GSK files a patent infringement lawsuit against Pfizer as the RSV vaccination war begins

GSK Sues Pfizer Over RSV Vaccine Patent

In the latest vaccine showdown, GSK and Pfizer are engaged in a legal battle over patent infringement claims. GSK alleges that Pfizer’s respiratory syncytial virus (RSV) shot, Abrysvo, violates four patents related to its own RSV antigen vaccine, Arexvy, which was approved in the US around the same time as Pfizer’s vaccine.

According to court documents, GSK argues that Pfizer initiated the project leading to Abrysvo no earlier than 2013, which is at least seven years after GSK began its RSV program.

GSK filed the lawsuit in a district court in Delaware, stating that Pfizer began its R&D into an RSV vaccine years after GSK did, and as a result, Abrysvo is infringing on the patents (8,563,002, 11,261,239, 11,629,181, and 11,655,284) owned by GSK. The lawsuit alleges that Pfizer knowingly used GSK’s claimed inventions in Abrysvo without permission. It also mentions that Pfizer had previously opposed the ‘002 and ‘239 patents in Europe, arguing their invalidity.

“In the US, GSK has initiated legal proceedings against Pfizer to enforce several patents relating to RSV vaccines. Intellectual property protections are the foundation of research-based companies’ ability to drive innovation.”

Despite the lawsuit, GSK asserts that its legal action will not hinder the launch of its own RSV vaccine, Arexvy, and the company remains focused on making it available for older adults in the US following FDA approval.

Pfizer, on the other hand, stands firm in its belief in the strength of its intellectual property and intends to vigorously defend its right to offer Abrysvo to patients.

The disputed GSK patents pertain to compositions used in RSV vaccines and methods for preparing those compositions. GSK accuses Pfizer of knowingly using their claimed inventions in Abrysvo without permission.

Seeking resolution through a jury trial, GSK is demanding damages or royalties from Pfizer and, if successful in court, a permanent injunction on future sales and manufacturing of Pfizer’s RSV vaccine in the US

The RSV vaccine market is a significant battleground in the pharmaceutical industry, with analysts estimating its potential opportunity to be over $10 billion. In addition to Pfizer and GSK, Moderna has reported positive Phase III results for its RSV vaccine.

The RSV vaccination market holds significant value, estimated to be worth between $5 billion and $10 billion globally. While GSK and Pfizer were the first to enter the market, other pharmaceutical companies like Moderna and Bavarian Nordic are also developing RSV vaccine candidates in late-stage development. Elsewhere, partners Sanofi and AstraZeneca recently obtained US approval for their preventive antibody against RSV, positioning it for use in all infants to protect them during their first RSV season. The antibody, known as Beyfortus, has also received approval in Europe.

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