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Illumina Wins Case Against FTC on Grail Acquisition - The Wall Street Journal

The FTC had sought to unwind Illumina’s $7.1 billion acquisition of cancer-test developer Grail Inc. on the grounds that it could diminish innovation.

Photo: MIKE BLAKE/REUTERS

An administrative law judge has ruled in favor of Illumina Inc. in its $7.1 billion acquisition of cancer-testing developer Grail Inc., dealing a defeat to the Federal Trade Commission’s efforts to unwind the deal on antitrust grounds, the company said.

Illumina said the judge rejected the FTC’s position that the deal would hurt competition in the market for multicancer early-detection tests.

“As we’ve stated from the outset, this transaction is procompetitive, will advance innovation, lower healthcare costs and save lives,” said Charles Dadswell, general counsel of Illumina.

The decision, which the FTC staff can appeal, suggests the agency could face hurdles as it tries to push into newer theories of harm that can result from unchecked merger activity. The FTC alleged Illumina’s purchase of Grail could diminish innovation—a concern that goes beyond antitrust’s traditional focus on price levels and output.

In a statement, FTC Bureau of Competition Director Holly Vedova said the agency’s staff is disappointed with the decision and believes it mounted a strong case. “We are reviewing the opinion and evaluating our options,” Ms. Vedova said.

San Diego-based Illumina, which makes genetic-sequencing products, agreed in 2020 to acquire Grail, which is developing blood tests for early cancer detection. Illumina founded Grail and had spun it off in 2017, retaining a minority ownership stake. The 2020 deal was to acquire the part of Grail that it didn’t already own.

But in 2021, the FTC moved to block the deal, claiming that it would harm competition in an emerging field of tests for early-stage detection of multiple types of cancers.

The FTC said Grail and other developers of early-stage cancer tests all rely on Illumina’s DNA-sequencing platform. “If the acquisition is consummated, Illumina will gain the incentive to foreclose or disadvantage firms that pose a significant competitive threat to Grail,” the FTC wrote in its complaint last year. Illumina countered that it has made an open offer to provide continued access to its DNA sequencing to any Grail competitors.

Illumina closed its acquisition of Grail in 2021, despite the pending legal challenges.

The case isn’t the first time that Chief Administrative Law Judge D. Michael Chappell has ruled against the FTC on one of its lawsuits. Earlier this year, he rejected the FTC’s challenge of Altria Group Inc.’s

purchase of a large stake in e-cigarette maker Juul Labs Inc. The FTC’s staff appealed that decision. The case is now pending before the commissioners.

Judge Chappell also ruled against the FTC in a data-security case in 2015.

The FTC under Chair Lina Khan has investigated more proposed mergers and vowed to take a stronger position against deals that could threaten competition. Ms. Khan has said antitrust enforcers need to be more forward-looking, prioritizing concerns such as preserving incentives for innovation, protecting workers and buttressing small businesses.

Illumina’s deal was an example of a vertical merger, a type of transaction that integrates complementary instead of competing companies, allowing the combined firm to expand into new or related businesses or lower its input costs. Vertical deals have often been viewed with far less skepticism, but the FTC last year withdrew guidelines for reviewing them, indicating enforcers planned to apply tougher scrutiny to them.

“This case was always something of a stretch,” said

Stephen Calkins, a law professor at Wayne State University. “It was a vertical case, which is a challenging area of law, and the law judge conspicuously noted during the oral arguments that there were very high stakes in terms of healthcare innovation.”

Illumina’s legal challenges aren’t over, as the FTC’s staff could appeal Judge Chappell’s decision to the agency’s commission. The commission authorized the legal challenge to the deal in March 2021 on a bipartisan vote. If the commission overruled Judge Chappell, the companies could take their case to a federal appeals court.

The FTC had initially sought a federal court injunction that would have blocked the closing of the acquisition, but it backed off because Illumina and Grail were facing antitrust scrutiny in Europe.

Instead, the FTC proceeded with an administrative complaint over the deal, resulting in a trial before an administrative law judge in August and September of 2021. The new ruling arises from that trial and post-trial briefs filed by Illumina and the FTC.

In July, a European Union court ruled that the EU’s competition regulator has jurisdiction to review the Illumina-Grail deal under European merger regulations. Illumina said it intends to appeal that decision. The European Commission said in July that Illumina’s decision to complete the Grail deal breached European regulations.

Illumina is keeping the Grail business separate from the rest of its business while these legal challenges play out.

For Illumina, full control of Grail would give it a solid position in what analysts estimate could be a $50 billion market for tests that can detect multiple cancers early.

Last year, Grail introduced Galleri, a test designed to detect more than 50 types of cancer. The test is intended for people with elevated risk of cancer, such as adults 50 and older, and as a complement to standard single-cancer screening tests. Galleri costs about $950 per test and generally isn’t covered by insurers.

But Galleri sales to date have been lower than expected, as some health systems have taken a measured approach toward using the test.

“We believe it’s a fantastic test,” Illumina Chief Executive Francis deSouza said in an interview. “We believe that in Illumina’s hands, we can make this test available to more people, more affordably and more quickly than in Grail’s hands.” He added that it could save many lives and healthcare costs.

Illumina shares declined 0.5% to $200.62 Thursday. SVB Securities analysts said in a research note that despite the win, there continues to be regulatory uncertainty around the deal, delaying Illumina’s full integration of Grail and its benefits.

Write to Peter Loftus at peter.loftus@wsj.com and Dave Michaels at dave.michaels@wsj.com

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The Wyoming Corner Crossing case is headed to federal court - Wyoming News Now

CHEYENNE, Wyo. (Wyoming News Now) -If you haven’t already heard about the corner crossing case in Wyoming, it involves four Missouri hunters who came to hunt in our state.

They were eventually charged with criminal trespass by a neighboring private land owner when the hunters built a makeshift ladder to cross from one corner point of public land to another.

The private owner alleged the hunters trespassed onto his private land and violated private airspace.

Well, they went to court, and the hunters won that case, and the lawsuit continued into civil litigation.

But now that case is moving in front of a U.S. District Judge where the rights of public citizens, outdoors enthusiasts, and private landowners may ultimately decide the fate of 8.3 million acres of public land access across the nation.

Hunters’ rights have been a long-standing and hotly contested issue in Wyoming for years and, frankly, for most rural states that hunt.

The case of these four hunters was splashed across headline news when supporters of public lands and hunters decided to push back against the status quo.

The public has raised over $83,000 to fund these hunters’ legal battle to fight back on this issue and help establish a clear law for outdoor enthusiasts.

“This public land its ... a public asset that we should all have access to,” said Ryan Semerad, civil defense attorney for the Wyoming corner crossing case.

Semerad also likened freedom of movement through our public spaces as an American right.

“The federal government really is a servant of the people in this instance and were just trying to use in our own case, federal law that’s been established for 150 years. To say private land owners do not have the right to exclude the public from public lands, and that’s what they are trying to do when they prevent people from accessing public lands in this way, “said Semerad.

The counselors are now working to gather evidence for next spring’s hearings. According to the defense, the judge will make a final decision or send it to a jury by next summer.

We also reached out to the opposing counsel and have not heard back in time for the broadcast.

Copyright 2022 KGWN. All rights reserved.

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Illumina Wins Case Against FTC on Grail Acquisition - The Wall Street Journal

The FTC had sought to unwind Illumina’s $7.1 billion acquisition of Grail Inc. on antitrust grounds.

Photo: MIKE BLAKE/REUTERS

An administrative law judge has ruled in favor of Illumina Inc. in its $7.1 billion acquisition of cancer-testing developer Grail Inc., dealing a defeat to the Federal Trade Commission’s efforts to unwind the deal on antitrust grounds, the company said.

Illumina said the judge rejected the FTC’s position that the deal would hurt competition in the market for multicancer early-detection tests.

“As we’ve stated from the outset, this transaction is procompetitive, will advance innovation, lower healthcare costs and save lives,” said Charles Dadswell, general counsel of Illumina.

An FTC spokesman didn’t immediately respond to a request seeking comment.

San Diego-based Illumina, which makes genetic-sequencing products, agreed in 2020 to acquire Grail, which is developing tests for early cancer detection. Illumina founded Grail and had spun it off in 2017.

But in 2021, the FTC moved to block the deal, claiming that it would harm competition in an emerging field of tests for early-stage detection of multiple types of cancers.

The FTC initially sought a federal court injunction that would have blocked the closing of the acquisition, but it backed off because Illumina and Grail were facing antitrust scrutiny in Europe.

Instead, the FTC proceeded with an administrative complaint over the deal, resulting in a trial before an administrative law judge in August and September of 2021. The new ruling arises from that trial and post-trial briefs filed by Illumina and the FTC.

Illumina closed its acquisition of Grail in 2021, despite the pending legal challenges.

—Dave Michaels contributed to this article.

Write to Peter Loftus at peter.loftus@wsj.com

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Federal judge hears arguments over special master in Trump documents case - CBS News

West Palm Beach, Florida — A federal judge is hearing arguments Thursday over whether to appoint a "special master" to review highly sensitive documents seized by federal agents at former President Donald Trump's Florida home last month.

A special master is an independent, third-party attorney — often appointed by a court in high profile or sensitive cases like this one — to execute court orders or make recommendations to the court. Trump's legal team requested the appointment of a special master last week, in what was his first move to challenge the FBI's search at his Mar-a-Lago estate on Aug. 8.

Investigators are probing Trump's alleged mishandling of classified material, specifically records that he took from the White House to his Mar-a-Lago residence when he left office in January 2021, as well as possible obstruction of the investigation.  

U.S. District Judge Aileen Cannon, who is overseeing Trump's lawsuit over the search, last weekend signaled her "preliminary intent" to grant the former president's request and appoint a special master, but said she had not made a final decision. She set a hearing for Thursday afternoon to hear arguments over the request.

Attorneys Chris Kise, Lindsey Halligan, Jim Trusty and Evan Corcoran appeared on Trump's behalf at the federal courthouse in West Palm Beach. Jay Bratt, the top counterintelligence official at the Justice Department, and Juan Antonio Gonzalez, the U.S. Attorney in Miami, appeared on behalf of the government, alongside two other attorneys.

In a filing earlier this week, Justice Department attorneys argued that a special master is "unnecessary" and appointing one "would significantly harm important governmental interests, including national security interests." 

Prosecutors said the FBI had evidence that "obstructive conduct" likely occurred at Mar-a-Lago, saying that "government records were likely concealed and removed from the Storage Room" at Mar-a-Lago where Trump's attorneys said the sensitive documents had been stored. 

During the search, the government seized 33 boxes, containers or items of evidence from both the storage room and Trump's office, the filing said. An investigative team reviewing the materials found that 13 boxes or containers contained documents with classified markings, including more than 100 unique documents with classification markings. Three documents marked classified were located in desks in Trump's office, prosecutors said, and 76 more were found in the storage room.

The government alleged that representatives for Trump misled the Justice Department when they told investigators on June 3 that all classified material responsive to a subpoena had been returned from the former president's residence after a "diligent" search of the property. 

In their response on Wednesday, Trump's lawyers said their actions had been "significantly mischaracterized" in the government's filing, but declined to go into further detail. Trump attorneys Halligan, Trusty and Corcoran signed Wednesday's response.

The lawyers wrote that the execution of a search warrant against a former president's home was "unprecedented, unnecessary, and legally unsupported." They argued that without a special master, prosecutors would "impugn, leak and publicize" details of the investigation. 

The attorneys for the former president also dismissed the government's unease regarding classified material found at Mar-a-Lago, writing that the "notion that presidential records would contain sensitive information should have never been cause for alarm."

But prosecutors have argued the sensitive records seized at Trump's Mar-a-Lago residence were not his to keep, and instead belong to the federal government and the National Archives.  

Notably absent from the Trump's team response was any assertion that the former president declassified the documents at issue, as he has claimed repeatedly in the weeks since the search. The attorneys also provided no explanation as to why the documents were moved to Mar-a-Lago in the first place.

In their filing, prosecutors included a photo of some of the records seized during the search, including some with cover sheets marked "SECRET//SCI" and "TOP SECRET//SCI."

Attorneys for the former president characterized the Justice Department's inclusion of the photo as "gratuitous" on Wednesday, and Trump himself condemned the photo on his social media platform Truth Social. He has harshly criticized the FBI and Justice Department for the search, calling it a politically motivated attack ahead of a potential run for president in 2024.

Trending News

Nicole Sganga

CBS News reporter covering homeland security and justice.

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Case Affirms Rights of Contractors Facing Debarment - National Defense Magazine

Case Affirms Rights of Contractors Facing Debarment

9/1/2022
By Frederic M. Levy, Michael Pierce and Michael Wagner

iStock photo

Experienced defense companies understand that suspension or debarment from U.S. government contracts can be a death knell.

The ultimate decision on these actions typically lies with the procuring agency’s suspension and debarment official, and those officials generally enjoy substantial discretion. However, a recent federal court case shows that contractors can obtain judicial relief when an agency fails to follow required processes.

On July 8, part supplier Precision Metals Corp. was granted a temporary restraining order vacating and setting aside a Defense Logistics Agency debarment and enjoining debarment while court proceedings are pending. The decision, which emphasized two procedural violations, serves as a reminder that an agency’s authority to debar contractors is not unlimited and that it must strictly adhere to the rights granted contractors before taking action.

Federal procurement regulations set forth the procedures for suspension and debarment proceedings and provide that contractors “may submit, in person, in writing, or through a representative, information and argument in opposition to the proposed debarment.” The language generally has been understood to entitle contractors to an in-person meeting if requested.

In Precision’s case, the contractor’s rights were augmented by the language in the agency’s notice of proposed debarment, stating that Precision could submit a response “either in person or in writing, or both.”

Precision asserted that it had requested an in-person meeting with the DLA on numerous occasions. However, the agency issued its decision without such a meeting. In response, Precision filed a federal lawsuit before the Eastern District of New York under the Administrative

Procedures Act, asserting that the DLA’s decision was arbitrary and capricious.

The federal court agreed and ruled that Precision had “shown a likelihood of success on their claims against defendants,” stating that the agency had violated the procedures act when it issued a debarment without granting an in-person meeting. The court further held that in addition to likely violating the procedures act, the failure to provide the meeting also likely violated Precision’s Fifth Amendment due process rights.

In its decision, the court acknowledged the potentially catastrophic and irreparable impact of a federal debarment, particularly for a company like Precision operating on thin margins. The court reaffirmed its ruling by extending the restraining order to July 22 pending an expedited hearing to be held in September.

For contractors facing proposed debarment, in-person meetings are often a critical means of demonstrating present responsibility. Precision’s case illustrates the importance of clearly and unambiguously requesting an in-person meeting when responding to a proposed debarment.

Other best practices include following up consistently to remind the agency of the meeting request and working diligently with the government to schedule the meeting. Failure to follow up and pursue a requested meeting may allow the agency to argue that the contractor waived its request.

In addition to the general procedural requirement to provide the contractor an opportunity to respond in person, federal procurement regulations require that “[i]n actions in which additional proceedings are necessary as to disputed material facts, written findings of fact shall be prepared by the suspension debarment official.”

Here, Precision asserted that the procedures act and its Fifth Amendment due process rights were violated when the DLA failed to conduct a fact-finding hearing, even though Precision’s written response to the proposed debarment had raised issues of material facts.

Precision argued that it had presented the agency with evidence that it was at fault for the delays that had precipitated the proposed debarment, and that there had been other contributing causes including unavoidable supplier delays, supply chain issues, COVID-19 related delays and the serious health issues experienced by Precision’s then leader.

Precision contended that the DLA had acted arbitrarily and capriciously when it ignored Precision’s request for a fact-finding hearing and issued a debarment decision that summarily asserted that there was no disputed material fact.

The federal court again sided with Precision. It held that the contractor had shown a likelihood of success on its claim that the agency had violated the procedures act and Precision’s due process rights when it failed to hold a fact-finding hearing.

In practice, agencies often have avoided providing contractors with fact-finding hearings on the theory that so long as there is one undisputed fact that arguably justifies a debarment, it does not matter if other facts are in dispute. The decision in Precision underscores the importance of contractors including any material disputed facts in their response to a proposed debarment and requesting a fact-finding hearing.

When disputed material facts exist, best practice is to present the disputed facts, build the record with support for the contractor version of events and request an evidentiary hearing should the debarment proceed.

Proposed debarments are high-stakes disputes that frequently pose existential threats to their targets. The U.S. government has recognized that debarment is an extraordinary remedy only to be used as a last resort to protect the government, and contractors possess due process rights.

The Precision restraining order reaffirms that the procedural rigor an agency must exercise when attempting to exercise a debarment is commensurate with the remedy’s harshness.

As the Eastern District of New York has demonstrated, courts will take agencies to task if they attempt to circumvent contractors’ rights.

Contractors facing exclusion must be aware of their rights and applicable procedures to ensure that they are upheld. The Precision decision demonstrates the risk to agencies when those demands are ignored. 

Fred Levy and Mike Wagner are partners and Mike Pierce is an associate in the government contracts practice group at Covington and Burling LLP.

Topics: Defense Contracting

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