Posts Tagged: "Pfizer"

The mRNA IP and Competitive Landscape Through One Year of the COVID-19 Pandemic – Part I

Shortly after we posted about Moderna, Inc.’s October 2020 pledge not to enforce its COVID-19-related patents during the pandemic, the United States Food & Drug Administration (FDA) granted emergency regulatory approval for two COVID-19 vaccines produced by Moderna and BioNTech (with Pfizer), making these groups the first to ever enter the commercial market with mRNA-based therapies. This little-known and never-before-approved mRNA technology has since been widely administered and represents a primary weapon being used to defeat the pandemic. While this effort carries on, market players are confident that COVID-19 is but one of many indications that the mRNA technology platform might be utilized for, and that approval of the mRNA vaccines could open the door for the approval of other mRNA-based medicines, creating a wide range of new markets. With the anticipated increase in market activity and competition, we will provide an overview of the mRNA IP and competitive landscape in a series of three posts in the context of certain key players’ patent positions, drug pipelines, strategic relationships, and other attributes. These posts are based on publicly available information, are non-exhaustive, and do not identify all market players or potential market players in this space.

Pfizer Rejects Accusations it Infringed COVID-19 Vaccine Assay Technology

Pfizer and BioNTech have hit back at Allele Biotechnology and Pharmaceuticals, Inc.’s October 2020 complaint accusing the COVID-19 vaccine manufacturers of infringing Allele’s U.S. patent covering a particular “tag” used to track vaccine in a patient’s blood…. U.S. regulatory approval requires Pfizer and BioNTech to show that their vaccine is safe and effective against SARS-CoV-2 infection. To meet the Food and Drug Administration’s (FDA’s) requirements, Pfizer and BioNTech have been and “continue to be engaged in large scale clinical trials to evaluate, among other things, whether individuals who receive the vaccine are less susceptible to COVID-19 infection.” As part of these trials, the results of laboratory tests on blood samples drawn from patients in the clinical trials who received the vaccine are evaluated. One of these tests is a “neutralization assay,” which is a laboratory procedure to detect the presence of antibodies in the blood of a patient after receiving a vaccination capable of neutralizing the SARS-CoV-2 virus. As part of the assay mentioned above, a fluorescent “tag” is used to track the vaccine in a patient’s blood. Allele alleged in its complaint filed in October 2020 that Pfizer and BioNTech infringed their patent for their particularly engineered tag.

Calls for WTO to Suspend IP Rights for Vaccine Innovation Would Jeopardize Incredible Progress

The biggest vaccination effort in the history of medicine is underway to eradicate the global pandemic, with several strong prospects appearing poised for regulatory approval. As of December 2020, data from the World Health Organization showed over 50 vaccine candidates in clinical research, and 163 more in the preclinical stage. The wait could soon be over. Two separate vaccines – one from Pfizer and BioNTech and one from Moderna – are pending emergency use authorization from the U.S. Food and Drug Administration. The former is already being administered for the first time outside of clinical trials following its approval by the UK government. That’s why recent calls to strip away intellectual property protections are so dangerous. Specifically, some nations have asked the World Trade Organization (WTO) to waive intellectual property protections related to COVID-19 – including not only vaccines, treatments, diagnostics, and medical technologies, but all forms of IP – until the majority of the world’s population has developed immunity. They argue that the current global intellectual property system is a barrier to accessing said COVID-19 vaccines, treatments, diagnostics, and medical technologies.

Breaking Down Moderna’s COVID-19 Patent Pledge: Why Did They Do It?

As Pfizer and BioNTech announced this week that results of their COVID-19 vaccine have exceeded expectations, the technology behind the vaccine (messenger RNA, or mRNA) has taken center stage. Last month, Moderna Therapeutics, one of the global leaders in the race to produce a COVID-19 vaccine using mRNA, made the following statement regarding enforcement of its patents: “We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible. Accordingly, while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic. Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post pandemic period.” This post examines why Moderna made this patent pledge by examining its mRNA technology, go-to-market status, patent landscape, and market position.

Regeneron, Pfizer and BioNTech Accused of Infringing Allele Patent in Connection with COVID-19 Technologies

Allele Biotechnology and Pharmaceuticals, Inc. (Allele) has accused Regeneron Pharmaceuticals, Inc. (Regeneron); Pfizer, Inc. (Pfizer); and BioNTech SE and BioNTech US, Inc. (collectively BioNTech) for allegedly infringing U.S. Patent No. 10,221,221 (the ’221 patent), which is directed to an artificial flourescent, i.e. mNeonGreen, used for testing COVID-19 assays against vaccine candidates.  Allele argues that Regeneron, Pfizer and BioNTech have been infringing the ‘221 patent by taking mNeonGreen “for their own unauthorized commercial testing and development.” Regeneron has been in the news lately for famously providing the “antibody cocktail” given to President Donald Trump shortly after he tested positive for COVID-19 last week. The cocktail is name in the complaint as one of the allegedly infringing technologies.