30, 2012, the NLRB (“Board”) issued a decision in Banner Health System dba Estrella Medical Center, 358 NLRB No. 93 holding, among other things, that the employer violated Section 8(a)(1) (which prohibits employers from interfering, restraining or coercing employees in the exercise of their rights), by restricting employees from discussing any complaint that was then the subject of an ongoing internal investigation.

To minimize the impact of such a confidentiality mandate on employees’ Section 7 rights, the Board found that an employer must make an individualized determination in each case that its “legitimate business justification” outweighed the employee’s rights to protected concerted activity in discussing workplace issues.  In Banner Health, the employer did not carry its burden to show a legitimate business justification because it failed to make a particularized showing that:

  • Witnesses were in need of protection;
  • Evidence was in danger of being destroyed;
  • Testimony was in danger of being fabricated; or
  • A cover-up must be prevented.

The Board concluded that the employer’s one-size-fits-all rule, prohibiting employees from engaging in any discussion of ongoing internal investigations, clearly failed to meet these requirements.

More recently, the NLRB’s Office of the General Counsel clarified the limits of how such policies could be drafted without running afoul of Section 7 in an advice memorandum released on April 24, 2013 (dated January 29, 2013).   The Region had submitted Verso Paper, Case 30-CA-089350 (January 29, 2013) to the Office of the General Counsel for advice regarding the confidentiality rule at issue and whether it unlawfully interfered with employees’ Section 7 rights.  Specifically, the Verso Code of Conduct contained this provision prohibiting employees from discussing ongoing internal investigations:

Verso has a compelling interest in protecting the integrity of its investigations.  In every investigation, Verso has a strong desire to protect witnesses from harassment, intimidation and retaliation, to keep evidence from being destroyed, to ensure that testimony is not fabricated, and to prevent a cover-up.  To assist Verso in achieving these objectives, we must maintain the investigation and our role in it in strict confidence.  If we do not maintain such confidentiality, we may be subject to disciplinary action up to and including immediate termination.

Reiterating that employees have a Section 7 right to discuss disciplinary investigations of their co-workers, the General Counsel’s Office found that the Verso Paper provision did not allow for a case-by-case analysis of whether or not the employer’s business justification for the restriction outweighed the employees’ Section 7 rights as required by Banner Health.  According to the General Counsel’s Office, the employer may establish this by presenting facts specific to a given investigation that give rise to a legitimate and substantial business justification for imposing confidentiality restrictions.

However, in footnote 7 of its advice, the General Counsel’s Office, after noting that the first two sentences of the Verso Paper rule lawfully set forth the employer’s interest in protecting the integrity of its investigations, surprisingly put forward a modified version of the remainder of the Verso Paper provision that it said would pass muster under Banner Health:

Verso may decide in some circumstances that in order to achieve these objectives, we must maintain the investigation and our role in it in strict confidence.  If Verso reasonably imposes such a requirement and we do not maintain such confidentiality, we may be subject to disciplinary action up to and including immediate termination.

Although this guidance is not binding, combining this language above with the first two sentences of the Verso Paper provision could certainly strengthen an employer’s argument that its intent was not to violate an employee’s Section 7 rights, but rather, to lawfully put employees on notice that if the employer “reasonably” imposes a confidentiality requirement, they must abide by it or face discipline.  However, employers must remain mindful that using a provision like this suggested does not obviate the need for the employer to engage in the particularized case-by-case determination of its substantial and legitimate business need that would permit it to impose confidentiality restrictions on the investigation.

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Twitter: Little Statements with Big Consequences for Companies

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Twitter is under attack. In recent months, accounts belonging to media giants CBS, BBC, and NPR have all been temporarily taken over by hackers. The Associated Press is the most recent victim. On April 23, 2013, a false statement about explosions at the White House and the President being injured sent shock waves through the Twitter-sphere. The real surprise is the effect the single tweet had in the real world: the Standard & Poor’s 500 Index dropped so sharply moments after the frightening tweet that $136 billion in market value was wiped out. While the hacking of these massive media outlets make headlines, everyday businesses are not safe from the threat, either. In February of this year, a hacker changed the @BurgerKing feed to resemble that of McDonald’s, putting the McDonald’s logo in place of Burger King’s. The hackers posted offensive claims about company employees and practices. If accounts belonging to well-established companies like these are vulnerable, so is yours. If a tweet can have a profound impact on the nation’s stock market, imagine what an ill-contrived tweet could do to your business.

Business owners may have the knee-jerk reaction to delete their Twitter account, but despite the recent blemishes to its security, Twitter remains one of the most important social media sites out there. Just recently, the Securities Exchange Commission made clear that companies could use social media like Twitter when announcing key information in compliance with Regulation Fair Disclosure. Twitter is not just a marketing or PR tool—Twitter is business. And you should never turn your back on existing business. So instead of hanging up your hashtags, consider some steps that can make your Twitter account safer.

Limit Access

Not every employee should have access to the company’s Twitter account. In fact, hardly anyone should, except a few designated employees like the marketing director or business owner. While those with access may never do anything harmful to the account, the more people who have the log-in information, the more likely it is to fall into the wrong hands.

Create a strong password

I know, you already have too many passwords to remember. But a creative password is your best defense against someone seeking to break into your account. Employers should, at minimum, have unique passwords for their most commonly used media sites; please do not use the same word for your Facebook, LinkedIn, and Twitter account. Once a hacker figures it out, they have control of your entire social media presence.

When creating a password, avoid using anything that would be too common. “Password,” “1234,” or the business’s name should never be the only thing standing between you and a hacker. The longer the password, the better. Use a mix of uppercase and lowercase letters, numbers, and symbols.

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Federal Trade Commission’s (FTC) New Chairwoman Ramirez Says Health Care Continues To Be Top Priority

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In remarks made this week at the International Competition Network annual conference, Federal Trade Commission (FTC) Chairwoman Edith Ramirez stated that health care will continue to be a top priority for the FTC.   Referring to health care and hospital mergers in particular, she said that the Commission will “guard[] against what we consider to be consolidation that may end up having adverse consequences for consumers.”  The Chairwoman’s comments indicate that the recent leadership change at the FTC from former Chairman Jon Leibowitz to Chairwoman Ramirez has not altered the Commission’s priorities.

Recent months have seen a flurry of FTC activity in the courts related to health care.  For example, two FTC cases came before the U.S. Supreme Court this term — the FTC’s challenge to Phoebe Putney’s acquisition of Palmyra Park Hospital in Georgia and the FTC’s challenge to “pay-for-delay” patent infringement litigation settlements between branded and generic pharmaceutical manufacturers.

In February, the Supreme Court ruled that the state action doctrine did not immunize Phoebe Putney’s hospital transaction from federal antitrust scrutiny, and the FTC has subsequently filed renewed motions in federal district court to stop further integration of the two hospitals even as it prepares for a full administrative hearing on the merits that will begin in August.

A decision on the “pay-for-delay” case is expected in June.  The Supreme Court’s ruling may have a large impact on further FTC efforts against what it perceives as anticompetitive efforts to delay generic drug entry.

Health care clients considering acquisitions are advised to consult antitrust counsel early in the transaction process.  Given the FTC and DOJ’s close scrutiny of health care transactions, early advocacy before the antitrust agencies is often critical to a deal closing on schedule.

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Automation of U.S. Customs & Border Protection (CBP) Form I-94 and Release of New Immigration Form I-9

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Visitors to the United States May Need to Print Form I-94 Arrival/Departure Records

U.S. Customs & Border Protection (CBP) will begin a new program on April 30, 2013 that will end issuance of paper Form I-94 Arrival/Departure Records for many visitors. Foreign visitors arriving in the United States via air or sea who need to prove their lawful immigration status will be required to access their arrival information online and print their own Form I-94 Arrival/Departure Records (Form I-94). A hard copy of Form I-94 is required to begin employment, apply for a Social Security Number, and obtain a driver’s license or identification document.

CBP indicated that it expects this automation to save the government an estimated $15.5 million per year. Because advance information is transmitted only for air and sea travelers, CBP will continue to issue paper Forms I-94 at land border ports of entry.

CBP will phase in the I-94 automation at air and sea ports of entry in April and May. Foreign visitors will continue to receive a paper I-94 until the automated process arrives at their port of entry. If a visitor does not receive a paper Form I-94 record to verify immigration status or employment authorization, the record number and other admission information will be available here. A CBP officer will stamp the travel document (passport) of each arriving nonimmigrant traveler showing the date of admission, class of admission and the date until which the traveler is admitted. The visitor will not need to print Form I-94 to provide to the government upon departure. A CBP Fact Sheet may be found here.

All U.S. Employers Required to Use New Employment Eligibility Verification Form I-9 as of May 7, 2013

U.S. Citizenship and Immigration Services (USCIS) will require all U.S. employers to use its revised Employment Eligibility Verification Form I-9 as of May 7, 2013. All employers are required to complete an Employment Eligibility Verification Form I-9 (Form I-9) for each new employee hired in the United States. The updated Form (Revision Date 03/08/13) includes new information fields and has been expanded to two pages. USCIS has stated that the new formatting will reduce errors and provide clearer instructions for both employees and employers. The List of Acceptable Documents has not changed.

Employers should NOT require current employees to complete the new Form I-9. The new Form will be used only for new employees or when reverifying the work authorization for current employees. The new employee may complete the Form after acceptance of the job offer, and no later than the first date of hire. The new instructions confirm that an employer has three business days to complete the Form; in the case of reverification, the employer must re-verify the document(s) before the work authorization expires.

The new Form I-9 does NOT change any requirements relating to remote hires. USCIS’s position is that the employer representative who signs the attestation must be the same person who physically examines each original document to determine if it reasonably appears to be genuine and relates to the employee. An employer with remote hires may delegate the verification to a person who serves as an agent of the employer, but that agent must examine the documents and complete Section 2 or Section 3 of the Form I-9. The employer retains the liability for the actions of the agent.

A Spanish language version of the new Form is also available on the USCIS website for use in Puerto Rico only. Spanish-speaking employers and employees in the 50 states, Washington, DC, and other U.S. territories may refer to the Spanish version but must complete the English-language version of the Form.

Employers may receive monetary fines for all substantive and uncorrected technical Form I-9 violations. Penalties for these violations, which include failure to utilize the correct version of the Form I-9, range from $110 to $1,100 per violation.

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Early Patent Trial and Appeal Board Orders Demonstrate Differences Between America Invents Act (AIA) Patent Trials and District Court Trials

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Patent practitioners are still absorbing some of the differences and advantages that are unique to litigation in the PTAB as opposed to district court litigation.  For example, PTAB proceedings only decide questions of validity and are not directed to rule on questions of infringement or damages, as is the practice in traditional litigation.  Another example is that PTAB trials require that the petitioner provide a lot of technical arguments and factual evidence in the original petition, as opposed to traditional litigation where parties make sure they have a good faith basis to sue and then rely on discovery to later develop the case.  Thus, a petition for review of patentability in PTAB practice is more akin to a summary judgment motion than a complaint in trial practice.  But a PTAB petition is still very different than a summary judgment motion.  And these differences can be exploited to more inexpensively and quickly resolve validity issues.

In considering summary judgment, a judge must decide if there is “no genuine dispute as to any material fact,” as set forth in FRCP Rule 56.  In contrast, the technical patent judges on the Board can decide technical disputes instantly and can resolve disputes of technical and legal nature.  PTAB panels use their technical and patent law experience to quickly identify dispositive issues and focus the parties on how their respective positions are being viewed by the Board early in the proceedings.  This means that PTAB trials will put a premium on identification of technical defects in patents early in the proceedings, as opposed to traditional litigation approaches that favor discovery before attempting summary judgment or that shy away from summary judgment as a mechanism for resolution of complex technical disputes.

Examples of the Board’s unique capabilities are already being demonstrated in recent orders.  For example, in an inter partes review by Chimei Innolux Corporation against Semiconductor Energy Laboratory Co.,Ltd. concerning U.S. Patent No. 8,068,204 (IPR2013-00068), the Board squarely addressed technical disputes between what the petition asserted versus what the patent owner’s preliminary statement set forth when the Board decided to institute trial.

The Board took great care to understand and sift through extremely technical differences between the claimed subject matter and the prior art as it was characterized by the parties.  This is a highly complicated task, because the patent relates to improvements for substrate bonding and electrical connections in liquid-crystal displays and because the parties were advancing very technical arguments on both sides of the validity issue.  In this early order to institute trial the Board construed a phrase from the claims and used that construction to decide the merits of the positions taken by the petitioner and patent owner.  The Board then considered technical arguments made by both parties, such as whether a reference used in combination in an obviousness challenge teaches away from the combination (page 15), or whether it would have been obvious to employ a known (contact) structure (page 18).  The Board decided that certain arguments were not persuasive and used the order to focus the parties on the issues it ruled upon.  The following excerpt from pages 19-21 of the the order instituting trial demonstrates the attention to detail that the Board is devoting to these proceedings:

SEL responds that “[. . .] a person of ordinary skill in the art does not know whether an insulating film (first insulating film) is formed between the bottom layer of the first wiring line 127 (formed in the step of forming the scanning lines Yj) and the top layer of the first wiring line 127 (formed in the step of forming the data lines Xi).” (Prelim. Resp. 31.) According to SEL, Shiba’s “‘two-layered structure’” might be “sequentially stacked” without an insulating layer therebetween. (Id.) As noted, claim 31 requires such an intervening insulating layer.

SEL’s argument is not persuasive. Shiba implies or suggests that the two wiring layers in the two-layered structure 127, formed in the same manner as the two-layered scanning and data lines as the quoted passage shows, have an insulating layer therebetween just like the scanning and data lines. [cite omitted]  [. . .  .]  Skilled artisans also would have understood that overlapping portions readily could have been “partially connected” together by known methods, including using a connecting hole through such an insulating layer. [cite omitted]

Because the two-layered structure in Shiba’s lines 127 connect to pad 751, SEL maintains that under various hypothetical scenarios, pad 751 also must have a two-layered structure, and as such, with Sukegawa’s transparent layer modified to be on Shiba’s pad as CMI proposes in its ground of unpatentability, the pad structure would become a three-layered structure. . . .  SEL also argues that the Petition inconsistently conflates or interchanges Sukegawa’s transparent layer and the top layer of Shiba’s two-layered wiring structure 127, and thereby fails to show how the combination renders obvious the external connection line and transparent conductive film as recited in claims 31 and 54. (See Prelim. Resp. 25-26.)

It is clear from the analysis set forth by the Board that it is not afraid to weigh in on very technical issues and clarify how it perceives the arguments.  Of course, the preliminary response by the patent owner is considered a first initial response and is not a comprehensive response with evidence.  Therefore, the Board’s institution of trial is based on limited argument and is well before the patent owner has had an opportunity to fully respond.  But this process focuses the parties on issues that the Board (at least initially) perceives to be negative to the patent.  It is a preliminary ruling on the disputed issues by the Board that will shape discovery to come, as opposed to traditional litigation where discovery often leads and shapes the issues brought before the court.

Parties who believe that an asserted patent has validity issues may find it difficult to challenge disputed technical issues in summary judgment motion practice.  Validity issues are frequently accompanied with fact questions and in litigation there is a clear and convincing standard for invalidity that makes it hard to prove invalidity.  And it is unlikely that counsel will recommend a motion for summary judgment before conducting at least some discovery.  In contrast, in patent reviews and reexaminations the burden of proof is based on a preponderance of the evidence and can be done without discovery.  Given the different standards and the costs of e-discovery, there are significant advantages to the PTAB patent review option for defendants with genuine validity arguments.  But one must be careful to choose the PTAB trial option carefully to avoid estoppel should the proceeding not result in destruction of the relevant patent claims.

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Making Copies! The Fourth Circuit Defines Taxable Costs Associated With eDiscovery

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Can this happen to your client? Your client gets sued, is forced to spend over $100,000 on eDiscovery despite you making all the right objections, you deliver a clean victory on dispositive motions and the District Court awards costs of … $200. Here is what happened in the Fourth Circuit and what you can do to help your clients avoid the same fate:

The Fourth Circuit just decided the scope of taxable eDiscovery costs under 28 U.S.C. § 1920(4) in Country Vintner of North Carolina v. E. & J. Gallo Winery, Inc., __ F.3d __, 2013 WL 1789728 (4th Cir. Apr. 29, 2013). Section 1920(4) allows the District Courts to “tax as costs … [f]ees for exemplification and the costs of making copies of any materials where the copies are necessarily obtained for use in the case.” Id. 1   Under Federal Rule of Civil Procedure 54(d)(1), the cost of making copies “should be allowed to the prevailing party.” As an initial matter, the Fourth Circuit concluded that section 1920(4) applies to the costs related to documents produced in discovery – not just used at trial or in connection with a dispositive motion. Country Vintner, 2013 WL 1789728, *7. The Fourth Circuit then examined the meaning of “making copies,” and held that section 1920(4) “limits taxable costs to … converting electronic files to non-editable formats and burning files onto discs.” Id., *9. 2   In reaching that conclusion, the Fourth Circuit explicitly rejected the argument that “ESI processing costs constitute[d]” “making copies” under Section 1920(4). Id., *7. As a consequence, Appellant Gallo was awarded only $218.59 out of the $111,047.75 in eDiscovery costs it sought.

What does that mean?

Appellant Gallo sought more than $70,000 for “indexing” and “flattening” ESI – processing methods that extracted irrelevant files and duplicates, made the remaining data searchable, and organized the data; spent more than $15,000 extracting and organizing metadata and preparing it for review; less than $100 on electronic bates numbering; and over $20,000 on quality assurance and preparing the document production. None of these costs were taxed. Instead, Gallo received only $178.59 to convert certain native files into TIFF and PDF format and another $40 to burn images onto CDs. While the documents could not be “copied” without all of the processing that preceded it, such processing costs will not be shifted through a bill of costs. Id., *8-9 (citing Race Tires Am., supra n. 2, 674 F.3d at 169).

What lessons can we learn?

The Fourth Circuit seems to recognize the harshness of its ruling and provides two helpful clues for future litigants seeking to manage their eDiscovery burdens. The court first observes: “That Gallo will recover only a fraction of its litigation costs under our approach does not establish that our reading of the statute is too grudging in an age of unforeseen innovations in litigation-support technology.” Id., *9. Then, the court leaves open the question of whether the allowable costs of production might include the processing costs had the parties “clearly agreed to the production of ESI on a particular database or in native file format.” Id., *9 n. 20 (citing In re Ricoh Co., Ltd. Patent Litig., 661 F.3d 1361, 1365–66 (Fed. Cir. 2011) (holding that $234,702.43 for the cost of an electronic database which the parties agreed to use for document production would have been allowed, but for the parties’ agreement to share costs)). Next, the court points out that, where discovery costs are excessive, the responding party can move for a protective order and, if that motion is denied (as Gallo’s motion was denied), then the responding party “can appeal that decision” Id., *9; id., *9 n. 21 (noting that Gallo had not appealed the denial of its motion for protective order).

Lesson #1: While it is not entirely clear how the parties’ agreement to utilize a particular format or database alters the conclusion that processing is not “making copies,” the Fourth Circuit seems to suggest that it might. 3  So, any party seeking to shift its eDiscovery costs should consider agreeing with the other side regarding the format or database to be used to handle the parties’ productions.

Lesson #2: While it is not entirely clear whether parties are entitled to file an interlocutory appeal with respect to the denial of a motion for protective order, the Fourth Circuit seems to urge parties to do so. 4  Either the court is encouraging interlocutory appeals before the ESI expenses are incurred, or the court is suggesting that a final judgment (for either party) does not moot the trial court’s refusal to shift pre-trial eDiscovery costs.

 1 Because appellant Gallo’s eDiscovery costs neither involved authentication of public records nor demonstrative exhibits – two potential meanings of exemplification – the Fourth Circuit did not define the meaning of exemplification in this case.  Country Vintner, 2013 WL 1789728, *10.

 2 In reaching that conclusion, the Fourth Circuit aligned itself with the Third Circuit’s approach in Race Tires Am., Inc. v. Hoosier Racing Tire Corp., 674 F.3d 158 (3d Cir. 2012).

3  In distinguishing In re Ricoh Co., the Third Circuit explained: “we have acknowledged that the costs of conversion to an agreed-upon production format are taxable as the functional equivalent of ‘making copies.’ It is all the other activity, such as searching, culling and deduplication that are not taxable.” Race Tires Am., 674 F.3d at 171 n.11.

 4 On one hand, discovery orders against a party are not immediately appealable. See, e.g., Nicholas v. Wyndham Int’l, Inc., 373 F.3d 537 (4th Cir. 2004). On the other hand, most discovery orders will be moot by the time a final order is entered. See, e.g., E. H. Reise v. Bd. of Regents of the Univ. of Wisconsin, Sys., 957 F.2d 293, 295-296 (7th Cir. 1992).

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Vapor Intrusion Regulation and Environmental Remediation

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EPA recently issued two draft guidance documents on vapor intrusion and will accept comments on them through May 24, 2013. If finalized in current form, these guidance documents would formalize and enhance EPA’s existing practice of prioritizing vapor intrusion as a central issue in environmental remediation and could result in increases in the expense and effort required from responsible parties to achieve compliance for cleanup of contaminated sites conducted under federal authorities such as CERCLA or RCRA. They could also be highly influential in clean-ups overseen by state regulators.

Lastly, while intended for use in the regulatory context, recommendations in these guidance documents may be used to establish a standard of care in litigation involving vapor intrusion (e.g., RCRA citizen suits or common law toxic tort litigation).

Vapor intrusion is the migration of hazardous vapor from contaminated soil or groundwater into an overlying building.  It is considered potentially harmful to human health, creates risks in real estate transactions and financing due to potentially diminished property values and environmental liability, increases exposure in toxic tort litigation, and, in the federal regulatory context, is considered a pathway of possible exposure that must be evaluated as part of the evaluation and selection of a site remediation plan.

The first of these two guidance documents was prepared by EPA’s Office of Solid Waste and Emergency Response (OSWER) and is a comprehensive set of technical and policy recommendations regarding indoor air contamination arising from subsurface-source vapor intrusion attributable to all classes of volatile, or vapor-forming, chemicals (VI Guidance).[1]  The VI Guidance modifies and expands draft guidance on vapor intrusion issued by the agency in 2002 (2002 Draft VI Guidance), which provided general direction for evaluating the potential for vapor intrusion pathways at cleanup sites but omitted any measures for delineation and mitigation of potential risks.[2]  In a 2009 report, EPA’s Office of the Inspector General (OIG) recommended that EPA update the 2002 Draft VI Guidance to reflect the numerous technical and policy advancements made since that time in both the public and private sectors.

The second guidance document was prepared by EPA’s Office of Underground Storage Tanks (OUST) and is focused on investigations and assessments at petroleum contaminated sites where vapor intrusion by petroleum hydrocarbons may occur (Petroleum VI Guidance).[3]

VI Guidance

The VI Guidance presents a step-by-step vapor intrusion assessment plan, beginning with gathering and evaluating data for an initial conceptual site model, through collecting and evaluating additional data from various sources, and culminating in a risk assessment.  According to EPA, the VI Guidance addresses the recommendations made in the OIG’s 2009 report and takes into consideration more recent guidance developed by states and other technical working groups.  Some of the elements in this document may well trigger an increase in expense in addressing VI risks and lengthen the site evaluation process.

·        Superfund Five-Year Reviews: At Superfund sites that require five-year reviews,[4]EPA will gather data on vapor intrusion pathways and assess the sufficiency of the selected remedy for follow up in the five-year review report.  Therefore, according to the VI Guidance and related Directive 9200.2-84,[5] the five-year review process could result in the re-opening of established Superfund remedies to address vapor intrusion, “even if vapor intrusion was not addressed as part of the original remedial action.”[6]

·        Preemptive Mitigation/Early Action: EPA recommends consideration of engineered methods to reduce vapor in buildings (e.g., by installing a radon-type detection system or vapor barriers), even in the absence of all pertinent lines of evidence necessary to characterize the vapor intrusion pathway.  Any such measure would be an early effort to cut off exposure before completing investigations, but would not address the subsurface vapor source.  The agency’s rationale is that installation of engineered exposure controls in buildings is typically more cost-effective and less disruptive than conventional vapor intrusion investigations and subsurface characterization.  Once preemptive mitigation measures are installed, however, that may conclude only an initial step rather than complete remediation.  In the context of brownfields programs, treating preemptive mitigation now as only an interim solution may affect long term redevelopment plans.

·        Aggregate Noncancer Health Risk: Even when the exposure level for each contaminant at a site is below screening levels and it is assumed that each “acts independently (i.e., there are no synergistic or antagonistic toxicity interactions among the chemicals)”, the VI Guidance nevertheless proposes that a risk manager aggregate the individual noncancer health risks associated with each contaminant exposure to determine whether a response is warranted.  The aggregated risk is reflected in a “noncancer hazard quotient” that would ultimately drive the response.  This approach could be overly precautionary if the aggregated sum overstates the actual risks presented by the individual constituents.  Furthermore, the VI Guidance recommends use of multiple lines of evidence in calculating and evaluating these risks, a process that may prolong response decisions and negatively affect situations where quick resolution of VI issues is paramount (e.g., brownfield redevelopment projects).  On the other hand, evaluation of multiple lines of evidence may be more advantageous to the extent it provides for a more informed view of likely risk.

·        Background Levels: Time-integrated sampling of volatile chemicals (as opposed to short-duration, or “grab” sampling) at multiple locations in and around a site is, in EPA’s view, necessary to distinguish among potential sources of these chemicals (i.e., ambient sources, indoor sources, or vapor intrusion).  In the past, generic values of historic background concentrations have been used to characterize ambient or indoor source concentrations.  However, EPA now recommends against the use of these generic values, even those from peer-reviewed sources, and instead asserts that only site-specific data (e.g., sub-slab, indoor air, and ambient air sampling data) should be used.  This recommendation will likely lead to improved accuracy and better understanding of site conditions, while at the same time increasing the time and cost related to characterization efforts.

Petroleum VI Guidance

The 2009 OIG report expressed concern that EPA’s 2002 Draft VI Guidance did not address petroleum vapor intrusion at UST sites.  The proposed Petroleum VI Guidance seeks to address that concern for UST sites and RCRA-driven activities undertaken by private UST owners and operators.  In addition to the traditional chemicals found in petroleum products (such as benzene), the Petroleum VI Guidance would require consideration of vapor risks associated with gasoline additives (such as MTBE) and chemicals that develop from biodegradation of petroleum in soil and groundwater (such as methane).

As proposed, at least two parts of the Petroleum VI Guidance may, in comparison with past experience, result in increased response costs and delays for responsible parties.[7]  First, the Petroleum VI Guidance rejects the notion that a single sampling event is a sufficient basis to conclude that further vapor intrusion investigation is unnecessary because “periodic monitoring and sampling over more than one annual cycle is generally needed” to address fluctuations in groundwater levels and contaminant plumes over time.  Second, the Petroleum VI Guidance includes a number of recommendations that suggest EPA seeks to reduce reliance on models.  Specifically, when modeling requires the use of literature values due to the unavailability of site-specific data, EPA “recommends that an uncertainty analysis be conducted to provide error bounds on predictions of the computer model,” and that the results of any modeling exercise be verified with field data.

Considerations for Both Guidance Documents

In conclusion, both of these proposed guidance documents signal an increased focus on vapor intrusion within EPA.  As they are amended and finalized, there is a limited opportunity to comment on them to try to encourage a final guidance that is workable and effective for remediation of sites with vapor intrusion issues.  There may be ways to improve the guidance by clarifying where there is site-specific flexibility and where the guidance is overly prescriptive.

Notably, these guidance documents may help define the standard of care in the context of RCRA citizen suits or common law toxic tort litigation.  Clarifying key assumptions in the guidance may buffer some of that impact.

Even though these guidance documents are in draft form and will likely be subject to considerable comment, EPA regions and states can be expected to consult and employ them during what may be a long interval before they are finalized.  To the extent EPA or a state regulatory agency does so and an affected party disagrees with aspects of the guidance at issue, parties should be aware that the draft guidances are non-binding on their face.  The documents state that they do “not impose any requirements or obligations on the [EPA], the states, or the regulated community.”  Accordingly, parties should be free to suggest alternative, technically sound approaches to regulators.  Moreover, because these documents are solely drafts and have not been tested by external expertise that will be provided in public comment, reliance on them in their current state is arguably premature.

Given the potential long term impact on cleanup requirements, interested parties should evaluate the guidance and strongly consider submitting comments to EPA by May 24, 2013.  In light of the complex technical issues involved, interested parties may also wish to request that EPA extend the comment period.

[1] EPA OSWER, “Final Guidance for Assessing and Mitigating the Vapor Intrusion Pathway from Subsurface Sources to Indoor Air” (Apr. 11, 2013)

[2] EPA OSWER, “Draft Guidance for Evaluating the Vapor Intrusion to Indoor Air Pathway from Groundwater and Soils” (Nov. 29, 2002).  This draft document was never finalized.

[3] EPA OUST, “Guidance for Addressing Petroleum Vapor Intrusion at Leaking Underground Storage Tank Sites” (Apr. 9, 2013).

[4] Section 121 of CERCLA (42 U.S.C. § 9621) requires that remedial actions that result in any hazardous substances, pollutants, or contaminants remaining at the site be re-evaluated every five years to ensure that the remedy is and will continue to be protective of human health and the environment.

[5] “Assessing Protectiveness at Sites for Vapor Intrusion: Supplement to the ‘Comprehensive Five-Year Review Guidance’” (Nov. 14, 2012).

[6] In a related context, EPA officials have already acknowledged that later discovery of vapor intrusion at Superfund sites may trigger parties to litigate over whether site remedies provided for in consent decrees should be revisited under the reopener provisions in those decrees.  SeeInsideEPA, “EPA Official Says Vapor Intrusion May Drive Suits To Reopen Cleanup Pacts” (May 3, 2013), available at http://insideepa.com/201305032433234/EPA-Daily-News/Daily-News/epa-official-says-vapor-intrusion-may-drive-suits-to-reopen-cleanup-pacts/menu-id-95.html?s=mu. 

[7] These issues may also be relevant in scenarios involving vapor intrusion from sources other than those covered by the Petroleum VI Guidance.  However, because these points were emphasized in that guidance document, we highlight them here.

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