By: Jennifer Gomes

While the race to market for the COVID-19 vaccines may be a thing of the past, companies have taken the fight from the labs and manufacturing floors to the courts.  A complex web of patent infringement litigation has developed between competing vaccine manufacturers Moderna and Pfizer-BioNTech, both in the U.S. and abroad.

In August 2022, Moderna filed infringement claims against Pfizer and BioNTech for two patents filed between 2010 and 2016 for mRNA technology.  Moderna claimed that Pfizer-BioNTech copied this technology, which was essential to the development of Moderna’s mRNA COVID-19 vaccine, Spikevax, and used it to develop their own vaccine.  According to Moderna, their mRNA technology had been in development for long enough to bestow their scientists with a level of expertise that Pfizer-BioNTech could not have mastered in such a shortened timeline.  Specifically, the Cambridge-based biotechnology company is protecting its claims for “encod[ing] for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus.”

Now, Pfizer and BioNTech are fighting back, asserting that the claims in Moderna’s patents are “unimaginably broad” and cover a “basic idea that was known long before” Moderna filed provisional patents for mRNA technology in 2015.  They seek to cancel the patents and invalidate them as anticipated and obvious.

Generally, to obtain a patent in the U.S., the inventor must prove a new or novel product or process that was not obvious to the existing art in the field.  Only then does the inventor gain the right to exclude others from making, selling, using, or offering for sale the claimed invention.  Under 35 U.S.C. § 102, inventions must be novel over any prior art in every element of the claims in the patent application read with a broad, reasonable interpretation.  Under 35 U.S.C. § 103, obviousness is afforded when “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.”

Messenger RNA (mRNA) technology can be simplified and broken down into two distinct aspects: a delivery system and the coded mRNA.  The mRNA itself is no innovative piece of technology – it is a form of nucleic acids made in the body that produces a single-stranded RNA through the process of transcription.  It’s used in protein synthesis as an information carrier between DNA and a cell’s cytoplasm, where it’s translated and used to assemble amino acids into proteins.  Scientists are able to create synthetic mRNA to be used to prevent or treat diseases such as COVID-19.  The delivery system of mRNA mainly uses lipid nanoparticles (LNPs) and is the main focus of mRNA technology disputes, as multiple companies have filed patents for these delivery formulations.

Pfizer-BioNTech is bringing this fight to the PTAB, or the Patent Trial and Appeal Board.  While they mainly review ex parte appeals as to patentability, the PTAB will review petitions challenging an issued patent on the grounds of identified prior art showing anticipation or obviousness.  Pfizer and BioNTech are arguing that Moderna is basically trying to “coopt an entire field of mRNA technology.”   Pfizer-BioNTech’s petitions state that they had breakthroughs using mRNA for vaccines as early as 1990 and that Moderna’s patents are invalidated by pre-dated patent applications disclosing the use of mRNA for vaccines.  While Pfizer-BioNTech brings up the issue of disputed prior art, Moderna alleges that its rivals never had actually developed a vaccine using mRNA, and the LNP formulation was “the same or essentially the same” across both companies’ disputed patents.  Further, Pfizer-BioNTech brought four vaccine candidates for clinical testing but proceeded only with the mRNA vaccine, which showed signs of copied mRNA chemical modifications.

While it’s difficult to know how the PTAB will analyze the merits of the petition, it is hard to believe that the board would invalidate such high-profile patents as anticipated and obvious.  Though there are some skeptics who still discuss the vaccine’s rushed development and emergency approval, it’s harder to argue that the USPTO rushed a patent application and missed review of an entire sphere of technological development, especially one that had such a large spotlight on it during the pandemic.  The PTAB is usually a defendant’s alternative to fend off patent infringement claims, and it seems like a more compelling argument that Pfizer-BioNTech may be using this pathway as a last-ditch effort to stop Moderna’s district court case.

So, what does the next round have in store?  The infringement litigation currently ongoing in district court seems to be swaying towards Moderna coming out on top.  In early August, a district court judge interpreted four of five key terms in the patents at issue in Moderna’s favor.  However, if the PTAB concede Pfizer and BioNTech’s claims, it could mean that Moderna’s district court case be completely upended by the invalidation of their patents.  The petitions were filed on August 28, 2023, and are likely to be decided upon approximately six months from the filing date.

 

Student Bio: Jennifer Gomes is a second-year law student at Suffolk University Law School.  She is a staff writer for the Journal of High Technology Law.  Jennifer received a Bachelor’s of Science in Biomedical Engineering with a minor in Mechanical Engineering from Worcester Polytechnic Institute (WPI) in 2020.  Prior to law school, she worked in the biotechnology industry.

 

Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHTL or Suffolk University Law School.