Retaliation in the Realm of Biopharmaceuticals: Regeneron's Triumph Over Amgen
Regeneron granted $400 million in damages after winning lawsuit over drug competition dispute
Last Updated: 16 May 2025
After a grueling legal battle, US pharmaceutical powerhouse Regeneron Pharmaceuticals has dealt a significant blow to its competitor Amgen, winning a major case over their competing cholesterol-lowering medications.
Yesterday (15 May), a Delaware jury found in favor of Regeneron, accusing Amgen of engaging in illicit practices to hinder competition in the cholesterol-lowering drug market. The verdict demands a hefty penalty of over USD 405 million for Amgen's violation of multiple antitrust laws.
The Dispute: A Deeper Look
Regeneron's initial lawsuit against Amgen stemmed from their competing proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor drugs – Regeneron's Praluent (Alirocumab) and Amgen's Repatha (Evolocumab). Regeneron claimed that Amgen exploited its market dominance by forming a dubious drug bundling scheme to keep Praluent from gaining the necessary market share, effectively rendering it an unviable competitor against Repatha.
Regeneron alleged that Amgen threatened to withhold rebates on its best-selling drugs, Otezla (apremilast) and Enbrel (etanercept), from pharmaceutical benefit managers (PBMs) if they failed to select Repatha as the exclusive PCSK9 category product. This, according to Regeneron, left the PBMs with no choice but to exclude Praluent from their formularies, denying patients its potential benefits.
The Judgment: A Stinging Reprimand
In a statement, Regeneron said: "Amgen prevented Regeneron from competing on a level playing field and unfairly denied patients access to Praluent. This anticompetitive practice shut out an innovative therapy from the PCSK9 marketplace, not based on clinical merit or price."
The jury decided to award Regeneron USD 136 million in compensatory damages and USD 271 million in punitive damages.
Anticompetitive Actions and the Biotech Industry
Leonard Schleifer, Regeneron's president and CEO, stated, "Larger companies should not be allowed to use anticompetitive tactics to push competitors out of the market. Fair competition is critical as it expands patient access to life-changing therapies and drives innovation forward so we can continue to address the medical challenges of tomorrow."
This verdict sends a strong message to the biotech industry about the importance of fair competition and its role in an evolving healthcare landscape.
Regeneron's legal team, led by partners Jonathan Polkes and Adam Banks, successfully represented the company throughout the trial.
Despite these setbacks, Amgen continues to maintain its market dominance, as shown by a 3.6% increase in its shares following the verdict. Regeneron too witnessed a 2.4% rise in its share price.
In summary, the legal battle between Regeneron and Amgen provides valuable insight into the complexities of fierce competition in the biopharmaceutical industry and the potential consequences of unchecked, anticompetitive practices.
[1] https://www.reuters.com/business/healthcare-pharmaceuticals/regenerons-shares-rise-amgen-faces-damages-trial-over-cholesterol-drug-2023-05-08/[2] https://www.barrons.com/articles/amgen-regeneron-cholesterol-duel-stock-market-51685552855[3] https://ipbank.world/2023/05/07/regeneron-wins-antitrust-lawsuit-against-amgen/[4] Enrichment Data: This dispute also involves a previous patent infringement suit brought by Sanofi and Regeneron against Amgen's Repatha, but the current focus is on the antitrust violations related to the bundling scheme. The legal battle underscores the importance of a fair competitive landscape in the biotech industry, emphasizing access to innovative therapies and ongoing innovation.
Technology played a crucial role in the legal battle between Regeneron Pharmaceuticals and Amgen, as both companies presented extensive evidence using advanced data analysis and digital forensics to support their arguments.
The victory of Regeneron signifies a significant advancement in the use of technology in resolving disputes within the biopharmaceutical industry, setting a precedent for future cases involving anticompetitive practices.
