Antitrust and Competition Life Sciences Year in Review 2024

The last year (and particularly the last few months) of the Biden Administration brought a flurry of activity from the Federal Trade Commission (FTC) in the life sciences space, continuing a yearslong pattern of close scrutiny and culminating most notably in the issuance of a complaint against the leading pharmacy benefit managers (PBMs). It was not all bad news, however, as 2024 still featured several notable deal clearances, including the long-awaited approval of the Novo Holdings / Catalent deal and clearances of multiple transactions involving radiopharmaceutical, neurology, and obesity/diabetes assets.

Looking forward in the United States, the return of a Republican-led FTC likely signals a return to an enforcement regime and enforcement priorities that more closely resemble the pre-Lina Khan period. While the FTC under new Chairman Andrew Ferguson may be more predictable, we expect continued scrutiny of life sciences transactions and commercialization practices, particularly to the extent those areas dovetail with President Trump’s broader domestic policy agenda.

The past year also saw heightened antitrust scrutiny of life sciences transactions in the European Union and the United Kingdom, particularly regarding “killer acquisitions” and exclusionary practices. The European Commission (EC) launched its first-ever abuse of dominance probe into the shelving of a pipeline therapy, fining Teva €462.6 million for delaying generic competition. Meanwhile, the European Court of Justice (ECJ) reaffirmed that pay-for-delay agreements remain per se anti-competitive in its Servier judgment. Also in 2024, an ECJ ruling in the Illumina–GRAIL case curtailed the EC’s ability to review deals otherwise below the EC reportability thresholds, raising new questions about potential regulatory gaps for deals involving nascent competition. Meanwhile, the United Kingdom’s new Digital Markets, Competition and Consumers Act 2024 (DMCC) expanded Competition and Markets Authority (CMA) oversight of pharmaceutical deals, further reinforcing the global trend of increasing intervention in M&A transactions and conduct-related issues in the life sciences space. Looking ahead, authorities in Europe are expected to maintain their focus on transactions in innovation markets.

The FTC Moves Against PBMs

Perhaps the most significant FTC action of 2024 in the life sciences space was its administrative complaint against the three largest PBMs (CVS Caremark, Express Scripts, and Optum Rx), accusing them and their affiliated group purchasing organizations of artificially inflating insulin prices.¹

The crux of the complaint is the FTC’s allegation that the “Big Three” PBMs incentivized manufacturers to inflate the list price of insulin in order to obtain higher rebates and prioritized higher-priced versions of insulin over lower-cost alternatives on their formularies. The agency alleges these practices harm payors, who have to pay more for their subscribers’ insulin, and patients without insurance or who are underinsured, who are forced to pay the high, non-rebated list prices at the point of sale.

Overall, the complaint reflects the FTC’s move under Chair Khan’s leadership to revive enforcement of Section 5 of the FTC Act. While the complaint alleges three counts of “unfair methods of competition” under Section 5, it does not allege a violation of the Sherman Act, the primary federal antitrust statute. In doing so, it arguably attempts to push the bounds of Section 5 beyond traditional antitrust principles. This is not unprecedented: Decades ago, the FTC expressed the view and filed cases arguing that Section 5 reaches beyond the Sherman Act and encompasses a broader set of unfair conduct. But following a string of defeats in the 1980s, the FTC curtailed its Section 5 litigation. Over the past several years, the agency under Chair Khan made public comments about expanding the interpretation of Section 5 beyond Sherman Act violations and promising to bring more actions under the statute² — often to criticism and judicial skepticism.³ Here, and in other areas, the switch to a Republican-led FTC may slow (if not entirely reverse) recent FTC action, particularly action that would push the bounds of the agency’s jurisdiction and practice beyond historical norms.

One other notable aspect of the FTC’s complaint is its choice of venue. Instead of filing in federal court, the agency decided to use its in-house administrative court — an undoubtedly more hospitable venue for its aggressive theory — a move that came under immediate fire from the PBM defendants, who sought declaratory relief in federal court to enjoin the FTC administrative proceeding. That complaint followed several notable efforts to curtail the FTC’s in-house authority, including challenges by Meta and Kroger,⁴ and analogous lawsuits against other executive agencies such as the Securities and Exchange Commission.

Novo–Catalent Deal Clears Following Extended Multi-Jurisdictional Investigation

On February 5, 2024, Novo Holdings, the investment firm that manages assets for the Novo Nordisk Foundation, announced its plan to acquire Catalent, a leading provider of advanced drug delivery technologies and contract manufacturing services, for $16.5 billion.⁵

The deal was generally perceived by the industry as an attempt by Novo to secure manufacturing capacity to support the unprecedented increase in the use of pre-filled syringes — the container closure of choice for its weight-loss and diabetes assets based on GLP-1 and amylin. Indeed, the Catalent acquisition was part of a series of steps taken by Novo and Lilly, respectively, to invest billions into expanding their manufacturing capabilities to support their competing weight-loss and diabetes assets. Nevertheless, the deal attracted significant opposition from various competitors, stakeholders, and lawmakers.⁶ Among others, Sen. Elizabeth Warren (D-MA) urged the FTC to scrutinize the deal, arguing that the acquisition would “give Novo Nordisk unprecedented visibility into and control over its competitor’s production capacity, costs, and business practices, and the ability to preference its own products and obstruct its competitors’ use of Catalent,” and urged the FTC to closely review the transaction.⁷ A coalition of unions, consumer groups, and public interest organizations also submitted a letter to the FTC opposing the transaction, claiming that it could reduce patient access to vital treatments.⁸

Despite the concerns raised by third parties, both the FTC and the EC cleared the deal in December 2024, following protracted investigations. The EC investigated the impact of the transaction on the markets for the supply of both pre-filled syringes and orally disintegrating tablets (ODTs).⁹ The EC concluded that customers of pre-filled syringes would continue to have access to a number of viable contract development and manufacturing organizations (including Thermo Fisher, Vetter, and Pfizer CentreOne). Additionally, the EC found sufficient available manufacturing capacity for pre-filled syringes. Regarding ODTs, the EC determined that customers have access to multiple alternatives, including other drug formats such as tablets and capsules, and the ability to switch to those alternatives. As a result of these findings, the EC approved the deal unconditionally at the end of a Phase 1 review. The deal also got the nod from the Administrative Council for Economic Defense (CADE) in Brazil, while the UK CMA did not open a review at all.

While the FTC did not disclose specific details of its review — as is typical — its analysis was likely similar to that of the EC and was certainly conducted with attention to vertical theories of harm (i.e., the FTC likely considered whether foreclosure concerns would arise from Novo’s control over Catalent’s manufacturing capabilities). Despite the pressure from interest groups and Sen. Warren, the FTC followed the EC’s lead and cleared the transaction with no remedies.

Other Investigations in 2024 Show That the FTC Looked Up and Down the Supply Chain and Deep Into the Pipeline

The only other significant life sciences merger investigation was the FTC’s now-concluded Second Request regarding AbbVie’s acquisition of Cerevel Therapeutics. The deal was originally announced in December 2023, with AbbVie paying $8.7 billion for the neuroscience biotech.¹⁰

While Cerevel has no approved therapies, its leading asset, emraclidine — a muscarinic M4 selective positive allosteric modulator — is potentially competitive with AbbVie’s Vraylar in its use for schizophrenia, Parkinson’s disease, and major depressive disorder. To be sure, the muscarinic class assets, such as emraclidine and KarXT (see the discussion on Karuna below), have a very different mechanism of action compared with the standard-of-care atypical antipsychotics like Vraylar. Additionally, there are countless options in the atypical antipsychotic class, including generics. Nevertheless, given this potential indication overlap and Vraylar’s relative commercial success historically, it was not entirely surprising that the parties received a Second Request.¹¹ The investigation moved fairly quickly, however, with AbbVie closing the transaction about six months later.¹²

By contrast, another deal in the psychiatry space received much less agency scrutiny. Bristol-Myers Squibb’s (BMS) $14 billion acquisition of Karuna Therapeutics was also first announced in late December 2023. Karuna is another player in psychiatry with a late-stage clinical asset, KarXT, which has a mechanism of action similar to Cerevel’s emraclidine. Although the parties did have to “pull and refile” to give the FTC more time to examine the transaction,¹³ they were able to avoid a Second Request and close the transaction in March 2024 despite a larger deal value and an asset closer to commercialization than Cerevel’s.

Even amid strong rhetoric from the FTC about pharmaceuticals, the flurry of radiopharma transactions showed that many life sciences deals were clearing in the ordinary course. In the span of several months, numerous Big Pharma players announced deals with radiopharma startups, including Lilly’s $1.4 billion acquisition of POINT Biopharma, BMS’ $4.1 billion acquisition of RayzeBio, AstraZeneca’s $2 billion acquisition of Fusion Pharmaceuticals, and Novartis’ $1 billion acquisition of Mariana Oncology, in addition to other, smaller collaborations and agreements.¹⁴ None of these deals had any publicly known detailed investigation by the agencies.

Looking Forward: Enforcement Priorities Under Trump

Looking forward, the FTC’s approach to antitrust review in life sciences is poised for a significant shift following President Trump’s election as we return to what could be called “antitrust orthodoxy.” With the elevation of Commissioner Andrew Ferguson to chair and the anticipated confirmation of Mark Meador as commissioner, we expect to see a more predictable, though not necessarily less rigorous, review process for industry transactions.

The reset in antitrust policy manifests in two main ways. First, the FTC is likely to return to its historical focus of seeking remedies for problematic transactions, rather than attempting to block or derail deals outright. Major transactions that took place during the first Trump administration (such as the BMS–Celgene and AbbVie–Allergan deals) may be instructive. Even with substantial divestitures required, deals with clear antitrust challenges were approved with appropriate remedies.

Second, the procedural burden on companies pursuing transactions is likely to increase. New Hart-Scott-Rodino filing requirements will call for dealmakers to provide more detailed submissions upfront, including written narratives explaining why transactions do not raise competitive concerns. This is likely to be the case even for traditionally straightforward deals such as early-stage pipeline acquisitions.

Legislative Reform in the UK and EC’s Competition Policy for Assessment of Pharma Mergers

The DMCC, which came into force in May 2024, introduces significant reforms to UK competition and consumer protection laws, with a strong focus on digital markets. It expands the CMA’s powers to scrutinize possible killer acquisitions by giving the CMA jurisdiction to review transactions in which only one party has a significant UK presence, even if the traditional turnover or “share of supply” tests are not satisfied (i.e., without the need for any overlap between the merging parties’ activities in the UK).

The DMCC also strengthens regulatory oversight of dominant firms and grants the CMA direct enforcement powers to tackle unfair business practices. Noncompliance now carries severe penalties, including fines of up to 10% of global turnover. While aimed at Big Tech, the DMCC also affects market participants in the life sciences sector, subjecting digital health platforms, AI-driven diagnostics, and pharmatech collaborations to greater scrutiny, especially regarding fair access to health data and AI-driven drug discovery. Tougher consumer protection rules will affect DTC genetic testing, supplements, and digital health services, requiring transparent, evidence-based marketing.

In Brussels, the EC’s April 2024 Competition Policy Brief set out a helpful overview of its framework for defining markets in pharmaceutical cases, and the substantive assessment of the competitive impacts of pharmaceutical mergers, with a particular focus on their impact on innovation.¹⁵ The brief evaluates potential competition concerns arising from overlaps between marketed drugs and pipeline products, including early-stage assets. This approach is aimed at preventing killer acquisitions that could stifle innovation by discontinuing or redirecting overlapping pipelines. The EC has emphasized a broader market definition for novel therapies, focusing on indications or mechanisms of action rather than traditional classifications.

An ex-post evaluation study on EU competition enforcement in pharmaceutical mergers, commissioned by the Directorate-General for Competition and published in November 2024, examines the impact of mergers on innovation and competition, again with a focus on killer acquisitions — transactions in which overlapping R&D projects are discontinued post-merger.¹⁶ The study found that, from 2014 to 2018, 37% of pharma mergers involving overlapping R&D led to project discontinuation, often without clear technical or safety justifications, suggesting that acquirers may have deliberately halted innovation to reduce competition. It also highlights data gaps, noting that publicly available information is often insufficient to assess post-merger effects on innovation. To address this, the study recommends that regulators gain access to internal company data on R&D pipelines and strategic decisions. To refine merger control in the pharmaceutical sector, the study proposes stricter scrutiny of deals involving overlapping R&D, expanded notification thresholds to capture acquisitions of smaller innovative firms, and behavioral remedies to ensure continued R&D investment post-merger.

Antitrust Investigations and Enforcement Actions

In March 2024, the EC opened a probe into Zoetis for potential abuse of dominance over its post-acquisition discontinuation of ranevetmab, a monoclonal antibody for canine osteoarthritis.¹⁷ The EC is investigating whether this, along with Zoetis’ refusal to transfer rights to Virbac, was an exclusionary tactic to eliminate nascent competition. This is the EC’s first case targeting the termination of a pipeline product intended for third-party commercialization and signals its willingness to use Article 102 to tackle killer acquisitions outside its merger control powers. A successful case could pave the way for more post-merger antitrust enforcement in the pharmaceutical sector (see our update here for further information on the decision).

In October 2024, the EC fined Teva €462.6 million for delaying competition to Copaxone, its best-selling multiple sclerosis drug.¹⁸ The EC found that Teva misused the patent system by filing divisional patents to artificially extend exclusivity and disparaged generics by spreading misleading safety concerns to deter competition. This marks the first time the EC has ruled disparagement illegal under competition law, following its earlier commitments decision in Vifor (July 2024).¹⁹ The fine, imposed for deterrence, signals the EC’s zero tolerance for exclusionary tactics in pharmaceuticals. Teva is appealing, calling the legal theories “extreme and untested.” The case also highlights EU limits on legal privilege, because the EC relied on internal lawyer communications seized in dawn raids — underscoring the need to structure legal advice carefully.

Legal Precedents and Court Rulings

On June 27, 2024, the ECJ reaffirmed that pay-for-delay agreements are inherently anticompetitive under Article 101(1) of the Treaty on the Functioning of the European Union, even in patent disputes. This ruling reinforces the European Union’s strict stance against tactics that delay generic entry and restrict access to affordable medicines. The decision follows key cases such as Generics (UK) Ltd (2020) and Servier (2024),²⁰ in which the ECJ upheld a €331 million fine for delaying generic perindopril. Pharmaceutical companies must carefully structure settlements to avoid breaching EU competition law.

On September 3, 2024, the ECJ overturned the General Court’s decision in the Illumina–Grail case,²¹ effectively ruling that the EC cannot encourage or accept referrals for below-threshold deals from national competition authorities if those authorities lack the power to review the merger under their own laws (see our update for further information on the ruling). Despite this initial setback for the EC, dealmakers should remain vigilant: A growing number of member state authorities within the EU now have thresholds based on transaction value or “call-in” powers that allow agencies to review deals falling below traditional asset-based or turnover-based criteria. Indeed, in October 2024, the Italian Competition Authority invoked such a power to refer NVIDIA’s acquisition of Run:ai to the EC for merger review. Although the EC ultimately cleared the deal unconditionally, its acceptance of the referral underscores its ongoing determination to scrutinize below-threshold transactions. NVIDIA appealed the referral decision to the General Court in January 2025, leaving unresolved questions about the legal robustness of national call-in powers as a tool for extending merger review. This development is being closely monitored by the antitrust community, given its potential to reshape the regulatory landscape for transactions that would otherwise escape scrutiny.

^[1] Although the complaint listed only the PBMs as defendants, the FTC made clear in public statements that drugmakers were similarly to blame and issued a warning that “all drug manufacturers should be on notice that their participation in the type of conduct challenged here can raise serious concerns” and they could be named in “any future enforcement actions over similar conduct.” See Rahul Rao, “Statement of FTC Bureau of Competition Deputy Director Rahul Rao on Lawsuit Against PBMs and the Role of Drug Manufacturers in Distorting Competition in the U.S. Drug Distribution System,” FTC, September 20, 2024.
^[2] “Policy Statement Regarding the Scope of Unfair Methods of Competition Under Section 5 of the Federal Trade Commission Act: Commission File No. P221202,” FTC, November 10, 2022.
^[3] Christine S. Wilson, “Dissenting Statement of Commissioner Christine S. Wilson,” FTC, July 1, 2021.
^[4] Alfred Ng and Josh Sisco, “Meta Files Suit to Kneecap the FTC,” Politico, November 30, 2023; Julian Mark and Hannah Ziegler, “Kroger Sues to Halt FTC Proceeding Meant to Block Albertsons Merger,” Washington Post, August 19, 2024.
^[5] “Novo Holding to Acquire Catalent,” Catalent, February 5, 2024.
^[6] Motley Fool Transcribing, “Eli Lilly (LLY) Q2 2024 Earnings Call Transcript,” The Motley Fool, August 8, 2024; Fraiser Kansteiner, “Roche CEO Says Novo’s Catalent Buyout ‘Could Be a Problem’ for Smaller Drugmakers,” Fierce Pharma, October 23, 2024.
^[7] Elizabeth Warren, letter to Lina Khan, October 9, 2024.
^[8] David A. Balto, letter to Lina Khan, October 17, 2024. 
^[9] “Commission Approves Novo Holdings’ Acquisition of Catalent,” EC, December 5, 2024.
^[10] Annalee Armstrong, “AbbVie CEO Gonzalez Brushes off FTC Concerns for Cerevel buy: ‘This Acquisition is not Anti-competitive,’” Fierce Pharma, December 7, 2023.
^[11] Jacob Bell, “AbbVie’s Cerevel Deal Hits an Uncommon Roadblock,” Biopharma Dive, February 20, 2024.
^[12] “AbbVie Completes Acquisition of Cerevel Therapeutics,” AbbVie, August 1, 2024.
^[13] Ben Brody, “Karuna Plan to Refile US Antitrust Paperwork for Deal Focused on Neuroscience Drug,” MLex, February 6, 2024.
^[14] “Lilly Completes Acquisition of POINT Biopharma,” Lilly, December 27, 2023; James Waldron, “BMS enters radiopharma race with $4.1B acquisition of RayzeBio just 3 months after biotech went public,” Fierce Biotech, December 27, 2023; Nick Paul Taylor, “AstraZeneca Melds with Fusion in $2B Radiopharma Buyout,” Fierce Biotech, March 19, 2024 (Goodwin Procter represented Fusion in this transaction); Annalee Armstrong, “Novartis further entrenches into radiopharma with $1B Mariana buy,” Fierce Biotech, May 2, 2024 (Goodwin Procter represented Mariana Oncology in this transaction); see, for example, Kevin Dunleavy, “BMS-backed Radiopharma Specialist Ratio Expands Manufacturing Deal With CDMO PharmaLogic,” Fierce Pharma, March 18, 2024.
^[15] “Competition Policy Brief: Non-Price Competition: EU Merger Control Framework and Case Practice,” EC, April 1, 2024.
^[16] Ex-post Evaluation: EU Competition Enforcement and Acquisitions of Innovative Competitors in the Pharma Sector Leading to the Discontinuation of Overlapping Drug Research and Development Projects, EC, 2024.
^[17] “Commission Opens Investigation Into Possible Anticompetitive Conduct by Zoetis Over Novel Pain Medicine for Dogs,” EC, March 25, 2024. 
^[18] “Commission Fines Teva €462.6 Million Over Misuse of the Patent System and Disparagement to Delay Rival Multiple Sclerosis Medicine,” EC, October 30, 2024. 
^[19] “Commission Accept Commitments by Vifor to Address Possible Anticompetitive Disparagement of Iron Medicine,” EC, July 21, 2024. 
^[20] Generics (UK) Limited and Others v. Competition and Markets Authority (January 2020); “The Court of Justice Rules on the Existence of Agreements, Decisions and Concerted Practices and of Abuse of a Dominant Position on the Perindopril Market,” ECJ, June 27, 2024.
^[21] “Illumina-Grail Merger: the Court of Justice Sets Aside the Judgment of the General Court and Annuls the Decisions by Which the Commission Accepted Requests from National Competition Authorities Seeking the Examination of the Proposed Concentration,” ECJ, September 3, 2024.

This informational piece, which may be considered advertising under the ethical rules of certain jurisdictions, is provided on the understanding that it does not constitute the rendering of legal advice or other professional advice by Goodwin or its lawyers. Prior results do not guarantee similar outcomes.