Did Novartis break U.S. antitrust laws in the storied Eylea-Lucentis rivalry? Thanks to an appeals court ruling, Regeneron has another chance to lay out its argument.
The U.S. Court of Appeals for the Second Circuit has reversed (PDF) a lower court’s ruling to dismiss Regeneron’s antitrust lawsuit against Novartis, saying Regeneron has met the burden to warrant further legal proceedings.
Novartis and its partner Vetter Pharma must now defend against Regeneron’s allegation that the companies conspired to use a patent to delay competition from a prefilled syringe version of Regeneron’s eye drug Eylea, which was originally presented in vials.
Prefilled syringe versions of Lucentis and Eylea are preferred over vials because of their accuracy, convenience and significantly lower risk of complications and infections. After the pharma rivals launched their respective drugs in vials, they raced to develop prefilled syringe versions to gain an edge over one another.
The Eylea-Lucentis legal battle started in 2020, when Novartis filed a patent infringement lawsuit against Regeneron focused on the so-called “’631 patent” covering prefilled syringe technology. That patent was invalidated by the U.S. Patent and Trademark Office in 2022, a decision Novartis is appealing.
About a month after Novartis launched the patent litigation, Regeneron filed the antitrust lawsuit against Novartis and Vetter.
Regeneron partnered with Vetter in 2005 to develop a prefilled syringe version of Eylea. But, according to Regeneron, Vetter in 2009 secretly entered into a similar deal with Novartis around Lucentis, which led to Novartis obtaining the ’631 patent in 2015.
In the years following 2009, Vetter took several steps that Regeneron alleged were intended to help Novartis monopolize the prefilled syringe anti-VEGF market. Regeneron also alleged that Novartis fraudulently obtained the ’631 patent by withholding information from authorities.
Novartis and Vetter’s actions delayed the launch of the Eylea prefilled syringe by several years as Regeneron worked to establish a new supply chain for the updated product, Regeneron contends. When the prefilled version reached the market in late 2019, 80% of Eylea patients switched to it within six months, according to Regeneron.
At the center of the two courts’ contrasting decisions is whether anti-VEGF prefilled syringes constitute their own market that’s separate from the market for vials.
The lower court judge, in dismissing Regeneron’s case in 2022, focused on the similarities between the two product types and figured they compete in the same market.
The appeals court sided with Regeneron, saying that the New York company made plausible antitrust allegations.
“The fact that vials and [prefilled syringes] contain the same medicines and treat the same condition does not automatically mean that they compete in the same market,” the appeals court said in an opinion.
Previously, the Department of Justice and the Federal Trade Commission also argued that the district court made errors in its legal analysis.
Whether vials and prefilled syringes constitute separate antitrust markets shouldn’t be viewed from the perspective that they are “functional” substitutes for each other, the federal agencies said in an amicus brief (PDF). Instead, the evaluation should take place from the perspective of consumers.
Thanks to increased competition, Lucentis last year brought Novartis about $1.5 billion in sales, which marked a 21% decline over 2022. Novartis' U.S. marketing partner Roche saw its Lucentis revenues drop 52% to 452 million Swiss francs (about $510 million).
Regeneron, for its part, recorded $5.9 billion sales for Eylea in the U.S. alone in 2023.