The market for Covid-19 vaccines has proven to be larger than originally expected. (Photo: Bloomberg)
A legal battle is taking shape over lucrative patent rights for Covid-19 vaccines, with pharmaceutical companies facing each other and government and academic scientists over who invented what.
The U.S. government and Moderna Inc., whose collaboration led to one of the most widely used shots, have been battling over who discovered a key component and owns its rights.
Meanwhile, Pfizer Inc. and BioNTech SE, manufacturers of another leading vaccine, in a patent battle with a smaller company, and some analysts believe they may end up facing Moderna.
At the heart of the controversy: Who can claim to have invented important elements of the Covid-19 vaccines?
Hundreds of millions of dollars are at stake. If anyone succeeds in establishing a role in the discovery of the vaccines, Pfizer and Moderna would have to share with others a major cut in the tens of billions of dollars in vaccine sales generated.
“It’s scientific credit and money. It’s what people want,” said Jacob Sherkow, a professor specializing in biotechnological intellectual property at the University of Illinois College of Law. “This is a great biotechnological invention that is running on tens of billions of dollars.”
The new patent disputes cast a shadow over what has otherwise been a remarkable scientific, governmental and business achievement: the development of several effective Covid-19 vaccines at unprecedented speeds during a pandemic.
Whoever deserves credit for medical discoveries has long been a battleground for companies, academia and government. Patents are particularly valuable in the pharmaceutical industry because they can give a company the exclusive right to sell a drug or vaccine for many years without generic competition.
They can also be valuable to scientists – and the universities and government laboratories they work for – if a pharmaceutical company licenses a patent and pays royalties on sales.
Princeton University built a $ 278 million chemistry lab using royalties from the sale of Eli Lilly & Co.’s cancer drug Alimta, based on research from a university professor.
Yet the controversies can be difficult to resolve because they involve who gets the credit for complicated research that is often based on a series of iterative discoveries.
Patent litigation between several companies has previously erupted over lucrative new drug markets, such as treatments for hepatitis C in the mid-2010s.
The market for Covid-19 vaccines has proven to be larger than Wall Street originally expected. Pfizer and Moderna have set aside total sales of $ 35 billion in Covid-19 vaccine sales globally for the first nine months of 2021.
Analysts estimate that the two vaccines will have total sales of more than $ 52 billion by 2022, aided by demand for booster shots.
Pfizer, BioNTech and Moderna are already paying royalties on the sale of their vaccines because they rely in part on research conducted elsewhere.
Both BioNTech and Moderna have previously licensed patents on messenger RNA research conducted by researchers at the University of Pennsylvania, and BioNTech has licensed a federal government patent for which Pfizer is sublicensed.
Moderna paid out $ 400 million in royalties, including to companies that hold the rights to the Penn patents, on the sale of their Covid-19 vaccine in the first nine months of 2021.
A dispute stems from Moderna’s decision to reject a request from the National Institutes of Health to list government scientists as co-inventors on the company’s application for a U.S. patent covering a key component of its Covid-19 vaccine.
The patent would have claimed the invention of a genetic sequence incorporated into the Moderna vaccine to elicit an immune response against coronavirus.
The dispute was previously reported by New York Times.
Moderna worked with the NIH on vaccine research for some years before the new coronavirus appeared, and they collaborated to develop and test the Covid-19 vaccine shortly after the pandemic began.
Moderna said it has credited government researchers on other patent applications related to its vaccine, such as one that covers dosage, but government scientists did not help invent the genetic sequence used in the vaccine.
Moderna said only its researchers found the messenger RNA sequence, which instructs the body’s cells to make a version of the tip protein found on the surface of the coronavirus and triggers the immune response.
This month, Moderna dropped the patent application, saying it wanted to allow more time for discussions with the NIH with a view to an amicable settlement.
The NIH said it welcomed the opportunity to work with the company to resolve patent issues in a way that recognizes the contributions of NIH researchers.
Another dispute may arise over an NIH patent for a engineered version of the coronavirus tip protein.
The engineered tip protein helps a vaccine elicit a stronger immune response. Versions of the genetic sequence of the tip protein are found in mRNA vaccines, including Modernas and Pfizers.
Vaccine manufacturers, including Pfizer and partner BioNTech, obtained a license for the NIH patent, but Moderna has not.
As long as Moderna does not have a license, its vaccine violates the NIH patent, according to Christopher Morten, associate professor of clinical law at Columbia Law School, who researches biotech and other patents.
He has estimated that Moderna may be on the hook to pay more than $ 1 billion to the government for infringing the patent.
Moderna did not respond to a request for comment regarding the patent.
Both Pfizer and Moderna are already involved in patent fights with other companies in connection with their vaccines.
In October 2020, a small company in San Diego sued Allele Biotechnology & Pharmaceuticals, Pfizer and BioNTech, saying the companies used a protein in their vaccine test that violated an Allele patent.
Pfizer and BioNTech dispute the claim, and the lawsuit is pending.
Prior to the pandemic, Moderna initiated a U.S. patent authority proceeding to invalidate patents in Arbutus Biopharma Corp.
They claim the invention of certain nanoparticles, such as those found in Modernas Covid-19 vaccine, which help deliver a vaccine’s RNA inside human cells.
Moderna said it uses its own proprietary nanoparticles, which are not covered by the requirements of the Arbutus patents.
A Moderna loss could ultimately cause the company to pay royalties to Arbutus, according to some analysts.
On December 1, a U.S. Court of Appeals approved some of Arbutus’ patent claims. Arbutus and a partner company that licensed the patents said they are happy with the court’s decision.
Several patent cases may arise.
Last year, Moderna said it would not enforce patents related to their Covid-19 vaccine while the pandemic continued, but would seek to license its patents to other companies once the pandemic is over.
This prospect has left open the possibility that Moderna could file patent infringement lawsuits against other companies, including Pfizer and BioNTech, if they do not agree on licensing terms, according to some patent experts and Wall Street analysts.
A spokeswoman for Pfizer said the company does not expect intellectual property to be a barrier to the availability of their vaccine.
The Company expects that any desired third party licenses will be available on reasonable terms.