Patent Litigation over Covid-19 Vaccine – IPR – Part 2

This year’s Nobel Prize in Physiology or Medicine has been awarded to researchers who have made significant contributions to the development of mRNA vaccines.

Although the mRNA vaccine has become well known through the Covid-19 vaccine, last summer, Modela filed a patent lawsuit against Pfizer and Biontec in the U.S. for patents related to the technology. In response, Pfizer and Biontec filed an IPR with the U.S. Patent and Trademark Office this summer.

In this issue, we would like to take a closer look at the IPR filed by the two companies.

Patent Litigation over COVID-19 vaccine – IPR has been filed, according to the company.

IPR has been filed for two of the three patents that Moderna had raised at the time of the lawsuit.

10,702,600 (the “‘600 patent”) : Betacolonavirus mRNA vaccine

The patent is for packaging mRNA in lipid nanoparticles so that mRNA is not degraded when administered to a living body, facilitating mRNA transport into the body and delivering the target substance into the cell.

10,933,127 (the “‘127 patent”) : Betacolonavirus mRNA vaccine

The patent is for administering an mRNA vaccine, which induces a balanced immune response to the target substance by specifying the ratio of mRNA and lipid nanoparticles, formulated in lipid nanoparticles.

IPR Overview

The patents were accompanied by about 90 exhibits, and almost all of them were challenged mainly on the grounds of Anticipation and obviousness (novelty and inventive step in Japan), The Nobel Prize-winning paper by Dr. Karienko et al. was also included in the EXHIBITS.

It is further argued in both IPRs that the Trial and Appeal Board’s use of discretion under U.S. Patent Law §325(d) to reject the IPR itself is inappropriate because the IPR here relies on prior art references that were submitted to the Patent Office but not substantively considered, or that were not previously submitted to the Patent Office. and that it is not appropriate because the Examiner erred in permitting the patent to issue against prior art.

*U.S. Patent Law §325(d): IPR by “the same or substantially the same prior art
Authority is given to the USPTO to dismiss the claim.

Pfizer and Biontec are represented at the PTAB by Williams & Connolly andPaul Hastings, and Moderna by Wolf, Greenfield & Sacks.

Reference materials:

Pfizer/BioNTech Take COVID Vaccine Fight with Moderna to PTAB

http://www.jipa.or.jp/kaiin/kikansi/honbun/2019_03_388.pdf

The photo shows the view of the Thames River from the Tate Modern Museum in London, which I visited this summer.