GSK, Pfizer resolve RSV patent feud amid vaccine market uncertainty

 As the respiratory syncytial virus (RSV) vaccine field grapples with a significantly reduced market size thanks to regulatory uncertainties, GSK and Pfizer have decided to lay to rest their patent feud.

GSK and Pfizer have moved to scrap a patent lawsuit around their respective RSV vaccines, according to a filing in the U.S. District Court in Delaware.

The settlement comes after a U.K. high court in November sided with Pfizer, ruling that two GSK RSV vaccine patents were invalid.

GSK brought the lawsuit to Pfizer in 2023, shortly after the FDA’s back-to-back approvals for GSK’s RSV shot Arexvy and Pfizer’s rival product Abrysvo. The British pharma claimed that the Pfizer vaccine infringed on four of its patents related to the antigen technology used in its shot.

At that time, the emerging RSV vaccine market was billed as a major blockbuster opportunity. And GSK’s first-to-market Arexvy lived up to that expectation with $1.5 billion sales in its first year of commercialization.

Things took a drastic turn in mid-2024, when a Centers for Disease Control and Prevention (CDC) advisory committee narrowed its age recommendation for RSV vaccinations. Both GSK and Pfizer felt the pain immediately, with sales of GSK’s Arexvy declining 70% year over year in the last three months of 2024 and Pfizer’s Abrysvo revenues dropping 62% during the same period.

Moderna’s newer entry, mRESVIA, also suffered a muted launch since its May 2024 approval, with merely $15 million in fourth-quarter sales. The disastrous RSV rollout was a significant reason behind Moderna’s launch of a $1.5 billion cost-cutting initiative. 

While the companies didn’t expect the CDC to change its position on RSV vaccines this year, they were at least hopeful that with forthcoming longer-term data, a more favorable policy might emerge. Then vaccine skeptic Robert F. Kennedy Jr. became the new secretary of the Department of Health and Human Services (HHS).

Just a few weeks into his tenure, RFK Jr. has pushed his anti-vaccine agenda on many fronts. A regular meeting of the CDC vaccination committee was postponed days after RFK Jr. took office. Then, an FDA vaccine advisory committee meeting was canceled.

If those weren’t clear enough signals that the RFK Jr.-led health department had turned against vaccines, Peter Marks, M.D., Ph.D., the longtime director of the FDA’s Center for Biologics Evaluation and Research, was pushed out last week because of a disagreement with the HHS boss on vaccine policy.

Then, word came out that the FDA’s principal deputy commissioner, Sara Brenner, M.D., intervened in the review process of Novavax’s COVID-19 vaccine candidate and demanded to see more data. The unusual move by a political appointee at the agency led to the FDA missing its deadline to decide on approval for the Novavax shot.

“If you’re going to be a biotech company right now, don’t be a vaccine company,” Leerink Partners analyst Mani Foroohar, M.D., told Fierce Pharma in an interview this week.

For drugmakers to keep pressing patent litigation, there needs to be a big enough potential financial gain to make the effort worthwhile. In GSK’s suit against Pfizer, the British pharma was seeking monetary damages or royalties and potentially a permanent injunction on the commercialization of Pfizer’s RSV vaccine in the U.S.

Meanwhile, the two companies still appear to be locked in a patent battle around mRNA COVID vaccine technologies. 

https://www.fiercepharma.com/pharma/gsk-pfizer-end-rsv-patent-feud-entire-vaccine-market-faces-volatility