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Showing results for:  “Section 5, Collateral Consequences, and Counting Unicorns”

DMA: Setting the Goalposts

In a little less than a month, the European Union’s Digital Markets Act (DMA) will start to bite, but how will it taste? By March 7, companies that were designated as “gatekeepers” in September 2023 will be required to meet the obligations of Articles 5, 6, and 7 of the DMA Regulation. With the exception ... DMA: Setting the Goalposts

Navigating the AI Frontier, Part I

The European Union is on the verge of enacting the landmark Artificial Intelligence Act (AI Act), which will—for better or worse—usher in a suite of new obligations, and hidden pitfalls, for individuals and firms trying to navigate the development, distribution, and deployment of software. Over the coming months, we will be delving into the nuances ... Navigating the AI Frontier, Part I

March-Right-on-In Rights?

The National Institute for Standards and Technology (NIST) published a request for information (RFI) in December 2023 on its “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights.” It’s quite something, if not in a good way. March-In Rights Provide Very Limited Exceptions to Intellectual-Property Rights What are “march-in” rights? In brief, they ... March-Right-on-In Rights?

The FTC’s Misguided Campaign to Expand Bayh-Dole ‘March-In’ Rights

The Federal Trade Commission (FTC) has now gone on record in comments to the National Institute of Standards and Technology (NIST) that it supports expanded “march-in rights” under the Bayh-Dole Act (Act). But if NIST takes the FTC’s (unexpected, but ultimately unsurprising) contribution seriously, such an expansion could lead to overregulation that would ultimately hurt ... The FTC’s Misguided Campaign to Expand Bayh-Dole ‘March-In’ Rights

The WHO’s Insufficient Curiosity and Humility

Five months from now, health ministers from the 194 sovereign states recognized by the United Nations (UN) will meet in Geneva to discuss and possibly agree to amendments to the International Health Regulations (IHRs), which are intended to “prevent, protect against, prepare, control and provide a public health response to the international spread of diseases.” ... The WHO’s Insufficient Curiosity and Humility

How the FTC’s Amazon Case Gerrymanders Relevant Markets and Obscures Competitive Processes

As Greg Werden has noted, the process of defining the relevant market in an antitrust case doesn’t just finger which part of the economy is allegedly affected by the challenged conduct, but it also “identifies the competitive process alleged to be harmed.” Unsurprisingly, plaintiffs in such proceedings (most commonly, antitrust enforcers) often seek to set ... How the FTC’s Amazon Case Gerrymanders Relevant Markets and Obscures Competitive Processes

What Do We Do with Presumptions in Antitrust?

Winter was coming, as it does. We knew the agencies were going to issue new merger guidelines, and then they did. On Dec. 18, 2023, the Federal Trade Commission (FTC) and U.S. Justice Department (DOJ) jointly issued merger guidelines, supplanting 2023’s draft guidelines, the 2010 Horizontal Merger Guidelines, and the 2020 (partially withdrawn) Vertical Merger ... What Do We Do with Presumptions in Antitrust?

Four Problems with the Supreme Court’s Refusal To Hear the Epic v Apple Dispute

The U.S. Supreme Court this week rejected both parties’ petitions for certiorari in appeals of the 9th U.S. Circuit Court of Appeals’ Epic Games v Apple decision. Many observers—including Epic CEO Tim Sweeney—have marked this as an unmitigated loss for Epic.  That’s partly right. The district court had correctly rejected Epic’s federal antitrust claims against ... Four Problems with the Supreme Court’s Refusal To Hear the Epic v Apple Dispute

Slouching Toward Disconnection and the End of the ACP

It’s our first post of the New Year, and we’re having a hard time feeling the Hootenanny vibes. Rather than Congress taking a “new year, new you” approach to telecom policy, it seems that D.C. is starting the year with the “same old, same old” of brinkmanship. This time, with broadband subsidies. The Affordable Connectivity ... Slouching Toward Disconnection and the End of the ACP

The Conundrum of Out-of-Market Effects in Merger Enforcement

Section 7 of the Clayton Act prohibits mergers that harm competition in “in any line” of commerce. And, indeed, the Supreme Court’s decisions in Philadelphia National Bank and Topco are often cited on behalf of the proposition that this means any single cognizable market, and that anticompetitive effects in one market cannot be offset by ... The Conundrum of Out-of-Market Effects in Merger Enforcement

FTC v. Illumina/Grail – A Rare FTC Merger Victory? (Actually, a Loss for Consumers)

Although it was overshadowed by the Federal Trade Commission (FTC) and U.S. Justice Department’s (DOJ) year-end release of the 2023 merger guidelines, one should also note the abrupt end of the FTC v. Illumina/Grail saga. The saga finished with the FTC’s Dec. 18 press release announcing that Illumina decided on Dec.17 to divest itself of ... FTC v. Illumina/Grail – A Rare FTC Merger Victory? (Actually, a Loss for Consumers)

Three Problems with Accelerated Access: Will They Be Overcome?

This post discusses three important problems with the Food and Drug Administration’s (FDA) accelerated-approval process. The first is that regulatory authorities and patient groups maintain that, legally, the standards of accelerated approval are the same as standard approval. Yet from a risk perspective, the standards are quite different; by shifting risk taking from regulator to ... Three Problems with Accelerated Access: Will They Be Overcome?