FTC Releases Controversial Interim Staff Report on PBMs’ Purported Impact on Drug Prices

At an Open Commission Meeting on August 1, 2024, the Federal Trade Commission (FTC) presented a report prepared by its staff entitled Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies.

Although characterized as “interim,” the report posits the following observations about pharmacy benefit managers (PBMs):

  • “PBMs have gained significant power over prescription drug access and prices through increased concentration and vertical integration.”
  • “Increased concentration and vertical integration may have enabled PBMs to lessen competition, disadvantage rivals, and inflate drug costs.”
  • “The largest PBMs’ outsized bargaining leverage may operate to the disadvantage of smaller unaffiliated pharmacies.”
  • “PBM and brand drug manufacturer rebate contracts may impair or block less expensive competing products, including generic and biosimilar drugs.”
  • “PBMs lead to higher prices” (a conclusion based on only two case studies).

Commissioner Melissa Holyoak, in dissenting from the release of the report, stated that “the Report was plagued by process irregularities and concerns over the substance—or lack thereof—of the original order. In fact, the politicized nature of the process appears to have led to the departure of at least one senior leader at the Commission.” Commissioner Holyoak added that “[e]ven if the Report’s assertions of increasing concentration are accurate, increased concentration ‘does not prove that competition in that market has declined.’ Though the Report baldly asserts that PBMs ‘have gained significant power over prescription drug access and prices,’ the Report does not present empirical evidence that demonstrates PBMs have market power—i.e., ‘the ability to raise price profitably by restricting output.”’

Commissioner Andrew N. Ferguson, although concurring in the release of the report, was likewise critical of the process and its findings. In particular, Commissioner Ferguson found the report to be “especially unusual” in that it “relies, throughout, in large part on public information that was not collected from the PBMs or their affiliates during the 6(b) process.” Furthermore, Commissioner Ferguson was critical of the finding, based on only two case-study drugs, that PBMs lead to higher prices and pleaded with the FTC “to determine whether these findings are representative of market dynamics for other drugs.” He added that “[w]e need to understand whether any anticompetitive or unfair or deceptive acts or practices on the part of PBMs or any other market participants are contributing to these prices.”

FCC’s New Notice of Inquiry – Is This Big Brother’s Origin Story?

The FCC’s recent Notice of Proposed Rulemaking and Notice of Inquiry was released on August 8, 2024. While the proposed Rule is, deservedly, getting the most press, it’s important to pay attention to the Notice of Inquiry.

The part which is concerning to me is the FCC’s interest in “development and availability of technologies on either the device or network level that can: 1) detect incoming calls that are potentially fraudulent and/or AI-generated based on real-time analysis of voice call content; 2) alert consumers to the potential that such voice calls are fraudulent and/or AI-generated; and 3) potentially block future voice calls that can be identified as similar AI-generated or otherwise fraudulent voice calls based on analytics.” (emphasis mine)

The FCC also wants to know “what steps can the Commission take to encourage the development and deployment of these technologies…”

The FCC does note there are “significant privacy risks, insofar as they appear to rely on analysis and processing of the content of calls.” The FCC also wants comments on “what protections exist for non-malicious callers who have a legitimate privacy interest in not having the contents of their calls collected and processed by unknown third parties?”

So, the Federal Communications Commission wants to monitor the CONTENT of voice calls. In real-time. On your device.

That’s not a problem for anyone else?

Sure, robocalls are bad. There are scams on robocalls.

But, are robocalls so bad that we need real-time monitoring of voice call content?

At what point, did we throw the Fourth Amendment out of the window and to prevent what? Phone calls??

The basic premise of the Fourth Amendment is “to safeguard the privacy and security of individuals against arbitrary invasions by governmental officials.” I’m not sure how we get more arbitrary than “this incoming call is a fraud” versus “this incoming call is not a fraud”.

So, maybe you consent to this real-time monitoring. Sure, ok. But, can you actually give informed consent to what would happen with this monitoring?

Let me give you three examples of “pre-recorded calls” that the real-time monitoring could overhear to determine if the “voice calls are fraudulent and/or AI-generated”:

  1. Your phone rings. It’s a prerecorded call from Planned Parenthood confirming your appointment for tomorrow.
  2. Your phone rings. It’s an artificial voice recording from your lawyer’s office telling you that your criminal trial is tomorrow.
  3. Your phone rings. It’s the local jewelry store saying your ring is repaired and ready to be picked up.

Those are basic examples, but for them to someone to “detect incoming calls that are potentially fraudulent and/or AI-generated based on real-time analysis of voice call content”, those calls have to be monitored in real-time. And stored somewhere. Maybe on your device. Maybe by a third-party in their cloud.

Maybe you trust Apple with that info. But, do you trust someone who comes up with fraudulent monitoring software that would harvest that data? How do you know you should trust that party?

Or you trust Google. Surely, Google wouldn’t use your personal data. Surely, they would not use your phone call history to sell ads.

And that becomes data a third-party can use. For ads. For political messaging. For profiling.

Yes, this is extremely conspiratorial. But, that doesn’t mean your data is not valuable. And where there is valuable data, there are people willing to exploit it.

Robocalls are a problem. And there are some legitimate businesses doing great things with fraud detection monitoring. But, a real-time monitoring edict from the government is not the solution. As an industry, we can be smarter on how we handle this.

DOJ Implements New Whistleblower Reward Program

Companies who submit healthcare claims to private payors, provide financial services to customers, interact with domestic or foreign public officials, or otherwise operate in highly regulated industries should take note that the Department of Justice (DOJ) has taken another significant step in its ongoing effort to encourage new whistleblowers with information about potential corporate criminal malfeasance to report that information to the government. On August 1, 2024, the DOJ announced its long awaited Corporate Whistleblower Awards Program. The program seeks to fill “gaps” in existing whistleblower programs by providing awards of up to 30% of forfeited proceeds for reporting criminal conduct that is not otherwise covered by an existing system for awarding whistleblowers. The silver lining for companies is that the program incentivizes the whistleblowers to cooperate with the company’s internal compliance function. DOJ also provides for a presumptive declination of criminal charges for companies that self-report to DOJ within 120 days of the time the issue is first raised internally by the whistleblower, providing strong incentives for companies to investigate issues quickly.

The program represents the DOJ’s latest effort to increase the number of voluntary self-disclosures of corporate criminal activity. In January 2023, the DOJ announced its revised Corporate Enforcement and Voluntary Self Disclosure Policy, which sought to expand the incentives for companies to voluntarily self-disclose misconduct, cooperate with DOJ investigations, and take prompt and full remedial measures. The policy’s primary incentive was the prospect of a presumed declination for companies who followed its mandates.

As we discussed in a previous post, efforts to increase voluntary self-disclosures continued in April 2024 when the DOJ launched a Pilot Program on Voluntary Self Disclosures for Individuals. That initiative expanded the scope of potential whistleblowers by including those complicit in wrongdoing, granting them eligibility for immunity from prosecution in return for reporting the activity. In substance, that structure incentivized both individual wrongdoers and the corporations for whom they worked to be the first to report criminal activity. By pitting the would-be whistleblowers and the companies against each other, the DOJ effectively constructed a prisoners’ dilemma where the government stood to benefit regardless of which party acted first.

The program is a different verse from the same hymnal. It offers a different (but more traditional) incentive for whistleblowers – the opportunity for financial reward – while maintaining the goal of increasing the number of voluntary self-disclosures. The program seeks to achieve that objective by motivating those who are aware of misconduct, but perhaps are otherwise unable to qualify for a bounty under the current framework or otherwise uninterested in reporting the activity without a personal benefit.

The Basic Framework

Under the program, eligible individuals who voluntarily provide original information to the government in certain areas of focus and cooperate with the resulting investigation stand to receive 30% of any criminal or civil forfeitures over $1 million in accordance with a defined payment priority. The program lays out a basic structure for determining whether an individual is entitled to an award, but also affords the DOJ substantial discretion in deciding whether to make such awards, and in what amount. The key elements are:

  • Areas of focus – The program identifies four subject matter areas: 1) violations by financial institutions, their insiders and agents involving money laundering, fraud, and fraud against or non-compliance with regulators; 2) foreign corruption and bribery and violations of money laundering statutes; 3) domestic corruption violations including bribes and kickbacks paid to domestic public officials; and 4) healthcare offenses involving private or non-public healthcare benefit programs and fraud against patients, investors or other non-governmental entities in the healthcare industry, or other violations of federal law not covered by the federal False Claims Act (FCA).
  • Eligible individuals – The program excludes several categories of individuals, including those eligible to report under other whistleblower programs and those who “meaningfully participated” in the criminal activity reported (although those who played a “minimal role” can still participate).
  • “Original information” – Essentially, independent non-public knowledge or analysis in the individual’s possession is considered “original” information. Notably, information can be deemed “original” if it “materially adds to the information that the Department already possesses.” Information that the individual has already reported through the company’s internal whistleblower, legal or compliance procedures can still be deemed “original,” provided the individual also reports that information to the government within 120 days of reporting internally. Privileged information is not considered “original” unless the crime, fraud or other exception to state attorney conduct rules apply.
  • “Voluntary” submission – The information must be reported before the DOJ or any federal law enforcement or civil enforcement agency initiates any inquiry relating to the subject matter.
  • “Cooperation” – Individuals who report must also cooperate fully with the DOJ’s investigation, including by participating in interviews, testifying before a grand jury or at trial, producing documents and, if requested, working in a “proactive manner” with federal law enforcement. This could include clandestine activities to gather evidence, such as recording phone calls or wearing a wire.
  • Criteria for determining amount of award – The program lists several factors that could militate in favor of increasing or decreasing the whistleblower’s financial award. Increases may be justified by the significance of the information provided, by the nature and extent of assistance provided, and, notably, by participation in internal compliance programs. Decreases may be appropriate where the reporting individual was a minimal participant in the underlying activity, or where the individual unreasonably delayed reporting, interfered with the company’s internal compliance and reporting systems, or had management or oversight responsibilities over the offices or personnel involved in the conduct.
  • Payment priority – When the victim is an individual, he or she must first be compensated “to the fullest extent possible” before a whistleblower can recover. When the victim is a corporate entity or government agency, the whistleblower jumps the line and is compensated first.
  • Relationship to the Corporate Enforcement and Voluntary Self Disclosure Policy – While the program incentivizes whistleblower reports to the DOJ, a simultaneous amendment to the self-disclosure policy provides that “if a whistleblower makes both an internal report to a company and a whistleblower submission” to the DOJ, companies who self-report that conduct within 120 days of the internal report “will still qualify for a presumption of a declination[.]” This amendment underscores the DOJ’s focus on increasing self-disclosures, inasmuch as it effectively removes the need for them to be truly “voluntary.” A company that receives a complaint through its whistleblower program may still be eligible under the self-disclosure policy even if the individual has already reported the conduct to the DOJ, but it has a limited time to investigate and decide whether to self-report the conduct.

Key Takeaways

Reading the tea leaves, we see several potentially significant takeaways for companies evaluating the program’s likely impact.

  1. As a starting point, companies should evaluate whether and to what extent their operations create new reporting opportunities under the program, and thus necessitate action. That process should involve answering the following questions:
    • Does the company operate in one of the areas of focus? If so, the program creates new opportunities and incentives for whistleblowers, and the company must assess whether it is prepared to address an increase in reports and to recognize that a reporter may have already disclosed information to the DOJ.
    • Is the company publicly traded? If so, the company is already subject to the Sarbanes-Oxley Act (SOX), which should mean that systems are already in place to receive, investigate and determine whether to take action, including potentially making a voluntary self-disclosure. The program provides an opportunity to reassess the efficacy of those systems but should not necessarily require the creation of new ones. Note that even those companies with existing whistleblower programs should consider the need to expand those systems to cover new areas of focus. For example, a company with a SOX whistleblower policy should consider the need to expand its scope to cover domestic corruption violations, which may not otherwise be covered.
    • Does the company submit claims to government payors? If so, it is already subject to the FCA and should already have a system in place to analyze internal compliance concerns. If that system focuses on or prioritizes issues regarding government payors, the company should expand its focus to include claims and conduct regarding private payors, which may now be subject to whistleblower bounties under the program.
  2. For privately held companies operating in the areas of focus that are not subject to the FCA, the program necessitates a thorough and candid assessment of the risk the program creates. Depending on the extent of that danger, companies should consider the following measures:
    • Create, or enhance as necessary, internal reporting mechanisms to receive and evaluate whistleblower reports.
    • Publicize the company’s expectation that employees should promptly report concerns internally about potential violations of law or company policy, making clear that no retaliation will result from reports made in good faith.
    • Design a process for investigating whistleblower reports based on their nature and seriousness. Establish criteria for identifying those that can be investigated by HR, those that require the involvement of in-house counsel, and those that must be handled by outside counsel. If there is any possibility of criminal exposure, ensure an appropriate investigation is conducted and concluded in time to allow the company to determine whether to self-report in the 120-window for a presumptive declination.
  3. All companies should have in place a system for quickly and accurately evaluating whether to voluntarily self-disclose violations. This process is a multi-factor calculus that considers a range of factors, including primarily the merits of the underlying information and the amount of financial loss or gain that resulted. While decision-making in this context varies by situation, one essential element remains constant: the need for accurate information regarding the nature, scope and effect of the underlying conduct.

Only time will tell exactly how the program will impact the number and nature of whistleblower reports. But companies can take practical steps now to gauge whether and to what extent they are likely to be affected and begin installing the measures necessary to minimize the risk that might otherwise result.

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OSHA Proposes New, Far-Reaching Workplace Heat Safety Rule

In July 2024, the Department of Labor’s Occupational Safety and Health Administration (OSHA) announced a proposed rule (the “Proposed Rule” or “Rule”) aimed at regulating and mitigating heat-related hazards in the workplace. If enacted, the long-anticipated Rule will have far-reaching impacts on businesses with employees who work in warm climates or who are otherwise exposed to heat-related hazards.

According to OSHA, out of all hazardous weather conditions, heat is the leading cause of death in the U.S. The Proposed Rule seeks to protect employees from hazards associated with high heat in the workplace and would apply to both indoor and outdoor work settings. Among other requirements, the Proposed Rule would mandate that employers evaluate heat-related workplace hazards and implement a Heat Illness and Injury Prevention Plan (HIIPP) to address heat hazards through methods which include rest breaks, shade requirements, the provision of drinking water, acclimatization procedures, heat monitoring, and other tactics to protect workers. The proposed HIIPP requirement takes cues from state-level occupational safety and health agencies — like Cal/OSHA (California) and Oregon OSHA — which have already implemented heat safety and HIIPP requirements.

One provision of the Proposed Rule that has garnered significant attention is the paid rest break provision. As currently drafted, the Proposed Rule would require employers to provide one paid15-minute rest break every two hours on days where the heat index reaches 90° F or higher. The paid rest break provision implicates questions about the concurrent application of the Fair Labor Standards Act. For example, does this 15-minute break period count toward an employee’s “hours worked” for the purposes of calculating overtime?

Moreover, in light of the Supreme Court’s recent decision in Loper Bright Enterprises v. Raimondo — in which the court overturned the longstanding principle of deference to agency interpretations previously set out under the 1984 Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc. case — significant questions remain about whether far-reaching mandates (like the paid rest break provision) are within OSHA’s authority. Given this new administrative landscape, if the Proposed Rule is enacted, we can expect challenges stemming from Loper Bright.

The Proposed Rule has not yet been published in the Federal Register. However, when such publication occurs, the Rule will be open to commentary from the public before becoming final. When OSHA announced the Proposed Rule, it simultaneously “encourage[d] the public to participate by submitting comments when the proposed standard is officially published in the Federal Register[,]” in order to “develop a final rule that adequately protects workers, is feasible for employers, and is based on the best available evidence.”

For more information regarding how to provide comments on this Proposed Rule, visit https://www.osha.gov/laws-regs/rulemakingprocess#v-nav-tab2.

DOJ Launches Corporate Whistleblower Awards Pilot Program

The Department of Justice (“DOJ”) released its Corporate Whistleblower Awards Pilot Program on August 1, 2024. This initiative, which is expected to last three years, aims to enhance corporate crime detection, expand enforcement and prosecution efforts, and encourage reporting by incentivizing whistleblowers with the potential of significant payouts. Going forward, companies should pay close attention to DOJ’s  statements  and  guidance  and assess their existing compliance program to ensure that they are encouraging internal reporting and have procedures in place to quickly investigate, remediate, and potentially disclose misconduct.

For years, the Securities and Exchange Commission, Commodity Futures Trading Commission, and the Financial Crimes Enforcement Network have maintained whistleblower programs. When announcing the DOJ’s Pilot Program last March, Deputy Attorney General Lisa Monaco said these programs, while successful, do not address “the full range of corporate and financial misconduct” that DOJ prosecutes. Monaco emphasized that DOJ’s new program aims to fill the gaps in the existing patchwork. The Pilot Program goes into effect immediately.

Impacting the Pilot Program is DOJ’s recent  amendment  to its Corporate Enforcement and Voluntary Self-Disclosure (“VSD”) Policy. Under the amendment, a company that receives an internal report of misconduct from a whistleblower and reports that misconduct to DOJ within 120 days is eligible for a presumption in favor of declining prosecution. To be eligible for the presumption, the company must also cooperate fully and commit to remediation of the wrongdoing. Along with the whistleblower awards program, this amendment provides DOJ with more tools to encourage companies to strengthen internal reporting systems and to incentivize voluntary self-disclosure of corporate crimes and misconduct.

Foreign and domestic companies should reassess anti-corruption, trade compliance, and other compliance programs and should consider revising existing programs as needed to encourage internal reporting of concerns regarding potential non-compliance with company policies and applicable laws.

Covered Violations 

To qualify for an award, the information provided by a whistleblower must be related to one of the following types of criminal conduct:

  • Violations by financial institutions, their insiders, or agents, including schemes involving money laundering, anti-money laundering compliance violations, registering of money transmitting businesses, fraud statutes, and fraud against or non-compliance with financial institution regulators.
  • Foreign corruption and bribery violations under the Foreign Corrupt Practices Act, the Foreign Extortion Prevention Act, or money laundering statutes.
  • Violations related to the payment of bribes or kickbacks to domestic (U.S.) public officials.
  • Federal health care offenses not covered by the False Claims Act, including federal health care offenses and related crimes involving private or other nonpublic health care benefit programs and health care fraud schemes involving private insurance plans.

Eligibility and Rewards 

  • Whistleblowers may be eligible for an award under the Pilot Program if, alone or jointly with other individuals, the whistleblower provides DOJ with original information, in writing, which leads to criminal or civil forfeiture exceeding $1 million in connection with a successful prosecution, criminal resolution, or civil forfeiture action. The whistleblower must cooperate fully with DOJ’s investigation.
  • Whistleblowers must provide truthful, original, non-public information about corporate misconduct to qualify for potential compensation under the program.
  • Whistleblowers may report suspected misconduct internally before reporting to DOJ but are not required to do so in order to be eligible under the pilot program. If the whistleblower reports the alleged misconduct internally through company reporting channels, they must subsequently report it to DOJ within 120 days. A whistleblower may therefore choose to go directly to DOJ without first reporting through internal channels.
  • Information will not be considered original if it was obtained through communications subject to attorney-client privilege, or if the whistleblower’s principal duties include compliance or audit responsibilities. Whistleblowers who work for third-party firms conducting or supporting internal investigations will also not be eligible for any rewards.
  • Whistleblowers that would be eligible for an award through another U.S. whistleblower, False Claims Act qui tam, or similar program will not be eligible for an award under the Pilot Program if they report the same misconduct. However, DOJ encourages whistleblowers to submit information to multiple programs to allow DOJ and other agencies to decide which program is best suited to address the alleged misconduct.

Whistleblowers are eligible for an award even if they initially report information through their employer’s internal reporting procedures. However, the whistleblower must also report the same information to DOJ within 120 days of making an internal report. Whistleblowers may receive up to 30 percent of the first $100 million in net proceeds forfeited, and up to 5 percent of net proceeds between $100 million and $500 million. There is no award on net proceeds forfeited above $500 million. The maximum potential award is set at $35 million. The payment of any award is subject to DOJ’s discretion. DOJ will take into consideration, among other things, the significance of the information provided and the whistleblower’s cooperation and level of assistance. A whistleblower’s level of culpability, unreasonable delay in reporting, and interference with internal compliance and reporting systems may decrease award amounts. A whistleblower is not eligible for payment if they meaningfully participated in the misconduct or criminal activity. DOJ may, however, determine that a whistleblower is eligible if he or she played a minimal role and any misconduct was “sufficiently limited” in scope.

VSD Policy Amendment 

The VSD Policy amendment provides that, where a whistleblower makes both an internal report and a report to DOJ, a company may qualify for a presumption of declination under the VSD Policy even if the whistleblower reports the misconduct to DOJ before the company does. The company, however, must report the conduct to DOJ within 120 days of receiving the internal report  and  before DOJ contacts the company about the misconduct. Thus, the “declination window” may be shorter than 120 days, as DOJ could reach out before then. The amended VSD Policy and the Pilot Program effectively require companies to swiftly investigate and disclose misconduct to avoid steep penalties and prosecution.

What Companies Can Do Now 

The Pilot Program will be administered by the Criminal Division’s Money Laundering and Asset Recovery Section (“MLARS”). MLARS has taken a leading role in prosecuting foreign corruption and other international crimes in recent years but will likely expand its role into domestic corruption and national security issues as a result of its mandate here. MLARS will certainly place increased focus on the seizure and forfeiture of money.

Companies can take proactive steps to mitigate risk by re-evaluating their voluntary self-disclosure decision making and to improve existing compliance policies and procedures.

A few steps companies can take include:

  1. Clear Policies and Procedures: 
    • Establish clear guidelines and encourage employees to report misconduct.
    • Communicate these policies to all employees through training sessions, handbooks, and regular reminders.
  2. Anonymous Reporting Channels: 
    • Provide confidential or anonymous reporting channels (such as hotlines or online platforms).
  3. Non-Retaliation Assurance: 
    • Assure employees that they will not face retaliation for reporting.
    • Implement strong anti-retaliation policies and enforce them consistently.
  4. Leadership Support: 
    • Leadership should actively promote a culture of integrity and transparency.
  5. Incentives and Recognition: 
    • Consider offering incentives for early reporting or successful outcomes.
    • Recognize and appreciate employees who report misconduct.
  6. Training and Awareness: 
    • Regularly train employees on recognizing red flags and reporting procedures.
    • Foster awareness about the importance of reporting for the company’s well-being.
  7. Testing of Internal Controls: 
  • Ensure that existing compliance policies and procedures are working and are accurately identifying risks and detecting potential misconduct.
  1. Voluntary Disclosure: 
  • Review and strengthen internal investigation policies and procedures.
  • Conduct thorough, timely investigations into alleged misconduct.
  • Companies have 120 days or less to review internal complaints and reports of misconduct and to disclose to DOJ to qualify for declination under the amended VSD Policy.

The DOJ’s New Corporate Whistleblower Awards Pilot Program: A Victory for Wall Street – A Setback for Accountability

On August 1, 2024, the U.S Department of Justice announced the rules governing its new corporate whistleblower program. Unfortunately for whistleblowers, the Justice Department based its new program on proposals long advocated by the U.S. Chamber of Commerce and Wall Street special interests.

These Wall Street-friendly features contain most of the major elements of a long dreamed of “wish list” sought by the very companies that have been successfully prosecuted as a result of whistleblower disclosures. This wish list includes: making the payment of awards discretionary, capping the amount of awards, blocking the best informants from coverage, pushing whistleblowers into internal compliance programs instead of having them report directly to the government, and placing a major caveat on the right to file anonymous claims.

In adopting this Wall Street wish-list, the Justice Department ignored the empirical data demonstrating that programs which reject these proposals, such as the Dodd-Frank Act, have proven to be the most successful fraud-detection whistleblower laws.

New Program Announced

Deputy Attorney General (DAG) Lisa Monaco first announced the DOJ’s decision to establish  a new whistleblower award program during her keynote remarks at the American Bar Association’s 39th National Institute on White Collar Crime on March 7. She recognized the importance of paying monetary awards to whistleblowers and how such programs have created massive opportunities to pursue major fraud prosecutions:

Ever since Dodd-Frank created whistleblower programs at the SEC and the CFTC, those agencies have received thousands of tips, paid out many hundreds of millions of dollars, and disgorged billions in ill-gotten gains from corporate bad actors.”

“These programs have proven indispensable — but they resemble a patchwork quilt that doesn’t cover the whole bed. They simply don’t address the full range of corporate and financial misconduct that the Department prosecutes.

“So, we are filling these gaps.”

Monaco detailed that the Pilot Program would use existing statutory authorities under the little-used Asset Forfeiture Whistleblower Award Law, 28 U.S.C. § 524, as a basis for paying whistleblower awards. This law, in existence since 1984, was, for years, ignored by the DOJ. For example, in FY 2023, the United States obtained $3.4 billion from asset forfeitures but only used $13 million to compensate whistleblowers or informants. All whistleblower payments were made by the Drug Enforcement Authority ($12 million) or the FBI ($1 million)).

The failure to pay whistleblowers from the Fund has contributed to the Fund’s massive balance. As of the end of FY 2023, the Fund had $8.5 billion in assets. The Justice Department’s annual Asset Forfeiture Fund report confirmed that whistleblower-initiated cases were a major driving force in adding billions to the Fund. The report identified income from the Danske Bank money laundering case as the largest contributor to increasing the Fund’s assets. As Danske Bank itself admitted, that scandal, and the resulting enforcement actions were initiated by a whistleblower report, and the DOJ admitted that $1.2 billion was deposited into the Fund from that case.

Significantly, Congress entrusted the Justice Department to establish rules for paying whistleblowers or other informants. Unlike other whistleblower award laws such as the False Claims or Dodd-Frank Acts, Congress did not establish mandatory guidelines limiting the ability of the Department to compensate whistleblowers. Instead, the Justice Department could establish progressive and pro-whistleblower regulations to fully achieve the goals behind establishing the Fund. As explained by the Justice Department, the Fund is supposed to be “an essential component of the Department’s efforts to combat the most sophisticated criminal actors and organizations – including terrorist financiers, cyber criminals, fraudsters, human traffickers, and transnational drug cartels.”

Thus, whistleblower advocates were optimistic when the DAG announced the DOJ’s intent to use its authority under the Asset Forfeiture Fund to build a new corporate whistleblower program. Not only had the DAG acknowledged the success of the Dodd-Frank model for incentivizing informants, but the DOJ also clearly understood the international nature of many of the crimes resulting in asset forfeiture (including the DOJ’s acknowledgment that the Fund was created to combat “transnational drug cartels,” “human traffickers” and “terrorist financiers”). Advocates hoped that the Justice Department would incorporate policies outlined in the United States Strategy on Countering Corruption into the new program. Under this Strategy, the United States pledged to act in “solidarity” with whistleblowers and bolster human rights defenders, investigative journalists, and other key players in the worldwide fight against corruption.

After the DAG’s announcement,, the Justice Department engaged in “listening sessions” to “gather information” so they could “design a thoughtful, well-informed program.” Numerous whistleblower experts met with the Justice Department team crafting the new program and provided input. Additionally, written guidance was provided by leading whistleblower law firmsa former SEC Commissioner with expertise on the Dodd-Frank whistleblower law, and all the major whistleblower advocacy groups, including 23 international anti-corruption organizations, the National Whistleblower Center, Transparency International (USA), The Anti-Fraud Coalition (TAF), and the Government Accountability Project. These persons and groups endorsed a framework modeled on the Dodd-Frank Act consistent with the legal structure explained in the paper “Why Whistleblowing Works: A New Look at the Economic Theory of Crime.” 

The groundwork was set for the creation of a highly effective, transnational anti-corruption whistleblower program, that was designed to close gaps in existing laws, and use the billions in assets sitting in the Asset Forfeiture Fund to incentivize reporting and ensure that whistleblowers were properly compensated.

What Happened? The DOJ Adopts Proposals Advocated by Anti-Whistleblower Corporate Lobbyists

For years, the U.S. Chamber of Commerce and numerous corporations (many of which have pleaded guilty to committing frauds) have lobbied against highly successful qui tam whistleblower award laws. They actively lobbied to water-down both the Dodd-Frank and False Claims Act. Given the unquestionable effectiveness of these qui tam laws, the Chamber and its numerous members that were found to have committed frauds promoted tactics that would impede the ability of whistleblowers to use the laws or obtain compensation.

In December 2010, the Chamber urged the SEC to implement proposed rules that would have crippled the Dodd-Frank Act, but the SEC rejected those proposals. In 2013, the Chamber issued a comprehensive report, entitled “Fixing the False Claims Act,” which likewise urged Congress to enact legislation that would cripple the False Claims Act. Congress ignored these proposals.

However, the Justice Department adopted the main proposals advocated by the Chamber, all of which have been discredited by empirical evidenceBy following the lead of the Chamber of Commerce, Justice ignored guidelines Congress incorporated into the leading whistleblower award laws, and instead yielded to the lobbying power of Wall Street.

MANDATORY AWARDS

All of the successful whistleblower award laws require the government to pay qualified whistleblowers a mandatory award if they adhere to the criteria established by law or regulation. The mandatory nature of the award laws is the single most important feature of every successful whistleblower qui tam law. The most successful whistleblower laws in the United States require the payment of an award, not less than 10% and not more than 30% of the monies collected by the United States. Thus, whistleblowers are not compensated by taxpayer funds, but instead monies obtained from the fraudsters they report are used to pay the awards.

What did Justice Do?

Although the Justice Department had the discretion to follow the precedent under Dodd-Frank, False Claims, and AML laws, it ignored these precedents and created a discretionary program. In other words, the Justice Department can deny a fully qualified whistleblower, for any reason or no reason. There is no appeal. The Justice Department’s written regulations are clear: “The Department’s Award Determination is entirely discretionary, and neither appealable nor subject to judicial review.”

A whistleblower whose information results in hundreds of millions of dollars in recoveries, but who suffers tremendous retaliation, simply has no right to an award.

Not surprisingly, all discretionary whistleblower award laws have failed. Why should a whistleblower risk everything if the government has no obligation whatsoever to live up to its end of the bargain?

LIMITS ON AWARD AMOUNTS

The successful whistleblower award laws have no caps on the amount of an award. Awards are based on the quality of information provided, the cooperation a whistleblower provides to the government, the risks or sacrifices of the whistleblower, and the size of the frauds or crimes the whistleblower uncovers and reports. All awards are tied to the amount of actual recovery collected from the fraudster.

The Chamber of Commerce has tried, for years, to cap or limit the amount of an award. They fully understand that the handful of very large awards drives thousands of whistleblowers to come forward. Large awards publicize the programs, send a message that the government will honor its commitments, and incentivizes well-paid and high-level executives to become whistleblowers. Thus, capping the amount of an award is the number one goal of the corporate lobbyists attempting to weaken or undermine whistleblower rights.

In 2018 the SEC instituted a rulemaking proceeding which would have limited the amount of awards paid to whistleblowers in large cases. The initial proposal was approved in a 3-2 vote (all of the SEC Commissioners more supportive of Wall Street interests voted for limiting the size of awards). The proposal was debated internally within the SEC for two years, and leading whistleblower experts and advocates provided empirical evidence that large awards were a cornerstone to the program, incentivized some of the most important whistleblowers, and had a deterrent effect on wrongdoing.

Based on the objective evidence the Commission, 5-0, withdrew the proposal and rejected a rule that would have limited awards in large cases.

What did Justice Do?

Breaking with 35-years of Congressional legislation and ignoring the empirical evidence concerning the importance of large awards, the Justice Department, in an unprecedented move, decided to cap the amount of awards. This was the most significant victory Wall Street, and the Chamber of Commerce obtained, and it sets a terrible precedent.

Incredibly, the Justice Department instituted a rule that was even more regressive than the proposal made by the Chamber of Commerce. In its report Fixing the False Claims Act, the Chamber advocated changing the False Claims Act’s mandatory minimum 15% award, to a sliding scale that would create a “Graduated Reduction” in a whistleblower’s award. The amount of awards would be slowly reduced, and ultimately whistleblowers would only obtain “1 to 3 percent of amounts recovered above $100 million.”

The Justice Department took an even more extreme position. They adopted the Chamber’s recommendation to gradually reduce the size of an award, but instead of permitting tiny awards in large cases, they decided to zero these awards out, and pay nothing. Under the DOJ criteria, a whistleblower would not be entitled to any compensation based on recoveries that topped $500 million and would be subjected to a 5% cap on recoveries above $100 million. These caps need to be understood in the context of the right of the DOJ to reduce or deny awards at will. The DOJ capped the maximum amount of awards, yet established no minimum award, and provided itself with authority to pay no awards to fully qualified whistleblowers. The Chamber of Commerce never went this far in its proposal to undermine the False Claims Act.

CRIMINAL CULPABILITY

All the existing award laws have addressed the issue of the potential criminal culpability of the whistleblower. The original False Claims Act fully recognized this issue when it was signed into law by President Abraham Lincoln on March 2, 1863. The Senate sponsors of the bill explicitly called for participants in the frauds to step forward and use the law to assist the government in detecting these types of crimes. The Senate sponsor of the original False Claims Act recognized that it “takes a rogue to catch a rogue” and the primary intent of the award laws was to induce persons involved in the criminal conspiracy to turn on their fellow conspirators.

Thus, all successful whistleblower award laws permit participants in the frauds to turn in their co-conspirators and collect an award. This aspect of the law is perhaps the most important tool in incentivizing highly placed whistleblowers to step forward. In the context of asset forfeiture, there are no better sources of who the bad actors are who are hiding their assets than the bankers who opened their accounts. All of the laws prohibit persons convicted of the crime they are reporting from collecting an award. But likewise, all of the laws encourage participants, such as international bankers, to step forward.

What did Justice Do?

The Chamber of Commerce and its corporate allies have long advocated against the primary goal of the qui tam laws, i.e. to induce conspirators to turn on their co-conspirators. The fact that “trusted” persons sitting around a corporate board when the company is discussing paying a bribe sends chills within corporate America. In 2010,, the Chamber of Commerce made its position on this issue perfectly clear: “Exclude culpable individuals from award eligibility . . . corporate employees should not be rewarded if they engage in, perpetuate, or fail to take action to stop internal wrongdoing. Individuals who participated in wrongdoing should be excluded from award eligibility.”

Although Congress has continuously rejected such a broad disqualification, and the SEC explicitly rejected this proposal submitted by the Chamber and numerous corporate allies, the Justice Department has now adopted the essence of this position. Under the DOJ’s rules, the vast majority of participants in any fraud are now blocked from obtaining an award.

The DOJ regulation bars anyone who “meaningfully participated” in the fraud. This would cover the overwhelming majority of the best sources of information, and would give comfort to corporate insiders knowing that their co-conspirators could not obtain an award if they turned them in. The only exception would be for those who had a “minimal role,” i.e. those who would have the least valuable information, such as a secretary who may have mailed a letter related to the fraud. The regulation states: “An individual is not eligible for payment if they meaningfully participated in the criminal activity, including by directing, planning, initiating, or knowingly profiting from that criminal activity” (emphasis in original).

CONFIDENTIAL REPORTING

Dodd-Frank and the new AML whistleblower award law permits confidential and anonymous filing.

What did Justice Do?

Although the Justice Department permits anonymous filings, the regulations require that an anonymous whistleblower be identified whenever the Justice Department requests it. The regulation states: “The Department reserves the right to require information regarding your identity at any time the Department, in its sole discretion, deems it necessary to the prosecution of a case or to meet the Department’s legal obligations, policies, or procedures.”

Thus, DOJ can waive confidentiality and anonymity at-will, unbound by the legal restraints contained in Dodd-Frank and the AML whistleblower laws.

INTERNAL REPORTING

The DOJ’s new program strongly encourages whistleblowers to make internal reports to the very companies they suspect are violating the law. Similarly, the program provides companies who “self-report,” even after whistleblowers disclose violations of law to the government, major benefits and radical reductions in the amount of fines and penalties.

According to the DOJ factsheet:

“DOJ recognizes the value of companies’ internal compliance programs and has designed the pilot program to encourage employees to report misconduct internally before submitting information to DOJ.” (emphasis added).

This focus on encouraging whistleblowers to report to their companies ignored the fact that the very companies that benefit from these internal reports have lobbied and successfully fought in court to strip whistleblowers of protection against retaliation. In other words, the DOJ is encouraging employees to engage in a behavior that is not protected under federal law, and can result in their being fired and harassed, without legal protections.

All whistleblower laws protect employees who report to the government. But the following laws do not:

  • Commodity Exchange Act: No protection for internal disclosures.
  • Security Exchange Act/Foreign Corrupt Practices Act: No protection for internal disclosures.
  • Federal Obstruction of Justice Whistleblower Law: No protection for internal disclosures.
  • Anti-Money Laundering and Sanctions Whistleblower Law: No protection for internal disclosures for any employees who work for FDIC insured institutions or credit unions.
  • Asset Forfeiture Whistleblower Award (Fund): No protection for internal disclosures.

A recent study published in SSRN demonstrated that 92% of all corporate whistleblower retaliation cases arise from employees who make internal disclosure, while only 5% of retaliation cases arise from employees who report to the government, but avoid internal compliance programs.

It is extremely troubling that the DOJ would encourage whistleblowers to engage in behaviors that are not protected under federal law, will result in many of them losing the ability to report confidentially, and that the empirical evidence demonstrates is the most dangerous method for an employee to report concerns.

Moreover, the DOJ ignored the fact that Wall Street, led by the Chamber of Commerce, strongly argued that internal reporting should not be protected under the Dodd-Frank Act. The Chamber succeeded in having the Supreme Court overturn an SEC regulation that protected internal whistleblower disclosures from protection under law and resulted in stripping employees who reported to corporate counsel, corporate boards, corporate audit committees, or corporate compliance programs from all protections against retaliation under Dodd-Frank.

Options for Whistleblowers

The DOJ’s Corporate Whistleblower Awards Pilot Program represents a colossal lost opportunity to use a Fund created by Congress to combat major financial crimes to incentivize and compensate whistleblowers and otherwise encourage human rights defenders to assist in reporting domestic and international corruption. The Fund has billions of dollars that could have been creatively, aggressively and effectively utilized to fill loopholes in current laws and implement the important recommendations of the United States Strategy on Countering Corruption.

However, existing whistleblower award laws, that do not share the defects of the DOJ Pilot Program, can still be used by whistleblowers. Given the broad scope of these laws, much of the negative impact of the Justice Department’s regulations can be mitigated. Dodd-Frank can be used to report foreign bribery by most corporations worldwide; the Anti-money laundering laws can be used to hold banks and financial exchanges accountable, and to report violations of U.S. sanctions; the IRS program can be used to report tax evasion and permits awards for IRS investigations related to asset forfeiture; and finally, the Commodity Exchange Act can be used to report foreign corruption in the international commodities markets.

Employees who report directly to federal law enforcement authorities are also fully protected under the federal obstruction of justice laws. Under the obstruction law passed as part of the Sarbanes-Oxley corporate reform law, employers who fire employees for reporting to federal law enforcement are subjected to fines and up to ten years in prison.

These numerous (and highly effective) laws do not contain the problems that undermine whistleblower rights under the DOJ Pilot Program, and they should be used whenever available.

Conclusion

The Justice Department adopted proposals long sought after by Wall Street special interests and the Chamber of Commerce and created a program that delivered on the corporate wish-list for undercutting the effectiveness of whistleblower award programs. By making the program discretionary, capping the amount of awards, blocking the best informants from coverage, and placing a major caveat on the right to file anonymous claims, the Justice Department’s program runs counter to the significant amount of empirical evidence concerning the specific policies and procedures necessary to operate a successful program. Worse still, it creates a dangerous precedent for future whistleblower laws.

To understand just how terrible discretionary programs with compensation caps are and why Congress has repeatedly rejected them since 1986, one need only look at older and discredited award programs.

For example, between 1989 and 2010, the SEC had a discretionary award program covering whistleblowers who disclosed insider trading. The SEC Inspector General reviewed that program and found that it was a total failure and was unable to stop frauds like the ENRON scandal or frauds associated with the 2008 financial collapse.

The Inspector General described the program and its operation over its eleven years of existence as follows:

“All bounty determinations, including whether, to whom, or in what amount to make payments, are within the sole discretion of the SEC.”

“Since the inception of the SEC bounty program in 1989, the SEC has paid a total of $159,537 to five claimants.”

Thus, in July 2010, Congress repealed this discredited law and passed Dodd-Frank, which has mandatory award laws, no caps, and no discretion to deny qualified whistleblowers compensation.

The old IRS law and the False Claims Act of 1943 had similar problems, and both laws were amended to make the payment of awards mandatory, eliminate all caps, and end the discretion of government agencies to deny awards. All of the modern award laws also permit whistleblowers to challenge any denial in court.

The Justice Department had the discretion to create a highly effective program based on the Dodd-Frank Act. They dropped the ball. Now Congress needs to fix the mess Justice created.

In the meantime, whistleblowers should continue to use the highly effective award laws: the False Claims Act, the Dodd-Frank Act, the AML Whistleblower Improvement Act and the Foreign Corrupt Practices Act. Whistleblowers should also take advantage of the strong protections offered under the federal obstruction of justice statutes by reporting concerns directly to law enforcement.

The Justice Department did get one thing right. As part of its pilot program, Justice ruled that whistleblowers who are covered under the existing highly effective whistleblower laws cannot obtain any awards under the pilot program. Intentionally or not, this was the best advice Justice could give to whistleblowers: Make sure you use the existing laws and not rely on the pilot program.

Top Competition Enforcers in the US, EU, and UK Release Joint Statement on AI Competition – AI: The Washington Report


On July 23, the top competition enforcers at the US Federal Trade Commission (FTC) and Department of Justice (DOJ), the UK Competition and Markets Authority (CMA), and the European Commission (EC) released a Joint Statement on Competition in Generative AI Foundation Models and AI products. The statement outlines risks in the AI ecosystem and shared principles for protecting and fostering competition.

While the statement does not lay out specific enforcement actions, the statement’s release suggests that the top competition enforcers in all three jurisdictions are focusing on AI’s effects on competition in general and competition within the AI ecosystem—and are likely to take concrete action in the near future.

A Shared Focus on AI

The competition enforcers did not just discover AI. In recent years, the top competition enforcers in the US, UK, and EU have all been examining both the effects AI may have on competition in various sectors as well as competition within the AI ecosystem. In September 2023, the CMA released a report on AI Foundation Models, which described the “significant impact” that AI technologies may have on competition and consumers, followed by an updated April 2024 report on AI. In June 2024, French competition authorities released a report on Generative AI, which focused on competition issues related to AI. At its January 2024 Tech Summit, the FTC examined the “real-world impacts of AI on consumers and competition.”

AI as a Technological Inflection Point

In the new joint statement, the top enforcers described the recent evolution of AI technologies, including foundational models and generative AI, as “a technological inflection point.” As “one of the most significant technological developments of the past couple decades,” AI has the potential to increase innovation and economic growth and benefit the lives of citizens around the world.

But with any technological inflection point, which may create “new means of competing” and catalyze innovation and growth, the enforcers must act “to ensure the public reaps the full benefits” of the AI evolution. The enforcers are concerned that several risks, described below, could undermine competition in the AI ecosystem. According to the enforcers, they are “committed to using our available powers to address any such risks before they become entrenched or irreversible harms.”

Risks to Competition in the AI Ecosystem

The top enforcers highlight three main risks to competition in the AI ecosystem.

  1. Concentrated control of key inputs – Because AI technologies rely on a few specific “critical ingredients,” including specialized chips and technical expertise, a number of firms may be “in a position to exploit existing or emerging bottlenecks across the AI stack and to have outside influence over the future development of these tools.” This concentration may stifle competition, disrupt innovation, or be exploited by certain firms.
  2. Entrenching or extending market power in AI-related markets – The recent advancements in AI technologies come “at a time when large incumbent digital firms already enjoy strong accumulated advantages.” The regulators are concerned that these firms, due to their power, may have “the ability to protect against AI-driven disruption, or harness it to their particular advantage,” potentially to extend or strengthen their positions.
  3. Arrangements involving key players could amplify risks – While arrangements between firms, including investments and partnerships, related to the development of AI may not necessarily harm competition, major firms may use these partnerships and investments to “undermine or coopt competitive threats and steer market outcomes” to their advantage.

Beyond these three main risks, the statement also acknowledges that other competition and consumer risks are also associated with AI. Algorithms may “allow competitors to share competitively sensitive information” and engage in price discrimination and fixing. Consumers may be harmed, too, by AI. As the CMA, DOJ, and the FTC have consumer protection authority, these authorities will “also be vigilant of any consumer protection threats that may derive from the use and application of AI.”

Sovereign Jurisdictions but Shared Concerns

While the enforcers share areas of concern, the joint statement recognizes that the EU, UK, and US’s “legal powers and jurisdictions contexts differ, and ultimately, our decisions will always remain sovereign and independent.” Nonetheless, the competition enforcers assert that “if the risks described [in the statement] materialize, they will likely do so in a way that does not respect international boundaries,” making it necessary for the different jurisdictions to “share an understanding of the issues” and be “committed to using our respective powers where appropriate.”

Three Unifying Principles

With the goal of acting together, the enforcers outline three shared principles that will “serve to enable competition and foster innovation.”

  1. Fair Dealing – Firms that engage in fair dealing will make the AI ecosystem as a whole better off. Exclusionary tactics often “discourage investments and innovation” and undermine competition.
  2. Interoperability – Interoperability, the ability of different systems to communicate and work together seamlessly, will increase competition and innovation around AI. The enforcers note that “any claims that interoperability requires sacrifice to privacy and security will be closely scrutinized.”
  3. Choice – Everyone in the AI ecosystem, from businesses to consumers, will benefit from having “choices among the diverse products and business models resulting from a competitive process.” Regulators may scrutinize three activities in particular: (1) company lock-in mechanisms that could limit choices for companies and individuals, (2) partnerships between incumbents and newcomers that could “sidestep merger enforcement” or provide “incumbents undue influence or control in ways that undermine competition,” and (3) for content creators, “choice among buyers,” which could be used to limit the “free flow of information in the marketplace of ideas.”

Conclusion: Potential Future Activity

While the statement does not address specific enforcement tools and actions the enforcers may take, the statement’s release suggests that the enforcers may all be gearing up to take action related to AI competition in the near future. Interested stakeholders, especially international ones, should closely track potential activity from these enforcers. We will continue to closely monitor and analyze activity by the DOJ and FTC on AI competition issues.

PTAB MTA Pilot Program to the Rescue

On review of a final written decision from the Patent Trial & Appeal Board in an inter partes review (IPR), the US Court of Appeals for the Federal Circuit found that all challenged claims were obvious but left open the possibility of the patent owner amending the claims under the Motion to Amend (MTA) Pilot Program. ZyXEL Communications Corp. v. UNM Rainforest Innovations, Case Nos. 22-2220; -2250 (Fed. Cir. July 22, 2024) (Dyk, Prost, Stark, JJ.)

ZyXEL Communications petitioned for IPR challenging claims 1 – 4, 6, 7 and 8 of a patent owned by UNM Rainforest Innovation (UNMRI). The patent relates to methods for constructing frame structures in communication systems using orthogonal frequency-division multiple access (OFDMA) technologies. The patent describes a method for constructing a frame structure with two sections, each of which is configured for a different communication system, where the second communication system is used to support high mobility users (i.e., faster moving users).

Before the Board, ZyXEL argued that claims 1 – 4, 6 and 7 were unpatentable in light of two prior art references (Talukdar and Li), and that claim 8 was unpatentable in light of Talukdar and another prior art reference (Nystrom). During the Board proceedings, UNMRI filed a contingent motion to amend if any of the challenged claims were found to be unpatentable. As part of its motion, UNMRI requested preliminary guidance from the Board pursuant to the Board’s MTA Pilot Program. In its opposition to UNMRI’s motion to amend, ZyXEL argued that UNMRI’s amended claims lacked written description support, and in its preliminary guidance, the Board agreed. UNMRI attempted to file a revised motion to amend, but the Board rejected the revised motion and instead permitted UNMRI to file a reply in support of its original motion. It also allowed ZyXEL to file a sur-reply. The Board determined that claims 1 – 4, 6 and 7 were unpatentable, but that claim 8 was not. The Board also granted UNMRI’s motion to amend and determined that the new claims were nonobvious over the prior art of record. Both sides appealed.

With respect to the Board’s decision on the obviousness of claims 1 – 4, 6 and 7, the Federal Circuit found that substantial evidence supported the ruling. UNMRI’s primary argument was that a person of skill in the art (POSA) would not have been motivated to combine Talukdar and Li, but the Court credited the Board’s reliance on ZyXEL’s expert, who demonstrated sufficient motivation to combine the two references.

The Federal Circuit reversed the Board’s finding that claim 8 had not been shown to be obvious, however. The Court noted that while the Nystrom reference may not explicitly state the benefit of the missing limitations, “a prior art reference does not need to explicitly articulate or express why its teachings are beneficial so long as its teachings are beneficial and a POSA would recognize that their application was beneficial.”

Regarding UNMRI’s motion to amend, ZyXEL argued that the Board erred in granting the motion because UNMRI did not satisfy the requirement that the motion itself contain written description support for all of the claim limitations of the substitute claims. The parties agreed that UNMRI’s reply contained the missing written description, but ZyXEL argued that this could not cure the procedural defect. The Federal Circuit acknowledged the procedural error but determined that “the core purpose of the MTA Pilot Program is to allow for the correction of errors in the original motion [and is thus] designed to allow reply briefs to address and correct errors.” The Court noted that ZyXEL had opportunity to respond in its sur-reply brief. The Court upheld the Board’s decision to grant UNMRI’s motion to amend and remanded the IPR back to the Board to determine, in light of the Court’s rulings on claim 8 and the fair teachings of Nystrom, whether the substitute claims were nonetheless obvious.

The Federal Circuit also reminded the Board that it may sua sponte identify a patentability issue for the proposed substitute claims based on any prior art of record in the proceedings.

15% Discount on Chinese Patent Annuities for Open Licensing

Per a slightly ambiguous notice from the Ministry of Finance and the National Development and Reform Commission released July 24, 2024 (财政部 国家发展改革委关于调整优化专利收费政策的通知), annuity fees will be reduced by 15% for Chinese patents for participating in China’s open licensing system. As of the time of writing, there were over 2,000 open licenses published on China’s Intellectual Property Administration’s (CNIPA) online publication system.

15% Discount on Chinese Patent

Specifically, section 2 reads:

A 15% reduction in annual patent fees during the implementation period of patent open licensing. If other patent fee reduction policies are also applicable, the most favorable policy can be selected, but it cannot be enjoyed repeatedly.

However, it is unclear if this requires an actual license or simply having an offer to license published on CNIPA’s open license system.

In addition, there appears to be an additional annuity fee due for patents that receive patent term compensation (presumably for both patent term extensions for pharmaceutical patents and patent term adjustment for CNIPA delay in patent examination). It is unclear if this additional annuity is due for the entire patent term or just for the added patent term.

Specifically, section 1 reads, in part:

A patent owner who files a request for patent term compensation shall pay a patent term compensation request fee.

If a request for patent term compensation is found to meet the conditions for term compensation upon review, an annual patent compensation fee shall be paid…

CNIPA earlier this month also released additional information about open licensing system including royalty rates.

The full text of the Notice if available here (Chinese only).

Triggers That Require Reporting Companies to File Updated Beneficial Ownership Interest Reports

On January 1, 2024, Congress enacted the Corporate Transparency Act (the “CTA”) as part of the Anti-Money Laundering Act of 2020 and its annual National Defense Authorization Act. Every entity that meets the definition of a “reporting company” under the CTA and does not qualify for an exemption must file a beneficial ownership information report (a “BOI Report”) with the US Department of the Treasury’s Financial Crimes Enforcement Network (“FinCEN”). Reporting companies include any entity that is created by the filing of a document with a secretary of state or any similar office under the law of a state or Indian tribe (this includes corporations, LLCs, and limited partnerships).

In most circumstances, a reporting company only has to file an initial BOI Report to comply with the CTA’s reporting requirements. However, when the required information reported by an individual or reporting company changes after a BOI Report has been filed or when either discovers that the reported information is inaccurate, the individual or reporting company must update or correct the reporting information.

Deadline: If an updated BOI Report is required, the reporting company has 30 calendar days after the change to file an updated report.

What triggers an updated BOI Report? There is no materiality threshold as to what warrants an updated report. According to FinCEN, any change to the required information about the reporting company or its beneficial owners in its BOI Report triggers a responsibility to file an updated BOI Report.

Some examples that trigger an updated BOI Report:

  • Any change to the information reported for the reporting company, such as registering a new DBA, new principal place of business, or change in legal name.
  • A change in the beneficial owners exercising substantial control over the reporting company, such as a new CEO, a sale (whether as a result of a new equity issuance or transfer of equity) that changes who meets the ownership interest threshold of 25%, or the death of a beneficial owner listed in the BOI Report.
  • Any change to any listed beneficial owner’s name, address, or unique identifying number provided in a BOI report.
  • Any other change to existing ownership information that was previously listed in the BOI Report.

Below is a reminder of the information report on the BOI report:

  • (1) For a reporting company, any change to the following information triggers an updated report:
    • Full legal name;
    • Any trade or “doing business as” name;
    • A complete current address (cannot be a post office box);
    • The state, territory, possession, tribal or foreign jurisdiction of formation; and
      TIN.
  • (2) For the beneficial owners and company applicants, any change to the following information triggers an updated report:
    • Full legal name of the individual;
    • Date of the birth of the individual;
    • A complete current address;
    • A unique identifying number and the issuing jurisdiction from one of the following non-expired documents; and
    • An image of the document.

It is important to note that if a beneficial owner or company applicant has a FinCEN ID and any change is made to the required information for either individual, then such individuals are responsible for updating their information with FinCEN directly. This is not the responsibility of the reporting company