GSK sued the New York-based Pfizer last Aug. 2 by means of a complaint filed in a federal court in Delaware. It alleged that Pfizer infringes its patent by making, using, selling and importing its Abrysvo shot for RSV in the United States. Arexvy, GSK's version of the RSV shot, was allegedly copied by the American drug firm.
According to the London-based GSK, Pfizer began working on its RSV vaccine in 2013 – seven years after it commenced research that led to Arexvy in 2013. Abrysvo infringes four of its patents related to the antigen – a weakened version of the RSV – used in its vaccine, GSK added.
"GSK patents describe and claim inventions relating to compositions used in RSV vaccines, and methods for preparing those compositions," the Aug. 2 lawsuit noted. "Upon information and belief, Pfizer knowingly used GSK's claimed inventions in Abrysvo without permission."
GSK moreover claims Pfizer knew about its patents since at least October 2019, when the U.S. drug firm challenged the validity of the patent in the European Union. Pfizer subsequently filed an action against GSK in the Royal Courts of Justice at the British capital in June 2022.
A GSK spokesperson confirmed the lawsuit filed in federal court, adding that "intellectual property protections are the foundation of research-based companies' ability to drive innovation."
They added: "This action does not impact GSK's ability to launch its RSV vaccine, Arexvy, and we remain fully focused on making our RSV vaccine for older adults available in the U.S. following its recent approval by the [country's] Food and Drug Administration (FDA). As proceedings are ongoing, we can't comment further at this time."
A Pfizer spokesperson also confirmed the legal action by GSK. "Pfizer is confident in its intellectual property position and will strongly defend its right to bring its RSV vaccine to patients," the spokesperson said.
The FDA has approved both Arexvy from GSK and Abrysvo from Pfizer for use in the United States. It green-lit Arexvy for use in those above 60 years of age on May 3, and approved Abrysvo for the same cohort on May 31. However, regulators in the United Kingdom have only approved the GSK shot – doing so in June.
Both GSK and Pfizer are in a race for their vaccines to be rolled out worldwide, with a view to making billions of annual revenue as countries work to slash RSV-related hospitalizations and deaths. According to experts, the RSV vaccine market could hit $10 billion by 2030. (Related: First RSV emergency declared as Pfizer and GSK race to get vaccines approved.)
RSV is a very common pathogen that can cause a runny nose, cough, sneezing, fever and wheezing. While it usually goes away within two weeks, it can lead to lung infections that can hospitalize patients.
According to studies, RSV may hospitalize more elderly people with flu. Those suffering from pre-existing diabetes, heart disease and lung disease comprise most RSV-related admissions.
RSV is responsible for hospitalizing up to 160,000 and kills up to 10,000 older adults in the United States, say official sources. Across the pond, the pathogen causes 14,000 hospitalizations and 8,000 deaths among older British adults every year.
There is currently no treatment for RSV, so physicians only aim to ease patients' symptoms. Enter the vaccines, which work by exposing the immune system to proteins from the surface of the virus. This prompts the body's immune system to make antibodies to fight off the pathogen, according to the Daily Mail.
In April, GSK said it expects sales of Arexvy to hit $3.8 billion per year. But it appears that Pfizer is now leading the race, saying it would have supplies of its Abrysvo vaccine by fall after the FDA authorized the shot.
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Watch Dr. Sam Bailey talking about the RSV vaccine up-sell in the video below.
This video is from the Pool Pharmacy channel on Brighteon.com.