By Aparajita Lath
Final month, the patent battle between COVID-19 mRNA vaccine producers continued with BioNTech/Pfizer submitting a powerful protection and counter-claim to Moderna’s allegations of patent infringement.
Of their preliminary August 2022 criticism, Moderna alleged that three of its mRNA patents had been infringed by Pfizer/BioNTech. Apparently, as of January 12, 2023, Moderna has listed 10 patents overlaying Spikevax (its mRNA vaccine) on its web site. Since biotechnology innovations could be lined by a number of patents, every of which will not be simple to determine by way of public searches, the choice to publish a consolidated listing of patents is a transfer in the suitable path. Nevertheless, the listing is an evolving one, and, because it occurs, one among three patents at subject, i.e., patent no. 10,933,127 (‘127) has not been listed.
The next article explains the important thing patents at stake within the mental property dispute.
Moderna’s first infringement declare:
Patent no. ’574: By which Moderna claims unique rights to the 1-methyl-pseudouridine modification to mRNA (mRNA modification).
Pfizer/BioNTech’s response:
Pfizer and BioNTech declare that Moderna is misappropriating the exhausting work and impartial analysis carried out by a complete area of analysis within the years earlier than COVID-19 emerged.
Certainly, for the reason that Nineteen Seventies, scientists have acknowledged that mRNA can induce protein expression to deal with or stop illness in people. In mid-2000s, Drs. Katalini Kariko and Drew Weissman of the College of Pennsylvania made foundational discoveries that overcame crucial issues plaguing using mRNA in medication. They found that sure chemical modifications to mRNA (the 1-methyl-pseudouridine modification) and sure purification methods (high-performance liquid chromatography) might scale back harmful immune responses. In 2005, they revealed their analysis and insights in a sequence of analysis papers and likewise filed a patent utility disclosing this modification (which ultimately issued as patent no. 966).
This is similar modification that Moderna now claims unique rights over. Nevertheless, this discovery was made a lot earlier than Moderna’s patent utility and even earlier than Moderna was included.
The founders of Moderna had been conscious of Drs. Kariko and Weissman’s work and even lauded their discovery. Moderna additionally licensed their mRNA know-how from Cellscript LLC – College of Pennsylvania’s successor-in-interest to the 966 patent. As claimed, Moderna additionally discovered purification methods from Drs. Kario and Weissman.
Moderna’s different infringement claims:
Patent no. ’600: By which Moderna claims unique rights to mRNA encoding for the full-length spike protein in a lipid nanoparticle formulation (LNP) (full-length spike protein and LNP).
Patent no. ’127: By which Moderna claims unique rights to a way of administering mRNA encoding the full-length spike protein in an LNP formulation.
Pfizer/BioNTech’s response:
- Lipid nanoparticles: Lipid nanoparticles are particles that encase mRNA constructions for supply into cells. Pfizer and BioNTech declare that Moderna is making an attempt to take credit score for a broad discovery of lipid nanoparticles that it didn’t make. The parts and ratios of the LNP know-how utilized by Moderna declare to have been disclosed in a previous worldwide patent utility no. 2010/144740 and within the 966 patent. Moderna is at the moment being sued for patent infringement for using sure third social gathering LNP know-how.
- Encoding the full-length spike protein: BioNTech and Pfizer declare that the broad idea of encoding for the full-length spike protein was not a brand new discovery made by Moderna. By 2009, earlier than Moderna’s patent utility, scientists knew that the full-length spike protein is extremely immunogenic and can be utilized to induce safety in opposition to sure viruses.
Additional, Moderna’s patents are indefinite and over-broad, as they declare the full-length spike protein normally, with out disclosing an precise mRNA vaccine that encodes a SARS-CoV-2 protein.
BioNTech and Pfizer additionally declare that Moderna ignores the contributions of NIH scientists. It has been reported that NIH scientists had been those who found {that a} specific alteration of the sequence of the coronavirus spike protein stabilizes the spike protein and permits it for use by human cells to elicit an immune response.
The massive image: are Moderna’s patents even enforceable?
In October 2020, Moderna pledged to not implement its patents amid the continuing pandemic.
The corporate revoked its patent pledge on March 7, 2022, and the infringement declare in opposition to Pfizer/BioNTech got here shortly after. However, of their response, Pfizer and BioNTech allege that Moderna knew that the pandemic was not over even when revoking its pledge. As highlighted in Pfizer/BioNTech’s response, Moderna continued to make statements that “the battle’s nonetheless happening” as not too long ago as September 2022.
Because the pandemic is just not over, and since Moderna pledged to not implement its patents during the pandemic, BioNTech and Pfizer argue that Moderna has granted an implied license to 3rd events.
Extra broadly, BioNTech and Pfizer spotlight Moderna’s surreptitious conduct of acquiring its mRNA patents with out disclosing the federal government’s function in its funding and growth. Certainly, as made public, the U.S. authorities dedicated a couple of billion {dollars} to Moderna for growth of its COVID-19 vaccines. Moderna has since made over $30 billion in COVID-19 vaccine gross sales.
