Category: Administrative & Regulatory

Second Circuit Certifies Smoking-Related Medical Monitoring Issue for Ruling by New York High Court

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In an effort to clarify the availability and scope of medical monitoring claims under New York law, the Second Circuit last week certified to the New York State Court of Appeals questions relating to whether smokers who have not been diagnosed with a smoking-related disease may bring a stand-alone claim against a tobacco company for medical monitoring. The Court of Appeals’ decision will likely have broad implications for toxic tort cases involving allegations of potential health effects.

The action was brought by long-term smokers who had not contracted lung cancer. They alleged that Defendant Philip Morris USA, Inc. knew that it was feasible to develop a less carcinogenic cigarette, but deliberately designed its product to deliver an excessive amount of carcinogens when smoked. As relief for their claims of negligence, strict liability and breach of warranty, the plaintiffs sought funding for a medical monitoring program to address their increased risk of lung cancer.

The Second Circuit affirmed Defendant’s motion to dismiss the smokers’ claims of negligence, strict liability and breach-of-warranty claims. Rather than dismiss the request for medical monitoring outright, however, the Circuit judges asked the Court of Appeals to consider whether, under New York law, a current or former heavy smoker not diagnosed with smoking-related disease may pursue an independent equitable cause of action for medical monitoring for such a disease. If the court determines that an independent cause of action for medical monitoring exists, the Second Circuit asked the court to then consider what the elements of that cause of action would be, what statute of limitations would apply, and when the cause of action would begin to accrue.

Although several New York courts have allowed medical monitoring damages as a remedy in connection with other claims, the Second Circuit noted that no New York court has directly addressed the questions it certified, and invited the Court of Appeals to expand on or alter those questions as it sees fit. Regardless of the result reached by the Court of Appeals, its decision in this matter will likely have far-reaching effects on the availability and scope of medical monitoring claims and remedies under New York law.

Seventh Circuit Addresses Obligations Regarding the Interactive Process under the Americans With Disabilities Act (ADA)

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A common scenario often faced by employers under the Americans with Disabilities Act (ADA) involves an employee’s request for time off as a reasonable accommodation. In Basden v. Professional Transportation, Inc., No. 11-2880 (7th Cir, May 8, 2013), the Seventh Circuit U.S. Court of Appeals provides guidance in this area. There, the court explained that the employer was not liable under the ADA, even though it failed to engage in the interactive process, because the employee failed to show that the requested accommodation (a 30-day leave) would have resulted in her ability to perform the essential functions of the job.

Employee Two Weeks Shy of Leave Entitlement

Professional Transportation, Inc. (PTI) provides 24-hour ground transportation services. Terri Basden was hired as a dispatcher in June, 2007. After numerous absences in 2007 and early 2008, she received a verbal warning for absences in March 2008 and a written warning for further absences in April 2008.

Basden provided doctors’ notes reflecting that she had been referred to a neurologist with a possible diagnosis of multiple sclerosis after emergency room tests showed brain abnormalities indicative of the disease. After several job transfers, Basden was granted a request for a part time position on May 1, 2008. She incurred additional absences in May which resulted in suspension. While on suspension, Basden submitted a request for a 30-day leave of absence due to “complications due to medical illness (MS).” PTI policy provides employees with one year of service may be eligible to take a 30-day, unpaid leave of absence. However, Basden had not been employed for one year. PTI denied her request for leave, and thereafter terminated Basden when she failed to return to work following her suspension.

Employee Could Not Show Leave Would Enable Her to Perform Essential Functions

Basden sued PTI, claiming that PTI violated the ADA by terminating her instead of accommodating her request for 30 days leave, that PTI failed to engage in the interactive accommodation process required by the ADA, and that PTI did not show that the requested leave was unreasonable. The district court granted summary judgment for PTI.

On appeal, the Seventh Circuit first observed that an employee’s request for an accommodation under the ADA requires the employer to engage in a flexible, interactive process to identify a reasonable accommodation. In this case, the employee requested a 30-day leave that, according to the employer’s policy, she would have been eligible for with two weeks’ additional seniority. The court noted that PTI’s response to this request, specifically, failing to engage in an interactive process, denying the leave, and terminating her, was not an appropriate employer response under the ADA.

However, the court held that PTI’s actions did not violate the ADA. The failure to engage in the interactive process is not an independent basis for liability under the statute, and in any event, such a failure is actionable only if it prevents identification of an appropriate accommodation. Thus, even if an employer fails to engage in the interactive process, that failure need not be considered if the employee fails to show that she was able to perform the essential functions of her job with an accommodation.

Here, PTI cited regular attendance as an essential function of Basden’s job. Yet, Basden did not demonstrate that she was able to come to work regularly at the time of her termination, or that her regular attendance could have been expected either following the requested leave or with any other accommodation. Therefore, the court held, summary judgment for PTI was appropriate on the ADA claim despite any shortcomings in PTI’s response to Basden’s request. (Basden also alleged violation of the Family and Medical Leave Act, which the court also affirmed summary judgment on because Basden had not worked for PTI for 12 months at the time of her leave request and thus was not eligible for leave under the statute.)

Identify and Document Essential Functions

Of course, employers should continue to comply with their obligations to engage in the interactive process. However, as this case suggests, the obligation to explore and provide accommodation does not necessarily extend to accommodations that are or would be futile and would not enable the employee to perform essential functions. This case highlights the importance of well-written job descriptions that clearly set forth essential job functions. An employer’s identification of and ability to prove essential functions of the job can be used to guide the interactive process and its obligations to provide accommodation under the ADA, and can play a key role in defending a lawsuit under the ADA.

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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International Trade Commission Rules Lack of Domestic Industry Results in a Termination of Investigation

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The International Trade Commission (ITC) is an independent, quasi-judicial agency that adjudicates the importation of products that allegedly infringe U.S. intellectual property rights. The ITC can halt the importation of goods that infringe U.S. patents and/or trademarks, and thus is an effective tool for obtaining a relatively rapid determination of infringement (one year) and an exclusion order. One of the requirements for such an order is to prove harm to a domestic industry. The following case (ITC investigation 337-TA-874) is an example of one way that such an investigation can be defeated.

In a recent decision, the ITC ordered an investigation into whether certain laminated products infringed the claims of a nonpracticing entity’s (NPE) patent. In initiating the investigation, the ITC ordered the administrative law judge (ALJ) overseeing the investigation to hold a preliminary hearing and to issue a decision as to whether the NPE has the required domestic industry in the United States to bring an investigation before the ITC. A finding of a lack of domestic industry would result in a termination of the investigation, as the NPE would not have standing with the ITC. This is a departure from current ITC practice, and it may provide an effective tool for preventing NPEs from bringing frivolous suits before the ITC.

Under 19 U.S.C. § 1337(a), the ITC has jurisdiction to hear matters in which a party alleging infringement (the complainant) has, or is in the process of establishing, a domestic industry in the United States. The determination of domestic industry is a two-prong test. The first prong, referred to as the “technical prong,” requires the complainant to show that it is practicing a valid claim of each asserted patent in a product sold in the United States. The analysis of the technical prong is similar to an infringement analysis, in which each claim is compared to the domestic product.1 The second prong of the test, referred to as the “economic prong,” requires the complainant to demonstrate “(a) a significant investment in plant and equipment, (b) significant employment of labor and capital, or (c) a substantial investment in its exploitation, including engineering, research and development, or licensing.”2

The complaint in the present investigation (337-TA-874) was brought by Lamina Packaging Innovations, an NPE, against a group of companies including Hasbro, John Jameson Import Company, Cognac Ferrand USA, Inc. and Camus Wines & Spirits Group. In the investigation, Lamina Packaging alleged that the respondents were infringing two of Lamina’s patents directed to a packaging material. In initiating the investigation, the ITC ordered the ALJ to issue an initial determination as to whether Lamina has satisfied the economic prong of the domestic industry requirement. Further, the ITC stated that the initial determination would become the ITC’s final determination 30 days after the date of service of the initial determination. Accordingly, a finding of no domestic industry by the ALJ would result in a termination of the investigation. The ITC ordered the ALJ to issue a decision on domestic industry within 100 days from the institution of the investigation.

Typically, lack of domestic industry is an affirmative defense presented by a respondent. The new ruling by the ITC may allow respondents to terminate ITC investigations early, opposed to the current practice that requires respondents to endure a summary judgment motion or a trial before a domestic industry decision is rendered. As more NPEs file complaints with the ITC in an attempt to “test run” future district court cases, this recent decision may greatly reduce the number of NPE cases filed with the ITC.

1 Alloc, Inc. v. Int’l Trade Comm’n, 342 F.3d 1361, 1375 (Fed. Cir. 2003).

2 19 U.S.C. § 1337(b).

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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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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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