BioNTech and Pfizer’s BNT162 Vaccine Patent Landscape

By Mario Gaviria and Burcu Kilic

BNT162 Vx patent landscape

Safe and effective vaccines are key to combating the Covid-19 pandemic; however, patents and other intellectual property claims directed at vaccine technologies create legal barriers for equitable access and fair allocation. No corporation produces at scale to supply the world. Providing timely global access will depend in significant part on increasing supply, including by transferring technology to qualified manufacturers. Much of this technology is claimed as patented, proprietary, or confidential in nature.

German company BioNTech and its U.S. partner Pfizer’s2 vaccine candidate, BNT162 SARS-CoV-2, employs the use of lipid nanoparticle (NP) technology to deliver mRNA to cells. Once the lipid nanoparticle is injected into a patient, it travels into the cells and instructs them to produce the SARS-CoV-2 spike protein. The presence of this coronavirus protein is thought to trigger an immune response leading to the production of antibodies.3  If the patient is infected with coronavirus, the antibodies will identify and bind to the virus, which triggers a series of events resulting in the elimination of the virus.
BNT1
BNT162 is in Phase 3 clinical trials. Pfizer announced promising but preliminary trial results on November 9th.4

We identified several patents claimed by BioNTech relating to the pertinent vaccine technologies.5 We placed them in three groups based on their description and their primary independent claim:

  • Patents directed at RNA
  • Patents directed at Lipids/NP + mRNA
  • Patents specifically directed at pharmaceutical compositions involving lipid NP + mR

Below is our non-exhaustive list. In a recent financial statement, BioNTech suggested that its patent claims extend to mRNA structure, formulations, and manufacturing, and relies on trade secrets and confidential know-how to protect aspects of mRNA manufacturing technologies.6

Patent/Published Application Applicant/Assignee Filing Date Status Invention Type
US 10,576,146 BioNTech March 15, 2018 Active Lipids/NP + mRNA
US 10,485,884 BioNTech March 5, 2013 Active Lipids/NP + mRNA
US 9,950,065 BioNTech September 26, 2013 Active Lipids/NP + mRNA
US2020/0155671 BioNTech January 22, 2020 Pending Lipids/NP + mRNA
US2020/0197508 BioNTech March 21, 2018 Pending RNA immune response
US2019/0153428 BioNTech August 24, 2016 Pending RNA immunogenicity
US2019/0321458 BioNTech July 14, 2017 Pending PC: Lipids/NP + mRNA
US2018/0263907 BioNTech March 30,2016 Pending Lipids/NP + mRNA
US2017/0273907 BioNTech September 17, 2015 Pending Lipids/NP + mRNA
US2014/0030808 BioNTech December 2, 2011 Pending RNA expression
WO2016/156398 BioNTech March 30,2016 Published Lipids/NP + mRNA
WO2015/043613 BioNTech September 26, 2013 Published Lipids/NP + mRNA
WO2013/087083 BioNTech December 15, 2011 Published Lipids/NP + mRNA

 

2 All patents and patent applications identified in this study were claimed by BioNTech indicating that they are the inventor of the relevant vaccine technology, while Pfizer is acting as the innovator and leading the large-scale manufacturing, development, and regulatory approval process.

3 https://www.nejm.org/doi/10.1056/NEJMoa2027906

4 https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against

5 Pharmaceutical companies are not the only claimants of key technology. The U.S. government claims a patent on a key technology which may be relevant for BioNTech and Pfizer to stabilize the spike protein.  See Public Citizen, Leading COVID-19 Vaccine Candidates Depend on NIH Technology (Nov. 10, 2020), https://www.citizen.org/article/leading-covid-19-vaccines-depend-on-nih-technology/.

6 “Certain of our technologies, including in particular certain proprietary manufacturing processes or technologies and/or neoantigen prediction technologies, are protected as trade secrets”,.BioNTech SE, SEC Filing (July 21 2020), https://www.sec.gov/Archives/edgar/data/1776985/000119312520195911/d939702df1.htm.